Submission Details
| 510(k) Number | K211597 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 24, 2021 |
| Decision Date | September 08, 2021 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
Sep 2021
Decision
107d
Days
Class 2
Risk
About This 510(k) Submission
K211597 is an FDA 510(k) clearance for the EPIQ Series Diagnostic Ultrasound System, Affiniti Series 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 8, 2021, 107 days after receiving the submission on May 24, 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
Similar Devices — IYN System, Imaging, Pulsed Doppler, Ultrasonic
All 1150
K260595 · FUJIFILM Sonosite, Inc.
· Mar 2026
K253049 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
· Feb 2026
K253597 · Canon Medical Systems Corporation
· Jan 2026
K253370 · GE Medical Systems Ultrasound and Primary Care Diagnostics
· Jan 2026
K253366 · GE Medical Systems Ultrasound and Primary Care Diagnostics
· Jan 2026
K252018 · Samsung Medison Co., Ltd.
· Jan 2026
More from Philips Medical Systems
View all
K212704
· IYN · Sep 2021
K210560
· DPS · Jun 2021
K191738
· DPS · Sep 2020
K192875
· DRG · Apr 2020
K183387
· MHX · Aug 2019