The following data is part of a premarket notification filed by Onlume Inc. with the FDA for Asimov-mks Imaging System.
| Device ID | K192761 |
| 510k Number | K192761 |
| Device Name: | Asimov-MKS Imaging System |
| Classification | System, X-ray, Angiographic |
| Applicant | OnLume Inc. 3300 Commercial Ave Madison, WI 53714 |
| Contact | Greg Bange |
| Correspondent | Greg Bange OnLume Inc. 3300 Commercial Ave Madison, WI 53714 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-30 |
| Decision Date | 2020-01-17 |