K Number

Device Name

FUJI COMPUTED RADIOGRAPHY (FCR) CLEARVIEW CS IMAGE READER

Manufacturer

FUJIFILM MEDICAL SYSTEM U.S.A., INC.

Date Cleared

2004-08-25

(28 days)

Product Code

MQB

Regulation Number

892.1680

Intended Use

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

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

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

FCR 9000HQ Image Reader, FCR 5501D Image Reader, FCR 9000 Image Reader

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard digital image processing techniques for X-ray images and does not mention any AI or ML components.

Therapeutic

No
The device is described as an image reader for diagnostic x-ray images, processing and displaying image data, not for treating or preventing disease.

Diagnostic

Yes

The device processes "diagnostic x-ray images of the human body," indicating its role in generating images used for diagnosis, which is a characteristic of a diagnostic device.

SaMD (Software as a Medical Device)

The device description clearly outlines multiple hardware components including an image reader, imaging plates, cassettes, and other physical equipment necessary for capturing and processing x-ray images. While it involves digital processing, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
Device function: The description clearly states that the device processes diagnostic x-ray images of the human body. It captures and processes images generated by external x-ray radiation passing through the body.
No mention of biological samples: There is no mention of the device interacting with or analyzing any biological samples (blood, urine, tissue, etc.).

Therefore, the Fuji Computed Radiography (FCR) ClearView CS Image Reader is a medical imaging device, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

MQB

Device Description

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 (basere si 9) ent geribeer refla .lengis letigib s ot behevnoo neut bas edul

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-Ray

Anatomical Site

Human body

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

FCR 9000HQ Image Reader, FCR 5501D Image Reader, FCR 9000 Image Reader

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
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.(b)
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.

Summary

K042 023

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FUJIFILM MEDICAL SYSTEMS USA, INC.

419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926

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.
419 West Avenue
Stamford, CT 06902 |
|---------------------------|------------------------------------------------------------------------------|
| CONTACT PERSON / TEL NO: | Frank Gianelli
Regulatory Coordinator |
| DATE SUMMARY PREPARED: | June 29, 2004 |
| ESTABLISHMENT NO .: | 2443168 |
| TRADE/PROPRIETARY NAME: | Fuji Computed Radiography (FCR) ClearView CS
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
FCR 5501D Image Reader
FCR 9000 Image Reader |

DEVICE DESCRIPTION:

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THENDED USE:

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

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

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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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

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

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

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