The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Scanx D5000 Series Scanner Model: D5000-f, D5000-fb, D5000-fvb, D5000-q, D5000-qb.
| Device ID | K101289 |
| 510k Number | K101289 |
| Device Name: | SCANX D5000 SERIES SCANNER MODEL: D5000-F, D5000-FB, D5000-FVB, D5000-Q, D5000-QB |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. Melville, NY 11747 |
| Contact | Pablo Martinez |
| Correspondent | Pablo Martinez AIR TECHNIQUES, INC. 1295 WALT WHITMAN RD. Melville, NY 11747 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-07 |
| Decision Date | 2010-08-03 |
| Summary: | summary |