Cleared Traditional

K092471 - MODEL SENTINELLA 102

K092471 is an FDA 510(k) clearance for MODEL SENTINELLA 102, manufactured by General Equipment For Medical Imaging, S.A.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K092471 · General Equipment For Medical Imaging, S.A. · Radiology device
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Oct 2009
Decision
52d
Days
Class 1
Risk

K092471 is an FDA 510(k) clearance for the MODEL SENTINELLA 102. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by General Equipment For Medical Imaging, S.A. (Valencia, ES). The FDA issued a Cleared decision on October 2, 2009 after a review of 52 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all General Equipment For Medical Imaging, S.A. devices

FDA 510(k) Submission Details - K092471

510(k) Number K092471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2009
Decision Date October 02, 2009
Days to Decision 52 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYX Camera, Scintillation (gamma)

All 91
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K092471.
ERGO IMAGING SYSTEM
K100838 · Digirad Corp. · Apr 2010
PROXISCAN MODEL 101
K093706 · Hybridyne Imaging Technologies, Inc. · Apr 2010
GAMMALOC SYSTEM, MODEL 03-00001
K082588 · Dilon Technologies, LLC · Dec 2009
VERISTA IMAGING ISOCAM II GAMMA CAMERA
K081757 · Verista Imaging, Inc. · Aug 2008
CAPIMAGE
K081829 · Danish Diagnostic Development A/S · Jul 2008
T-QUEST SYSTEM
K073456 · Medx, Inc. · Dec 2007