EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
FDA 510(k) clearance K053281 · decided 2005-12-07
Clearance details
- K-number
- K053281
- Device name
- EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)
- Applicant
- Emageon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-11-25
- Decision date
- 2005-12-07
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Madison, WI, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Emageon
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
| Record | Firm | Date |
|---|---|---|
| iConnect Enterprise Archive when used with RadSuite. The firm name on the label is Merge H recall (Z-1470-2017) | Merge Healthcare, Inc. | 2017-03-10 |
| Merge RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-1180-2017) | Merge Healthcare, Inc. | 2017-02-09 |
| Merge RadSuite software. Radiological image processing system. recall (Z-2715-2016) | Merge Healthcare, Inc. | 2016-09-02 |
| RadSuite software. The firm name on the label is Merge Healthcare, Hartland, WI. recall (Z-2627-2016) | Merge Healthcare, Inc. | 2016-08-23 |
| EVMS (Enterprise Visual Medical System); Picture archiving and communications system; Mode recall (Z-1644-2008) | Emageon | 2008-05-28 |