Cleared Traditional

K920539 - ORWO X-RAY FILM (FDA 510(k) Clearance)

Class I Radiology device.

K920539 · Burkhart Roentgen Intl., Inc. · Radiology device
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Jun 1992
Decision
146d
Days
Class 1
Risk

K920539 is an FDA 510(k) clearance for the ORWO X-RAY FILM. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by Burkhart Roentgen Intl., Inc. (Pinellas Park, US). The FDA issued a Cleared decision on June 30, 1992 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - 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 Burkhart Roentgen Intl., Inc. devices

Submission Details

510(k) Number K920539 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1992
Decision Date June 30, 1992
Days to Decision 146 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 107d · This submission: 146d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
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.