FUJIFILM FCR VIEW, MODEL CR-VW674

K081308 · Fujifilm Medical Systems U.S.A, Inc. · LLZ · Jun 4, 2008 · Radiology

Device Facts

• Record ID: K081308
• Device Name: FUJIFILM FCR VIEW, MODEL CR-VW674
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Jun 4, 2008
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.2050
• Device Class: Class 2

Intended Use

FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.

Device Story

FCRView is an image viewer workstation for managing CR modality images; integrates viewing, archiving, and distribution. Inputs include FCR reader images, DICOM multi-modality images, ultrasound images, and general-purpose images (e.g., JPEG). Device applies image processing to facilitate diagnosis; provides tools for image reading; includes built-in CDR/DVDR archiving and output system. Used in clinical settings by healthcare professionals to manage patient/exam information and display images. Output facilitates clinical decision-making by providing processed images for review. Benefits include centralized image management and workflow integration.

Clinical Evidence

Bench testing only. Device evaluated for electrical, mechanical, and radiation safety; conforms to applicable medical device safety standards. No clinical data provided.

Technological Characteristics

Image viewer workstation; supports DICOM connectivity; includes built-in archiving and CDR/DVDR output. Software-based image processing for diagnostic facilitation. No specific materials or hardware standards cited.

Indications for Use

Indicated for clinical use as a workstation to associate FCR images with patient/exam data, process images to facilitate diagnosis, display images, and output data for distribution or archiving. Supports DICOM multi-modality image viewing. Contraindicated for primary diagnosis of mammography images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Predicate Devices

• Fujifilm CR Console (K041990)
• FCR AXON

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the logo, the words "Fujifilm Medical Systems, USA" are written in a smaller font.

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K08/308

JUN - 4 2008

# SECTION 5

# SPECIAL 510(K) SUMMARY

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FUJIFILM FCRView Special 510(k)

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Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the logo, the words "Fujifilm Medical Systems, USA" are written in a smaller, sans-serif font.

Special 510(k) Summary

Date: May 5, 2008

### Contact Person:

| Name: | Debbie Peacock |
|------------|------------------------|
| Title: | Regulatory Coordinator |
| Telephone: | [phone] |
| Facsimile: | [phone] |

## ldentification of Device:

| Proprietary/Trade Name: | FCR View |
|-------------------------|----------|
| Classification: | Class II |
| Classification Name: | PACS |
| Product Code: | LLZ |
| Common Name: | PACS |

#### INDICATIONS FOR USE l.

FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.

#### -DEVICE DESCRIPTION

The FCRView is an image viewer workstation that offers a fully integrated solution for managing the CR modality, as well as built-in viewing, archiving and distribution capabilities. It can import and display ultrasonic images and generalpurpose images from digital cameras, and other general purpose images (such as jpeg images) on screen and/or print via a typical paper printer. Images captured on the FCR reader unit are displayed on the FCRView along with typical tools to aid in reading the images. The FCRView also incorporates a builtin archiving and CDR/DVDR image output system.

A summary description of the key features of the system follows:

- FCRView (CR VW 674) is a modality and Image Viewing workstation . intended to associate FCR images (except mammography images) with patient and exam information, and apply image processing to facilitate diagnosis.
- . Currently interfaces with Fuji CR and also accepts images from other modalities such as Ultrasound as well as general purpose (jpg) images.
- . FCRView incorporates a built-in archiving and CDR/DVDR image output svstem

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Image /page/2/Picture/0 description: The image shows the Fujifilm logo. The logo is in black and consists of the word "FUJIFILM" in large, bold letters. Below the main logo, in a smaller font, is the text "Fujifilm Medical Systems, USA".

#### III. SUMMARY OF STUDIES

The FCRView has been evaluated for electrical, mechanical and radiation safety and conforms with applicable medical device safety standards.

#### IV. SUBSTANTIAL EQUIVALENCE

The Fujifilm FCR View covered by this submission is a modification to and is substantially equivalent the Fujifilm CR Console (K041990) cleared by CDRH on 08/06/04 and the FCR AXON (Class I Exempt) image management and communication device. The combination of both Fujifilm devices utilizes similar technology and materials, comparable safety and effectiveness features, and are similar in design and construction to our proposed modified device. .

The Indications for Use for the proposed device is the same as the combined Indications for Use of the Fuji CR Console and the FCR AXON (Exempt). In addition, the labeling for all three devices are the same.

#### V. CONCLUSION

The FCRView is a modification to and substantially equivalent to our currently cleared CR Console (IIP) along with the image archive and retrieval functionality found in our Class I AXON product, and conforms to applicable medical device safety standards. The modifications do not change the indications for use, introduce new technology or significantly affect the safety or effectiveness.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

## DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN - 4 2008

Ms. Debbie Peacock Regulatory Coordinator FUJIFILM Medical Systems USA 419 West Avenue STAMPFORD CT 06902

Re: K081308

Trade/Device Name: FCRView Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 5, 2008 Received: May 9, 2008

### Dear Ms. Peacock:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050,

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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|-----------------|----------------------------------|--------------|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrb/industry/support/index.html.

Sincerely yours,

Nancy Bragdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the Fujifilm logo in bold, black letters. Below the logo, in a smaller font, is the text "Fujifilm Medical Systems, USA". The logo is a stylized version of the company name, with a distinctive design.

## Indications for Use

510(k) Number (if known):

Device Name: FCRView

Indications for Use:

FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)

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## Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

FUJIFILM FCRView Special 510(k)