Cleared Traditional

Sentinella 102; Sentinella 102 Horus

K143156 · General Equipment For Medical Imaging (Oncovision- · Radiology

Nov 2014

Decision

15d

Days

Class 1

Risk

About This 510(k) Submission

K143156 is an FDA 510(k) clearance for the Sentinella 102; Sentinella 102 Horus, a Camera, Scintillation (gamma) (Class I — General Controls, product code IYX), submitted by General Equipment For Medical Imaging (Oncovision- (Valencia, ES). The FDA issued a Cleared decision on November 18, 2014, 15 days after receiving the submission on November 3, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number	K143156 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 03, 2014
Decision Date	November 18, 2014
Days to Decision	15 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement