GE Medical Systems, LLC

Giraffe OmniBed Field Replaceable Unit (FRU), Model Numbers 6600-1056-400 and 6600-1461-500

GE Medical Systems, LLC

Giraffe OmniBed, a combination of an infant incubator and an infant warmer, All Models

GE Medical Systems, LLC

Giraffe OmniBed Carestations and Giraffe OmniBed Carestation CS1, a combination of an infant incubator and an infant war

GE Medical Systems, LLC

Allia IGS 3 Pulse angiographic X-ray system

GE Medical Systems, LLC

Allia IGS Pulse angiographic X-ray system

GE Medical Systems, LLC

Allia Moveo angiographic X-ray system

GE Medical Systems, LLC

Allia IGS 5 Pulse angiographic X-ray system

GE Medical Systems, LLC

Allia IGS 7 Pulse angiographic X-ray system

GE Medical Systems, LLC

Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15

GE Medical Systems, LLC

Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300

GE Medical Systems, LLC

Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27

GE Medical Systems, LLC

Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23

GE Medical Systems, LLC

Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20

GE Medical Systems, LLC

Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25

GE Medical Systems, LLC

Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6

GE Medical Systems, LLC

Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E8

GE Medical Systems, LLC

Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that displays medical images (including

GE Medical Systems, LLC

Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that displays medical images (inclu

GE Medical Systems, LLC

Centricity Universal Viewer Software Versions 7.0 through 7.0 Sp2.0.1, a device that displays medical images (including

GE Medical Systems, LLC

Photonova Spectra, Photonova Spectra Select

Ge Medical Systems, LLC

SIGNA™ Bolt

Ge Medical Systems, LLC

SIGNA™ Sprint Select

Ge Medical Systems, LLC

AIR Recon DL

Ge Medical Systems, LLC

Senographe Pristina, Pristina Serena, and Pristina Serena 3D. for screening and diagnostic mammography

GE Medical Systems, LLC

MAC VU360 Acquisition Trunk Cable and Module Holder, high performance, multichannel resting electrocardiograph, Model Nu

GE Medical Systems, LLC

LOGIQ P10 R4.5 HD ultrasound system with system software version R4.5.7., Model Number 5877535

GE Medical Systems, LLC

LOGIQ P9 R4.5 ultrasound system with system software version R4.5.7., Model Number 5877533

GE Medical Systems, LLC

LOGIQ P10 series with software version R4.5.7 Model Number 5877534

GE Medical Systems, LLC

SIGNA™ Sprint

Ge Medical Systems, LLC

GE HealthCare OEC 9900 Elite C-arm Systems.

GE Medical Systems, LLC

GE HealthCare OEC 9800.

GE Medical Systems, LLC

GE Signa Artist, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Premier Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Premier XT (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE Signa Voyager, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE Discovery MR750 3.0T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE Discovery MR450 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Hero XT (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Artist Evo, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA PET/MR AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA PET/MR, Tomographic Imager Combining Emission Computed Tomography with Nuclear Magnetic Resonance

GE Medical Systems, LLC

GE SIGNA Hero Elite (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Voyager AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA PET/MR AIR Plus (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Hero MAX (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Architect AIR (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Premier MAX (China Only), Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Architect, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE Discovery MR750w 3.0T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Premier, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE Optima MR450w 1.5T, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA UHP, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

GE SIGNA Hero, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Revolution Vibe

Ge Medical Systems, LLC

SIGNA Architect

GE Medical Systems, LLC

SIGNA Architect AIR

GE Medical Systems, LLC

SIGNA PET/MR

GE Medical Systems, LLC

Discovery MR750w 3.0T

GE Medical Systems, LLC

OEC Elite: The OEC Elite mobile C-arm is intended to provide fluoroscopic and digital spot images of the patient anatomy

GE Medical Systems, LLC

OEC 3D

GE Medical Systems, LLC

Sonic DL

Ge Medical Systems, LLC

Venue Go Models: R2 (Model Number H45181VG), R3 (Model Number H45193VG), R4 (Model Number H45114VG), R5 (Model Numbers H

GE Medical Systems, LLC

Venue Fit Models: R3 (Model Number H45303VFSC, H45303VFSW), R4 (Model Number H45314VFS, H45314VFSW), Venue Fit R5 system

GE Medical Systems, LLC

GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution CT, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed

GE Medical Systems, LLC

SIGNA Prime Elite

Ge Medical Systems, LLC

Optima XR646 HD. X-Ray imaging system.

GE Medical Systems, LLC

Definium 656HD & Discovery XR656HD (GTINs: 00840682138598, 00195278840226, 00840682136709). X-Ray imaging system.

GE Medical Systems, LLC

Discovery XR656 HD. X-Ray imaging system.

GE Medical Systems, LLC

Discovery XR656HD. X-Ray imaging system.

GE Medical Systems, LLC

Portrait Core Services, a set of software services that enable the communication and interaction of the Portrait Mobile

GE Medical Systems, LLC

Tec 820 ISO Anesthesia Vaporizer, Reference Number 1177-9820-ISO

GE Medical Systems, LLC

Tec 850 SEV Anesthesia Vaporizer, Reference Number 1177-9850-SEV

GE Medical Systems, LLC

GE Healthcare Optima XR220amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-12; 2) 5555000-5; 3)

GE Medical Systems, LLC

GE Healthcare Optima XR200amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-3; 2) 5555000-4: 3)

GE Medical Systems, LLC

GE Healthcare Optima XR240amx, Mobile Digital Radiographic System, Model Numbers: 1) 5555000-27; 2) 5555000-31; 3

GE Medical Systems, LLC

Tec 6 Plus Anesthesia Vaporizer, Reference Numbers 1107-9601-000, 1107-9602-000, 1107-9603-000, 1107-9604-000, 1107-9610

GE Medical Systems, LLC

Tec 850 ISO Anesthesia Vaporizer, Reference Number 1177-9850-ISO

GE Medical Systems, LLC

Tec 820 SEV Anesthesia Vaporizer, Reference Number 1177-9820-SEV

GE Medical Systems, LLC

SIGNA Architect AIR, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Discovery MR750w 3.0T, whole body magnetic resonance scanner

GE Medical Systems, LLC

SIGNA Architect, Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance: 1) SIGNA PET/MR, 2) DISCOVER

GE Medical Systems, LLC

SIGNA MAGNUS

Ge Medical Systems, LLC

SIGNA Explorer, with affected software versions: SV25.5, SV25.6, SV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Ima

GE Medical Systems, LLC

SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1,

GE Medical Systems, LLC

SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emi

GE Medical Systems, LLC

Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imagi

GE Medical Systems, LLC

SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magne

GE Medical Systems, LLC

Optima MR360, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging Syste

GE Medical Systems, LLC

SIGNA UHP, with affected software versions: RX28.0, MR30.1; Nuclear Magnetic Resonance Imaging System - research use on

GE Medical Systems, LLC

SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Ma

GE Medical Systems, LLC

SIGNA Creator, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nucle

GE Medical Systems, LLC

Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1

GE Medical Systems, LLC

SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

3.0T SIGNA HDxt Family, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1HD16

GE Medical Systems, LLC

SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

Discovery MR950, with affected software versions: 7T23.0; Nuclear Magnetic Resonance Imaging System - research use only

GE Medical Systems, LLC

SIGNA Artist, with affected software versions: DV26.0, DV27.1, DV28.1, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonan

GE Medical Systems, LLC

SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

SIGNA Premier, with affected software versions: RX27.0 to RX27.3, RX28.0, RX29.0 to RX29.2, MR30.0, MR30.1; Nuclear Mag

GE Medical Systems, LLC

SIGNA MAGNUS, with affected software versions: MR29.1, RX29.1; Nuclear Magnetic Resonance Imaging System - research use

GE Medical Systems, LLC

1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30

GE Medical Systems, LLC

SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

SIGNA Pioneer, with affected software versions: PX25.0 to PX25.5, PX26.0, PX26.1, PX28.0 to PX28.4, PX29.0, PX29.1, MR3

GE Medical Systems, LLC

Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.

GE Medical Systems, LLC

Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System

GE Medical Systems, LLC

ECG-less Cardiac

Ge Medical Systems, LLC

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

Ge Medical Systems, LLC

Auto Segmentation

Ge Medical Systems, LLC

Spectral Bone Marrow

Ge Medical Systems, LLC

Vivid S6 ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O

GE Medical Systems, LLC

Vivid S5 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina

GE Medical Systems, LLC

Vivid S5 Ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small O

GE Medical Systems, LLC

Vivid i ultrasound. Marketed under the following 510(k) numbers: K033139, K061525, K082374, K092140, K102388, K121062).

GE Medical Systems, LLC

B105P Patient Monitor (with E-module slot option), REF 6160000-001-XXXXXX,

GE Medical Systems, LLC

B125M Patient Monitor, REF 6160000-004-XXXXXX

GE Medical Systems, LLC

Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and data from various imagin

GE Medical Systems, LLC

Vivid q ultrasound. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal/GYN; Pediatric; Small Or

GE Medical Systems, LLC

Vivid q N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomin

GE Medical Systems, LLC

B125P Patient Monitor (with E-module slot option), REF 6160000-002

GE Medical Systems, LLC

B105M Patient Monitor, REF 6160000-003

GE Medical Systems, LLC

Vivid S6 N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdomina

GE Medical Systems, LLC

Vivid i N ultrasound. Not marketed in the US. Used in ultrasound imaging and analysis in Fetal/Obstetrics; Abdominal

GE Medical Systems, LLC

B125M Patient Monitor, REF 6160000-005-XXXXXXX

GE Medical Systems, LLC

Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Including mammograms) and dat

GE Medical Systems, LLC

Deep Learning Image Reconstruction

Ge Medical Systems, LLC

SIGNA PET/MR

Ge Medical Systems, LLC

Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Re

Ge Medical Systems, LLC

Discovery MI Gen2

Ge Medical Systems, LLC