The following data is part of a premarket notification filed by Bioptics, Inc. with the FDA for Biovision Digital Specimen Radiography System.
| Device ID | K091558 |
| 510k Number | K091558 |
| Device Name: | BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM |
| Classification | Cabinet, X-ray System |
| Applicant | BIOPTICS, INC. 3440 E BRITANNIA DR SUITE 150 Tucson, AZ 85743 |
| Contact | Carlos Reyes |
| Correspondent | Carlos Reyes 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 | 2009-05-28 |
| Decision Date | 2009-07-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857069006036 | K091558 | 000 |
| 00857069006029 | K091558 | 000 |
| 00857069006012 | K091558 | 000 |
| 00857069006265 | K091558 | 000 |