FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇪 Sweden
SyMRI
K Number: K162943
·
Decision Aug 29, 2017
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
6
Review Days
312
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Basic Information
- Device Name
- SyMRI
- K Number
- K162943
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntheticmr AB
- Date Received
- October 21, 2016
- Decision Date
- August 29, 2017
- Product Code
- LNH
- 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 |
|---|---|---|---|
| LNH | System, Nuclear Magnetic Resonance Imaging | FDA class 2 | Radiology |
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