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510(k) K860797

MEDICAL X-RAY FILM by India-America Trading Co. — Product Code IWZ

K860797 is an FDA 510(k) premarket notification submitted by India-America Trading Co. for the device "MEDICAL X-RAY FILM". The FDA issued a decision of Substantially Equivalent on March 13, 1986. The device falls under product code IWZ (Film, Radiographic), a Class I device regulated under 21 CFR 892.1840.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 1986
Date Received
March 4, 1986
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 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)
  • K920539 — ORWO X-RAY FILM (June 30, 1992)
  • 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)
  • K844554 — BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG (February 21, 1985)
  • K840806 — FR MEDICAL X-RAY FILM (April 24, 1984)

FDA data resources