FerriSmart v01
by Resonance Health Analysis Services Pty, Ltd.
FerriSmart v01 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 7 Jun 2024 (UDI-DI 09369998038619), 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 | Number09369998038619 | Date7 Jun 2024 | StatusListed |
| United States | FDA 510(k) | NumberK182218 | Date30 Nov 2018 | StatusActive |
Official records
- AccessGUDID record 09369998038619
- FDA 510(k) database K182218
Across registries
- FDA 510(k) K182218 decided 30 Nov 2018 Active
- FDA GUDID UDI-DI 09369998038619 listed 7 Jun 2024 Listed
Timeline
- Cleared FDA 510(k) K182218
- Listed FDA GUDID 09369998038619
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FerriSmart
- Generic name
- MRI system application software
- Model / reference
- v01
- Primary DI / UDI-DI
- 09369998038619
- 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
Similar devices in this category
Other devices filed under MRI system application software.
Other devices from Resonance Health Analysis Services Pty, Ltd.
See all devices from Resonance Health Analysis Services Pty, Ltd. →