FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
MeVis Liver Suite
K Number: K232045
·
Decision Oct 27, 2023
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
6
Review Days
109
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Basic Information
- Device Name
- MeVis Liver Suite
- K Number
- K232045
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MeVis Medical Solutions AG
- Date Received
- July 10, 2023
- Decision Date
- October 27, 2023
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
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Other Clearances by MeVis Medical Solutions AG
| K Number | Device Name | ||
|---|---|---|---|
| K201501 | Veolity | Feb 23, 2021 | 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 |