EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Summary
Philips Medical Systems received 510(k) clearance for EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System, a IYN device. Cleared on 2021-09-08.
Details
Source
510(k) Clearance
External ID
K211597
Action Date
2021-09-08
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 Medical Systems has received 2 total clearances in our database.
Philips Medical Systems has 10 FDA actions in our database, including 8 recalls and 2 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 Medical Systems have FDA actions?
Philips Medical Systems has 10 FDA actions in our database, including 8 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K211597" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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