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Multiple

by Larson Medical Products, Inc.

510(k) K112460

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 NumberK112460 Date7 Oct 2011ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Multiple is a Class II medical device in the Radiology specialty. It is a linear accelerator used for medical purposes.

The device is intended for use by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic. It received FDA 510(k) clearance under K-number K112460 in 2011 and is manufactured by Larson Medical Products, Inc.

Questions

AI-generated answers, 25 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 MULTIPLE device used for?

    The MULTIPLE device is a linear accelerator intended for use by trained medical professionals to provide stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic.

  • Who manufactures the MULTIPLE device and when was it cleared?

    The MULTIPLE device is manufactured by Larson Medical Products, Inc. and received FDA 510(k) clearance under K-number K112460 in 2011.

  • What regulatory classification and product code apply to the MULTIPLE device?

    The MULTIPLE device is classified as a Class II medical device in the Radiology specialty with product code IYE and regulation number 892.5050.