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Gemini Imaging System

by Adac Laboratories

510(k) K013521

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK013521 Date7 Nov 2001ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2451-2012 FDA Class II initiated 21 Aug 2012

    A bolt which attaches the oil accumulator within the gantry may fail, resulting in the oil accumulator detaching from the tube housing assembly within the gantry.

    • Terminated Z-1417-05 FDA Unclassified (pre-2012) initiated 11 Mar 2005

    When two product applications called Flip and Secondary Capture are used together, it is possible for image orientation labels to be incorrect.

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  • Withdrawn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, 24 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 Gemini Imaging System is a Class II CT scanner classified as a System, X-ray, Tomography, Computed. It integrates an ADAC ALLEGRO PET scanner and a Marconi MX8000 CT scanner into a hybrid imaging system used in radiology.

The device is manufactured by Adac Laboratories and was FDA 510(k) cleared on November 7, 2001 under K-number K013521. It is supplied as a system and is intended for use in radiology departments. The device is subject to special controls as a Class II medical device.

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Questions

AI-generated answers, 24 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 Gemini Imaging System used for?

    The Gemini Imaging System is a hybrid imaging system used in radiology departments, integrating PET and CT scanning capabilities to provide combined functional and anatomical imaging for diagnostic purposes.

  • How is the Gemini Imaging System supplied and configured?

    The Gemini Imaging System is supplied as an integrated system combining an ADAC ALLEGRO PET scanner and a Marconi MX8000 CT scanner into a single hybrid imaging unit designed for use in radiology settings.

  • What regulatory pathway was used for the Gemini Imaging System?

    The Gemini Imaging System received FDA 510(k) clearance on November 7, 2001, under K-number K013521, as a substantially equivalent Class II medical device subject to special controls.