(15 days)
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications.
The FCR Go battery powered, mobile x-ray system features a built-in Carbon XL CR reader and a notebook version of the CR Console (Flash IIP) or technologist console. Because the CR reader and CR console are incorporated in the equipment, the images are available to the technologist in a very short time, allowing the technologist to assure the exam has been performed adequately, minimizing return trips. Wireless communication is available, as an option, for updates to the patient worklist from the RIS/HIS. The FCR Go uses the same Image Plates (IPs) and cassettes used with other FCR systems.
The FCR Go provides smooth and quiet motorized travel capability via rear wheels independently driven by dual motors, a versatile radiography range through the telescopic arm, and easy-to-operate positioning of detector cassette providing sharp image quality with a short exam completion time.
Radiographic technique and exposure settings (KV, mAs) can be set up on the generator's control panel, as well as pre-configured from the CR console, based on exam type and typical recommended pre-programmed settings.
The provided document is a 510(k) summary for the FUJIFILM FCR Go, a mobile X-ray system. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with acceptance criteria and performance data. Therefore, many of the requested details about a study proving device performance against acceptance criteria are not found in this document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or a "reported device performance" in a structured table. The 510(k) process for a mobile X-ray system typically involves demonstrating that the device is substantially equivalent in terms of technical characteristics, safety, and effectiveness to legally marketed predicate devices. This largely relies on engineering tests and comparisons rather than clinical performance metrics like sensitivity, specificity, or reader improvement.
2. Sample Size Used for the Test Set and Data Provenance:
No information regarding a "test set" for performance evaluation is provided, as the submission focuses on equivalence. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Since a detailed clinical performance study with a test set and ground truth establishment is not described, there is no information about the number or qualifications of experts.
4. Adjudication Method:
No adjudication method is mentioned as a clinical performance study is not detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
The document does not mention an MRMC study or any assessment of human reader improvement with or without AI assistance. The FCR Go is described as a mobile X-ray system with a CR reader and console, not primarily an AI-driven image analysis tool.
6. Standalone Performance Study:
No standalone (algorithm-only) performance study is mentioned. The FCR Go is a hardware system for image acquisition and initial processing.
7. Type of Ground Truth Used:
No type of ground truth is specified, as the document does not describe a performance study requiring ground truth. For an X-ray system, "ground truth" related to image quality would typically involve physical phantoms and expert review of image characteristics rather than patient-level diagnostic outcomes for a device like FCR Go.
8. Sample Size for the Training Set:
No information about a training set is provided. The FCR Go is a hardware device; any image processing algorithms would likely be based on established principles of digital radiography rather than deep learning models requiring large training sets in the modern sense.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided as no training set is mentioned.
Summary of Device and 510(k) Context:
The FUJIFILM FCR Go is a mobile X-ray system. Its 510(k) submission (K080945) primarily focuses on demonstrating substantial equivalence to existing predicate devices (Mobilett XP CR and GE Definium AMX 700) regarding its intended use, technical specifications, and safety. The 510(k) process for such a device does not typically require extensive clinical performance studies with acceptance criteria in the manner that an AI diagnostic algorithm would. Instead, the focus is on engineering safety, performance testing (e.g., radiation output, image quality parameters with phantoms), and comparison of technical features to proven predicate devices.
The "Indications for Use" for the FCR Go are: "generating radiographic images of the human anatomy. This device is not intended for mammographic applications." This indicates the device's function is to produce images, and the substantial equivalence claim implies that the images it produces are diagnostically acceptable and of comparable quality to those from predicate devices. The document does not delve into the nuances of diagnostic accuracy metrics.
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FUJIFILM
Fujifilm Medical Systems, USA
K080945
APR 18 2005
510(k) Summarv
Date: March 7, 2008
Contact Person:
| Name: | Debbie Peacock |
|---|---|
| Title: | Regulatory Coordinator |
| Telephone: | (203) 602-3774 |
| Facsimile: | (203) 363-3813 |
Identification of Device:
| Proprietary/Trade Name: | FUJIFILM FCR Go |
|---|---|
| Classification: | Class II |
| Classification Name: | Mobile X-Ray System |
| Product Code: | IZL |
| Common Name: | Mobile X-Ray System |
INDICATIONS FOR USE ﺎ.
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications.
11. DEVICE DESCRIPTION
The FCR Go battery powered, mobile x-ray system features a built-in Carbon XL CR reader and a notebook version of the CR Console (Flash IIP) or technologist console. Because the CR reader and CR console are incorporated in the equipment, the images are available to the technologist in a very short time, allowing the technologist to assure the exam has been performed adequately, minimizing return trips. Wireless communication is available, as an option, for updates to the patient worklist from the RIS/HIS. The FCR Go uses the same Image Plates (IPs) and cassettes used with other FCR systems.
The FCR Go provides smooth and quiet motorized travel capability via rear wheels independently driven by dual motors, a versatile radiography range through the telescopic arm, and easy-to-operate positioning of detector cassette providing sharp image quality with a short exam completion time.
Radiographic technique and exposure settings (KV, mAs) can be set up on the generator's control panel, as well as pre-configured from the CR console, based on exam type and typical recommended pre-programmed settings.
FCR Go 510(k)
Section 5 - 510(k) Summary
2/3
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Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the main logo is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and professional, and it is likely used on the company's products and marketing materials.
10. Indications for Use:
Proposed FCR Go IFU:
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications.
Predicate Indications for Use:
- The Mobilett XP CR is a radiographic system designed for use in wards, � intensive care and premature birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
- The GE Definium AMX 700 is indicated for use in generating radiographic � images of the human anatomy. This device is not intended for mammographic applications.
11. Confidentiality:
We consider all information contained in this submission as well as its existence to be Confidential and request FDA to consider it as such. Fuji requests that FDA not make public disclosure of this information without prior consultation with Fuji as provided by 21 CFR 20.45.
If you have any additional questions, please phone me at (203) 602-3774, or fax (203) 363-3813, or e-mail @ debbie peacock@fujimed.com.
Sincerely,
Delha G. Peacock
Debra A. Peacock Regulatory Coordinator
FCR Go 510(k)
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines. The symbol is black, and the background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 8 2008
Fujifilm Medical Systems, USA, Inc. % Mr. Jeff D. Rongero Senior Project Engineer, Medical Business Unit Underwriters Laboratories, Inc. 12 Laboratory Drive Research Triangle Park, NC 27709
Re: K080945
Trade/Device Name: FCR Go Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: II Product Code: IZL Dated: April 2, 2008 Received: April 3, 2008
Dear Mr. Rongero:
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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known): _ K180 945-
Device Name: FCR Go_
Indications for Use:
1999 - 1999
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications. and the control concession
.
Prescription Use _ X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number __
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.