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Mevassist(Setup Controller)

by Magus Microcontrollers, Inc.

510(k) K852609

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 NumberK852609 Date6 Feb 1986ClearedStatusActive

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  • Withdrawn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, 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.

MEVASSIST(SETUP CONTROLLER) is a Class II medical device classified as an Accelerator, Linear, Medical under FDA device classification. It is substantially equivalent to a legally marketed device and was cleared via the traditional 510(k) pathway.

The device is used in radiology and was manufactured by Magus Microcontrollers, Inc. It received FDA 510(k) clearance under K852609 on February 6, 1986, with product code IYE and regulation number 892.5050.

Other devices from Magus Microcontrollers, Inc.

  • Mevacheck

    Class II

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 MEVASSIST(SETUP CONTROLLER) used for?

    The MEVASSIST(SETUP CONTROLLER) is a Class II medical device classified as an Accelerator, Linear, Medical, used specifically in radiology settings for medical procedures.

  • What is the regulatory status of the MEVASSIST(SETUP CONTROLLER)?

    The MEVASSIST(SETUP CONTROLLER) received FDA 510(k) clearance under K852609 on February 6, 1986, with product code IYE and regulation number 892.5050. It is classified as substantially equivalent to a legally marketed device.

  • Who manufactures the MEVASSIST(SETUP CONTROLLER)?

    The MEVASSIST(SETUP CONTROLLER) is manufactured by Magus Microcontrollers, Inc., located at 4252 Commerce Cir., Victoria, B.C., Canada V8z4mz.

  • What is the classification of the MEVASSIST(SETUP CONTROLLER)?

    The MEVASSIST(SETUP CONTROLLER) is classified as a Class II medical device under the FDA device classification system, specifically as an Accelerator, Linear, Medical.