Centricity Universal Viewer
FDA 510(k) clearance K182419 · decided 2018-12-14
Clearance details
- K-number
- K182419
- Device name
- Centricity Universal Viewer
- Applicant
- GE Healthcare
- Decision
- Substantially Equivalent
- Date received
- 2018-09-05
- Decision date
- 2018-12-14
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- LLZ
- Device class
- 2
- Regulation number
- 892.2050
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Chicago, 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 7.0 through 7.0 Sp2.0.1, a device that displ recall (Z-1569-2026) | GE Medical Systems, LLC | 2026-03-16 |
| GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908- recall (Z-1483-2025) | GE Healthcare | 2025-03-28 |
| Centricity Universal Viewer Workflow Manager, Image processing radiological system recall (Z-0142-2024) | GE Healthcare | 2023-10-23 |
| (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Vie recall (Z-1566-2022) | GE Healthcare, LLC | 2022-08-24 |
| Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system recall (Z-0012-2022) | GE Healthcare, LLC | 2021-10-02 |
| Centricity Universal Viewer 6.0, a device that displays medical images and data from vario recall (Z-0819-2020) | GE Healthcare, LLC | 2020-01-17 |
| Centricity Universal Viewer 6.0 Is a device that displays medical images and data from var recall (Z-1910-2019) | GE Healthcare, LLC | 2019-07-01 |
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 |