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Accuimage Smartgate Upgrade

by Accuimage Diagnostics Corp.

510(k) K012106

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 NumberK012106 Date25 Sep 2001ClearedStatusActive

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  • Withdrawn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
JAK
Device Class
Class II
Regulation
21 CFR Part 892.1750
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

Accuimage Smartgate Upgrade is a computed tomography (CT) scanner. It is substantially equivalent to a predicate device and cleared for use in radiology.

The device is supplied as a Class II medical device with FDA 510(k) clearance under K012106. It is manufactured by Accuimage Diagnostics Corp. and intended for use in computed tomography imaging.

Other devices from Accuimage Diagnostics Corp.

Questions

AI-generated answers, 1 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 Accuimage Smartgate Upgrade used for?

    The Accuimage Smartgate Upgrade is a computed tomography (CT) scanner intended for use in radiology imaging, as it is substantially equivalent to a predicate device cleared for this purpose.

  • How is the Accuimage Smartgate Upgrade supplied and what is its regulatory status?

    The device is supplied as a Class II medical device with FDA 510(k) clearance under K012106, indicating it underwent a traditional review process and was found substantially equivalent to a legally marketed device.

  • Who manufactures the Accuimage Smartgate Upgrade and where is it made?

    The Accuimage Smartgate Upgrade is manufactured by Accuimage Diagnostics Corp., located at 16303 Panoramic Way, San Leandro, CA 94578, United States.