FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
MODIFICATION TO FMRI HARDWARE SYSTEM
K Number: K092253
·
Decision Oct 8, 2009
Classifications
1
FEI Numbers
152
Registration Numbers
152
Same Product Code
1071
Applicant Total
6
Review Days
72
Basic Information
- Device Name
- MODIFICATION TO FMRI HARDWARE SYSTEM
- K Number
- K092253
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NORDICNEUROLAB
- Date Received
- July 28, 2009
- Decision Date
- October 8, 2009
- 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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Other Clearances by NORDICNEUROLAB
| K Number | Device Name | ||
|---|---|---|---|
| K140956 | LCD MONITOR | Aug 7, 2014 | Substantially Equivalent |
| K133910 | NORDICBRAINEX | Apr 4, 2014 | Substantially Equivalent |
| K123306 | NORDIC TUMOREX | May 20, 2013 | Substantially Equivalent |
| K080515 | FMRI HARDWARE SYSTEM | May 16, 2008 | Substantially Equivalent |
| K073099 | FMRI HARDWARE SYSTEM | Nov 20, 2007 | Substantially Equivalent |