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GE Advantage DICOM CR Reprocessing Station

FDA 510(k)

Class II (US FDA 510(k))

510(k) K955185

by Ge Medical Systems

Identifiers

510(k) Number
K955185 FDA 510(k)
FDA Product Code
LLZ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 892.2050 FDA 510(k)
Regulation Number
892.2050 FDA 510(k)
Advisory Committee
Radiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

This device is a system for image processing in radiology, classified under the LLZ product code as a radiological image processing system. It is designed for the reprocessing of computed radiography (CR) images using DICOM standards.

It is supplied as a Class II medical device with traditional 510(k) clearance (K955185) granted by the FDA on January 3, 1996. The device is used in radiology settings for image processing and is manufactured by GE Medical Systems in Waukesha, Wisconsin.

Frequently asked questions

What is the GE Advantage DICOM CR Reprocessing Station used for?

This device is designed for the reprocessing of computed radiography (CR) images using DICOM standards, enabling image processing in radiology settings as a radiological image processing system under product code LLZ.

How is the GE Advantage DICOM CR Reprocessing Station supplied and what is its regulatory status?

It is supplied as a Class II medical device with traditional 510(k) clearance (K955185) granted by the FDA on January 3, 1996, indicating it was found substantially equivalent to a legally marketed predicate device.

Who manufactures the GE Advantage DICOM CR Reprocessing Station and where is it made?

The device is manufactured by GE Medical Systems in Waukesha, Wisconsin, United States, as indicated by the applicant and address details in the FDA 510(k) submission.

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: K955185 FDA 510(k) - GE ADVANTAGE DICOM CR REPROCESSING STATION, GE Advantage DICOM CR Reprocessing Station - allmed.wiki, GE ADVANTAGE DICOM CR REPROCESSING STATION by GE MEDICAL SYSTEMS | FDA ...

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) K955185 24 fields · synced Oct 6, 2026