FDA.reportPublic FDA data

syngo.MI Neurology

Primary DI
04056869950167
Brand
syngo.MI Neurology
Company
SIEMENS MEDICAL SOLUTIONS USA, INC.
Model
11431559
Published
2022-05-27
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
LLZSystem, image processing, radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211459000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211459000syngo.via MI WorkFlows, Scenium, syngo MBFSiemens Medical Solutions USA, Inc.2021-06-10QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04056869950167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04056869950167040568699501674056869950167

GMDN Terms#

Term, Definition table
TermDefinition
SPECT system application software"An individual software program or group of programs, routines or algorithms that add specific image processing and/or analysis capabilities to a single photon emission computed tomography (SPECT) imaging system configuration. A basic set of applications programs and routines is included with such computer-controlled imaging systems and they can be upgraded to correct programming errors or to add new system capabilities. Some packages must be combined with specific hardware or firmware 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
868230876
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04056869264745Symbia Pro.specta Q311364751113647512022-02-21
04056869264769Symbia Pro.specta X711364753113647532022-02-21
04056869264752Symbia Pro.specta X311364752113647522021-06-23
04056869001210Symbia_Intevo_Excel107648012016-09-24
04056869001289Biograph mCT-S (20) -3R105077862016-09-24
04056869001296Biograph mCT S(20)-3R105341592016-09-24
040568692435737L2 Transducer112895622020-05-14
04056869055466L10-5v Transducer113196822018-03-10
0405686905921118H5 Transducer112849242018-02-20
04056869002828ACUSON X300 Diagnostic Ultrasound System100374092016-09-24
04056869002750ACUSON S1000 Diagnostic Ultrasound System104417012016-09-24
04056869002767ACUSON S2000 Automated Breast Volume Scanner104347302016-09-24
04056869002774ACUSON S2000 Diagnostic Ultrasound System100414612016-09-24
04056869002781ACUSON S2000 Diagnostic Ultrasound System104400172016-09-24
04056869002798ACUSON S3000 Diagnostic Ultrasound System104417302016-09-24
04056869002811ACUSON X150 Diagnostic Ultrasound System101316612016-09-24
04056869002835ACUSON X300 PE Diagnostic Ultrasound System105661442016-09-24
04056869002859ACUSON X700 Diagnostic Ultrasound System106588442016-09-24
04056869004297Acuson NX3 Diagnostic Ultrasound System112356122016-09-24
04056869004303Acuson NX3 Elite Diagnostic Ultrasound System112354112016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B359OAIIV2026051RamsoftRamsoft IncLLZ2026-06-04
M722CD26127V260970ClearRead CT DockerRiverain Technologies, Inc.LLZ2026-05-28
17540262200096Change Healthcare Stratus Imaging Diagnostic ViewerChange Healthcare Canada CompanyLLZ2026-05-27
75401622522101Synthesis Vision ViewerSynthesis Health Intelligence IncLLZ2026-05-27
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
08437021722093ADAS 3DADAS3D MEDICAL S.L.LLZ2026-05-12
08800133400003ZeTTA PACSTae Young Soft Co., Ltd.LLZ2026-05-12
08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
G725QFR300QFRQFR Solutions B.V.LLZ2026-05-11
G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
08800066200787JLK-CTPJLK, Inc.LLZ2026-03-25
08800066200794JLK-PWIJLK, Inc.LLZ2026-03-25