suiteHEART 4.0.1
by Neosoft, LLC
suiteHEART 4.0.1 is a Class II device made by Neosoft, LLC, cleared under FDA 510(k) K130228 on 20 Mar 2013 and listed in FDA GUDID since 24 Jan 2017 (UDI-DI 00864747000224), active (FDA 510(k)), not in commercial distribution (GUDID) as of 22 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 | Number00864747000224 | Date24 Jan 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130228 | Date20 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 00864747000224
- FDA 510(k) database K130228
Across registries
- FDA 510(k) K130228 decided 20 Mar 2013 Active
- FDA GUDID UDI-DI 00864747000224 listed 24 Jan 2017 Listed
Timeline
- Cleared FDA 510(k) K130228
- Listed FDA GUDID 00864747000224
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- suiteHEART
- Generic name
- MRI system application software
- Model / reference
- 4.0.1
- Primary DI / UDI-DI
- 00864747000224
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- MRI system application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- Not in Commercial Distribution
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