FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEURO II-S
K Number: K050132
·
Decision Feb 15, 2005
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
2
Review Days
25
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Basic Information
- Device Name
- NEURO II-S
- K Number
- K050132
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Innovative Magnetic Resonance Imaging Systems, Inc.
- Date Received
- January 21, 2005
- Decision Date
- February 15, 2005
- 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 Innovative Magnetic Resonance Imaging Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002964 | NEURO II | Dec 19, 2000 | Substantially Equivalent |