Cleared Traditional

CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D (K871119) - FDA 510(k) Clearance

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

K871119 · Canon USA, Inc. · Radiology device
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Mar 1987
Decision
12d
Days
Class 2
Risk

K871119 is an FDA 510(k) clearance for the CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D. Classified as System, X-ray, Fluoroscopic, Image-intensified (product code JAA), Class II - Special Controls.

Submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on March 31, 1987 after a review of 12 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 K871119 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1987
Decision Date March 31, 1987
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JAA System, X-ray, Fluoroscopic, Image-intensified
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
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.

Regulatory Peers - JAA System, X-ray, Fluoroscopic, Image-intensified

All 59
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K871119.
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LP LATERAL FLUORO POSITIONER (B5077A)
K872061 · General Electric Co. · Jun 1987
SCX SYSTEM
K862120 · General Electric Co. · Jun 1986
PET-SCOPE II IMAGE INTENSIFIER
K855213 · Philips Medical Systems (Cleveland), Inc. · Jan 1986
DIGITAL FLUOROGRAPHIC X-RAY SYSTEM
K833530 · General Electric Co. · Nov 1983