Sentinella 102; Sentinella 102 Horus— 510(k) K143156

Name: FDA 510(k) clearance K143156
Creator: U.S. Food and Drug Administration
Published: 2014-11-18

Substantially Equivalent

General Equipment For Medical Imaging (Oncovision-

FDA 510(k) clearance K143156 for Sentinella 102; Sentinella 102 Horus, Substantially Equivalent on 2014-11-18. Applicant: General Equipment For Medical Imaging (Oncovision-. Device class: 1.

Clearance details

Applicant: General Equipment For Medical Imaging (Oncovision-
Product code: Code IYX
Device class: Class 1
Regulation: 21 CFR 892.1100
Advisory panel: Radiology
Date received: 2014-11-03
Decision date: 2014-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Valencia, ES

Download summary PDF View on FDA.gov ↗

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