FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
K Number: K112112
·
Decision Aug 25, 2011
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
1
Review Days
31
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Basic Information
- Device Name
- SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS
- K Number
- K112112
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sentinel Medical, Inc.
- Date Received
- July 25, 2011
- Decision Date
- August 25, 2011
- Product Code
- MOS
- 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 |
|---|---|---|---|
| MOS | Coil, Magnetic Resonance, Specialty | FDA class 2 | Radiology |
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