Cleared Traditional

K853861 - CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105 (FDA 510(k) Clearance)

Class I Radiology device.

K853861 · Canon USA, Inc. · Radiology device
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Oct 1985
Decision
37d
Days
Class 1
Risk

K853861 is an FDA 510(k) clearance for the CANON X-RAY I.I. RAPID SEQUENCE CAMERA CRS-105. Classified as Oil, Clearing (product code IJZ), Class I - General Controls.

Submitted by Canon USA, Inc. (Jericho, US). The FDA issued a Cleared decision on October 24, 1985 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 864.4010 - 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 K853861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1985
Decision Date October 24, 1985
Days to Decision 37 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 107d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IJZ Oil, Clearing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.4010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.