FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
LiverSmart
K Number: K213776
·
Decision Dec 29, 2021
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
7
Review Days
27
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Basic Information
- Device Name
- LiverSmart
- K Number
- K213776
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.1001
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Date Received
- December 2, 2021
- Decision Date
- December 29, 2021
- 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.
FerriSmart Analysis System
FDA 510(k)
FDA Class 2
·Radiology
FERRISCAN R2-MRI 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 |
| 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 |
| K111222 | MRI-Q SYSTEM | Jul 28, 2011 | Substantially Equivalent |