Cleared Traditional

K945635 - TRANS X-1000

K945635 is an FDA 510(k) clearance for TRANS X-1000, manufactured by Canon USA, Inc.. The device is a Class 2 Radiology device with product code KPX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K945635 · Canon USA, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1995
Decision
77d
Days
Class 2
Risk

K945635 is an FDA 510(k) clearance for the TRANS X-1000. 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 February 1, 1995 after a review of 77 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

FDA 510(k) Submission Details - K945635

510(k) Number K945635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1994
Decision Date February 01, 1995
Days to Decision 77 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 107d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPX Device Classification - Class 2, Special Controls

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 12
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K945635.
NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS
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SHIMADZU RADIOGRAPJHIC STAND BR-100
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DU PONT COMPACT DAYLIGHT SYSTEM 2000
K922483 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
FRANKLIN 9000 WALL STAND
K905789 · Mallinckrodt Group, Inc. · May 1991
AUTOMATIC CASSETTE LOADER
K902761 · Mallinckrodt Group, Inc. · Oct 1990
ADDITIONAL MODEL TO CANON UNIVERSAL STAND
K870048 · Canon USA, Inc. · Jan 1987