CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
FDA 510(k) clearance K123174 · decided 2012-11-16
Clearance details
- K-number
- K123174
- Device name
- CENTRICITY PACS-IW WITH UNIVERSAL VIEWER
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2012-10-10
- Decision date
- 2012-11-16
- Days to decision
- 37 days
- Clearance type
- Special
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Barrington, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Centricity Universal Viewer Software Versions 5.0 SP6 through UV 5.0 SP7.1, a device that recall (Z-1571-2026) | GE Medical Systems, LLC | 2026-03-16 |
| GE Healthcare Centricity PACS-IW (PACS-IW), Model Numbers: 1) 2042988-001; 2) 2049587-009; recall (Z-1484-2025) | GE Healthcare | 2025-03-28 |
| Centricity PACS-IW with Universal Viewer, versions 5.0 SPx with PACS-IW foundation; Radiol recall (Z-0139-2024) | GE Healthcare | 2023-10-20 |
| Centricity PACS-IW with Universal Viewer, Model/Catalog Numbers: a) 2066908-061, b) 206690 recall (Z-1500-2023) | GE Healthcare | 2023-05-02 |
| Centricity PACS-IW with Universal Viewer version 5.0. Used to display medical images (Incl recall (Z-0721-2023) | GE Medical Systems, LLC | 2022-12-16 |
| Centricity PACS-IW with Universal Viewer - Product Usage: Is a device that displays medica recall (Z-2502-2021) | GE Healthcare, LLC | 2021-09-22 |
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 |