FDA.reportPublic FDA data

AVIEW CAC

Primary DI
08800025300237
Brand
AVIEW CAC
Company
CORELINE SOFT CO.,LTD.
Model
1.1
Published
2024-04-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233211000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233211000AVIEW CACCoreline Soft Co., Ltd.2024-03-29QIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025300237PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025300237088000253002378800025300237

GMDN Terms#

Term, Definition table
TermDefinition
Radiological PACS-dedicated management softwareA software program dedicated for installation on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of a broad range of radiological images throughout the healthcare system. As a PACS-dedicated software, it is not primarily intended for diagnosis support, triage, or treatment planning. It does not incorporate adaptive/dynamic machine learning (ML) models.

Regulatory Flags#

DUNS number
689517146
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
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
08800025300435AVIEW Lung Nodule CAD2.02026-07-01
08800025300299AVIEW2.02025-03-27
08800025300367AVIEW CAC2.02025-03-24
08800025300152AVIEW1.12023-01-09
08800025300176AVIEW Lung Nodule CAD1.12023-03-03
08800025300145AVIEW RT ACS1.12022-11-30
08800025300022AVIEW Modeler1.12021-08-09
08800025300039AVIEW LCS1.02021-08-09
08800025300077AVIEW1.12021-08-09
08800025300084AVIEW LCS1.12021-08-09
08800025300015AVIEW1.02021-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04262352350059DS Core CBCT AnatomyZetta25 AGQIH2026-08-26
03663999000429VEA AlignEOS IMAGINGQIH2026-06-12
00850025268417Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-06-05
10810068810940MONARCH™ Advanced Imaging Accessory KitAuris Health, Inc.JAK2026-06-02
10810068810841MONARCH™ Navigation SensorsAuris Health, Inc.JAK2026-05-27
04068151018226syngo Application SoftwareSiemens Healthcare GmbHQIH2026-05-15
00754016387128ANDIImeka Solutions IncQIH2026-05-14
00860013927820Overjet Iris Intelligent Imaging SystemOverjet, Inc.QIH2026-05-13
00850025268424Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-05-12
04262352351605DS Core DiagnosisZetta25 AGQIH2026-04-30
00884838122154EchoNavigatorPhilips Medical Systems Nederland B.V.QIH2026-03-25
00850025268400Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-02-27
00850025268394Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2026-01-21
03663999000436AutoDensityEOS IMAGINGQIH2025-12-09
04260729622006VELYS Traumametamorphosis GmbHQIH2025-12-01
07332747221855DTX Studio™ AssistNobel Biocare ABQIH2025-12-01
07332747221862DTX Studio™ AssistNobel Biocare ABQIH2025-12-01
00850025268387Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-11-03
00850025268370Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-09-24
04262352353517DS Core DiagnosisZetta25 AGQIH2025-09-05
00884838129276Ultrasound WorkspacePhilips Ultrasound LLCQIH2025-08-29
03663999000412VEA AlignEOS IMAGINGQIH2025-08-01
07290109943015TraumaCad NeoBRAINLAB LTDQIH2025-07-16
03770019599112inHEART Models ExplorerINHEARTQIH2025-07-15
00850025268349Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-07-11
00850025268363Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-06-03
00850025268356Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-23
00850025268332Vitrea Advanced VisualizationCanon Medical Informatics, Inc.JAK2025-05-16
B761R60RapidIschemaview, Inc.QIH2025-05-07
03770020839108BoneMetrics USGLEAMERQIH2025-04-02