Atlas FDA

REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS

FDA 510(k) clearance K051967 · decided 2005-08-09

Clearance details

K-number
K051967
Device name
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
Applicant
GE Healthcare
Decision
Substantially Equivalent
Date received
2005-07-20
Decision date
2005-08-09
Days to decision
20 days
Clearance type
Traditional
Product code
KPR
Device class
2
Regulation number
892.1680
Medical specialty
Radiology
Advisory committee
Radiology
Location
Waukesha, WI, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Healthcare Revolution XR/d; GE Healthcare, 3000 North Grandview , Waukesha, WI, 53188 M recall (Z-1788-2012)General Electric Med Systems LLC2012-06-08
REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS The Revolution XR/d recall (Z-1065-2012)GE Healthcare, LLC2012-02-21
GE Healthcare Definium 8000.Model # 5131070. GE Healthcare, 3000 North Grandview, Waukesha recall (Z-0528-2010)GE Medical Systems, LLC2009-12-16
Revolution XR/d system control room PC model 5117866-2 with Software collector 5115434 recall (Z-0002-2009)GE Medical Systems, LLC2009-09-24
Revolution XR/d systems with control room PC model 5117866-2 with Software collector 51943 recall (Z-0003-2009)GE Medical Systems, LLC2009-09-22
GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE Healthcare Revolution recall (Z-1822-2008)GE Healthcare2008-09-25
GE Healthcare Definium 8000 Digital Radiographic System. recall (Z-1882-2008)GE Healthcare2008-09-25
GE Healthcare Definium 8000 Digital Radiographic System, model number 5135678. GE Healthca recall (Z-1883-2008)GE Healthcare2008-09-25
GE Definium 8000 , model 5135678, Digital Radiographic Systems. GE Healthcare, 3000 North recall (Z-1476-2008)GE Healthcare2008-09-18

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