(14 days)
The Fuji CR Console is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
The CR Console (Flash IIP) is used by a radiographer to view CR images for final quality assurance (QA) checking and image processing/optimization prior to transfer of those images to external (&A) oncelling and intage problem. Furthermore, when connected to Fuji Image Readers via a network, the CR Console is used to enter patient ID information, exposure information and register Inage Plate (IP) barcode numbers. The CR Console application software runs on an "off-the-shell" personnel computer under the Windows 2000 or Windows XP operating system with a choice of a high resolution monitor (Plus configuration) or standard resolution monitor (Lite configuration) for image display.
The provided text is a 510(k) summary for the Fuji Medical CR Console, Model Flash IIP, which is a medical image processing workstation. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.
However, there is explicitly no mention of acceptance criteria, study design, or performance metrics related to diagnostic accuracy or clinical effectiveness for the device. This document focuses on the technological characteristics and safety information to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific performance criteria through a clinical study.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size, data provenance, number of experts, adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone algorithms.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document does not contain any of this information. It is a regulatory submission focused on demonstrating equivalence based on technological features and safety, not on clinical performance metrics from a study.
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K04 1990
AUG = 6 2004
Image /page/0/Picture/2 description: The image contains the Fujifilm logo. The logo consists of a stylized square shape on the left, followed by the word "FUJIFILM" in bold, sans-serif font. Below the wordmark, there is a line of text that reads "I&I - Imaging & Information" in a smaller font size.
FUJIFILM MEDICAL SYSTEMS
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 AvenueStamford, CT 06902 |
|---|---|
| CONTACT PERSON / TEL NO: | Frank GianelliRegulatory Coordinator |
| DATE SUMMARY PREPARED: | June 11, 2004 |
| ESTABLISHMENT NO.: | 2443168 |
| TRADE/PROPRIETARY NAME: | Fuji Medical CR Console, Flash IIP |
| COMMON/USUAL NAME: | Medical Image Processing Workstation |
| CLASSIFICATION NAME: | Picture archiving and communications system |
| CLASS/PANEL: | Class II, 90-LLZ, 21CFR 892.2050 |
| PREDICATE DEVICE(S): | Fuji CR DMS CRT Image Console HI-C654 (for networks) |
DEVICE DESCRIPTION:
The CR Console (Flash IIP) is used by a radiographer to view CR images for final quality assurance (QA) checking and image processing/optimization prior to transfer of those images to external (&A) oncelling and intage problem. Furthermore, when connected to Fuji Image Readers via a network, the CR Console is used to enter patient ID information, exposure information and register Inage Plate (IP) barcode numbers. The CR Console application software runs on an "off-the-shell" personnel computer under the Windows 2000 or Windows XP operating system with a choice of a high resolution monitor (Plus configuration) or standard resolution monitor (Lite configuration) for image display.
INTENDED USE:
The Fuji CR Console (Flash IIP) is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to (xxcept manimography image, and output the resulting image and exam data for further display, distribution, or archiving.
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Image /page/1/Picture/1 description: The image shows the Fujifilm logo. The logo consists of a stylized graphic to the left of the word "FUJIFILM" in bold, sans-serif font. Below the wordmark is the text "I&I - Imaging & Information" in a smaller, lighter font.
FUJIFILM MEDICAL SYSTEMS USA,
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
TECHNOLOGICAL CHARACTERISTICS:
Fuji CR Console (Flash IIP) is considered comparable and substantially equivalent to the Fuji CR DMS CRT Image Console HI-C654 manufactured by Fuji.
| Feature | CR Console Plus(Flash Plus IIP) | CR Console Lite(Flash Lite IIP) | Fuji HI-C654 |
|---|---|---|---|
| Minimum BasicComputerConfiguration | Computer "Off the Shelf"Desktop or TowerCPU: Pentium 4Bus: ISA/PCIRAM: 512MBHard Drive: 40 GByteFloppy Drive: 3¼"CD-ROMKeyboardMouseBarcode scanner | Computer "Off the Shelf"Desktop or TowerCPU: Pentium 4Bus: ISA/PCIRAM: 512MBHard Drive: 40 GByteFloppy Drive: 3½"CD-ROMKeyboardMouseBarcode scanner | Computer (custom design):DesktopCPU: 68020Bus: Fuji-BusRAM: 5MBHard Drive: 4 GbyteFloppy Drive: 3½"KeyboardMouse |
| Operating SystemSoftware | Microsoft Windows 2000or Windows XP | Microsoft Windows 2000or Windows XP | proprietary |
| Ethernet Capability &Type | Yes: LAN | Yes: LAN | Yes: LAN |
| Image Transfer | via DICOM 3.0 &via Fuji DMS Network | via DICOM 3.0 &via Fuji DMS Network | via Fuji DMS network |
| Image Display | 19" Monochrome 2MP LCDwith Touch screen | 15" color 1MP LCDwith Touch screen | 20" 1MP Monochrome CRT |
| Fuji Image processingfunctions | Yes, enhanced | Yes, enhanced | Yes |
| Image viewing &orientation functions | Yes, enhanced | Yes | Yes |
| Connects to Fuji CRImage Readers | Yes | Yes | Yes |
| Connects to Fuji ImageRecorders (Printers) | Yes | Yes | Yes |
SAFETY INFORMATION:
Fuji CR Console (Flash IIP) introduces no new safety and efficacy issues other than those already identified with the predicate device. The results of a hazard analysis, combined with the appropriate lientifice measures taken indicate that the device is of minor level of concern as per the May 29, 1998 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Fuji CR Console (Flash IIP) comply with the following mandatory and voluntary standards:
- Information Technology Equipment Part 1: General Requirements for Safety UL Standard . 60950
- Information Technology Equipment, Radio Disturbance (Emissions) Characteristics-Limits . and Methods of Measurements, IEC/CISPR 22 (EN55022)
- Information Technology Equipment, Immunity Characteristics-Limits and Methods of . Measurement, IEC/CISPR 24 (EN55024)
- DICOM (Digital Imaging and Communications in Medicine) Developed by the American . College of Radiology and the National Electrical Manufacturers Association.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 6 2004
FUJIFILM Medical Systems USA, Inc. % Mr. William J. Sammons Project Engineer Underwriters Laboratories, Inc. Research Triangle Park Division 12 Laboratory Drive P.O. Box 13995 Research Triangle Park, NC 27709-3995 Re: K041990
Trade/Device Name: Fuji Medical CR Console, Model Flash IIP Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: July 20, 2004 Received: July 23, 2004
Dear Mr. Sammons:
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 for use stated in the encreation 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.
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.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his letter will and in you to organizatial equivalence of your-device of your-device to a legally promance noticated. " 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 If you desire of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, roll and (301) 594-4639. Also, please note the regulation entitled, "Misbranding Other or othernation to the ation" (21CFR Part 807.97) you may obtain. Other general of receive to premainted notifies under the Act may be obtained from the Division of Small intormation on your respondent Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon.
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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Indications For Use
510(k) Number (if known): _ Ko4 1990
Device Name: Fuji CR Console (Flash IIP)
Indications For Use:
The Fuji CR Console is a CR modality workstation intended to associate FCR images (except mammography images) with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving.
X Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
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)
Nancy Bergdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Kc41990
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§ 892.2050 Medical image management and processing system.
(a)
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.(b)
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).