FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
Veolity
K Number: K201501
·
Decision Feb 23, 2021
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
6
Review Days
263
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Basic Information
- Device Name
- Veolity
- K Number
- K201501
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MeVis Medical Solutions AG
- Date Received
- June 5, 2020
- Decision Date
- February 23, 2021
- Product Code
- OEB
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | FDA class 2 | Radiology |
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Other Clearances by MeVis Medical Solutions AG
| K Number | Device Name | ||
|---|---|---|---|
| K232045 | MeVis Liver Suite | Oct 27, 2023 | Substantially Equivalent |
| K120207 | VISIA | Apr 23, 2012 | Substantially Equivalent |
| K120484 | VISIA ONCOLOGY | Mar 27, 2012 | Substantially Equivalent |
| K113701 | VISIA NEURO | Feb 16, 2012 | Substantially Equivalent |
| K113337 | VISIA DYNAMIC REVIEW | Dec 30, 2011 | Substantially Equivalent |