Veolity
Lung Computed Tomography System, Computer-aided Detection
MeVis Medical Solutions AG
The following data is part of a premarket notification filed by Mevis Medical Solutions Ag with the FDA for Veolity.
Pre-market Notification Details
| Device ID | K201501 |
| 510k Number | K201501 |
| Device Name: | Veolity |
| Classification | Lung Computed Tomography System, Computer-aided Detection |
| Applicant | MeVis Medical Solutions AG Caroline-Herschel-Strasse 1 Bremen, DE 28359 |
| Contact | Rolf Rzodeczko |
| Correspondent | Rolf Rzodeczko MeVis Medical Solutions AG Caroline-Herschel-Strasse 1 Bremen, DE 28359 |
| Product Code | OEB |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2021-02-23 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04260483290183 | K201501 | 000 |
| 04260483290176 | K201501 | 000 |
Trademark Results [Veolity]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VEOLITY 79154190 4774779 Live/Registered |
MeVis Medical Solutions AG 2014-06-17 |
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