Cleared Traditional

K093706 - PROXISCAN MODEL 101

K093706 is an FDA 510(k) clearance for PROXISCAN MODEL 101, manufactured by Hybridyne Imaging Technologies, Inc.. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K093706 · Hybridyne Imaging Technologies, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K093706

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.

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 109
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K093706.
DISCOVERY NM 750B
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K093706 · PROXISCAN MODEL 101
Download PDF FDA Summary Hybridyne Imaging Tec…