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HiSpeed Advantage II

by GE Medical Systems

510(k) K940606

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 NumberK940606 Date23 Aug 1994ClearedStatusActive

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  • Withdrawn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, 19 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 HiSpeed Advantage II is a computed tomography x-ray system, classified under product code JAK. It is designed to generate cross-sectional images of the body through computer reconstruction of axial x-ray transmission data, enabling detailed diagnostic imaging for radiology applications.

This device is intended for use in radiology settings and has received FDA 510(k) clearance under K-number K940606, classified as a Class II device under Special Controls. It is not specified as single-use or reusable, nor is its sterility or MRI safety status detailed in the available data. The device was submitted to the FDA Radiology Advisory Committee in 1994 and remains authorized for use as a diagnostic imaging tool.

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Questions

AI-generated answers, 19 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 type of imaging does the HiSpeed Advantage II provide?

    The HiSpeed Advantage II is a computed tomography (CT) x‑ray system that creates cross‑sectional images by reconstructing axial x‑ray transmission data, allowing detailed diagnostic imaging in radiology. This answer is based on the description stating it generates cross‑sectional images through computer reconstruction of axial x‑ray data.

  • In which clinical setting is the HiSpeed Advantage II intended to be used?

    The device is intended for use in radiology settings, as explicitly noted in the description that it is designed for diagnostic imaging applications within radiology. This conclusion follows directly from the statement that it is “intended for use in radiology settings.”

  • Is the HiSpeed Advantage II a single‑use or reusable system, and is sterility addressed?

    The available data do not specify whether the system is single‑use or reusable, nor do they provide any information on sterility. Because the description explicitly mentions that sterility and single‑use status are not detailed, we must acknowledge the lack of that information rather than assume any characteristic.

  • What regulatory pathway was used for the HiSpeed Advantage II’s market clearance?

    The HiSpeed Advantage II received FDA 510(k) clearance (K940606) as a Class II device under Special Controls, using the Traditional clearance type. This is derived from the “AUTHORIZATIONS: FDA_510K” line and the specifications listing clearance_type as Traditional and decision_description as Substantially Equivalent.