Skip to content

Ralco Collimator, Automatic Radiographic

by Tecnomed, Inc. 510(k)

Active United States

510(k) K820306

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK820306 Date5 Mar 1982ClearedStatusActive

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  • Withdrawn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 6 Oct 2026.

Specification

510(k)

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

Overview

AI-generated summary, 22 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 Ralco Collimator, Automatic Radiographic is a beam limiting device for diagnostic X-ray systems. It is classified under product code KPW as a Class II medical device with special controls.

This device received FDA 510(k) clearance K820306 on March 5, 1982, following a traditional submission review. It is manufactured by Tecnomed, Inc. in McHenry, Illinois, and is intended for use in radiology applications.

Other devices from Tecnomed, Inc.

See all devices from Tecnomed, Inc. →