The following data is part of a premarket notification filed by Bioptics, Inc. with the FDA for Pixarray 100 Digital Specimen Radiography (dsr) System.
| Device ID | K052433 |
| 510k Number | K052433 |
| Device Name: | PIXARRAY 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
| Classification | Cabinet, X-ray System |
| Applicant | BIOPTICS, INC. 3496 S. DODGE BLVD., SUITE 110 Tucson, AZ 85713 |
| Contact | Jeffrey Orach |
| Correspondent | Jeffrey Orach BIOPTICS, INC. 3496 S. DODGE BLVD., SUITE 110 Tucson, AZ 85713 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-06 |
| Decision Date | 2005-10-18 |
| Summary: | summary |