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ThinkQA Edition 2

by Dosisoft 2 variants

Ref TK2010, TK2020

ThinkQA Edition 2 is a Class I device made by Dosisoft, registered in EUDAMED on 25 Jul 2024 (Basic UDI-DI ++B501THINKQA0200000RP) and cleared under FDA 510(k) K180106 on 13 Mar 2018, active as of 24 Oct 2026.

Active European Union and United States

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K180106↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B501THINKQA0200000RP Basic UDI-DI Date25 Jul 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK180106 Date13 Mar 2018IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++B501THINKQA0200000RP registered 25 Jul 2024 Active
  • FDA 510(k) K180106 decided 13 Mar 2018 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K180106
  2. Registered EUDAMED ++B501THINKQA0200000RP

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  • Withdrawn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)

Model / reference
TK2010, TK2020
Primary DI / UDI-DI
+B501THINKQA0200020, +B501THINKQA0200010
Basic UDI-DI
++B501THINKQA0200000RP
Direct marketing DI
+B501THINKQA0200020
+B501THINKQA0200010
EMDN code
Z11019092 Various radiotherapy and radiosurgery instruments - medical device software
Device class
Class I
Special device type
Software
EU registration type
Standard device
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000014706

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Properties

Other properties (14, all answered No)