FDA.reportPublic FDA data

Quality Care Suite

Primary DI
00195278584441
Brand
Quality Care Suite
Company
GE Medical Systems, L.L.C.
Model
2.0
Catalog number
5833126
Device description
Quality Care Suite 2.0, Medical Device
Published
2023-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LHOInstrument, quality-assurance, radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195278584441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195278584441001952785844411952785844410195278584441

GMDN Terms#

Term, Definition table
TermDefinition
Diagnostic x-ray digital imaging system workstation application softwareAn individual software application program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to a diagnostic x-ray system workstation so that it may function according to its intended purpose, e.g., for the rendering, visualization and manipulation of medical images to support the image display needs of clinicians, diagnosticians and technicians. A basic set of applications programs and routines are included with the multi-purpose diagnostic x-ray system workstation and can be upgraded to correct programming errors or to add new system capabilities.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144879404
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00198953085950PhotonovaSpectra5590000-502026-05-11
00195278789365Critical Care Suite2.158331262023-10-19
00195278460271RevolutionApex Elite5590000-232022-12-16
00195278471277Revolution CTES with Apex edition5826588-X2022-12-16
00195278502179RevolutionApex Plus5590000-252022-12-16
00195278486813NASIGNA Hero2022-02-11
00195278472083NA6265300-202021-12-31
00195278098603DiscoveryMI2020-10-20
00195278023643NASIGNA Architect2020-07-20
00198953255315NA9265300-32026-07-08
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953081839NA6265300-602026-04-02
00198953081877NA6265300-622026-04-02
00840682120784Flashpad HD25302017-07-28
00840682120807Flashpad HD35432017-07-28
00840682103053DiscoveryPETCT 6102016-08-01
00840682143974O560 to 610 Upgrade5607000-22018-12-05
00840682145749OptimaXR240amx HD Upgrade Gen22019-07-15
10840682142875Discovery PET CT690 VCT Boost Upgrade2018-11-16
00840682102490RevolutionDiscovery CT2016-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04995047069485RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071655RadiCSEIZO CORPORATIONLHO2026-09-04
04995047071662RadiCSEIZO CORPORATIONLHO2026-09-04
00889024707443OrthoGrid®Orthogrid Systems, Inc.LHO2026-07-15
00889024707450OrthoGrid®Orthogrid Systems, Inc.LHO2026-07-15
05060608881499RapidCHECKSUN NUCLEAR CORP.LHO2026-05-10
EIBAE30635000myQA StarTrack³, including Energy Verification Plates and SoftwareIBA Dosimetry GmbHLHO2026-04-24
EPTWT20020Q1Q1000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q1300COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q2000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q3100COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT20020Q1Q4000COUCHFIXPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0100MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41018Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0040MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0050MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0060MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0070MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT41019Q1Q0120MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410250MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410330MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT410520MP1 Manual Water PhantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-16
EPTWT110620DIAMENTORPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT110640DIAMENTORPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT296720RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU100RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU140RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15
EPTWT29672JU150RW3 slab phantomPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2026-04-15