Cleared Traditional

K020643 - EZ-SCOPE AN & EZ-SCOPE AN LITE (FDA 510(k) Clearance)

Class I Radiology device.

K020643 · Health Policy Resorters Group, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
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.