FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MRI-Q SYSTEM
K Number: K111222
·
Decision Jul 28, 2011
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
7
Review Days
87
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Basic Information
- Device Name
- MRI-Q SYSTEM
- K Number
- K111222
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Date Received
- May 2, 2011
- Decision Date
- July 28, 2011
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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|---|---|---|---|
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| K213776 | LiverSmart | Dec 29, 2021 | Substantially Equivalent |
| K201039 | HepaFat-AI | Dec 7, 2020 | Substantially Equivalent |
| K182218 | FerriSmart Analysis System | Nov 30, 2018 | Substantially Equivalent |
| K122035 | HEPAFAT SCAN | Dec 13, 2013 | Substantially Equivalent |
| DEN130012 | FERRISCAN R2-MRI ANALYSIS SYSTEM | Jan 23, 2013 | Unknown |