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Upscan

by Merlin Engineering Works, Inc.

510(k) K933512

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 NumberK933512 Date19 Apr 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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
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.

The Upscan is a System, X-Ray, Stationary, used in radiology. It is a Class 2 device.

The Upscan is supplied with FDA 510K authorization, and its regulation number is 892.1680. The device has a product code of KPR, and its medical specialty description is Radiology. The Upscan is manufactured by Merlin Engineering Works, Inc.

Other devices from Merlin Engineering Works, Inc.

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    Class I

  • Upscan 120

    Class II

  • Downscan 120

    Class II

  • Uniscan

    Class I

See all devices from Merlin Engineering Works, 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 Upscan used for?

    The Upscan is used in radiology for X-ray imaging, providing diagnostic capabilities for medical professionals.

  • What is the regulatory status of the Upscan?

    The Upscan has been authorized by FDA 510K, with a regulation number of 892.1680, and is classified as a Class 2 device.

  • Who manufactures the Upscan?

    The Upscan is manufactured by Merlin Engineering Works, Inc., with a contact person of Robert Van Walelden.

  • What is the product code of the Upscan?

    The Upscan has a product code of KPR, indicating its classification as a radiology device.