(15 days)
Not Found
No
The description focuses on the hardware and basic image acquisition and display functionalities. There is no mention of AI/ML terms, image processing beyond basic display, or any data sets for training or testing.
No
The device generates radiographic images for diagnostic purposes, it does not provide therapy.
No
The device is an imaging system (mobile x-ray) used to generate radiographic images of the human anatomy. It does not state that it is used to diagnose a disease or condition, but rather for imaging purposes.
No
The device description clearly outlines a physical, battery-powered, mobile x-ray system with integrated hardware components like a CR reader, console, motors, wheels, and a telescopic arm. It is not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to generate radiographic images of the human anatomy. This is an in-vivo imaging process, meaning it's performed on a living organism.
- Device Description: The description clearly outlines a mobile x-ray system that captures images directly from the patient using x-rays and image plates.
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
The FCR Go is a medical imaging device used for diagnostic purposes, but it falls under the category of radiological imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FCR Go is indicated for use in generating radiographic images of the human anatomy. This device is not intended for mammographic applications.
Product codes
IZL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
wards, intensive care and premature birth wards, pediatric and emergency departments, operating theatres as well as the central X-ray department.
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
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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)
2
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 __