The following data is part of a premarket notification filed by Osko, Inc. with the FDA for Edge Digital Flat Panel X-ray Detector.
| Device ID | K172682 |
| 510k Number | K172682 |
| Device Name: | Edge Digital Flat Panel X-ray Detector |
| Classification | Solid State X-ray Imager (flat Panel/digital Imager) |
| Applicant | Osko, Inc. 8085 NW 90 Street Miami, FL 33166 |
| Contact | Richard Jeon |
| Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
| Product Code | MQB |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-06 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869126000437 | K172682 | 000 |