AW SERVER
FDA 510(k) clearance K081985 · decided 2008-09-25
Clearance details
- K-number
- K081985
- Device name
- AW SERVER
- Applicant
- Ge Medical Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-07-14
- Decision date
- 2008-09-25
- Days to decision
- 73 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
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System recall (Z-2553-2026) | GE Medical Systems SCS | 2026-06-24 |
| AW Server 2.0, AW Server 3.0, AW Server 3.1, AW Server 3.2 recall (Z-0068-2026) | GE Medical Systems, SCS | 2025-10-08 |
| 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, AW Server. Product Usage: . AW Server is a medical software system that all recall (Z-1137-2013) | GE Healthcare, LLC | 2013-04-17 |
| GE Healthcare AW Server version 2.0 with release 2.0 - 4.0 A medical software system that recall (Z-0486-2012) | GE Healthcare, LLC | 2012-01-11 |