FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
FERRISCAN R2-MRI ANALYSIS SYSTEM
K Number: DEN130012
·
Decision Jan 23, 2013
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- FERRISCAN R2-MRI ANALYSIS SYSTEM
- K Number
- DEN130012
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 892.1001
- Medical Specialty
- Radiology
- Decision
- Unknown
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Date Received
- January 2, 2013
- Decision Date
- January 23, 2013
- Product Code
- PCS
- 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 |
|---|---|---|---|
| PCS | Liver Iron Concentration Imaging Companion Diagnostic For Deferasirox | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (PCS), ordered by most recent decision date.
LiverSmart
FDA 510(k)
FDA Class 2
·Radiology
FerriSmart Analysis System
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Resonance Health Analysis Services Pty, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231459 | HepaFatSmart (V2.0.0) | Jun 20, 2023 | Substantially Equivalent |
| 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 |
| K111222 | MRI-Q SYSTEM | Jul 28, 2011 | Substantially Equivalent |