FDA.reportPublic FDA data

Critical Care Suite

Primary DI
00840682146340
Brand
Critical Care Suite
Company
GE Medical Systems, L.L.C.
Model
1.0
Device description
Designated Medical Device, Critical Care Suite 1.0
Published
2019-11-08
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
KPSSystem, tomography, computed, emission
QFMRadiological computer-assisted prioritization software for lesions

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KPSSystem, Tomography, Computed, EmissionRadiology2
QFMRadiological Computer-Assisted Prioritization Software For LesionsRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183182000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183182000Critical Care SuiteGe Medical Systems, LLC2019-08-12QFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840682146340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840682146340008406821463408406821463400840682146340

GMDN Terms#

Term, Definition table
TermDefinition
X-ray image interpretive softwareAn interpretive software program intended to be used to analyse x-ray images (e.g., chest, mammograms, tomograms) to detect and localize suspected abnormalities (e.g., tumours, emphysema, tuberculosis, blunted costophrenic angle) and possibly provide results as clinically relevant tags. It typically utilizes artificial intelligence (AI) and deep learning techniques, and may be compatible with radiology information systems, data formats, and medical imaging software programs [e.g., picture archiving and communication system (PACS), digital imaging and communications in medicine (DICOM) format].

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
144879404
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840682138796Revolution160mm Detector Upgrade2018-01-11
00198953085950PhotonovaSpectra5590000-502026-05-11
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
00840682102995DiscoveryPETCT 7102016-08-01
00840682103107DiscoveryIQ2016-08-01
00840682104364Definium50002016-08-01
00840682108218DiscoveryMI2016-10-11
00840682115261OptimaXR220amx2016-08-01
00840682115278OptimaXR200amx2016-08-01
00840682119238Precision500D2016-08-01
00840682119658NA54216982016-08-01
00840682120975DiscoveryMI Digital Ready2016-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860007434716Cognet AIMedcognetics IncQFM2026-05-21
00841962120548Alpine Stirrups, Metric, LeftQfixKPS2026-04-14
00841962120555Alpine Stirrups, Metric, RightQfixKPS2026-04-14
00859873006240HermiaHermes Medical Solutions ABKPS2026-03-05
B133NEUROQ412601160NeuroQSYNTERMED INCORPORATEDKPS2026-03-04
B133ECTB422512090Cardiac ToolboxSYNTERMED INCORPORATEDKPS2026-02-26
07290018052365BriefCase TriageAIDOC MEDICAL LTDQFM2026-02-15
07290108670523D-SPECT RefurbishedSPECTRUM DYNAMICS MEDICAL, INCKPS2026-02-09
04068151020472BIOGRAPH OneSiemens Healthineers AGKPS2026-01-20
00841962120456Alta for HexaPODQfixKPS2026-01-14
04068151048070Biograph Trinion.X EP9 CT64SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2026-01-09
00841962120388Lumen AirShuttleQfixKPS2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixKPS2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixKPS2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixKPS2025-10-23
08809873532005BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532012BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532029BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532036BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532043BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
08809873532050BRIGHTONIXBrightonix Imaging Inc.KPS2025-09-23
00841439114841ZiFix TraverseMEDTEC, INC.KPS2025-09-12
00841962120340Edge Guide SystemQfixKPS2025-09-11
00198953061329NMCT 860G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
00198953061336NMCT 850G E MEDICAL SYSTEMS ISRAEL LTD.KPS2025-09-09
04068151048063Biograph Trinion.X EP9 CT128SIEMENS MEDICAL SOLUTIONS USA, INC.KPS2025-08-28
B133NEUROQ412507140NeuroQSYNTERMED INCORPORATEDKPS2025-08-06
06971576832033uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832163uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03
06971576832231uMIShanghai United Imaging Healthcare Co., Ltd.KPS2025-08-03