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Model 4100 14 Mev Neutron Gen. Therapy

by The Cyclotron Corp.

510(k) K811778

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 NumberK811778 Date23 Jul 1981ClearedStatusActive

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  • Withdrawn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
IWL
Device Class
Class II
Regulation
21 CFR Part 892.5300
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, Radiation Therapy, Neutron, Medical, as defined in the FDA classification. It is designed for use in radiation therapy applications involving neutron generation.

It is a Class II medical device cleared via FDA 510(k) submission K811778, granted on July 23, 1981, by The Cyclotron Corp. The device is used in radiology and is authorized for marketing in the United States under regulation number 892.5300.

Other devices from The Cyclotron Corp.

Questions

AI-generated answers, 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.

  • What is the Model 4100 used for?

    The Model 4100 is used in radiation therapy applications involving neutron generation, specifically in radiology.

  • Is the Model 4100 a single-use device?

    The device data does not specify if the Model 4100 is single-use or reusable, but it is designed for use in multiple radiation therapy applications.

  • What is the regulatory status of the Model 4100?

    The Model 4100 is cleared via FDA 510(k) submission K811778, granted on July 23, 1981, and is authorized for marketing in the United States under regulation number 892.5300.