Suiteheart
by Neosoft, LLC
510(k) K130228
Suiteheart is a Class II device made by Neosoft, LLC, cleared under FDA 510(k) K130228 on 20 Mar 2013, active 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 | FDA 510(k)SESE | NumberK130228 | Date20 Mar 2013 | StatusActive |
Official records
- FDA 510(k) database K130228
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K130228
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| suiteHEART 3.0.1 | 3.0.1 | 00864747000200 | No longer on the market | |
| suiteHEART 4.0.0 | 4.0.0 | 00864747000217 | No longer on the market | |
| suiteHEART 4.0.1 | 4.0.1 | 00864747000224 | No longer on the market | |
| suiteHEART 4.0.2 | 4.0.2 | 00864747000248 | No longer on the market | |
| suiteHEART 4.0.3 | 4.0.3 | 00864747000255 | No longer on the market | |
| suiteHEART 4.0.4 | 4.0.4 | 00864747000262 | No longer on the market | |
| suiteHEART 4.0.6 | 4.0.6 | 00864747000279 | No longer on the market | |
| suiteHEART 4.0.7 | 4.0.7 | 00850001088008 | No longer on the market | |
| suiteHEART 5 | 5 | 00850001088015 | On the market |
Similar devices
Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).
- WELCH ALLYN FRONT-LINE DOC by Welch Allyn, Inc.
- CARESTREAM PACS by CARESTREAM HEALTH, INC.
- VitreaView by Vital Images, Inc.
- ECHOLINK by Mpacs, LLC
- CLARISO PACS by Clariso, Inc.
- AmCAD-UV by AMCAD BIOMED CORPORATION
- DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0) by Howtek, Inc.
- RConsole1 1.0 by Drtech Corp.
- LUCION by Mevisys Co., Ltd.
- Synapse 3D Base Tools v6.6 by FUJIFILM CORPORATION