The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Visiq Diagnostic Ultra Sound System.
| Device ID | K141369 |
| 510k Number | K141369 |
| Device Name: | VISIQ DIAGNOSTIC ULTRA SOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 |
| Contact | Saraswathi Deora |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2014-05-23 |
| Decision Date | 2014-07-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068148 | K141369 | 000 |
| 00884838051133 | K141369 | 000 |