AVIEW Modeler

Primary DI
08800025300022
Brand
AVIEW Modeler
Company
CORELINE SOFT CO.,LTD.
Model
1.1
Published
2021-08-09
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192040000AVIEW ModelerCoreline Soft Co., Ltd.2019-12-20LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025300022PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025300022088000253000228800025300022

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
08800025300145AVIEW RT ACS1.12022-11-30
08800025300039AVIEW LCS1.02021-08-09
08800025300077AVIEW1.12021-08-09
08800025300084AVIEW LCS1.12021-08-09
08800025300015AVIEW1.02021-08-06

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00195278517340ViewPointGE Healthcare GmbHLLZ2023-02-15
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00670082000511Modus PlanSynaptive Medical IncLLZ2022-12-13
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00817886020448JointsMEDSTRAT, INC.LLZ2022-06-17