Cleared Traditional

K093706 - PROXISCAN MODEL 101 (FDA 510(k) Clearance)

Class I Radiology device.

K093706 · Hybridyne Imaging Technologies, Inc. · Radiology device
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Apr 2010
Decision
122d
Days
Class 1
Risk

K093706 is an FDA 510(k) clearance for the PROXISCAN MODEL 101. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Hybridyne Imaging Technologies, Inc. (Waltham, US). The FDA issued a Cleared decision on April 2, 2010 after a review of 122 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Hybridyne Imaging Technologies, Inc. devices

Submission Details

510(k) Number K093706 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2009
Decision Date April 02, 2010
Days to Decision 122 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 107d · This submission: 122d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.