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Clinac 4/100

by Varian Assoc., Inc.

510(k) K771808

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 NumberK771808 Date19 Oct 1977ClearedStatusActive

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  • Withdrawn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, 28 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 linear accelerator used in medical applications, specifically classified as an Accelerator, Linear, Medical under FDA device classification. It was determined to be substantially equivalent through a traditional 510(k) clearance process.

The Clinac 4/100 received FDA 510(k) clearance under K771808 on October 19, 1977, and is manufactured by Varian Assoc., Inc. It is classified under product code IYE and regulation number 892.5050, with the device falling under the radiology medical specialty and advisory committee classification.

Other devices from Varian Assoc., Inc.

See all devices from Varian Assoc., Inc. →

Questions

AI-generated answers, 28 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 Clinac 4/100 used for?

    The Clinac 4/100 is a linear accelerator used in medical applications, specifically for delivering radiation therapy in oncology treatment. It is classified under the radiology medical specialty and is designed to generate high-energy X-rays or electron beams for targeted tumor treatment, as indicated by its FDA classification as an Accelerator, Linear, Medical.

  • Who manufactures the Clinac 4/100 and where is it made?

    The Clinac 4/100 is manufactured by Varian Assoc., Inc., with the applicant and manufacturer listed as Varian Assoc., Inc. The device’s registration and FEI numbers include multiple entries associated with Varian facilities, and the address on file is 803 N. Front St. Suite 3, Mchenry, IL 60050, United States.

  • How was the Clinac 4/100 cleared for market release?

    The Clinac 4/100 received FDA 510(k) clearance through a traditional submission process under K771808, with a decision date of October 19, 1977. It was determined to be substantially equivalent (SESE) to a legally marketed predicate device, which allowed it to be cleared for commercial distribution without requiring a premarket approval application.