EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Summary
Philips Ultrasound, LLC received 510(k) clearance for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, a IYN device. Cleared on 2024-02-13.
Details
Source
510(k) Clearance
External ID
K233788
Action Date
2024-02-13
Status
Traditional
Category
device
Product Code
IYN
Product Description
EPIQ Series Diagnostic Ultrasound System, Affiniti Series 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. Philips Ultrasound, LLC has received 22 total clearances in our database.
Philips Ultrasound, LLC has 24 FDA actions in our database, including 2 recalls and 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 Philips Ultrasound, LLC have FDA actions?
Philips Ultrasound, LLC has 24 FDA actions in our database, including 2 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K233788" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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