FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
K Number: K103506
·
Decision Feb 2, 2011
Classifications
1
FEI Numbers
75
Registration Numbers
75
Same Product Code
487
Applicant Total
14
Review Days
65
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Basic Information
- Device Name
- 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)
- K Number
- K103506
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Imris, Inc.
- Date Received
- November 29, 2010
- Decision Date
- February 2, 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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