suiteHEART 3.0.1
by Neosoft, LLC
suiteHEART 3.0.1 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 23 May 2016 (UDI-DI 00864747000200), 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 | Number00864747000200 | Date23 May 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK130228 | Date20 Mar 2013 | StatusActive |
Official records
- AccessGUDID record 00864747000200
- FDA 510(k) database K130228
Across registries
- FDA 510(k) K130228 decided 20 Mar 2013 Active
- FDA GUDID UDI-DI 00864747000200 listed 23 May 2016 Listed
Timeline
- Cleared FDA 510(k) K130228
- Listed FDA GUDID 00864747000200
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- Withdrawn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
- 3.0.1
- Primary DI / UDI-DI
- 00864747000200
- 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
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- FLAT PANEL DISPLAYS, CDL SERIES by Totoku Electric Co., Ltd.
- R2 DIGITALNOW HD(DIGITALNOW HD) by Hologic, Inc.
- Xelis by INFINITT Healthcare Co., Ltd.
- COR ANALYZER II, MODEL V1.7 by Rcadia Medical Imaging, Ltd.
- 8MP COLOR LCD MONITOR, RADIFORCE RX840 by Eizo Nanao Corporation
- MD.ai Viewer by Mdai, Inc.
- PICKER MR WORKSTATIONS (VISTAR, MONTAGE AND ONCALL) by Philips Medical Systems (Cleveland), Inc.
- TraumaCad Mobile Release 1.0 by Voyant Health, Ltd.
- ATEC Alignment App by ALPHATEC SPINE, INC.
- ILUMA VISION by Imtec Corp.