CENTRICITY PACS WEB DIAGNOSTIC
FDA 510(k) clearance K083018 · decided 2008-11-14
Clearance details
- K-number
- K083018
- Device name
- CENTRICITY PACS WEB DIAGNOSTIC
- Applicant
- Ge Healthcare Dynamic Imaging Solutions
- Decision
- Substantially Equivalent
- Date received
- 2008-10-09
- Decision date
- 2008-11-14
- Days to decision
- 36 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Monroe, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a dev recall (Z-1782-2017) | Ge Medical Systems Information T | 2017-04-11 |
| Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives me recall (Z-0118-2014) | Ge Healthcare It | 2013-10-30 |
| GE Centricity Web Diagnostic (WebDX) software; GE Healthcare Integrated IT Solutions, Barr recall (Z-1403-2010) | Ge Healthcare It | 2010-04-16 |
| GE Centricity Web Diagnostic 1.0(WebDX) software; GE Healthcare Integrated IT Solutions, B recall (Z-1395-2010) | Ge Healthcare It | 2010-04-15 |