The following data is part of a premarket notification filed by Imaging Biometrics, Llc with the FDA for Stonechecker.
| Device ID | K191530 |
| 510k Number | K191530 |
| Device Name: | StoneChecker |
| Classification | System, Image Processing, Radiological |
| Applicant | Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove, WI 53122 |
| Contact | Timothy Dondlinger |
| Correspondent | Timothy Dondlinger Imaging Biometrics, LLC 13416 Watertown Plank Road, Suite 260 Elm Grove, WI 53122 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-10 |
| Decision Date | 2019-09-26 |
| Summary: | summary |