Cleared Traditional

K871119 - CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D

K871119 is an FDA 510(k) clearance for CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D, manufactured by Canon USA, Inc.. The device is a Class 2 Radiology device with product code JAA cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K871119 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K871119

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
Combination Product No
PCCP Authorized No
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.

JAA Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (JAA) and FDA review panel - the closest regulatory comparables to K871119.
THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION
K871911 · F. Spoon Co. · May 1987
DTV-411OP
K870869 · Adac Laboratories · May 1987
DTV-4112 FLUOROSCOPIC TELEVISION CAMERA
K871127 · Adac Laboratories · May 1987
EAZY COVERS
K863853 · Superior Medical Products · Mar 1987
EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186)
K870429 · The Mason Clinic · Feb 1987
TELAMAT
K864749 · Comet Ltd. C/O Radiology Resources, Inc. · Feb 1987
K871119 · CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D
Download PDF Canon USA, Inc.