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Canon X-Ray Image Distributor

by Canon USA, Inc. 510(k)

Active United States

510(k) K853984

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK853984 Date16 Oct 1985ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
JAA
Device Class
Class II
Regulation
21 CFR Part 892.1650
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a system for X-ray, fluoroscopic, image-intensified imaging. It is classified as a Class II medical device under FDA regulation 892.1650 with product code JAA.

It received traditional 510(k) clearance (K853984) on October 16, 1985, and is manufactured by Canon USA, Inc. The device is supplied as a non-sterile, reusable system intended for use in radiology settings.

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