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Linear Accelerator Collimator

by Medical Equipment Development Co., Inc.

510(k) K911973

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK911973 Date15 Oct 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 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  • Withdrawn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
IYE
Device Class
Class II
Regulation
21 CFR Part 892.5050
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 Linear Accelerator Collimator is a Class II medical device that produces high energy charged particles such as electrons and protons for use in radiation therapy. It is part of a system that may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

This device is manufactured by Medical Equipment Development Co., Inc. and is supplied as a single-use or reusable device depending on the specific model. It is used in radiology settings and has FDA 510(k) clearance with the number K911973, issued in 1992. The device is stored according to the manufacturer's specifications and is regulated under product code IYE.

Other devices from Medical Equipment Development Co., Inc.

Questions

AI-generated answers, 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.

  • What is the Linear Accelerator Collimator used for?

    The Linear Accelerator Collimator is a Class II medical device that produces high energy charged particles such as electrons and protons for use in radiation therapy. It is part of a system that may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.

  • Is the Linear Accelerator Collimator single-use or reusable?

    The Linear Accelerator Collimator is supplied as either a single-use or reusable device depending on the specific model. The manufacturer offers different models with different usage specifications to meet various clinical needs.

  • What are the storage requirements for the Linear Accelerator Collimator?

    The Linear Accelerator Collimator should be stored according to the manufacturer's specifications. Proper storage conditions help maintain the device's functionality and longevity for clinical use in radiology settings.

  • What is the regulatory status of the Linear Accelerator Collimator?

    The Linear Accelerator Collimator has FDA 510(k) clearance with the number K911973, issued in 1992. It is regulated under product code IYE and is classified as a Class II medical device.