Cleared Special

K162052 - Sentinella 102, Sentinella 102 Horus

K162052 is an FDA 510(k) clearance for Sentinella 102, manufactured by General Equipment For Medical Imaging (Oncovision-. The device is a Class 1 Radiology device with product code IYX cleared through the Special 510(k) pathway after a 24-day FDA review.

K162052 · General Equipment For Medical Imaging (Oncovision- · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
24d
Days
Class 1
Risk

K162052 is an FDA 510(k) clearance for the Sentinella 102, Sentinella 102 Horus. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by General Equipment For Medical Imaging (Oncovision- (Valencia, ES). The FDA issued a Cleared decision on August 18, 2016 after a review of 24 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1100 - the FDA radiology and imaging software oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K162052

510(k) Number K162052 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
83d faster than avg
Panel avg: 107d · This submission: 24d
Pathway characteristics
Modification to existing cleared device.

IYX Device Classification - Class 1, General Controls

Product Code IYX Camera, Scintillation (gamma)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1100
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 99
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