FDA.reportPublic FDA data

AVIEW LCS

Primary DI
08800025300084
Brand
AVIEW LCS
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
JAKSystem, X-Ray, Tomography, Computed
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201710000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201710000A View LCSCoreline Soft Co., Ltd.2020-10-16LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800025300084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800025300084088000253000848800025300084

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
08800025300022AVIEW Modeler1.12021-08-09
08800025300039AVIEW LCS1.02021-08-09
08800025300077AVIEW1.12021-08-09
08800025300015AVIEW1.02021-08-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024705999NavitrackerOrthosoft IncLLZ2026-10-26
05420060351235TRUMATCHMaterialise NVLLZ2026-10-22
05420060351242TRUMATCHMaterialise NVLLZ2026-10-22
05420060351259TRUMATCHMaterialise NVLLZ2026-10-22
05420060351266TRUMATCHMaterialise NVLLZ2026-10-22
05420060351273TRUMATCHMaterialise NVLLZ2026-10-22
05420060351280TRUMATCHMaterialise NVLLZ2026-10-22
05420060351297TRUMATCHMaterialise NVLLZ2026-10-22
05420060351303TRUMATCHMaterialise NVLLZ2026-10-22
05420060351310TRUMATCHMaterialise NVLLZ2026-10-22
05420060351327TRUMATCHMaterialise NVLLZ2026-10-22
05420060351334TRUMATCHMaterialise NVLLZ2026-10-22
05420060351341TRUMATCHMaterialise NVLLZ2026-10-22
05420060351358TRUMATCHMaterialise NVLLZ2026-10-22
05420060351365TRUMATCHMaterialise NVLLZ2026-10-22
05420060351372TRUMATCHMaterialise NVLLZ2026-10-22
05420060351389TRUMATCHMaterialise NVLLZ2026-10-22
05420060351396TRUMATCHMaterialise NVLLZ2026-10-22
05420060351402TRUMATCHMaterialise NVLLZ2026-10-22
B621ICOBRAINCTP1X7Y0icobrain ctpicometrix NVLLZ2026-10-22
00850631008919Roentgen WorksBrit Systems, LLCLLZ2026-10-21
00850631008926Roentgen WorksBrit Systems, LLCLLZ2026-10-21
05420060351228TruMatch CMF Titanium 3D Printed SplintsMaterialise NVLLZ2026-10-20
TKRL0001F1540PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F1B80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F34K0PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F6000PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7300PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7940PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20
TKRL0001F7F80PointCloud Knee InstrumentsUnik Orthopedics Inc.LLZ2026-10-20