FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMRIS iMRI 3T V
K Number: K212367
·
Decision Aug 23, 2021
Classifications
1
FEI Numbers
146
Registration Numbers
146
Same Product Code
1098
Applicant Total
2
Review Days
24
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Basic Information
- Device Name
- IMRIS iMRI 3T V
- K Number
- K212367
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1000
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Deerfield Imaging, Inc.
- Date Received
- July 30, 2021
- Decision Date
- August 23, 2021
- Product Code
- LNH
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
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 Deerfield Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K240157 | InVision 1.5 Surgical Theatre | Feb 15, 2024 | Substantially Equivalent |