510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231470Substantially Equivalent

Lunit INSIGHT DBT

Lunit Inc., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231470 is the FDA 510(k) clearance record for Lunit INSIGHT DBT, a class II device, cleared for Lunit, Inc. on under FDA product code QDQ (Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer). FDA's definition for product code QDQ reads: "A radiological computer assisted detection and diagnostic software for suspected lesions is an image processing device intended to aid in the detection, localization, and characterization of lesions suspicious for cancer on acquired...". FDA records list 6 510(k) clearances for Lunit, Inc., from to . As of , FDA records show no recalls naming K231470.

Clearance record

Decision date
Received
(168 days to decision)
Product code
QDQ Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer
Regulation
21 CFR 892.2090
Device class
Class II
Review panel
Radiology
Applicant
Lunit, Inc. 4-8f, 374, Gangnam-Daero, Gangnam-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QDQ

Trailing 12 months
10 clearances under product code QDQ in the twelve months to October 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20262
May 20260
June 20262
July 20261
August 20262
September 20261
October 20260