Cleared Traditional

K110601 - SENTINELLA 102

K110601 is an FDA 510(k) clearance for 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 16-day FDA review.

K110601 · General Equipment For Medical Imaging, S.A. · Radiology device
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Mar 2011
Decision
16d
Days
Class 1
Risk

K110601 is an FDA 510(k) clearance for the 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 March 18, 2011 after a review of 16 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 - K110601

510(k) Number K110601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2011
Decision Date March 18, 2011
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
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 Peers - IYX Camera, Scintillation (gamma)

All 65
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