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
07290018052402aiOS4.x.y2026-03-08
07290018052365BriefCase Triage24.y.z2026-02-15
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

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Primary DI, Brand, Company table
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