The following data is part of a premarket notification filed by Ascend Hit with the FDA for Ascend Image Viewer.
| Device ID | K192372 |
| 510k Number | K192372 |
| Device Name: | ASCEND Image Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | Ascend Hit 801 Warrenville Road Ste 200 Lisle, IL 60532 |
| Contact | Andy Miller |
| Correspondent | Andy Miller Ascend Hit 801 Warrenville Road Ste 200 Lisle, IL 60532 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-30 |
| Decision Date | 2020-02-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860006348021 | K192372 | 000 |
| 00860006348014 | K192372 | 000 |