The following data is part of a premarket notification filed by Clarix Imaging with the FDA for Volumetric Specimen Imager.
| Device ID | K192939 |
| 510k Number | K192939 |
| Device Name: | Volumetric Specimen Imager |
| Classification | Cabinet, X-ray System |
| Applicant | Clarix Imaging 2242 Harrison St Suite 201 Chicago, IL 60612 |
| Contact | Xiao Han |
| Correspondent | Xiao Han Clarix Imaging 2242 Harrison St Suite 201 Chicago, IL 60612 |
| Product Code | MWP |
| CFR Regulation Number | 892.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-18 |
| Decision Date | 2019-12-27 |
| Summary: | summary |