FerriSmart v2.2.4
by Resonance Health Analysis Services Pty, Ltd.
FerriSmart v2.2.4 is a Class II device made by Resonance Health Analysis Services Pty, Ltd., cleared under FDA 510(k) K182218 on 30 Nov 2018 and listed in FDA GUDID since 6 Jun 2024 (UDI-DI 09355529000057), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number09355529000057 | Date6 Jun 2024 | StatusListed |
| United States | FDA 510(k) | NumberK182218 | Date30 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 09355529000057
- FDA 510(k) database K182218
Across registries
- FDA 510(k) K182218 decided 30 Nov 2018 Active
- FDA GUDID UDI-DI 09355529000057 listed 6 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K182218
- Listed FDA GUDID 09355529000057
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FerriSmart
- Generic name
- MRI system application software
- Model / Ref / Catalog
- v2.2.4
- Primary DI / UDI-DI
- 09355529000057
- 510(k) Number
- FDA product code
- PCS
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.1001
- GUDID distribution status
- In Commercial Distribution
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