FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISIA ONCOLOGY
K Number: K120484
·
Decision Mar 27, 2012
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
6
Review Days
39
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Basic Information
- Device Name
- VISIA ONCOLOGY
- K Number
- K120484
- 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
- February 17, 2012
- Decision Date
- March 27, 2012
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 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 |
| K201501 | Veolity | Feb 23, 2021 | Substantially Equivalent |
| K120207 | VISIA | Apr 23, 2012 | Substantially Equivalent |
| K113701 | VISIA NEURO | Feb 16, 2012 | Substantially Equivalent |
| K113337 | VISIA DYNAMIC REVIEW | Dec 30, 2011 | Substantially Equivalent |