FDA.reportPublic FDA data

BriefCase-Quantification

Primary DI
07290018052235
Brand
BriefCase-Quantification
Company
AIDOC MEDICAL LTD
Model
BC.QTF.3.x.y
Device description
BriefCase-Quantification is an Automated Radiological Image Processing Software.
Published
2024-07-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K230534000
K231631000
K232083000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230534000BriefCase-QuantificationAidoc Medical , Ltd.2023-11-08QIH
K231631000BriefCase-QuantificationAidoc Medical , Ltd.2023-11-28JAK
K232083000BriefCase-QuantificationAidoc Medical , Ltd.2023-11-13QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290018052235PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290018052235072900180522357290018052235

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).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532230094
Device count
1

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290018052365BriefCase Triage24.y.z2026-02-15
07290018052402aiOS4.x.y2026-03-08
07290018052280BriefCase-QuantificationBC.QTF.5.y.z2025-03-05
07290018052273BriefCase Triage22.y.z2024-11-24
07290018052297BriefCase Triage23.y.z2024-11-24
07290018052266BriefCase-QuantificationBC.QTF.4.x.y2024-06-04
07290018052259BriefCase Triage21.x.y2023-12-27
07290018052198aiOS3.x.y2023-07-14
07290018052211BriefCase Triage19.x.y2023-07-14
07290018052044BriefCase for ICH, PE and CSF triage3.0.02019-11-17
07290018052013BriefCase1.1.0.02019-09-01
07290018052020BriefCase2.0.02019-09-01
07290018052037BriefCase3.0.02019-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00195278985613NAGE Medical Systems (China) Co.,Ltd.QIH2026-09-24
00198953126073VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172384VividGE Vingmed Ultrasound A/SQIH2026-09-21
00198953172551VividGE Vingmed Ultrasound A/SQIH2026-09-21
00884838128095Affiniti 50 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128101Affiniti 70 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128118Affiniti 30 Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
00884838128125EPIQ Elite Diagnostic Ultrasound SystemPhilips Ultrasound LLCQIH2026-09-18
08437021722109ADAS 3DADAS3D MEDICAL S.L.QIH2026-09-18
B720BX360HYPERDENSI1440Brainomix 360 HyperdensityBRAINOMIX LIMITEDQIH2026-09-18
00860016420922AI-CVDHeart Lung CorporationQIH2026-09-04
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
00884838129924AV Cardiovascular Suite V1Philips Medical Systems Nederland B.V.QIH2026-08-23
08800357291937V6 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357300165V7 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
08800357308208V8 ONE Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.QIH2026-08-18
00860006305734See-Mode TechnologiesSEE-MODE TECHNOLOGIES PTE. LTD.QIH2026-08-07
04068151012453syngo.CT Coronary CockpitSiemens Healthcare GmbHQIH2026-07-17
04068151034202syngo DynamicsSiemens Healthineers AGQIH2026-07-16
00889024707092OrthoGrid®Orthogrid Systems, Inc.QIH2026-07-15
04068151086584LungMapsSiemens Healthineers AGQIH2026-06-24
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
04068151049923MI View&GOSIEMENS MEDICAL SOLUTIONS USA, INC.QIH2026-06-10
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
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