The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Optional Remote Control, Model Rc-115, For Portable X-ray System, Model Sr-115.
| Device ID | K062472 |
| 510k Number | K062472 |
| Device Name: | OPTIONAL REMOTE CONTROL, MODEL RC-115, FOR PORTABLE X-RAY SYSTEM, MODEL SR-115 |
| 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 | 2006-08-24 |
| Decision Date | 2006-10-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868162000289 | K062472 | 000 |