The following data is part of a premarket notification filed by Bioptics, Inc. with the FDA for Core Vision Digital Specimen Radiography (dsr) System.
| Device ID | K082432 |
| 510k Number | K082432 |
| Device Name: | CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
| Classification | Cabinet, X-ray System |
| Applicant | BIOPTICS, INC. 15546 W. GELDING DR. Surprise, AZ 85379 |
| Contact | Patricia Wade |
| Correspondent | Patricia Wade BIOPTICS, INC. 15546 W. GELDING DR. Surprise, AZ 85379 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-22 |
| Decision Date | 2008-11-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00857069006005 | K082432 | 000 |
| 00857069006272 | K082432 | 000 |
| 15420045514218 | K082432 | 000 |
| 15420045514898 | K082432 | 000 |
| 15420045516649 | K082432 | 000 |
| 15420045516625 | K082432 | 000 |