Cleared Traditional

K853928 - UNIVERSAL STAND FOR FILM CHANGER

K853928 is the FDA 510(k) clearance for UNIVERSAL STAND FOR FILM CHANGER by Canon USA, Inc.. It is a Class 2 Radiology device (product code KPX) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K853928 · Canon USA, Inc. · Radiology device
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Oct 1985
Decision
34d
Days
Class 2
Risk

K853928 is an FDA 510(k) clearance for the UNIVERSAL STAND FOR FILM CHANGER. 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 October 28, 1985 after a review of 34 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 K853928 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1985
Decision Date October 28, 1985
Days to Decision 34 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
73d faster than avg
Panel avg: 107d · This submission: 34d
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.

Regulatory Peers - KPX Changer, Radiographic Film/cassette

All 8
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K853928.
DU PONT COMPACT DAYLIGHT SYSTEM 2000
K922483 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
ADDITIONAL MODEL TO CANON UNIVERSAL STAND
K870048 · Canon USA, Inc. · Jan 1987
UNIVERSAL STAND FOR FILM CHANGER
K862575 · Canon USA, Inc. · Jul 1986
CANON X-RAY FILM CHANGER CFC-U1
K851067 · Canon USA, Inc. · May 1985
CP-625 SEE-THRU FILM CHANGER
K811967 · Philips Medical Systems (Cleveland), Inc. · Aug 1981