FDA.reportPublic FDA data

AVIEW RT ACS

Primary DI
08800025300145
Brand
AVIEW RT ACS
Company
CORELINE SOFT CO.,LTD.
Model
1.1
Published
2022-11-30
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
QKBRadiological Image Processing Software For Radiation Therapy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKBRadiological Image Processing Software For Radiation TherapyRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220408000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220408000AVIEW RT ACSCoreline Soft Co., Ltd.2022-11-10QKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025300145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025300145088000253001458800025300145

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
08800025300237AVIEW CAC1.12024-04-25
08800025300152AVIEW1.12023-01-09
08800025300176AVIEW Lung Nodule CAD1.12023-03-03
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
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04068151034189AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2026-06-23
08809839660001OncoStudioOncoSoft. co.,Ltd.QKB2026-05-08
00860015780805INTContourCarina Medical LLCQKB2026-04-27
06973127400098AccuContourManteia Technologies Co.,Ltd.QKB2026-04-27
00860010267103DeepContourWisdom Technologies, IncQKB2026-04-22
06973127400135ARTAssistantManteia Technologies Co.,Ltd.QKB2026-04-22
00850009343345ContourProtégéAIMIM SOFTWARE INC.QKB2026-04-07
00850072631042AutoContourRadformation, IncQKB2026-03-30
00860009223660Neosoma Brain MetsNeosoma, Inc.QKB2026-02-10
00198953043387MR Contour DLGE HEALTHCAREQKB2026-01-23
03770019940013ART-PlanTHERAPANACEAQKB2025-12-10
03770019940020ART-PlanTHERAPANACEAQKB2025-12-10
06973127400029AccuContourManteia Technologies Co.,Ltd.QKB2025-06-16
04068151010404AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-06-05
04056869973371AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2025-04-30
00628011382184Limbus ContourLimbus Ai Inc.QKB2025-02-19
06429830064206Contour+ (MVision AI Segmentation) Mvision AI OyQKB2024-12-31
00195278560384Auto SegmentationGE Medical Systems, L.L.C.QKB2024-11-05
00850009343307ContourProtégéAIMIM SOFTWARE INC.QKB2024-03-20
00850009343291ContourProtégéAIMIM SOFTWARE INC.QKB2023-08-20
04719884900011VBrainVysioneer Inc.QKB2023-08-08
06973127400050AccuContourManteia Technologies Co.,Ltd.QKB2023-04-01
07350097430017MRI PlannerSpectronic Medical ABQKB2023-01-31
04056869955667AI-Rad Companion Organs RTSiemens Healthcare GmbHQKB2022-11-09
03770019940006ART-PlanTHERAPANACEAQKB2022-10-26
00850009343178ContourProtégéAI - CT AbdomenMIM SOFTWARE INC.QKB2022-05-16
00850009343215ContourProtégéAI - CT Lung and LiverMIM SOFTWARE INC.QKB2022-05-16
00850009343239ContourProtégéAI - CT SurePlan MRTMIM SOFTWARE INC.QKB2022-05-16
06975191150008RT-Mind-AIMedMind Technology Co., Ltd.QKB2022-03-15