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ThinkQA Edition 2 2.0.0

by Dosisoft

ThinkQA Edition 2 2.0.0 is a Class II device made by Dosisoft, cleared under FDA 510(k) K231573 on 18 Jan 2024, registered in EUDAMED and listed in FDA GUDID since 14 Aug 2024 (UDI-DI B501THINKQA0200000), active as of 12 Nov 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 12 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231573↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberB501THINKQA0200000 UDI-DI Date14 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK231573 Date18 Jan 2024IssuedStatusActive
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

3 registries list this device

  • FDA 510(k) K231573 decided 18 Jan 2024 Active
  • EUDAMED Active
  • FDA GUDID UDI-DI B501THINKQA0200000 listed 14 Aug 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K231573
  2. Listed FDA GUDID B501THINKQA0200000

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade name
ThinkQA Edition 2
Generic name
Radiation therapy software
Model / Ref / Catalog
2.0.0, TK2010, TK2020
Primary DI / UDI-DI
B501THINKQA0200000
510(k) Number
FDA product code
IYE
GMDN term
Radiation therapy software
Device class
Class II
Regulation number
892.5050
GUDID distribution status
In Commercial Distribution

Related devices

Category: Radiation therapy software

Cleared under the same submission (K231573)

Similar devices in this category

Other devices filed under Radiation therapy software.

Other devices from Dosisoft

See all devices from Dosisoft →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (12, all answered No)