510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Lunit Inc.

Seoul, KR

LUNIT INC. appears in FDA device records in Seoul, KR. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 6 510(k) clearances for Lunit Inc. between 2021 and 2026. The busiest year on record is 2021, with 2. The most recent is 2026, with 2.

Clearances by year, as a table
510(k) clearance decisions for Lunit Inc., by decision year
YearClearances
20212
20231
20241
20262
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K260320Lunit INSIGHT MMG (v1.1.10)QDQSubstantially Equivalent
K253796Lunit INSIGHT DBT (V1.2)QDQSubstantially Equivalent
K242652Lunit INSIGHT DBT v1.1QDQSubstantially Equivalent
K231470Lunit INSIGHT DBTQDQSubstantially Equivalent
K211678Lunit INSIGHT MMGQDQSubstantially Equivalent
K211733Lunit INSIGHT CXR TriageQFMSubstantially Equivalent

Registered establishments

FDA registered establishments for Lunit Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30212307773021230777LUNIT INC.4-8F, 374, Gangnam-daero, Gangnam-gu, Seoul 06241 KR2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain