510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920539Substantially Equivalent

Orwo X-Ray Film

Burkhart Roentgen Intl., Inc., Pinellas Park FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920539 is the FDA 510(k) clearance record for ORWO X-RAY FILM, a class I device, cleared for Burkhart Roentgen Intl., Inc. on under FDA product code IWZ (Film, Radiographic). FDA records list 3 510(k) clearances for Burkhart Roentgen Intl., Inc., from to . As of , FDA records show no recalls naming K920539.

Clearance record

Decision date
Received
(146 days to decision)
Product code
IWZ Film, Radiographic
Regulation
21 CFR 892.1840
Device class
Class I
Review panel
Radiology
Applicant
Burkhart Roentgen Intl., Inc. 6571 43rd St., N., Pinellas Park FL
510(k) summary
Statement
Third party review
No

Clearances, product code IWZ

Trailing 12 months

FDA records hold no clearances under product code IWZ in the trailing twelve months.

FDA records show no clearances under product code IWZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code IWZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260