The following data is part of a premarket notification filed by Philips Healthcare with the FDA for Lumify Ultrasound System.
| Device ID | K162549 |
| 510k Number | K162549 |
| Device Name: | Lumify Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Philips Healthcare 22100 Bothell Everett Highway Bothell, WA 98021 -8411 |
| Contact | Chuck Morreale |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | 2016-09-13 |
| Decision Date | 2016-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838086586 | K162549 | 000 |
| 00884838086579 | K162549 | 000 |
| 00884838086555 | K162549 | 000 |
| 00884838085947 | K162549 | 000 |
| 00884838085930 | K162549 | 000 |
| 00884838085183 | K162549 | 000 |
| 00884838085176 | K162549 | 000 |
| 00884838085169 | K162549 | 000 |
| 00884838074231 | K162549 | 000 |