CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000— 510(k) K052473

Name: FDA 510(k) clearance K052473
Creator: U.S. Food and Drug Administration
Published: 2005-10-28

Substantially Equivalent

Inter Medical Medizintechnik GmbH

FDA 510(k) clearance K052473 for CX 250 C PLUS WITH GAMMAXP SOFTWARE, MODEL 0121 0000, Substantially Equivalent on 2005-10-28. Applicant: Inter Medical Medizintechnik GmbH. Device class: 1.

Clearance details

Applicant: Inter Medical Medizintechnik GmbH
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2005-09-09
Decision date: 2005-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Luebbecke, DE

Download summary PDF View on FDA.gov ↗

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