The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Scanx 14.
| Device ID | K042397 |
| 510k Number | K042397 |
| Device Name: | SCANX 14 |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. PO BOX 870 Hicksville, NY 11802 -0870 |
| Contact | Joseph Carey |
| Correspondent | Joseph Carey AIR TECHNIQUES, INC. 70 CANTIAGUE ROCK RD. PO BOX 870 Hicksville, NY 11802 -0870 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-02 |
| Decision Date | 2004-10-05 |