ADVANTAGE WORKSTATION 4.3.
FDA 510(k) clearance K052995 · decided 2005-11-08
Clearance details
- K-number
- K052995
- Device name
- ADVANTAGE WORKSTATION 4.3.
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2005-10-25
- Decision date
- 2005-11-08
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- Yes
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch GE Healthcare
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 |
|---|---|---|
| AW VolumeShare 4 (ADVANTAGE WORKSTATION 4.3.), AW VolumeShare 5 (AW VOLUMESHARE 5 WITH ANG recall (Z-0270-2014) | GE Healthcare, LLC | 2013-11-13 |
| GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume recall (Z-2203-2012) | GE Healthcare, LLC | 2012-08-13 |
| GE Healthcare, Seno Advantage 2.1 and 2.2 Workstations with RIS CCOW integration, GE Healt recall (Z-3012-2011) | GE Healthcare, LLC | 2011-08-12 |
| GE Healthcare Advantage Workstations, Advantage Worksation version 4.2 and 4.3 with Volume recall (Z-0265-2008) | GE Healthcare | 2007-11-28 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Senographe Pristina 3D (P130020/S005) | GE Healthcare | 2025-11-21 |
| Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011) | GE Healthcare | 2025-02-04 |
| Senographe Pristina 3D and SenoClaire (P130020/S004) | GE Healthcare | 2021-03-23 |
| Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010) | GE Healthcare | 2018-08-24 |
| Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009) | GE Healthcare | 2018-05-11 |
| Senographe Pristina 3D (P130020/S003) | GE Healthcare | 2017-12-28 |
| Invenia ABUS Autoated Breast Ultrasound System (P110006/S008) | GE Healthcare | 2017-09-07 |
| Invenia ABUS - Automated Breast Ultrasound System (P110006/S007) | GE Healthcare | 2017-05-01 |