FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Synapse 3D Perfusion Analysis
K Number: K162287
·
Decision Apr 6, 2017
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
20
Review Days
234
Basic Information
- Device Name
- Synapse 3D Perfusion Analysis
- K Number
- K162287
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
- Date Received
- August 15, 2016
- Decision Date
- April 6, 2017
- 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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