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OncoStudio (OS-01)

by Oncosoft. Co., Ltd.

510(k) K242994

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242994 Date24 Feb 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QKB
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OncoStudio (OS-01) is Radiological Image Processing Software For Radiation Therapy, classified as a device in the field of Radiology. It is designed to process radiological images for radiation therapy. The device falls under the regulation number 892.2050. The OncoStudio (OS-01) is a software solution for radiation therapy image processing.

The OncoStudio (OS-01) is supplied with a device class of 2 and is associated with multiple FEI and registration numbers. It has been authorized with an FDA 510K clearance, with a decision date of 2025-02-24. The device is intended for use in radiation therapy, with its medical specialty described as Radiology. The OncoStudio (OS-01) has a product code of QKB and is manufactured by Oncosoft. Co., Ltd.

Other devices from Oncosoft. Co., Ltd.

Questions

AI-generated answers, 23 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the OncoStudio OS-01 used for?

    The OncoStudio OS-01 is used for processing radiological images for radiation therapy, falling under the medical specialty of Radiology.

  • What is the regulatory status of the OncoStudio OS-01?

    The OncoStudio OS-01 has been authorized with an FDA 510K clearance, with a decision date of 2025-02-24, and is classified as a device with a regulation number of 892.2050.

  • What type of device is the OncoStudio OS-01?

    The OncoStudio OS-01 is a software solution, classified as a device in the field of Radiology, with a product code of QKB and a device class of 2.

  • Who manufactures the OncoStudio OS-01?

    The OncoStudio OS-01 is manufactured by Oncosoft. Co., Ltd., with a contact person of Boram Kim, and is based in Seoul, South Korea.