LiverSmart
FDA 510(k) clearance K213776 · decided 2021-12-29
Clearance details
- K-number
- K213776
- Device name
- LiverSmart
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-12-02
- Decision date
- 2021-12-29
- Days to decision
- 27 days
- Clearance type
- Special
- Product code
- PCS
- Device class
- 2
- Regulation number
- 892.1001
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Perth, AU
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FerriSmart Analysis System (K182218) | Resonance Health Analysis Services Pty, Ltd. | 2018-11-30 |
| FERRISCAN R2-MRI ANALYSIS SYSTEM (DEN130012) | Resonance Health Analysis Services Pty, Ltd. | 2013-01-23 |
Recalls involving this device
No recalls on record reference this clearance.