The following data is part of a premarket notification filed by Applied X-ray Technologies, Inc. with the FDA for Axt 1400 Spotfilm Device.
| Device ID | K942367 |
| 510k Number | K942367 |
| Device Name: | AXT 1400 SPOTFILM DEVICE |
| Classification | Device, Spot-film |
| Applicant | APPLIED X-RAY TECHNOLOGIES, INC. 2727 WEST 92ND AVE., SUITE 10 Denver, CO 80221 |
| Contact | Howard Thomas |
| Correspondent | Howard Thomas APPLIED X-RAY TECHNOLOGIES, INC. 2727 WEST 92ND AVE., SUITE 10 Denver, CO 80221 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-05-18 |
| Decision Date | 1994-06-06 |