The following data is part of a premarket notification filed by Osko, Inc. with the FDA for Diagnostic X-ray System.
| Device ID | K150663 |
| 510k Number | K150663 |
| Device Name: | Diagnostic X-ray System |
| Classification | System, X-ray, Stationary |
| Applicant | OSKO, INC. 7260 NW 58TH STREET Miami, FL 33166 |
| Contact | Wang Choi |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | KPR |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-16 |
| Decision Date | 2015-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869126000420 | K150663 | 000 |
| 00869126000468 | K150663 | 000 |