Submission Details
| 510(k) Number | K212704 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 26, 2021 |
| Decision Date | September 24, 2021 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
Sep 2021
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K212704 is an FDA 510(k) clearance for the Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System, a System, Imaging, Pulsed Doppler, Ultrasonic (Class II — Special Controls, product code IYN), submitted by Philips Medical Systems (Bothell, US). The FDA issued a Cleared decision on September 24, 2021, 29 days after receiving the submission on August 26, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1550.
Device Classification
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1550 |
Manufacturer
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