SOFTVIEW, MODEL 2.01
FDA 510(k) clearance K092363 · decided 2010-03-18
Clearance details
- K-number
- K092363
- Device name
- SOFTVIEW, MODEL 2.01
- Applicant
- Riverain Medical Group
- Decision
- Substantially Equivalent
- Date received
- 2009-08-05
- Decision date
- 2010-03-18
- Days to decision
- 225 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Miamisburg, OH, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Riverain Medical Group
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RadioViewAI (K260936) | Neurocareai, Inc. (Dba Savelife.Ai) | 2026-07-31 |
| Cleerly LABS (K260588) | Cleerly, Inc. | 2026-07-29 |
| TheraSphere 360™ Y-90 Management Platform (K262462) | Boston Scientific Corporation | 2026-07-24 |
| ImageGrid StreamVue (K262143) | Candelis, Inc. | 2026-07-23 |
| ResolutionMD (K260500) | ResolutionMD, Inc. | 2026-07-21 |
| Avara Viewer (K262120) | Avara Software | 2026-07-10 |
| 3D-Anywhere (K253899) | Provect.AI | 2026-07-09 |
| INDIRA CLOUD VIEWER (K261465) | INDIGO TECHNOLOGIES | 2026-07-06 |
| MeVis AVM Contour (K260576) | MeVis Medical Solutions AG | 2026-06-30 |
| MiPACS V5 (1.0.0) (K260231) | Apryse Software Corp | 2026-06-25 |
| Perfusion Measurement Platform v1 (K253421) | Quantified Imaging Limited | 2026-06-22 |
| 2D Hip Planning Software (K261352) | One Ortho | 2026-06-08 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CLEAREAD DETECT (P000041/S011) | Riverain Medical Group | 2012-02-27 |
| CLEARREAD DETECT (P000041/S010) | Riverain Medical Group | 2011-11-08 |
| ONGUARD (P000041/S009) | Riverain Medical Group | 2010-06-10 |
| ONGUARD (P000041/S006) | Riverain Medical Group | 2007-08-30 |
| RAPIDSCREEN RS-2000D (P000041/S005) | Riverain Medical Group | 2006-11-01 |
| RAPID SCREEN RS-2000, RS-2000D AND RS-DIGITAL (P000041/S003) | Riverain Medical Group | 2006-07-27 |
| RAPIDSCREEN RS-2000D (P000041/S002) | Riverain Medical Group | 2003-08-08 |
| RAPIDSCREEN RS-2000D (P000041/S001) | Riverain Medical Group | 2003-06-30 |