FDA.reportPublic FDA data

AI-Rad companion Brain MR

Primary DI
04068151033977
Brand
AI-Rad companion Brain MR
Company
Siemens Healthcare GmbH
Model
11830481
Published
2026-04-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253057000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253057000AI-Rad Companion Brain MRSiemens Healthcare GmbH2026-01-22QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04068151033977PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04068151033977040681510339774068151033977

GMDN Terms#

Term, Definition table
TermDefinition
Radiology DICOM image processing application softwareA software application intended to facilitate management, distribution, and/or viewing of radiological digital imaging and communications in medicine (DICOM) image data; it is not intended for pathological image interpretation (i.e., not intended to detect and localize suspected abnormalities). It may be intended to facilitate image management (e.g., viewing, communication, printing, recording/disc burning) and/or image quality manipulation and quantification (e.g., non-interpretive graphical overlays).

Contacts#

Phone, Email table
PhoneEmail
+1(877)229-3711CONTACT@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
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
04068151000887AI-Rad Companion Prostate MR116660382026-01-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860008194435Cycle ClarityCycle Clarity, LLCQIH2026-05-21
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
08437021722093ADAS 3DADAS3D MEDICAL S.L.QIH2026-05-12
00198715128956AngiowaveAngioWave Imaging, LLCQIH2026-05-09
07613336231098Opulus Lymphoma PrecisionRoche Molecular Systems, Inc.QIH2026-05-08
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.QIH2026-05-06
B720BX360ECTA1430e-CTABRAINOMIX LIMITEDQIH2026-05-06
00860010264638EZRA PLEXO SOFTWAREEzra Ai, Inc.QIH2026-05-05
08437023642047NemoScanSOFTWARE NEMOTEC SLQIH2026-04-23
00860000171229SubtleSYNTHSubtle Medical, Inc.QIH2026-04-09
00860000171243SubtleHD(MR)Subtle Medical, Inc.QIH2026-04-09
08800124700136SwiftMRAIRS Medical Inc.QIH2026-04-01
G703AIORTAPLAN0AiORTA - PlanVitaa Medical Solutions Inc.QIH2026-03-30
B720BX360ECTA1210Brainomix 360 e-CTABRAINOMIX LIMITEDQIH2026-03-30
08800066200626MEDIHUB PROSTATEJLK, Inc.QIH2026-03-25
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
10603295562108VELYS Hip NavigationDEPUY ORTHOPAEDICS, INC.QIH2026-03-24
08800130400303Neurophet AQUA AD PlusNEUROPHET Inc.QIH2026-02-24
G762AISAPCARDIOV10AISAP Cardio V1.0AISAP LTDQIH2026-02-18
B720BX360ECTA1420e-CTABRAINOMIX LIMITEDQIH2026-02-03
08800290027471EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041767EA2-11AVSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290041811EA2-11ARSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042481PA2-9SSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290042726CA2-13MSAMSUNG MEDISON CO., LTD.QIH2026-01-28
08800290065473EV2-12SAMSUNG MEDISON CO., LTD.QIH2026-01-28
00195278932358Spectral Bone MarrowGE Medical Systems, L.L.C.QIH2026-01-26
00198953113554LOGIQGE Ultrasound Korea Ltd.QIH2026-01-26
00198953113493LOGIQGE Ultrasound Korea Ltd.QIH2026-01-21