Cleared Traditional

K920539 - ORWO X-RAY FILM

K920539 is an FDA 510(k) clearance for ORWO X-RAY FILM, manufactured by Burkhart Roentgen Intl., Inc.. The device is a Class 1 Radiology device with product code IWZ cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K920539 · Burkhart Roentgen Intl., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K920539

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.

IWZ Device Classification - Class 1, General Controls

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.

Regulatory Peers - IWZ Film, Radiographic

All 21
Devices cleared under the same product code (IWZ) and FDA review panel - the closest regulatory comparables to K920539.
KODAK EKTASIAN HG FILM (EHG-15)
K970154 · Eastman Kodak Company · Apr 1997
3M MEDICAL DIAGNOSTIC VIDEOCASSETTE
K931604 · 3M Health Care, Ltd. · Jul 1993
3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE
K931605 · 3M Health Care, Ltd. · Jul 1993
KODAK DENTAL BARRIER PAC
K884827 · Eastman Kodak Company · Jan 1989
KODAK CFT FILM SO-141
K862944 · Eastman Kodak Company · Aug 1986
KODAK T-MAT L FILM SO-387
K833234 · Eastman Kodak Company · Oct 1983