Cleared Special

Sentinella 102, Sentinella 102 Horus

K162052 · General Equipment For Medical Imaging (Oncovision- · Radiology

Aug 2016

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K162052 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 August 18, 2016, 24 days after receiving the submission on July 25, 2016. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1100.

Submission Details

510(k) Number	K162052 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 25, 2016
Decision Date	August 18, 2016
Days to Decision	24 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF