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Multiscan 7

by Multiscan, Inc.

510(k) K853852

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 NumberK853852 Date19 Nov 1985ClearedStatusActive

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  • Withdrawn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
ITX
Device Class
Class II
Regulation
21 CFR Part 892.1570
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

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

The Multiscan 7 is a radiology device that has been determined to be substantially equivalent. It is designed for use in radiology applications.

The device is manufactured by Multiscan, Inc. and was authorized through FDA 510K clearance with the product code ITX. It is supplied in various sizes and is intended for use in radiology settings.

Questions

AI-generated answers, 6 Oct 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 Multiscan 7 device used for?

    The Multiscan 7 is a radiology device designed for use in radiology applications. It has been determined to be substantially equivalent and is manufactured by Multiscan, Inc.

  • How is the Multiscan 7 supplied?

    The Multiscan 7 is supplied in various sizes to accommodate different radiology settings and requirements. This allows flexibility in its application across various radiology procedures.

  • What is the regulatory status of the Multiscan 7?

    The Multiscan 7 has received FDA 510K clearance with the product code ITX. It was authorized through the traditional clearance process on November 19, 1985, with the K number K853852.

  • Is the Multiscan 7 a single-use or reusable device?

    The device data does not specify whether the Multiscan 7 is designed for single-use or multiple uses. For information regarding reuse or disposal, please consult the manufacturer's instructions or contact Multiscan, Inc. directly.