FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

K042023 · Fujifilm Medical System U.S.A., Inc. · MQB · Aug 25, 2004 · Radiology

Device Facts

• Record ID: K042023
• Device Name: FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: MQB · Radiology
• Decision Date: Aug 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The indications for use of the Fuji Computed Radiography (FCR) ClearView CS Image Reader are the identification, capture, digitization, and processing of diagnostic x-ray images of the human body, and associating patient and exam identification with the images.

Device Story

FCR ClearView CS is a computed radiography image reader used in clinical settings to digitize x-ray images. The system utilizes photostimulable phosphor imaging plates (IPs) housed in cassettes; these plates capture x-ray energy during standard radiographic exposure. The cassette is manually inserted into the reader, which automatically extracts the IP and scans it with a laser beam. The resulting photostimulable luminescence is collected, sampled, and converted into a digital signal by a photo-electron multiplier. The device associates this digital image data with patient and exam identification. The processed images are output to workstations, monitors, or hard-copy printers for clinician review. By replacing traditional film-screen systems with digital capture, the device facilitates efficient image management, storage, and diagnostic review, potentially improving workflow and diagnostic accuracy for healthcare providers.

Clinical Evidence

Bench testing only. The device was evaluated through technical performance testing, including image quality assessment, processing time, and throughput comparisons against predicate FCR systems. No clinical studies were required or performed.

Technological Characteristics

Cassette-based computed radiography reader. Uses photostimulable phosphor imaging plates (IPs) and laser diode (675 nm) scanning. Employs photo-electron multiplier for signal conversion. 10-bit gray scale (1024 levels). Dimensions: 950x750x1760 mm; Weight: 350 kg. Connectivity: Network interface for image output to workstations/printers. Standalone operation with manual cassette insertion.

Indications for Use

Indicated for the identification, capture, digitization, and processing of diagnostic x-ray images of the human body for patients requiring radiographic imaging.

Regulatory Classification

Identification

A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

• FCR 9000HQ Image Reader
• FCR 5501D Image Reader
• FCR 9000 Image Reader

Submission Summary (Full Text)

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K042 023

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### FUJIFILM MEDICAL SYSTEMS USA, INC.

419 WEST AVENUE STAMFORD, CT 06902 Telephone: [phone] Fax: [phone]

# 510(K) Summary

In accordance with the requirements of the Safe Medical Device Act, FUJIFILM Medical Systems, USA, Inc. herewith submits a 510(K) summary of safety and effectiveness for the following device.

| SUBMITTER NAME / ADDRESS: | FUJIFILM Medical Systems, USA, Inc.<br>419 West Avenue<br>Stamford, CT 06902 |
|---------------------------|------------------------------------------------------------------------------|
| CONTACT PERSON / TEL NO: | Frank Gianelli<br>Regulatory Coordinator |
| DATE SUMMARY PREPARED: | June 29, 2004 |
| ESTABLISHMENT NO .: | 2443168 |
| TRADE/PROPRIETARY NAME: | Fuji Computed Radiography (FCR) ClearView CS<br>Image Reader (CR-IR363) |
| COMMON/USUAL NAME: | Computed Radiography Image Reader |
| CLASSIFICATION NAME: | Solid State X-Ray Imager |
| CLASS/PANEL: | Class II, 90-MQB, 21CFR 892.1650 |
| PREDICATE DEVICE(S): | FCR 9000HQ Image Reader<br>FCR 5501D Image Reader<br>FCR 9000 Image Reader |

#### DEVICE DESCRIPTION:

A Fuil Computed Radiography (FCR) system typically consists of an image reader (IR), patient ID terminal, imaging plates (IPs), IP cassettes, interface board, positioning monitor, laser printer for hard copy output, and optionally an image workstation, optical disk file, and network interface. This notification is for the image reader and associated imaging plates (IPs). IPs are used as twodimensional radiation detectors in place of radiographic film and intensifying screens to capture a portion of the projected x-ray patient image. In the image reader, the captured image data is associated electronically with patient and exam identification data and the latent image is read by laser emission by the phenomenon of photostimulable luminescence. The photostimulated fuminescence is then collected, sampled, and digitized. The image data is then digitally processed according to exam and user-specified parameters and may be displayed on a CRT monitor to confirm patient positioning, printed by a hard copy device (such as laser printer, or dry printer), or output to a workstation, optical disk file, or other destination. The device performs no lossy compression of image data.

FCR ClearView CS consists of an Image Reader and Imaging Plates of various sizes and types (described below). The Image Reader is casselle-based. The IP is placed into a cassette and exposed using standard x-ray equipment. The cassette containing the exposed image plate is then manually inserted into the ClearView CS Image Reader. The image reader automatically removes the IP from the cassette and moves the IP to the reading position where it is scanned by a laser beam. The luminescence from the IP is then converted to an electrical signal by a pholoelectron multiplier

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| PARAMETER | FCR 3000 | FCR 5501D | FCR 9000MQ | FCR ClearView CS |
|---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <b>Image Recording</b> | Digital Data (from Console) | Digital Data (from Console) | Digital Data (from Console) | Digital Data (from Console) |
| <b>Patient Identification</b> | | | | |
| <b>Recording Method</b> | Photostimulable Luminescence | Photostimulable Luminescence | Photostimulable Luminescence | Photostimulable Luminescence |
| <b>No. of Imaging Plates/Cassette Slots</b> | Four Cassette slots! | Two Built-in Imaging Plates | One Cassette slot | One Cassette slot |
| <b>Image plate types and sizes</b> | ST-VI 14"×17",<br>14"×14",<br>10"×12",<br>8"×10" | ST-55BD 460×510 mm (usable area) | ST-VN 14"×17",<br>14"×14",<br>10"×12",<br>8"×10" | ST-VN 14"×17",<br>14"×14",<br>10"×12",<br>8"×10"<br>HR-V 18"x10" |
| <b>Image Reading</b> | | | | |
| <b>Reading Method</b> | HR-V 24cm×30cm,<br>18cm×24cm | | HR-V 24cm×30cm,<br>18cm×24cm | HR-V 24cm×30cm,<br>18cm×24cm<br>HR-BD 24cm×30cm,<br>18cm×24cm |
| <b>Reading</b> | Raster Scan (ST/HR), Raster<br>Scan with dual-side<br>detector(HR-80) | Raster Scan with dual-side<br>detector | Raster Scan | Raster Scan |
| <b>Reading Laser</b> | Laser Diodes (660 nm) | Laser Diodes (680 nm) | Laser Diodes (675 nm) | Laser Diodes (675 nm) |
| <b>Sampling Raster</b> | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) |
| <b>Gray Scale</b> | IP Reading Area Pixels/mm | IP Reading Area Pixels/mm | IP Reading Area Pixels/mm | IP Reading Area Pixels/mm |
| | ST-VI 14"×17" 10<br>ST-VI 14"×14" 10<br>ST-VI 10"×12" 10<br>ST-VI 8"×10" 10<br>HR-V 24cm×30cm 10<br>HR-V 18cm×24cm 10<br>HR-BD 24cm×30cm 20<br>HR-BD 18cm×24cm 20 | ST-55BD 17x17 in 10<br>ST-55BD 14x17 in. 10<br>ST-55BD 14x14 in. 10<br>ST-55BD 10x12 in. 10<br>ST-55BD 8x10 in 10<br>ST-55BD 18x43 cm 10 | ST-VN 14"×17" 10<br>ST-VN 14"×14" 10<br>ST-VN 10"×12" 10<br>ST-VN 8"×10" 10<br>HR-V 8"×10" 10 | ST-VN 14"×17" 5<br>ST-VN 14"×14" 5<br>ST-VN 10"×12" 6.7<br>ST-VN 8"×10" 10<br>HR-V 8"×10" 10 |
| <b>Physical</b> | | | | |
| <b>WxHxD (mm)</b> | 655×740×1480 mm | 1170×800×1800 | 950×750×1760 mm | 950×750×1760 mm |
| <b>Weight (kg)</b> | 285 kg | 540 kg | 350 kg | 350 kg |
| <b>Throughput (Approximate)</b> | 122 IP's/hr | 150 IP's/hr | 75 IP's/hr | 110 IP's/hr |
| <b>Processing Time -14"×14" IP</b> | 53 seconds | 88 seconds | 142 seconds | 105 seconds |

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Image /page/2/Picture/0 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a stylized image of an eagle with its wings spread, enclosed within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

FUJIFILM Medical Systems USA, Inc. % Mr. William J. Sammons Project Engineer Underwriters Laboratories, Inc. 12 Laboratory Drive, P.O. Box 13995 Research Triangle Park, NC 27709-3995

AUG 23 2013

Re: K042023

Trade/Device Name: Fuii Computed Radiography (FCR) Clear View CS Image Reader (CR-IR363) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: August 10, 2004 Received: August 11, 2004

Dear Mr. Sammons:

This letter corrects our substantially equivalent letter of August 25, 2004.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Mdrrj Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indications For Use

510(k) Number (if known): K042023

Device Name: FCR ClearView CS Image Reader (CR-IR363)

Indications For Use:

The indications for use of the Fuji Computed Radiography (FCR) ClearView CS Image The Intolcations for abover the identification, capture, digitization, capture, digitization, and Reader with initials frials (1)
processing of diagnostic x-ray images of the human body, and associating patient and exam identification with the images.

Prescription Use _ X (Part 21 CFR 801 Subpart D) ANDIOR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Seymore

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ivision of Reproductive, Abdominal, and Radiological De 510(k) Number

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