The following data is part of a premarket notification filed by The Prometheus Group with the FDA for Morpheus Realtime Ultrasound, Pathway Realtime Ultrasound, Quickscan Bladder Ultrasound.
| Device ID | K160792 |
| 510k Number | K160792 |
| Device Name: | Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover, NH 03820 |
| Contact | Joshua Bird |
| Correspondent | Joshua Bird THE PROMETHEUS GROUP 1 WASHINGTON STREET SUITE 303 Dover, NH 03820 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-23 |
| Decision Date | 2016-04-15 |
| Summary: | summary |