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Quad 1200 Magnetic Resonance Imaging Scanner

by Fonar Corp.

510(k) K951681

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 NumberK951681 Date9 Nov 1995ClearedStatusActive

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  • Withdrawn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
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
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.

The Quad 1200 Magnetic Resonance Imaging Scanner is a nuclear magnetic resonance imaging system. It is designed to produce diagnostic images of the body for use in radiology.

This device is a Class II system that received FDA 510(k) clearance under the reference number K951681. It is manufactured by Fonar Corp. and is intended for clinical use in a radiology setting.

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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 primary clinical use of the Quad 1200?

    The Quad 1200 is a nuclear magnetic resonance imaging system intended for use in radiology settings to produce diagnostic images of the human body.

  • What is the regulatory status of this device?

    The Quad 1200 is a Class II medical device that received FDA 510(k) clearance under reference number K951681.

  • Who is the manufacturer of the Quad 1200?

    This device is manufactured by Fonar Corp., located in Melville, New York.