The following data is part of a premarket notification filed by Air Techniques, Inc. with the FDA for Scanx Touch/scanx Duo Touch.
| Device ID | K191623 |
| 510k Number | K191623 |
| Device Name: | ScanX Touch/ScanX Duo Touch |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | Air Techniques, Inc. 1295 Walt Whitman Road Melville, NY 11747 |
| Contact | Samir Ghevariya |
| Correspondent | Daniel Kamm Kamm & Associates 8870 Ravello Ct Naples, FL 34114 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-18 |
| Decision Date | 2019-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D678J12001 | K191623 | 000 |
| D67821701100011 | K191623 | 000 |