The following data is part of a premarket notification filed by Avant Medical Systems with the FDA for Model Hf-50r Computer Controlled X-ray System.
| Device ID | K052541 |
| 510k Number | K052541 |
| Device Name: | MODEL HF-50R COMPUTER CONTROLLED X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | AVANT MEDICAL SYSTEMS PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm AVANT MEDICAL SYSTEMS PO BOX 7007 Deerfield, IL 60015 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-15 |
| Decision Date | 2005-11-03 |
| Summary: | summary |