The following data is part of a premarket notification filed by Bioptics, Inc. with the FDA for 10 X 10 Vision.
| Device ID | K091928 |
| 510k Number | K091928 |
| Device Name: | 10 X 10 VISION |
| Classification | Cabinet, X-ray System |
| Applicant | BIOPTICS, INC. 3440 E BRITANNIA DR SUITE 150 Tucson, AZ 85743 |
| Contact | Akif Baysal |
| Correspondent | Akif Baysal BIOPTICS, INC. 3440 E BRITANNIA DR SUITE 150 Tucson, AZ 85743 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-30 |
| Decision Date | 2010-06-16 |
| Summary: | summary |