SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)— 510(k) K965161

Name: FDA 510(k) clearance K965161
Creator: U.S. Food and Drug Administration
Published: 1997-03-12

Substantially Equivalent

Sectra-Imtec AB

FDA 510(k) clearance K965161 for SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER), Substantially Equivalent on 1997-03-12. Applicant: Sectra-Imtec AB. Device class: 1.

Clearance details

Applicant: Sectra-Imtec AB
Product code: Code LMD
Device class: Class 1
Regulation: 21 CFR 892.2020
Advisory panel: Radiology
Date received: 1996-12-23
Decision date: 1997-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, US

Download summary PDF View on FDA.gov ↗

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