IMALUX NIRIS IMAGING SYSTEM— 510(k) K042894

Substantially Equivalent

Imalux Corporation

FDA 510(k) clearance K042894 for IMALUX NIRIS IMAGING SYSTEM, Substantially Equivalent on 2004-11-19. Applicant: Imalux Corporation. Device class: 2.

Clearance details

Applicant: Imalux Corporation
Product code: Code NQQ
Device class: Class 2
Regulation: 21 CFR 892.1560
Advisory panel: Radiology
Date received: 2004-10-20
Decision date: 2004-11-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.