FDA.reportPublic FDA data

Synapse 3D

Primary DI
04547410575392
Brand
Synapse 3D
Company
FUJIFILM CORPORATION
Model
SYNAPSE 3D SOFT V7.2 US UDI
Device description
The product “Synapse 3D” is a system that receives and retrieves DICOM data from modalities including CT, MR, PET, XA, etc. and constructs 3D images and performs image analysis.
Published
2026-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological
QIHAutomated Radiological Image Processing Software

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2
QIHAutomated Radiological Image Processing SoftwareRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120637000
K120679000
K123566000
K130542000
K141514000
K142521000
K162287000
K181773000
K191544000
K200973000
K221677000
K243762000
K254189000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120637000SYNAPSE 3D BRAIN PERFUSIONFujifilm Medical System U.S.A., Inc.2012-05-08LLZ
K120679000SYNAPSE 3D NODULE ANALYSISFujifilm Medical Systems U.S.A, Inc.2012-06-01LLZ
K123566000SYNAPSE 3D COLON ANALYSISFujifilm Medical Systems U.S.A, Inc.2013-01-22LLZ
K130542000SYNAPSE 3D LUNG AND ABDOMEN ANALYSISFujifilm Medical System U.S.A., Inc.2013-06-14LLZ
K141514000SYNAPSE 3D TENSOR ANALYSISFujifilm Meidcal Systems U.S.A.,Inc.2014-09-03LLZ
K142521000Synapse 3D Liver and Kidney AnalysisFujifilm Meidcal Systems U.S.A.,Inc.2014-12-01LLZ
K162287000Synapse 3D Perfusion AnalysisFujifilm Medical Systems U.S.A, Inc.2017-04-06LLZ
K181773000Synapse 3D Optional ToolsFujifilm Corporation2018-09-25LLZ
K191544000Synapse 3D Blood Flow AnalysisFujifilm Corporation2019-10-18LLZ
K200973000Synapse 3D Cardiac ToolsFujifilm Corporaton2020-08-27LLZ
K221677000Synapse 3D Base Tools v6.6Fujifilm Corporation2022-11-10LLZ
K243762000Synapse 3D Base Tools (V7.0)Fujifilm Corporation2025-05-21QIH
K254189000Synapse 3D Base Tools (V7.2)Fujifilm Corporation2026-04-30QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04547410575392PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04547410575392045474105753924547410575392

Regulatory Flags#

DUNS number
713565195
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04547410582901FDR CROSS SlimDR-XD 3000 SLIM MBL E2026-08-14
04547410524642FUJIFILMEB-840T2026-07-30
04547410524680FUJIFILMEB-840S2026-07-30
04573596212318S3ESCLSS3ESCLS2024-01-25
04573596212325S3ESELS3ESEL2021-07-18
04573596201367OASISMR-NVC-120OASIS RAPID NV Coil MR-NVC-1202026-05-29
04573596201398OASISMR-QFC-120OASIS QD Flexible Body Coil(L) MR-QFC-1202026-05-29
04573596201404OASISMR-QFC-120XLOASIS QD Flexible Body Coil(XL) MR-QFC-120XL2026-05-29
04573596201411OASISMR-RFC-120OASIS RAPID Foot Coil MR-RFC-1202026-05-29
04573596201435OASISMR-CTL-120OASIS CTL Coil MR-CTL-1202026-05-29
04573596202159OASISMR-IBC-120OASIS RAPID Breast Coil MR-IBC-1202026-05-29
04547410480269FUJIFILMVS-10002026-05-22
04547410529128FUJIFILMEG-S100XT2026-05-22
04573596200865APERTO LucentMR-JCR-82Joint coil (M) MR-JCR-82 for APERTO Lucent/APEROT 2026-05-22
04573596200889APERTO LucentMR-JC-81Joint coil (S) MRJC-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200896APERTO LucentMR-JCR-83Joint coil (L) MR-JCR-83 for APERTO Lucent/APEROT 2026-05-22
04573596200902APERTO LucentMR-CSC-81C-Spine coil MR-SCS-81 for APERTO Lucent/APERTO Et2026-05-22
04573596200940APERTO LucentMR-QWC-81Wrist coil MR-QWC-81 for APERTO Lucent/Aperto Eter2026-05-22
04573596200964APERTO LucentMR-MSC-81Shoulder coil MR-MSC-81 for APERTO Lucent/APERTO E2026-05-22
04573596200971APERTO LucentMR-QRC-81Head coil (L) MR-QRC-81 for APERTO Lucent/APERTO E2026-05-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05404028001370Mimics Cardiac PlannerMaterialise NVLLZ2026-10-30
08800025300374AVIEW Aorta MetricsCORELINE SOFT CO.,LTD.JAK2026-10-29
B745ELUCIDB1P1Elucid Plaque-IQELUCID BIOIMAGING INC.LLZ2026-10-29
04719878712002OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.LLZ2026-10-28
M722CD26272CA252790ClearRead CT CAC DockerRiverain Technologies, Inc.JAK2026-10-28
00889024671270ROSA® HipOrthosoft IncLLZ2026-10-27
00860013056506Cirrus Software ApplicationSORA NEUROSCIENCE, INC.QIH2026-10-26
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
00850018318020Bladder AIExo Imaging, Inc.QIH2026-10-22
00850018318075AI Platform IIExo Imaging, Inc.QIH2026-10-22
00850018318082Strain AIExo Imaging, Inc.QIH2026-10-22
03770033463055FETOLYDIAGNOLYQIH2026-10-22
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22