The following data is part of a premarket notification filed by Applied X-ray Technologies, Inc. with the FDA for Axt 150m Manual Collimator (axt 150m).
| Device ID | K972966 |
| 510k Number | K972966 |
| Device Name: | AXT 150M MANUAL COLLIMATOR (AXT 150M) |
| Classification | Collimator, Manual, Radiographic |
| Applicant | APPLIED X-RAY TECHNOLOGIES, INC. 2727 WEST 92ND AVE., SUITE 10 Denver, CO 80221 |
| Contact | Howard C Thomas |
| Correspondent | Howard C Thomas APPLIED X-RAY TECHNOLOGIES, INC. 2727 WEST 92ND AVE., SUITE 10 Denver, CO 80221 |
| Product Code | IZX |
| CFR Regulation Number | 892.1610 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-11 |
| Decision Date | 1997-08-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850077007194 | K972966 | 000 |
| 00850077007279 | K972966 | 000 |
| 00850077007002 | K972966 | 000 |
| 00850077007019 | K972966 | 000 |
| 00850077007026 | K972966 | 000 |
| 00850077007033 | K972966 | 000 |
| 00850077007057 | K972966 | 000 |
| 00850077007064 | K972966 | 000 |
| 00850077007132 | K972966 | 000 |
| 00850077007149 | K972966 | 000 |
| 00850077007156 | K972966 | 000 |
| 00850077007187 | K972966 | 000 |
| 00850077007286 | K972966 | 000 |