Atlas FDA

Centricity Universal Viewer

FDA 510(k) clearance K150420 · decided 2015-05-26

Clearance details

K-number
K150420
Device name
Centricity Universal Viewer
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2015-02-18
Decision date
2015-05-26
Days to decision
97 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

RecordFirmDate
Centricity Universal Viewer Software Versions 6.0 through 6.0 Sp10.4.1, a device that disp recall (Z-1570-2026)GE Medical Systems, LLC2026-03-16
GE Healthcare Centricity Universal Viewer (UV), Model Numbers: 1) 2066908-077; 2) 2066908- recall (Z-1483-2025)GE Healthcare2025-03-28
Centricity Universal Viewer, software versions 6.0 SP0 through 6.0 SP7.1; Radiological Ima recall (Z-0140-2024)GE Healthcare2023-10-20
Centricity Universal Viewer, Centricity Universal Viewer 6.0, Model/Catalog Numbers: a) 20 recall (Z-1501-2023)GE Healthcare2023-05-02
Centricity Universal Viewer 6.0. Used to display medical images (Including mammograms) and recall (Z-0722-2023)GE Medical Systems, LLC2022-12-16
(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Vie recall (Z-1566-2022)GE Healthcare, LLC2022-08-24
Centricity Universal Viewer and Viewer 6.0 - Product Usage: Is a device that displays medi recall (Z-2503-2021)GE Healthcare, LLC2021-09-22
Centricity Universal Viewer 6.0, a device that displays medical images and data from vario recall (Z-0819-2020)GE Healthcare, LLC2020-01-17
Centricity Universal Viewer 6.0 Is a device that displays medical images and data from var recall (Z-1910-2019)GE Healthcare, LLC2019-07-01

PMA approvals by this applicant

RecordFirmDate
Senographe Pristina 3D (P130020/S005)GE Healthcare2025-11-21
Invenia ABUS Premium, Invenia ABUS Prime (P110006/S011)GE Healthcare2025-02-04
Senographe Pristina 3D and SenoClaire (P130020/S004)GE Healthcare2021-03-23
Invenia ABUS (Automated Breast Ultrasound System) 2.0 (P110006/S010)GE Healthcare2018-08-24
Invenia ABUS 2.0 Automated Breast Ultrasound System (P110006/S009)GE Healthcare2018-05-11
Senographe Pristina 3D (P130020/S003)GE Healthcare2017-12-28
Invenia ABUS Autoated Breast Ultrasound System (P110006/S008)GE Healthcare2017-09-07
Invenia ABUS - Automated Breast Ultrasound System (P110006/S007)GE Healthcare2017-05-01