Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021230777

FEI Number

3021230777

Entity Name

LUNIT INC.

City/State/Country

Seoul, KR

Establishment Address

4-8F, 374, Gangnam-daero, Gangnam-gu, Seoul 06241, KR

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Lunit Inc. (Owner Number: 10076093)

Owner / Operator Contact Address

4-8 F, 374, Gangnam-daero, Gangnam-gu, Seoul, KR-11 06241, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211678

PMA Number

N/A

All Registered Proprietary Names

Lunit INSIGHT DBT v1.1 Lunit INSIGHT DBT Lunit INSIGHT DBT (V1.2) Lunit INSIGHT MMG

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2024-10-17
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2023-11-17
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2026-04-03
QDQ	Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2090	2021-12-20

Official Correspondent

No official correspondent registered.

US Agent Details

Dave Kim Business: Mtech Group LLC Email: davekim@mtechgroupllc.com Phone: (713) 4672607

Related Public Records

Same Entity

Lunit Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021230777. Last updated year: 2026. Please use registration number 3021230777 when referencing this establishment in official correspondence.