Cleared Traditional

K860797 - MEDICAL X-RAY FILM (FDA 510(k) Clearance)

Class I Radiology device.

K860797 · India-America Trading Co. · Radiology device
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Mar 1986
Decision
9d
Days
Class 1
Risk

K860797 is an FDA 510(k) clearance for the MEDICAL X-RAY FILM. Classified as Film, Radiographic (product code IWZ), Class I - General Controls.

Submitted by India-America Trading Co. (Santa Monica, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1840 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K860797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date March 13, 1986
Days to Decision 9 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 107d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IWZ Film, Radiographic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1840
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.