Cleared Traditional

K851067 - CANON X-RAY FILM CHANGER CFC-U1 (FDA 510(k) Clearance)

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

K851067 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1985
Decision
64d
Days
Class 2
Risk

K851067 is an FDA 510(k) clearance for the CANON X-RAY FILM CHANGER CFC-U1. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Canon USA, Inc. (Lake Success, US). The FDA issued a Cleared decision on May 21, 1985 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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 K851067 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1985
Decision Date May 21, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 107d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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.