The following data is part of a premarket notification filed by Source-ray, Inc. with the FDA for Uc-5000 Mobile X-ray.
| Device ID | K163063 |
| 510k Number | K163063 |
| Device Name: | UC-5000 Mobile X-Ray |
| Classification | System, X-ray, Mobile |
| Applicant | SOURCE-RAY, INC. 50 FLEETWOOD COURT Ronkonkoma, NY 11779 |
| Contact | Ray Manez |
| Correspondent | Daniel Kamm KAMM & ASSOCIATES 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | IZL |
| CFR Regulation Number | 892.1720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-02 |
| Decision Date | 2016-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00867538000304 | K163063 | 000 |