FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MRGFUS PELVIC PA COIL MODEL 1.0
K Number: K111060
·
Decision Sep 9, 2011
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
1
Review Days
144
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Basic Information
- Device Name
- MRGFUS PELVIC PA COIL MODEL 1.0
- K Number
- K111060
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Insightech, Ltd.
- Date Received
- April 18, 2011
- Decision Date
- September 9, 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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