510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K860797Substantially Equivalent

Medical X-Ray Film

India-America Trading Co., Santa Monica CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K860797 is the FDA 510(k) clearance record for MEDICAL X-RAY FILM, a class I device, cleared for India-America Trading Co. on under FDA product code IWZ (Film, Radiographic). FDA records list one 510(k) clearance for India-America Trading Co. As of , FDA records show no recalls naming K860797.

Clearance record

Decision date
Received
(9 days to decision)
Product code
IWZ Film, Radiographic
Regulation
21 CFR 892.1840
Device class
Class I
Review panel
Radiology
Applicant
India-America Trading Co. 1807 Wilshire Blvd., Suite B, Santa Monica CA
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