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510(k) K920539

ORWO X-RAY FILM by Burkhart Roentgen Intl., Inc. — Product Code IWZ

K920539 is an FDA 510(k) premarket notification submitted by Burkhart Roentgen Intl., Inc. for the device "ORWO X-RAY FILM". The FDA issued a decision of Substantially Equivalent on June 30, 1992. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840. Burkhart Roentgen Intl., Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1992
Date Received
February 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Film, Radiographic
Device Class
Class I
Regulation Number
892.1840
Review Panel
RA
Submission Type

Other clearances by Burkhart Roentgen Intl., Inc.

  • K920538 — PROTECTIVE RADIOGRAFIC GLOVE (May 29, 1992)
  • K920540 — RADIOLOGICAL PROTECTIVE EYE SHIELD (May 28, 1992)

Other clearances for product code IWZ

  • K970154 — KODAK EKTASIAN HG FILM (EHG-15) (April 4, 1997)
  • K954200 — VOXGRAM (September 29, 1995)
  • K931604 — 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE (July 21, 1993)
  • K931605 — 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE (July 20, 1993)
  • K884827 — KODAK DENTAL BARRIER PAC (January 30, 1989)
  • K862944 — KODAK CFT FILM SO-141 (August 12, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K860797 — MEDICAL X-RAY FILM (March 13, 1986)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)
  • K840806 — FR MEDICAL X-RAY FILM (April 24, 1984)

FDA data resources