The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Pxs-810, Podiatry X-ray System.
| Device ID | K071392 |
| 510k Number | K071392 |
| Device Name: | PXS-810, PODIATRY X-RAY SYSTEM |
| Classification | System, X-ray, Stationary |
| Applicant | SOURCE-RAY, INC. 167 KEYLAND CT. Bohemia, NY 11716 |
| Contact | Ray Manez |
| Correspondent | Ray Manez SOURCE-RAY, INC. 167 KEYLAND CT. Bohemia, NY 11716 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-18 |
| Decision Date | 2007-08-03 |