FDA.reportPublic FDA data

syngo.CT Brain Hemorrhage

Primary DI
04056869959023
Brand
syngo.CT Brain Hemorrhage
Company
Siemens Healthcare GmbH
Model
11664620
Published
2025-11-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
QASRadiological computer-assisted triage and notification software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QASRadiological Computer-Assisted Triage And Notification SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232431000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232431000syngo.CT Brain HemorrhageSiemens Medical Solutions USA, Inc.2024-03-22QAS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869959023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869959023040568699590234056869959023

GMDN Terms#

Term, Definition table
TermDefinition
CT system application softwareAn application software program intended to add specific image processing and/or analysis capabilities to an x-ray computed tomography (CT) imaging system; it is not dedicated to radiotherapy treatment planning. A basic set of applications programs and routines are included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some applications software routines or groups of routines must be combined with specific hardware or firmware accessories or configurations in order to function as intended. Applications program packages are typically identified by a proprietary name and version or upgrade number.

Contacts#

Phone, Email table
PhoneEmail
+1(800)888-7436CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
313217003
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04068151011807ARTIS icono.explore floor118320002026-05-15
04068151018226syngo Application Software118312342026-05-15
04068151033779ARTIS genio floor118321002026-05-15
04056869991771myAblation Guide108313732026-05-11
04056869295923ARTIS icono ceiling113281002022-10-01
04056869263168NAEOTOM Alpha113300032021-10-13
04056869063317ARTIS icono biplane113276002020-01-10
04056869149325ARTIS icono floor113277002020-01-10
04056869046877ARTIS pheno108490002017-05-15
04068151033977AI-Rad companion Brain MR118304812026-04-14
04068151020076syngo Dynamics117081242026-03-19
04056869973371AI-Rad Companion Organs RT116655082025-04-30
04068151036749MAGNETOM Flow.Rise117884172026-01-20
04056869299556MAGNETOM Flow.Neo115698352026-01-19
04056869299594MAGNETOM Flow.Neo115698392026-01-19
04068151034196MAGNETOM Flow.Elite118519112026-01-19
04068151036732MAGNETOM Flow.Elite118519122026-01-19
04068151047943MAGNETOM Flow.Neo118783442026-01-19
04068151047950MAGNETOM Flow.Elite118783452026-01-19
04056869299297MAMMOVISTA B.smartVB72026-01-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B720BX360TRIAGELVO1430Triage LVOBRAINOMIX LIMITEDQAS2026-05-06
B720BX360TRIAGESTRO1430Triage StrokeBRAINOMIX LIMITEDQAS2026-05-06
00199874323862NeuroICHNEUROCAREAI INCQAS2026-04-24
08800066200589JLK-ICHJLK, Inc.QAS2026-03-25
08800066200596JLK-LVOJLK, Inc.QAS2026-03-25
08800066200602JLK-SDHJLK, Inc.QAS2026-03-25
07290018052365BriefCase TriageAIDOC MEDICAL LTDQAS2026-02-15
B720BX360TRIAGESTRO142Triage StrokeBRAINOMIX LIMITEDQAS2026-02-03
B720BX360TRIAGESTRO141Triage StrokeBRAINOMIX LIMITEDQAS2025-11-28
04056869967844Update Label 127046Siemens Healthcare GmbHQAS2025-11-21
B720BX360TRIAGELVO1410Triage LVOBRAINOMIX LIMITEDQAS2025-10-16
B720BX360TRIAGEICH1120Triage ICHBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGELVO1120Triage LVOBRAINOMIX LIMITEDQAS2025-10-15
B720BX360TRIAGEICH1400Triage ICHBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGELVO1400Triage LVOBRAINOMIX LIMITEDQAS2025-08-18
B720BX360TRIAGESTRO1400Triage StrokeBRAINOMIX LIMITEDQAS2025-08-18
G140ANNALISECONTAINER60Annalise Critical Care AIHARRISON-AI MEDICAL PTY LTDQAS2025-07-28
G140ANNALISEENTP60Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-24
G140ANNALISECONTAINER70Annalise TriageHARRISON-AI MEDICAL PTY LTDQAS2025-07-02
B761R60Rapid Ischemaview, Inc.QAS2025-05-07
00882916001025StrokeSENS LVOCircle Cardiovascular Imaging IncQAS2025-02-05
07290018052273BriefCase TriageAIDOC MEDICAL LTDQAS2024-11-24
07290018052297BriefCase TriageAIDOC MEDICAL LTDQAS2024-11-24
B826CINACSPINE100CINA-CSpineAVICENNA.AIQAS2024-10-07
08800086200217Heuron ICHHeuron Co., Ltd.QAS2024-06-24
B826CINAIPE100CINA-iPEAVICENNA.AIQAS2024-03-29
B761R51011RapidIschemaview, Inc.QAS2024-02-13
B761R51020RapidIschemaview, Inc.QAS2024-02-13
B761R5711RapidIschemaview, Inc.QAS2024-02-13
B761R5721RapidIschemaview, Inc.QAS2024-02-13