CENTRICITY PACS IW
FDA 510(k) clearance K082318 · decided 2008-08-25
Clearance details
- K-number
- K082318
- Device name
- CENTRICITY PACS IW
- Applicant
- Ge Healthcare Dynamic Imaging Solutions
- Decision
- Substantially Equivalent
- Date received
- 2008-08-13
- Decision date
- 2008-08-25
- Days to decision
- 12 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-IW, software versions V3.7.x through 3.7.3.9 SP3; Radiological Image Proce recall (Z-0138-2024) | GE Healthcare | 2023-10-20 |
| Centricity PACS-IW, Product ID Numbers: a) 2041037-001, b) 2042988-001, c) 2049587-009, d) recall (Z-1502-2023) | GE Healthcare | 2023-05-02 |
| Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives me recall (Z-0023-2016) | GE Healthcare | 2015-10-05 |
| GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 6001 recall (Z-1402-2010) | Ge Healthcare It | 2010-04-16 |
| GE Centricity PACS-IW software; GE Healthcare Integrated IT Solutions, Barrington, IL 6001 recall (Z-1394-2010) | Ge Healthcare It | 2010-04-15 |