Lunit, Inc.

Korea, Republic · Seoul

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel — 9 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

2listed device types

Class I 0Class II 2Class III 0

plus 6 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

3registered devices

Class II 3

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

1registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

3 including historic records

TWTaiwanTFDA

2valid device licences

Class II 2

SGSingaporeHSA SMDR

2device registrations

CLASS B 2

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

IIa 1

HKHong KongMDACS

2valid listings

Class II 2

ILIsraelAMAR

2registrations

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 States6 registration records, 6 510(k), 0 PMA, 1 excluded

Brazil3 confirmed, 0 excluded

Saudi Arabia1 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: LUNIT INC. · LUNIT, INC. · LUNIT INC

FDA 510(k) clearances by year

22021 · K211678

12023 · K231470

12024 · K242652

22026 · K260320

FDA listed device types

Radiological Computer-Assisted Prioritization Software For Lesions 1Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260320	Lunit INSIGHT MMG (v1.1.10)	2026-04-23
US	K253796	Lunit INSIGHT DBT (V1.2)	2026-03-26
US	K242652	Lunit INSIGHT DBT v1.1	2024-10-04
BR	80686360424	Lunit INSIGHT DBT	Class II
BR	80686360338	Lunit INSIGHT CXR	Class II
BR	80686360323	Lunit INSIGHT MMG	Class II
SA	ME0000003493SFDAA00002	LUNIT INSIGHT CXR	—

Lunit, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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