Cleared Traditional

ORWO X-RAY FILM

K920539 · Burkhart Roentgen Intl., Inc. · Radiology

Jun 1992

Decision

146d

Days

Class 1

Risk

About This 510(k) Submission

K920539 is an FDA 510(k) clearance for the ORWO X-RAY FILM, a Film, Radiographic (Class I — General Controls, product code IWZ), submitted by Burkhart Roentgen Intl., Inc. (Pinellas Park, US). The FDA issued a Cleared decision on June 30, 1992, 146 days after receiving the submission on February 5, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1840.

Submission Details

510(k) Number	K920539 FDA.gov
FDA Decision	Cleared 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