CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
FDA 510(k) clearance K131977 · decided 2013-09-17
Clearance details
- K-number
- K131977
- Device name
- CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2013-06-28
- Decision date
- 2013-09-17
- Days to decision
- 81 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: 2110344-03 recall (Z-1475-2026) | GE Healthcare | 2026-02-27 |
| GE Healthcare Centricity Universal Viewer Zero Footprint, Model Numbers: 1) 2089507-083, G recall (Z-0318-2025) | GE Healthcare | 2024-11-07 |
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model/Catalog/Code Number recall (Z-0039-2025) | GE Healthcare | 2024-10-09 |
| GE Healthcare Centricity Universal Viewer Zero Footprint Client, Model Numbers: a) 2110344 recall (Z-3160-2024) | GE Healthcare | 2024-09-17 |
| GE Centricity Universal Viewer Zero Footprint. To view, communicate, process, and display recall (Z-1333-2022) | GE Healthcare, LLC | 2022-07-05 |
| Centricity Universal Viewer Zero Footprint Client recall (Z-1229-2022) | GE Healthcare, LLC | 2022-06-03 |
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 |