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
Combination Product No
PCCP Authorized No
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 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
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