Atlas FDA

CENTRICITY PACS SYSTEM

FDA 510(k) clearance K043415 · decided 2005-01-21

Clearance details

K-number
K043415
Device name
CENTRICITY PACS SYSTEM
Applicant
Ge Medical Systems Information Technologies
Decision
Substantially Equivalent
Date received
2004-12-13
Decision date
2005-01-21
Days to decision
39 days
Clearance type
Traditional
Product code
LLZ
Device class
2
Regulation number
892.2050
Medical specialty
Radiology
Advisory committee
Radiology
Location
Mount Prospect, IL, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
GE Healthcare Centricty PACS, V2, V3, V4, V6, V7; Radiological imaging processing system. recall (Z-3214-2024)GE Healthcare2024-09-24
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis t recall (Z-1214-2015)GE Healthcare2015-02-26
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis t recall (Z-1665-2014)GE Healthcare2014-05-28
Centricity PACS System versions 3.X and higher and 4.X and higher Product Usage: The Centr recall (Z-0731-2014)Ge Healthcare It2014-01-14
The Centricity PACS Workstation is intended for use as a primary diagnostic and analysis t recall (Z-0116-2014)GE Healthcare It2013-10-30
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation softwar recall (Z-0456-2010)GE Healthcare Integrated IT Solutions2009-11-24
GE Centricity PACS RA1000 Workstation software (for diagnostic image analysis); GE Healthc recall (Z-1543-2009)GE Healthcare Integrated IT Solutions2009-07-13
GE Centricity PACS (Picture Archiving and Communication System) software; GE Healthcare In recall (Z-1549-2009)GE Healthcare Integrated IT Solutions2009-07-01
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integ recall (Z-0969-2009)GE Healthcare Integrated IT Solutions2009-02-03
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integ recall (Z-0970-2009)GE Healthcare Integrated IT Solutions2009-02-03
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integ recall (Z-0928-2009)GE Healthcare Integrated IT Solutions2009-01-27
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis); GE Healthcare Integ recall (Z-0836-2009)GE Healthcare Integrated IT Solutions2009-01-23
GE Centricity PACS RA1000 Workstation (for diagnostic image analysis). GE Healthcare Integ recall (Z-0460-2009)GE Healthcare Integrated IT Solutions2008-12-13
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integr recall (Z-1826-2008)GE Healthcare Integrated IT Solutions2008-09-02
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integr recall (Z-1104-2008)GE Healthcare Integrated IT Solutions2008-05-01
GE Centricity PACS RA1000 Workstation; for diagnostic image analysis. GE Healthcare Integr recall (Z-0373-2007)GE Healthcare Integrated IT Solutions2007-01-25

PMA approvals by this applicant

RecordFirmDate
COROMETRICS MODEL 120 F-SERIES MATERNAL/FETAL MONITOR WITH INTERGRATED FETAL OXYGEN SATURATION MONITORING (P000016/S002)Ge Medical Systems Information Technologies2003-10-15
COROMETRICS MODEL 120 SERIES MATERNAL/FETAL MONITOR W/INTEGRATED FETAL PULSE OXIMETRY (P000016/S001)Ge Medical Systems Information Technologies2001-11-09
COROMETRICS 120F SERIES MATERNAL/FETAL MONITOR (P000016)Ge Medical Systems Information Technologies2001-02-09
MODEL 515 NEONATAL MONIOTR (P840037/S001)Ge Medical Systems Information Technologies1986-11-19