(180 days)
Not Found
No
The summary focuses on hardware modifications, portability, and wireless capabilities, with no mention of AI/ML or related concepts like image processing beyond basic digitization.
No.
The device is intended to capture for display radiographic images of human anatomy, which is a diagnostic function, not a therapeutic one.
No.
The device's intended use is to capture and display radiographic images of human anatomy, which is a key component for diagnostic imaging but does not perform the diagnosis itself.
No
The device description explicitly mentions "Flat Panel Detector System" and describes physical components like detectors and a Utility Box, indicating it is a hardware device that includes software for operation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "captur[ing] for display radiographic images of human anatomy." This is a function related to medical imaging, not in vitro testing of biological samples.
- Device Description: The description details a "portable digital FPD system that acquires and digitizes x-ray exposures." This further confirms its role in medical imaging.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
The device is a medical imaging device used for capturing X-ray images.
N/A
Intended Use / Indications for Use
The FDR Go Flex is intended to capture for display radiographic images of human anatomy. It is intended for use in general radiographic applications wherever conventional film/screen or CR systems may be used. The FDR Go Flex is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
90 MQB, MQB
Device Description
The proposed device, the FDR Go Flex (DR-ID700), is a modification of the Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System, K103596, cleared on 3/29/2011 (submitted as a Special 510(k)) and the Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE), K111548, cleared on 8/30/2011. The FDR D-EVO Flat Panel Detector System (DR-ID600) cleared on 3/29/2011 was a modification of the FDR D-EVO (DR-ID600) Flat Panel Detector, K100762, cleared on 7/15/2010. The FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011.
The FDR Go Flex is a portable digital FPD system that acquires and digitizes x-ray exposures from standard radiographic systems and is designed to be used in any environment that would typically use a radiographic cassette. However, the FDR Go Flex is more portable than its predecessors given its smaller size and ability for all components to operate using battery power in a fully wireless configuration (no cable connections are required between the FDR Go Flex components, although it will remain possible to physically connect components if the user so desires). Note: Only wireless communication is supported between detectors and the Utility Box.
The indirect X-ray conversion method using GOS and CsI Scintillators, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device.
Since the detectors (DR-ID601SE, DR-ID602SE, and DR-ID611SE) are capable of automatically detecting X-ray, direct connection with the X-ray system is not needed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The FDR Go Flex flat panel detector system successfully completed international IEC testing requirements. In addition, the FDA Draft Guidance Document, Radio-Frequency Wireless Technology in Medical Devices, issued on January 3, 2007 was followed for the wireless feature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white and features the word "FUJIFILM" in large, bold letters. Below the main logo, the text "Fujifilm Medical Systems, USA" is written in a smaller font.
AUG 28 2012
510(k) Summary FDR Go Flex (DR-ID700)
Flat Panel Detector System
Date: February 22, 2012
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
Contact Person:
| Name: | Peter Altman |
|---|---|
| Title: | Regulatory Consultant |
| Telephone: | (203) 602-3576 |
| Facsimile: | (203) 363-3950 |
Identification of the Proposed Device:
| Proprietary/Trade Name: | FDR Go Flex (DR-ID700) |
|---|---|
| Classification Name: | Solid State X-ray Imager (Flat Panel/Digital Imager) |
| Regulations Number: | 21 CFR 892.1650 |
| Product Codes: | 90 MQB |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Common Name: | Flat Panel Digital Detector |
I. INDICATIONS FOR USE
The FDR Go Flex is intended to capture for display radiographic images of human anatomy. It is intended for use in general radiographic applications wherever conventional film/screen or CR systems may be used. The FDR Go Flex is not intended for mammography, fluoroscopy, tomography, and angiography applications.
II. DEVICE DESCRIPTION
The proposed device, the FDR Go Flex (DR-ID700), is a modification of the Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System, K103596, cleared on 3/29/2011 (submitted as a Special 510(k)) and the Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE), K111548, cleared on 8/30/2011. The FDR D-EVO Flat Panel Detector System (DR-ID600) cleared on 3/29/2011 was a modification of the FDR D-EVO (DR-ID600) Flat Panel Detector, K100762, cleared on 7/15/2010. The FDR D-
1
Image /page/1/Picture/0 description: The image shows the Fujifilm Medical Systems, USA logo. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used to represent the company's brand.
EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011.
The FDR Go Flex is a portable digital FPD system that acquires and digitizes x-ray exposures from standard radiographic systems and is designed to be used in any environment that would typically use a radiographic cassette. However, the FDR Go Flex is more portable than its predecessors given its smaller size and ability for all components to operate using battery power in a fully wireless configuration (no cable connections are required between the FDR Go Flex components, although it will remain possible to physically connect components if the user so desires). Note: Only wireless communication is supported between detectors and the Utility Box.
The indirect X-ray conversion method using GOS and CsI Scintillators, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device.
Since the detectors (DR-ID601SE, DR-ID602SE, and DR-ID611SE) are capable of automatically detecting X-ray, direct connection with the X-ray system is not needed.
SUMMARY OF STUDIES III.
The FDR Go Flex flat panel detector system successfully completed international IEC testing requirements. In addition, the FDA Draft Guidance Document, Radio-Frequency Wireless Technology in Medical Devices, issued on January 3, 2007 was followed for the wireless feature.
IV. SUBSTANTIAL EQUIVALENCE
The proposed device, the FDR Go Flex (DR-ID700), is a modification of the Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System. K103596, cleared on 3/29/2011 (submitted as a Special 510(k)) and the Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE), K111548, cleared on 8/30/2011. The FDR D-EVO Flat Panel Detector System (DR-ID600) cleared on 3/29/2011 was a modification of the FDR D-EVO (DR-ID600) Flat Panel Detector, K100762, cleared on 7/15/2010. The FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE cleared on 8/30/2011 was a modification of the system cleared on 3/29/2011. All detectors (DR-ID601SE, and DR-ID611SE) used with the FDR Go Flex are capable of automatically detecting X-ray, a feature cleared in the latest predicate device.
V. CONCLUSION
The FDR Go Flex (DR-ID700) flat panel detector system is substantially equivalent to the cleared predicate devices and conforms to applicable medical device safety standards.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three overlapping wing shapes, representing the department's mission to protect the health of all Americans. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the logo.
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
AUG 28 2012
Mr. Peter Altman Regulatory Consultant FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD CT 06902
Re: K120629
Trade/Device Name: FDR Go Flex (DR-ID700) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 30, 2012 Received: August 1, 2012
Dear Mr. Altman:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed 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 commerce profit it May 26, 1776, the encordance with the provisions of the Federal Food, DINA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmelle Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the device, sabject to the enemal registration, listing of general controls provisions of the Act merelate is and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such alin title 21 II your device is Classified (see above) into enas ffecting your device can be found in Title 21, additional contors. Existing major regulations and the 895. In addition, FDA may publish further Code of Peacharts concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 3 issumes of a succession is a suith other requirements of the Act that FDA has made a decemmation analy other Federal agencies. You must of any Federal Statutes and regulations administer by not limited to: registration and issting of comply with an the Act Stequirements, therauling, carner called in the reporting (reporting of
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Division 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. Mor
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K |20 €29
Device Name: FDR Go Flex (DR-ID700)
Indications for Use:
The FDR Go Flex is intended to capture for display radiographic images of human anatomy. It is intended for use in general radiographic applications wherever conventional film/screen or CR systems may be used. The FDR Go Flex is not intended for mammography, fluoroscopy, tomography, and angiography applications.
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 OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
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