HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R
Summary
Samsung Medison Co., Ltd. received 510(k) clearance for HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System, a IYN device. Cleared on 2026-01-05.
Details
Source
510(k) Clearance
External ID
K252018
Action Date
2026-01-05
Status
Traditional
Category
device
Product Code
IYN
Product Description
HERA Z20 Diagnostic Ultrasound System; HERA Z20e Diagnostic Ultrasound System; HERA Z20s Diagnostic Ultrasound System; R20 Diagnostic Ultrasound System; HERA Z30 Diagnostic Ultrasound System; R30 Diagnostic Ultrasound System. Product code: IYN.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month. Samsung Medison Co., Ltd. has received 22 total clearances in our database.
Samsung Medison Co., Ltd. has 22 FDA actions in our database, including 22 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Samsung Medison Co., Ltd. have FDA actions?
Samsung Medison Co., Ltd. has 22 FDA actions in our database, including 0 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K252018" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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