510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K242994Substantially Equivalent

OncoStudio (OS-01)

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

K242994 is the FDA 510(k) clearance record for OncoStudio (OS-01), a class II device, cleared for Oncosoft. Co., Ltd. on under FDA product code QKB (Radiological Image Processing Software For Radiation Therapy). FDA's definition for product code QKB reads: "To provide semi-automatic or fully-automated radiological image processing and analysis tools for radiation therapy. Software implementing artificial intelligence (AI) including nonadaptive machine learning algorithms trained with clinical...". FDA records list 2 510(k) clearances for Oncosoft. Co., Ltd., from to . As of , FDA records show no recalls naming K242994.

Clearance record

Decision date
Received
(151 days to decision)
Product code
QKB Radiological Image Processing Software For Radiation Therapy
Regulation
21 CFR 892.2050
Device class
Class II
Review panel
Radiology
Applicant
Oncosoft. Co., Ltd. 37, Myeongmul-Gil, Seodaemun-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QKB

Trailing 12 months
10 clearances under product code QKB in the twelve months to October 2026, January 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QKB, trailing twelve months
MonthClearances
November 20250
December 20251
January 20262
February 20260
March 20262
April 20262
May 20260
June 20260
July 20262
August 20261
September 20260
October 20260