Cleared Traditional

K853983 - CANON X-RAY 35MM CINE CAMERA CSI-35 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K853983 · Canon USA, Inc. · Radiology device
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Oct 1985
Decision
19d
Days
Class 2
Risk

K853983 is an FDA 510(k) clearance for the CANON X-RAY 35MM CINE CAMERA CSI-35. Classified as Camera, X-ray, Fluorographic, Cine Or Spot (product code IZJ), Class II - Special Controls.

Submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on October 16, 1985 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1620 - 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.

View all Canon USA, Inc. devices

Submission Details

510(k) Number K853983 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1985
Decision Date October 16, 1985
Days to Decision 19 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IZJ Camera, X-ray, Fluorographic, Cine Or Spot
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1620
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.