The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Portable X-ray System, Model Powermax 1260.
| Device ID | K090655 |
| 510k Number | K090655 |
| Device Name: | PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 |
| Classification | System, X-ray, Mobile |
| 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 | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-11 |
| Decision Date | 2009-07-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868162000272 | K090655 | 000 |
| 00868162000265 | K090655 | 000 |