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Collimax X-Ray Collimator # R-182

by Ito X-Ray Corp.

510(k) K801168

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK801168 Date8 Jul 1980ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
IZX
Device Class
Class II
Regulation
21 CFR Part 892.1610
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Sep 2026

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

The Collimax X-Ray Collimator # R-182 is a manual radiographic collimator designed for use in radiology. It functions as an imaging accessory to control the size and shape of the X-ray beam during diagnostic procedures.

This device is classified as a Class II medical device under regulation number 892.1610. It received FDA 510(k) clearance under K801168 on July 8, 1980.

Questions

AI-generated answers, 27 Sep 2026

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

  • What is the primary function of the Collimax R-182?

    The Collimax R-182 is a manual radiographic collimator designed to serve as an imaging accessory. Its purpose is to control the size and shape of the X-ray beam during diagnostic radiology procedures.

  • How is this device classified for regulatory purposes?

    The Collimax R-182 is classified as a Class II medical device under regulation number 892.1610. It received FDA 510(k) clearance on July 8, 1980, under submission number K801168.

  • Who is the manufacturer of this collimator?

    The Collimax X-Ray Collimator # R-182 is manufactured by Ito X-Ray Corp., located in McHenry, Illinois.