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ThinkQA 3 3.0

by Dosisoft

ThinkQA 3 3.0 is a Class II device made by Dosisoft, cleared under FDA 510(k) K252937 on 12 Jun 2026 and listed in FDA GUDID since 24 Aug 2026 (UDI-DI B501THINKQA0300000), active as of 12 Nov 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

510(k) K252937

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB501THINKQA0300000 UDI-DI Date24 Aug 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK252937 Date12 Jun 2026DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K252937 decided 12 Jun 2026 Active
  • FDA GUDID UDI-DI B501THINKQA0300000 listed 24 Aug 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K252937
  2. Listed FDA GUDID B501THINKQA0300000

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
ThinkQA 3
Generic name
Radiation therapy software
Model / Ref / Catalog
3.0, TK3010, TK3020, TK3030, TK3040, TK3050, TK3060
Primary DI / UDI-DI
B501THINKQA0300000
510(k) Number
FDA product code
IYE, MUJ
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Similar devices

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

Other devices from Dosisoft

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Properties

  • Prescription use
  • Manufacturing date
Other properties (13, all answered No)