XELERIS 2 PROCESSING AND REVIEW WORKSTATION
FDA 510(k) clearance K051673 · decided 2005-07-18
Clearance details
- K-number
- K051673
- Device name
- XELERIS 2 PROCESSING AND REVIEW WORKSTATION
- Applicant
- GE Medical Systems
- Decision
- Substantially Equivalent
- Date received
- 2005-06-23
- Decision date
- 2005-07-18
- Days to decision
- 25 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Waukesha, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| GE Healthcare, Xeleris 2 Processing & Review Workstation. The display, processing, archivi recall (Z-1164-2013) | GE Healthcare, LLC | 2013-04-23 |
| Xeleris Processing and Review Workstation 1.0, 1.1, 2.0, 3.0 The display, processing, arch recall (Z-1250-2011) | GE Healthcare, LLC | 2011-02-15 |
| XELERIS (1.0, 1.1, 2.0 & 2.1) PROCESSING AND REVIEW WORKSTATION The display, processing, a recall (Z-0537-2011) | GE Healthcare, LLC | 2010-12-03 |