FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666

K970293 · Fujifilm Medical System U.S.A., Inc. · LMD · Mar 21, 1997 · Radiology

Device Facts

• Record ID: K970293
• Device Name: FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: LMD · Radiology
• Decision Date: Mar 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2020
• Device Class: Class 1

Intended Use

The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.

Device Story

Device acts as a protocol converter/gateway between proprietary Fuji FCR DMS networks and standard DICOM networks. Input consists of medical image data from FCR readers, workstations, optical disk files, or multiformatters (ultrasound, CT, MRI). Device performs simple image processing: rotation, reversal, and decompression of reversibly compressed data. Output is transmitted to DICOM-compliant networks. Operated by medical personnel in clinical settings; device does not display images for diagnostic interpretation. Provides connectivity for image management; does not control life-sustaining equipment. Benefits include interoperability between proprietary and standard imaging networks. Transmission failures are recoverable via retransmission.

Clinical Evidence

Bench testing only. No clinical data provided. Compliance with UL 1950 Standard for Safety of Information Technology Equipment demonstrated.

Technological Characteristics

Hardware: Sun SPARC Station, 64-bit micro-SPARC II microprocessor, 64MB RAM, 1.5 GB fixed magnetic disk. Connectivity: Proprietary FCR DMS network to ACR/NEMA DICOM network. Functions: DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class. Security: Password-protected operation. Safety: UL 1950 compliant.

Indications for Use

Indicated for use as a communication gateway between proprietary Fuji Computed Radiography (FCR) Data Management System (DMS) networks and standard ACR/NEMA DICOM networks to facilitate medical image data transfer.

Regulatory Classification

Identification

A medical image communications device provides electronic transfer of medical image data between medical devices. It may include a physical communications medium, modems, and interfaces. It may provide simple image review software functionality for medical image processing and manipulation, such as grayscale window and level, zoom and pan, user delineated geometric measurements, compression, or user added image annotations. The device does not perform advanced image processing or complex quantitative functions. This does not include electronic transfer of medical image software functions.

Predicate Devices

• Fuji FCR DMS Optical Disk Image Filing Unit OD-F6X4/L Series (K960326)

Submission Summary (Full Text)

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MAR 21 1997
K970293

# 510(k) Summary
[as required by 21 CFR 807.92]

## Date Prepared [21 CFR 807.92(a)(1)]
January 13, 1997

## Submitter's Information [21 CFR 807.92(a)(1)]
Fuji Medical Systems U.S.A., Inc.
Post Office Box 120035
Stamford, Connecticut 06912-0035
Telephone: [phone]
facsimile: [phone]
Contact: Robert A. Uzenoff

## Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
The device trade name is Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM 666.
The device common name is DICOM Gateway.

## Predicate Device [21 CFR 807.92(a)(3)]
Fuji views the subject device as an accessory to the predicate device, the Fuji FCR DMS Optical Disk Image Filing Unit OD-F6X4/L Series. FDA assigned the predicate to regulatory class II citing 21 CFR § 892.1750.
FDA’s accession number for the premarket notification for the predicate device is K960326. FDA cleared the marketing of the predicate device in a letter dated March 7, 1996.

## Description of the Device [21 CFR 807.92(a)(4)]
The device consists of a computer (console, display, keyboard, and mouse) and software. The device connects Fuji’s proprietary Data Management System (DMS) medical image data network to networks complying with the American College of Radiology (ACR) and National Association of Electrical Manufacturers (NEMA) Digital Imaging and Communications in Medicine (DICOM) standard.
The Fuji network may contain Fuji Computed Radiography (FCR) image readers, workstations, optical disk files, multiformatters, and hard copy image printers. The multiformatters may receive image data from other modalities such as ultrasound, computed tomography (CT), and magnetic resonance imaging (MRI).
The FCR/DICOM Gateway Unit CR-DM666 is a DICOM CR-Storage Service Class (SCU) and DICOM SC-Storage Service Class device.

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FCR DICOM Gateway
510(k)
1997 January 24

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FDA 510(k) Premarket Notification
Fuji Computed Radiography FCR/DICOM Gateway Unit CR-DM666
January 23, 1997

## Intended Use [21 CFR 807.92(a)(5)]

The indications for use of the FCR/DICOM Gateway Unit CR-DM666 is to serve as a gateway between a proprietary FCR DMS network and a standard ACR/NEMA Digital Imaging and Communications (DICOM) network.

## Technological Characteristics [21 CFR 807.92(a)(6)]

There device does not contact the patient, nor does it control any life sustaining devices. Images crossing the gateway are interpreted by a physician, providing ample opportunity for competent human intervention.

The subject and predicate devices are both based on an industry-standard Sun SPARC Station with 64-bit micro-SPACR II microprocessor, standard 64MB RAM, and 1.5 GB fixed magnetic disk storage. Both use a CRT for character display as part of the user interface. No image data is displayed.

Unlike the predicate, the subject device may perform simple image processing: image rotation, reversal, and the decompression of reversibly compressed (ratio: ½) image data. No compressed image data is sent to the DICOM network.

Data loss may occur because of hardware failure (e.g. hard disk crash) or operator error (e.g. turning off power during hard disk access). However, unlike the predicate, as the device is not the data source, the gateway transmission can be completed after correcting the cause of the failure. Operation is password protected to prevent unauthorized use.

## Performance Data [21 CFR 807.92(b)(1)]

The subject and predicate devices both use standard data communications controls to detect and correct errors.

The device complies with the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.

## Conclusion [21 CFR 807.92(b)(3)]

As is the case with the predicate, the subject device have no patient contact. Nor do the subject device control, monitor, or effect any devices directly connected to or effecting a patient. The images relayed by the subject devices are observed by medical personnel, offering ample opportunity for competent human intervention in the event of a failure.

The device functions as a communications protocol converter, and not as a permanent image store. Device failures which might result in a failed transmission may be recovered from by retransmission after correcting the problem. Passwords are required for operation to protect against unauthorized use.

The subject and predicate share the same certification of conformance to the UL 1950 Standard for Safety of Information Technology Equipment, Including Electrical Business Equipment.

We conclude that the subject devices are as safe and effective as the predicate device.

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FCR DICOM Gateway
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