CortexID Suite

Model / Reference

5694527

Primary DI / UDI-DI

D-00840682100397DY

Basic UDI-DI

B-00840682100397DY

EMDN Code

Z11020492 Positron emission tomography instruments - medical device software

Device Class

Class IIa

Special Device Type

-1192

Market of Registration

France

EUDAMED SRN

US-MF-000018315

Authorised representative

GE Medical Systems SCS FR-AR-000000344

• not applicable PRISTINA 2.10

  Class II

  GUDID on market

• SenoIris 1

  Class II

  GUDID on market

• Thoracic Vcar

  Class II

  FDA 510(k) K103480 Active Cleared 7 Mar 2011

• MaxFOV 2

  Class II

  FDA 510(k) K203617 Active Cleared 2 Mar 2021

• Ge 1.5T and 3.0T Signa Hdx Mr System Open recall

  Class II

  FDA 510(k) K052293 Active Cleared 21 Sep 2005

• Aw Server Open recall

  Class II

  FDA 510(k) K081985 Active Cleared 25 Sep 2008

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