ThinkQA 3

510(k) Number

K252937 ↗

FDA product code

IYE

FDA applicant

Dosisoft SA

Device class

Class II

Regulation

21 CFR Part 892.5050

Advisory committee

Radiology

FDA decision

SESE Substantially Equivalent

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Other devices filed under FDA product code IYE (Accelerator, Linear, Medical).

• KLARITY MEDICAL R7506-34C by Klarity Medical Products, LLC
• NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST by Victoreen, Inc.
• ExacTrac Dynamic by Brainlab AG
• ARTISTE SOLUTION, SYS_VC10C, PHASE 2 UPDATE WITH THE SYNGO RT THERAPIST & RT ONCOLOGIST WORKSPACES, V4.3.1_MR1 by SIEMENS MEDICAL SOLUTIONS USA, INC.
• VARIAN RMS-2000, RELEASE 2.5 by Varian Assoc., Inc.
• HT-RES RTP SYSTEM by Adac Laboratories
• KLARITY MEDICAL R550-CELC2 by Klarity Medical Products, LLC
• Delta4 Phantom+ PMMA SDOS101-20 by Scandidos AB
• MOSFET AUTOSENSE WIRELESS by Thomson & Nielsen Electronics, Ltd.
• PORTALVISION by Varian Medical Systems, Inc.

• ThinkQA 3 3.0

  Class II

  FDA 510(k) K252937 Active Cleared 12 Jun 2026 GUDID on market

• PLANET, PLANET Onco, PLANET Dose, PLANET Onco Dose 3.1.1

  Class II

  FDA 510(k) K182966 Active Cleared 6 Mar 2019 GUDID on market

• EPIgray 2.0.7

  Class II

  FDA 510(k) K112723 Active Cleared 8 Feb 2012 GUDID on market

• ThinkQA, EPIbeam 1.0.6

  Class II

  FDA 510(k) K180106 Active Cleared 13 Mar 2018 GUDID on market

See all devices from Dosisoft →