The following data is part of a premarket notification filed by Biovision, Inc. with the FDA for B-scan Opthalmic Ultrasound Imaging System.
| Device ID | K926251 |
| 510k Number | K926251 |
| Device Name: | B-SCAN OPTHALMIC ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | BIOVISION, INC. B.P. 11 63114 COUDES France, FR |
| Contact | William D Sterling |
| Correspondent | William D Sterling BIOVISION, INC. B.P. 11 63114 COUDES France, FR |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-14 |
| Decision Date | 1993-09-14 |