The following data is part of a premarket notification filed by Roche Medical Electronics, Inc. with the FDA for Roche Axiscan 5.
| Device ID | K771816 |
| 510k Number | K771816 |
| Device Name: | ROCHE AXISCAN 5 |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | ROCHE MEDICAL ELECTRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-09-27 |
| Decision Date | 1977-10-19 |