The following data is part of a premarket notification filed by Osko, Inc. with the FDA for Smart Stitching Software System, Image Processing, Radiological.
| Device ID | K163048 |
| 510k Number | K163048 |
| Device Name: | Smart Stitching Software System, Image Processing, Radiological |
| Classification | System, Image Processing, Radiological |
| Applicant | OSKO, INC. 8085 NW 90TH ST Medley, FL 33166 |
| Contact | Richard Jeon |
| Correspondent | Dave Kim MTECH GROUP 8310 BUFFALO SPEEDWAY Houston, TX 77025 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-01 |
| Decision Date | 2017-07-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00869126000451 | K163048 | 000 |