FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Scenium
K Number: K150192
·
Decision Mar 29, 2015
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
60
Basic Information
- Device Name
- Scenium
- K Number
- K150192
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SIEMENS MEDICAL SOLUTIONS USA, INC
- Date Received
- January 28, 2015
- Decision Date
- March 29, 2015
- 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 SIEMENS MEDICAL SOLUTIONS USA, INC
| K Number | Device Name | ||
|---|---|---|---|
| K163252 | Mammomat Fusion with Stereotactic Biopsy | Jan 10, 2017 | Substantially Equivalent |
| K162541 | syngo Application Software | Nov 16, 2016 | Substantially Equivalent |
| K162339 | Scenium | Sep 21, 2016 | Substantially Equivalent |
| K151192 | syngo.via MI Workflows | Jun 23, 2015 | Substantially Equivalent |