The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Podiatry X-ray System.
| Device ID | K133959 |
| 510k Number | K133959 |
| Device Name: | PODIATRY X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | SOURCE-RAY, INC. 50 Fleetwood Ct Ronkonkoma, NY 11779 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm SOURCE-RAY, INC. 50 Fleetwood Ct Ronkonkoma, NY 11779 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-24 |
| Decision Date | 2015-01-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817100020148 | K133959 | 000 |
| 00868162000296 | K133959 | 000 |