HomeKorea, RepublicCORELINE SOFT CO., LTD.

CORELINE SOFT CO., LTD.

Korea, Republic · Seoul
✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 7 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
5listed device types
Class I 0Class II 5Class III 0
plus 12 registration records and 12 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
1 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
1active ARTG entries
IIb 1
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States12 registration records, 12 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: CORELINE SOFT CO., LTD.

Company information

Country
Korea, Republic
City
Seoul

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12018
12019
32020
22022
12023
12024
32025

FDA listed device types

System, Image Processing, Radiological 1Automated Radiological Image Processing Software 1System, X-Ray, Tomography, Computed 1Radiological Image Processing Software For Radiation Therapy 1Lung Computed Tomography System, Computer-Aided Detection 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251203AVIEW Lung Nodule CAD2025-12-03
USK243689AVIEW2025-03-19
USK243696AVIEW CAC2025-02-14
BR83084440001AVIEWClass II

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