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Matrix LR, LR 22A & LR/Laser Recorder

by Matrix Instruments

510(k) K860776

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 NumberK860776 Date16 Jun 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  • Withdrawn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
LMC
Device Class
Class II
Regulation
21 CFR Part 892.2040
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.

The device is a Camera, Multi Format, Radiological, as defined by its classification name and medical specialty description in Radiology. It is a recorder system comprising the Matrix LR, LR 22A, and LR/Laser components, designed for radiological imaging applications.

It was granted FDA 510(k) clearance under number K860776 on June 16, 1986, with a traditional clearance pathway and a substantially equivalent decision. The device is classified as Class II, product code LMC, and is manufactured by Matrix Instruments in Orangeburg, New York.

Other devices from Matrix Instruments

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 Matrix LR, LR 22A & LR/Laser Recorder used for?

    This device is a recorder system comprising the Matrix LR, LR 22A, and LR/Laser components, designed for radiological imaging applications as a multi-format radiological camera system.

  • What regulatory clearance does the Matrix LR recorder system have?

    The device was granted FDA 510(k) clearance under number K860776 on June 16, 1986, through a traditional clearance pathway with a substantially equivalent decision.

  • Who manufactures the Matrix LR, LR 22A & LR/Laser Recorder and where is it made?

    The device is manufactured by Matrix Instruments in Orangeburg, New York, as indicated in the FDA 510(k) submission and registration details.