Cleared Traditional

K020643 - EZ-SCOPE AN & EZ-SCOPE AN LITE

K020643 is an FDA 510(k) clearance for EZ-SCOPE AN & EZ-SCOPE AN LITE, manufactured by Health Policy Resorters Group, LLC. The device is a Class 1 Radiology device with product code IYX cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K020643 · Health Policy Resorters Group, LLC · Radiology device
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May 2002
Decision
90d
Days
Class 1
Risk

K020643 is an FDA 510(k) clearance for the EZ-SCOPE AN & EZ-SCOPE AN LITE. Classified as Camera, Scintillation (gamma) (product code IYX), Class I - General Controls.

Submitted by Health Policy Resorters Group, LLC (Brookeville, US). The FDA issued a Cleared decision on May 28, 2002 after a review of 90 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 Health Policy Resorters Group, LLC devices

FDA 510(k) Submission Details - K020643

510(k) Number K020643 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 2002
Decision Date May 28, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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 92
Devices cleared under the same product code (IYX) and FDA review panel - the closest regulatory comparables to K020643.
ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM
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PORTABLE BREAST COMPRESSION DEVICE
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LUMAGEM SCINTILLATION CAMERA
K993813 · Gamma Medica · Jan 2000
DILON 2000, MODEL 2000-6X8 AND DILON 2000, MODEL 2000-5X5
K984466 · Dilon Technologies, Inc. · Mar 1999