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TOMO-LINK

FDA 510(k)

Class II (US FDA 510(k))

510(k) K944967

by Ge Medical Systems

Identifiers

510(k) Number
K944967 FDA 510(k)
FDA Product Code
IZF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.1740 FDA 510(k)
Regulation Number
892.1740 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

TOMO-LINK is a System, X-ray, Tomographic device used for medical imaging purposes. It is designed to produce tomographic images using X-ray technology.

The TOMO-LINK is manufactured by GE Medical Systems and received FDA 510(k) clearance on December 9, 1994. It is classified as a Class II device under product code IZF with regulation number 892.1740. The device is intended for use in radiology settings.

Frequently asked questions

What is the TOMO-LINK device used for?

The TOMO-LINK is a System, X-ray, Tomographic device designed for medical imaging purposes. It produces tomographic images using X-ray technology and is intended for use in radiology settings to assist in diagnostic imaging procedures.

What is the regulatory status of the TOMO-LINK device?

The TOMO-LINK received FDA 510(k) clearance on December 9, 1994, and is classified as a Class II device under product code IZF with regulation number 892.1740. It was determined to be substantially equivalent to other legally marketed devices.

Who manufactures the TOMO-LINK device and where is it located?

The TOMO-LINK is manufactured by GE Medical Systems, with their headquarters located at P.O. Box 414, Milwaukee, WI 53201, United States. The contact person for this device is Larry A Kroger.

What advisory committee reviewed the TOMO-LINK device?

The TOMO-LINK device was reviewed by the Radiology Advisory Committee (RA), which provides expert advice to the FDA on matters related to radiological devices and their safety and effectiveness.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: K944967 - TOMO-LINK | FDA 510 (k) | GE Medical Systems, TOMO-LINK (K944967) — FDA 510(k) | Innolitics, TOMO-LINK 510 (k) K944967 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Ge Medical Systems

Sources (1)

  • FDA 510(k) K944967 24 fields · synced Oct 6, 2026