# Lunit, Inc.

- Location (FDA's records): Seoul, KR
- FDA decisions: 6 (2021–2026): 6 510(k) clearances
- Product codes: QDQ (5), QFM (1)
- 510(k) review time since 2016: median 118 days, against 154 for FDA's reviews in the same codes and years (4 of 5 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 11 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Screenpoint Medical B.V.: 1 (https://510kreport.com/company/screenpoint-medical)
- Zebra Medical Vision, Ltd.: 1 (https://510kreport.com/company/zebra-medical-vision)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)

## Firms that cite its devices most
- AZmed: 1 (https://510kreport.com/company/azmed)
- Bering, Ltd.: 1 (https://510kreport.com/company/bering)
- Qure.Ai Technologies: 1 (https://510kreport.com/company/qure-ai-technologies)
- Envisionit Deepai, Ltd.: 1 (https://510kreport.com/company/envisionit-deepai)
- Milvue: 1 (https://510kreport.com/company/milvue)
- Neurocareai, Inc. (Dba Savelife.Ai): 1 (https://510kreport.com/company/neurocareai-dba-savelife-ai)
- Qure.Ai Technologies Pvt., Ltd.: 1 (https://510kreport.com/company/qure-ai-technologies-pvt)

## Its most-cited devices
- K211733: Lunit INSIGHT CXR Triage (2021), cited by 6
- K242652: Lunit INSIGHT DBT v1.1 (2024), cited by 2
- K211678: Lunit INSIGHT MMG (2021), cited by 2
- K231470: Lunit INSIGHT DBT (2023), cited by 1

## Recent decisions
- K260320: Lunit INSIGHT MMG (v1.1.10) (Apr 23, 2026)
- K253796: Lunit INSIGHT DBT (V1.2) (Mar 26, 2026)
- K242652: Lunit INSIGHT DBT v1.1 (Oct 4, 2024)
- K231470: Lunit INSIGHT DBT (Nov 6, 2023)
- K211678: Lunit INSIGHT MMG (Nov 17, 2021)
- K211733: Lunit INSIGHT CXR Triage (Nov 10, 2021)

Source page: https://510kreport.com/company/lunit