The following data is part of a premarket notification filed by Applied X-ray Technologies, Inc. with the FDA for A.x.t. Spotfilm Device.
| Device ID | K882492 |
| 510k Number | K882492 |
| Device Name: | A.X.T. SPOTFILM DEVICE |
| Classification | Device, Spot-film |
| Applicant | APPLIED X-RAY TECHNOLOGIES, INC. 10470 N. KING CIR Westminster, CO 80030 |
| Contact | Howard C Thomas |
| Correspondent | Howard C Thomas APPLIED X-RAY TECHNOLOGIES, INC. 10470 N. KING CIR Westminster, CO 80030 |
| Product Code | IXL |
| CFR Regulation Number | 892.1670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-16 |
| Decision Date | 1988-07-21 |