The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Scanx.
| Device ID | K013893 |
| 510k Number | K013893 |
| Device Name: | SCANX |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801 |
| Contact | Joseph Carey |
| Correspondent | Joseph Carey AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. Hicksville, NY 11801 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-02-01 |