Digitizer, Image, Radiological
Regulation 892.2030
0510(k)s in 12 months (61 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in LMA
| Company | 510(k)s | Recalls |
|---|---|---|
| Vidar Systems Corp. | 10 | 0 |
| Lumisys, Inc. | 5 | 0 |
| Array Corp. | 3 | 0 |
| Eastman Kodak Company | 3 | 0 |
| Howtek, Inc. | 3 | 0 |
| Dba Systems, Inc. | 2 | 0 |
| General Scanning, Inc. | 2 | 0 |
| Konica Medical Corp. | 2 | 0 |
| Radiographic Digital Imaging, Inc. | 2 | 0 |
| Adaptive Video, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 25, 2019 | Brainlab AG Patient Data Manager, Model/Catalogue Numbers:
25100-09 - PATIENT DATA MANAGER 2.1.1LICENSE ONLY
25100-10 - PATIENT DATA MANAGER 2.2.0 LICENSE ONLY
25100-11 - PATIENT DATA MANAGER 2.2.1 LICENSE ONLY Terminated |
LMA | None listed |
| Aug 13, 2005 | Konica Medical Imaging, Inc. Regius-IM. The Regius Image Manager for Centralized workflow and improved image quality software. Terminated |
LMA | None listed |
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