The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, Cx50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System.
| Device ID | K201012 |
| 510k Number | K201012 |
| Device Name: | EPIQ Diagnostic Ultrasound System Series, Affiniti Diagnostic Ultrasound System Series, CX50 Diagnostic Ultrasound System, Sparq Diagnostic Ultrasound System, Lumify Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Contact | Deep Pal |
| Correspondent | Deep Pal Philips Ultrasound, Inc. 22100 Bothell Everett Highway Bothell, WA 98021 -8431 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | QIH |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-17 |
| Decision Date | 2020-05-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838101043 | K201012 | 000 |
| 00884838098015 | K201012 | 000 |
| 00884838097971 | K201012 | 000 |