FERRISCAN R2-MRI ANALYSIS SYSTEM
FDA 510(k) clearance DEN130012 · decided 2013-01-23
Clearance details
- K-number
- DEN130012
- Device name
- FERRISCAN R2-MRI ANALYSIS SYSTEM
- Applicant
- Resonance Health Analysis Services Pty, Ltd.
- Decision
- Unknown
- Date received
- 2013-01-02
- Decision date
- 2013-01-23
- Days to decision
- 21 days
- Clearance type
- Direct
- Product code
- PCS
- Device class
- 2
- Regulation number
- 892.1001
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Irvine, CA, US
- 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 |
|---|---|---|
| LiverSmart (K213776) | Resonance Health Analysis Services Pty, Ltd. | 2021-12-29 |
| FerriSmart Analysis System (K182218) | Resonance Health Analysis Services Pty, Ltd. | 2018-11-30 |
Recalls involving this device
No recalls on record reference this clearance.