(14 days)
The indications for use of the Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images, and associating palient and exam identification with the images.
A Fuji Computed Radiography (FCR) system typically consists of an image reader (IR), palient ID terminal, imaging plates (IPs), IP cassettes, interface board, positioning monitor, laser printer for hard copy oulput, and optionally an image workstation, optical disk file, and network interface. This notification is for the image reader and associated imaging plates. 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 space. 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 collected, detected, 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 Velocity consists of an Image Reader and an Imaging Plate (described below). The Image Reader is cassetteless because the Image Plate is built into the upright exam stand configuration of the FCR Velocity Image Reader. Imaging plates are exposed via conventional X-ray devices. The Xray irradiated IP is then moved from the exposure position to the reading position, and images are read. After reading, the IP is erased, and moved to the exposure position again.
As with other FCR image readers, the FCR Velocity will feature a photostimulable phosphor imaging plate (IP) composed of europium activated barium fluorohalaid compounds in a crystal form held in an organic binder. The IP used with the subject device will have a rigid substrate, which enables it to be held in a constant plane. IPs are used as two-dimensional radiation detectors in place of radiographic film and intensitying screens to capture a portion of the projected x-ray palient image in space. 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 luminescence is 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.
This document describes the Fuji Computed Radiography (FCR) Velocity Image Reader, a medical device for capturing and processing diagnostic x-ray images. The provided text, however, focuses heavily on outlining the device's technical specifications, intended use, and substantial equivalence to a predicate device, rather than detailing specific clinical acceptance criteria or a comprehensive study demonstrating its performance.
Based on the information provided, here's what can be extracted and what is missing:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implied through the comparison with the predicate device, FCR 9501-HQ. The underlying assumption for "acceptance" is that the FCR Velocity performs equivalently or better than the predicate device across various technical parameters. There are no explicit clinical performance metrics (e.g., diagnostic accuracy, sensitivity, specificity) stated as acceptance criteria in this document.
| Acceptance Criterion (Implied/Technical) | Reported Device Performance (FCR Velocity) | Predicate Device Performance (FCR 9501-HQ) |
|---|---|---|
| Image Recording | ||
| Patient Identification | Digital Data (from Console) | Digital Data (from Console) |
| Recording Method | Photostimulable Luminescence | Photostimulable Luminescence |
| No. of Imaging Plates Used | One Built-in Imaging Plate | Four Built-in Imaging Plates |
| Imaging Plate Size | 497x456 mm | 495x377 mm |
| Image Reading | ||
| Reading Laser | Laser Diodes (658 nm) | He-Ne Laser (675 nm) |
| Gray Scale | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) |
| Sampling Raster | 10 Pixels/mm (for various IP sizes: 17x17 in., 17x14 in., 14x17 in., 14x14 in., 10x12 in., 12x10 in., 8x10 in., 10x8 in., 18x43 cm) | 10 Pixels/mm (for various IP sizes: 14x17 in., 14x14 in., 10x12 in., 8x10 in.) |
| Physical | ||
| WxHxD (mm) | 645x1835x450 (Image Reader) | 1163x1733x935 (Image Reader) |
| Weight (kg) | 220 | 580 |
| Throughput (Approximate) | 240 14x17 in. IP's/hr. | 80 14x14 in. IP's/hr |
| Processing Time | 80 seconds | 132 seconds |
Missing Information Regarding Device Performance Study:
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical performance study with explicit acceptance criteria for diagnostic efficacy. Therefore, much of the requested information about a specific study proving the device meets acceptance criteria is not present.
- Sample size used for the test set and the data provenance: Not mentioned. The document primarily focuses on technical specifications and comparison to a predicate device.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. No clinical test set or ground truth establishment is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is an imaging reader, not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers improving with AI assistance would not be applicable in this context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. The device is an image reader, not an algorithm for standalone diagnostic performance. It captures and processes images for human interpretation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not mentioned. No clinical ground truth is described.
- The sample size for the training set: Not applicable. This device is an image capture and processing system, not a machine learning model that requires a training set in the conventional sense.
- How the ground truth for the training set was established: Not applicable, as there is no training set in the context of machine learning.
Summary of What is Provided:
The document details the technical specifications of the FCR Velocity and compares them to its predicate device, the Fuji FCR 9501-HQ. The "acceptance criteria" here are implied by its substantial equivalence to the legally marketed predicate device, indicating that its technical performance is at least comparable and that it does not introduce new safety and efficacy issues. The compliance with various mandatory and voluntary standards (21 CFR 1040.10, 21 CFR 1020.30, UL Standard 60601-1, IEC 60601-1-2) also serves as a form of acceptance criteria for safety and electrical performance.
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NOV 26 2003
1&1-Imaging & Information
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 AvenueStamford, CT 06902 |
|---|---|
| CONTACT PERSON / TEL NO: | Frank GianelliRegulatory CoordinatorTel No: (203) 602-3774 |
| DATE SUMMARY PREPARED: | August 21, 2003 |
| ESTABLISHMENT NO.: | 2443168 |
| TRADE/PROPRIETARY NAME: | Fuji Computed Radiography (FCR) Velocity |
| 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): | Fuji FCR 9501-HQ |
DEVICE DESCRIPTION:
A Fuji Computed Radiography (FCR) system typically consists of an image reader (IR), palient ID terminal, imaging plates (IPs), IP cassettes, interface board, positioning monitor, laser printer for hard copy oulput, and optionally an image workstation, optical disk file, and network interface. This notification is for the image reader and associated imaging plates. 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 space. 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 collected, detected, 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 Velocity consists of an Image Reader and an Imaging Plate (described below). The Image Reader is cassetteless because the Image Plate is built into the upright exam stand configuration of the FCR Velocity Image Reader. Imaging plates are exposed via conventional X-ray devices. The Xray irradiated IP is then moved from the exposure position to the reading position, and images are read. After reading, the IP is erased, and moved to the exposure position again.
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Image /page/1/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the Fujifilm symbol on the left and the word "FUJIFILM" in bold, black letters on the right. Below the word "FUJIFILM" is the text "I&I-Imaging & Information" in a smaller font size.
FUJIFILM MEDICAL SYSTEMS USA, INC.
141-Imaging & Informatio
419 WEST AVENUE STAMFORD. CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
As with other FCR image readers, the FCR Velocity will feature a photostimulable phosphor imaging plate (IP) composed of europium activated barium fluorohalaid compounds in a crystal form held in an organic binder. The IP used with the subject device will have a rigid substrate, which enables it to be held in a constant plane. IPs are used as two-dimensional radiation detectors in place of radiographic film and intensitying screens to capture a portion of the projected x-ray palient image in space. 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 luminescence is 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.
INTENDED USE:
The Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is intended to be used for the identification, capture, digitization, and processing of diagnostic x-rav images, and associating palient and exam identification with the images.
PREDICATE DEVICE AND SUBSTANTIAL EQUIVALENCE INFORMATION:
FCR Velocity is considered comparable and substantially equivalent to the FCR 9501-HQ Image Reader manufactured by Fuji. FCR 9501-HQ has been granted a 510(k) clearance. Refer to accession number K951373.
| PARAMETER | FUJI FCR VELOCITY U | FUJI FCR 9501HQ | ||
|---|---|---|---|---|
| Image Recording | ||||
| Patient Identification | Digital Data (from Console) | Digital Data (from Console) | ||
| Recording Method | Photostimulable Luminescence | Photostimulable Luminescence | ||
| No. of Imaging Plates Used | One Built-in Imaging Plate | Four Built-in Imaging Plates | ||
| Imaging Plate Size | 497x456 mm | 495x377 mm | ||
| Image Reading | ||||
| Reading Laser | Laser Diodes (658 nm) | He-Ne Laser (675 nm) | ||
| Gray Scale | 10 bits (1024 gray levels) | 10 bits (1024 gray levels) | ||
| Sampling Raster | IP Reading Area | IP Reading Area | ||
| Pixels/mm | Pixels/mm | |||
| 17x17 in. | 10 | N/A | ||
| 17x14 in. | 10 | N/A | ||
| 14x17 in. | 10 | 14x17 in. | 10 | |
| 14x14 in. | 10 | 14x14 in. | 10 | |
| 10x12 in. | 10 | 10x12 in. | 10 | |
| 12x10 in. | 10 | |||
| 8x10 in. | 10 | 8x10 in. | 10 | |
| 10x8in. | 10 | |||
| 18x43 cm | 10 | N/A | ||
| Physical | ||||
| WxHxD (mm) | 645x1835x450 (Image Reader) | 1163x1733x935 (Image Reader) | ||
| Weight (kg) | 220 | 580 | ||
| Throughput (Approximate) | 240 14x17 in. IP's/hr. | 80 14x14 in. IP's/hr | ||
| Processing Time | 80 seconds | 132 seconds |
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Image /page/2/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, sans-serif font, with a stylized "F" symbol to the left. Below the main logo, the text "I&I-Imaging & Information" is printed in a smaller font size.
FUJIFILM MEDICAL SYSTEMS USA, INC.
419 WEST AVENUE STAMFORD, CT 06902 Telephone: 203/324-2000 Fax: 203/353-0926
SAFETY INFORMATION:
FCR Velocity introduces no new safety and efficacy issues other than those already identified with the predicale device. The results of a hazard analysis, combined with the appropriate preventive 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".
FCR Velocity complies with the following mandatory and voluntary standards:
- 21 CFR 1040.10 Performance Standards for Light Emitting Products (Laser Products) .
- 21 CFR 1020.30 Performance Standards for lonizing Radiation Emitting Products . (Diagnostic X-ray System and their Major Components)
- Medical Electrical Equipment Part 1: General Requirements for Safety UL Standard 60601-1 . (IEC 60601-1-1 included)
- . Medical Electrical Equipment - Part 1: General Requirements for Safety; Electromagnetic Compatibility - Requirements and Tests: IEC 60601-1-2
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Image /page/3/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper half 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: K033561
Trade/Device Name: Fuji Computed Radiography (FCR) Velocity Image Reader (CR-IR364) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 5, 2003 Received: November 12, 2003
Dear Mr. Sammons:
This letter corrects our substantially equivalent letter of November 26, 2003.
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 (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice modion as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as be form ar an are ag your device as described in your Section 510(k) premarket wifi anow you to began finding of substantial equivalence of your device to a legally marketed predication. The 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 11 you desire specific darres to: your use in Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket o 150. Thise, promotion and 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 Tou may 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
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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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name : FCR Velocity Image Reader (CR-IR364)
Indications For Use :
The indications for use of the Fuji Computed Radiography (FCR) Velocity Image Reader with Image Plate (IP) reading is the identification, capture, digitization, and processing of diagnostic x-ray images, and associating palient and exam identification with the images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive Abdominal
Division of Reproductive, Abdo and Radiological Devices 510(k) Number
Prescription Use ( Per 21 CFR 801.109
Over-The-Counter Use
(Optional Formal 1-2-96)
Page A3-2
§ 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.