FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
K Number: K101813
·
Decision Oct 5, 2010
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
14
Review Days
98
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Basic Information
- Device Name
- IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO
- K Number
- K101813
- 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
- June 29, 2010
- Decision Date
- October 5, 2010
- 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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| K103493 | HEAD FIATION DEVICE (HFD 100) | Mar 11, 2011 | Substantially Equivalent |
| K103506 | 1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300) | Feb 2, 2011 | Substantially Equivalent |
| K091166 | IMRX | Sep 2, 2009 | Substantially Equivalent |