(92 days)
Not Found
No
The document describes a flat panel detector system for capturing radiographic images. It mentions image processing is "Not Found" and explicitly states "Mentions AI, DNN, or ML: Not Found". The performance testing focuses on image quality comparison with a predicate device using human evaluators, not on the performance of an AI/ML algorithm.
No
The device is described as capturing and displaying radiographic images for diagnostic purposes in general projection radiographic applications, not for treating or mitigating disease.
Yes
The device captures radiographic images of human anatomy for display, which are then used by clinicians (not explicitly stated, but implied by the "board-certified radiologist" in performance testing) to make a diagnosis. The performance studies mention that "all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images," directly linking the output to diagnostic purposes.
No
The device description explicitly lists hardware components such as a flat panel detector, system control cabinet, and power supply unit, indicating it is a hardware-based system, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for capturing and displaying radiographic images of human anatomy for general projection radiographic applications. This involves imaging the internal structure of the body using X-rays.
- Device Description: The description details a flat panel detector system that captures X-ray images.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such specimens.
The device 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 Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO (DR-ID600) is not intended for mammorraphy, fluoroscopy, tomography and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
90 MQB
Device Description
The Wired/Wireless FDR D-EVO (DR-ID600/DR-ID601.SE).flat.panel.detector (FPD) consists of the Fujifilm D-EVO detector, Fujifilm D-EVO system control cabinet, and power sugply unit. Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the monitor.
Wired/Wireless FDR D-EVO flat panel detector is an indirect-conversion amorphous silicon (a-Si) portable flat panel detector utilizing GOS (Gadolinium OxySulfide) as a scintillator. Wired/Wireless FDR D-EVO detector has Fuji's unique Irradiation Side Sampling system (hereinafter "ISS system").
The X-ray Detection Feature is a minor change to our cleared Wired/Wireless FDR D-EVO FPD detector system which eliminates the need for an electrical interface between the D-EVO system's DR-ID 600 MP and the x-ray exposure system. This is accomplished by incorporating X-ray sensors into the exposure surface of the proposed Wired/Wireless FDR D-EVO Flat Panel Detector.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Radiographic images
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)
Wired/Wireless FDR D-EVO with X-ray Detection Feature has successfully completed internal and international IEC testing requirements, as well as Verification and Veliced in Studies, and the following anthropomorphic phantom image evaluation.
Identically exposed and processed anthropomorphic phantom image pairs (proposed device vs. predicate device) were judged by 3 Fujifilm Imaging Specialists, as well as a board-certified radiologist (See Section 18, Performance Testing). No participant was able to visualize the X-ray sensors, and all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images.
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/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 appears to be a standard corporate logo.
SEP 3 0 2011
Special 510(k) Premarket Notification Summary for Wired/Wireless FDR D-EVO with X-ray Detection Feature
Date: June 29, 2011
Contact Person:
| Name: | Debbie Peacock |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | (203) 602-3774 |
| Facsimile: | (203) 363-3813 |
ldentification of Device:
| Proprietary/Trade Name: | Wired/Wireless FDR D-EVO with X-ray Detection
Feature |
|-------------------------|----------------------------------------------------------|
| Classification Name: | Solid State X-ray Imager (Flat Panel/Digital Imager) |
| Classification: | Panel: Radiology |
| CFR Section: | 21 CFR 892.1650 |
| Product Codes: | 90 MQB |
| Common Name: | Flat Panel Digital Detector |
l, INDICATIONS FOR USE
The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO (DR-ID600) is not intended for mammorraphy, fluoroscopy, tomography and angiography applications.
II. DEVICE DESCRIPTION
The Wired/Wireless FDR D-EVO (DR-ID600/DR-ID601.SE).flat.panel.detector (FPD) ص ان الاست جي المورد الموري الموري الموري الموري الموري الاست Fujifilm D-EVO detector, Fujifilm D-EVO system control cabinet, and power sugply unit. Images captured with the flat panel digital detector can be communicated to the operator console via tethered connection. Data captured via operator console is sent electronically to the Fujifilm FDX Console to be displayed on the monitor.
Wired/Wireless FDR D-EVO flat panel detector is an indirect-conversion amorphous silicon (a-Si) portable flat panel detector utilizing GOS (Gadolinium OxySulfide) as a scintillator. Wired/Wireless FDR D-EVO detector has Fuji's unique Irradiation Side Sampling system (hereinafter "ISS system").
The X-ray Detection Feature is a minor change to our cleared Wired/Wireless FDR D-EVO FPD detector system which eliminates the need for an electrical interface between the D-EVO system's DR-ID 600 MP and the x-ray exposure system. This is accomplished by incorporating X-ray sensors into the exposure surface of the proposed Wired/Wireless FDR D-EVO Flat Panel Detector.
1
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 word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.
There is no difference in preparation between both the predicate and proposed device. In both cases, the FPDs are informed that an x-ray exposure is imminent by selecting an anatomical menu at the acquisition workstation. Once the anatomical menu is selected, the detectors become "ready" for the exposure. Ready indicators illuminate on both the detector and the acquisition workstation signaling to the technologist that an exposure can be made.
SUMMARY OF STUDIES
Wired/Wireless FDR D-EVO with X-ray Detection Feature has successfully completed internal and international IEC testing requirements, as well as Verification and Veliced in Studies, and the following anthropomorphic phantom image evaluation.
Identically exposed and processed anthropomorphic phantom image pairs (proposed device vs. predicate device) were judged by 3 Fujifilm Imaging Specialists, as well as a board-certified radiologist (See Section 18, Performance Testing). No participant was able to visualize the X-ray sensors, and all participants found the D-EVO images with the X-ray Detection Feature were diagnostically equal to the predicate device images.
III. SUBSTANTIAL EQUIVALENCE
The WiredWireless FDR D-EVO with X-ray Detector Feature is a modification to Fuji's WiredWireless FDR D-EVO Flat Panel Detector System, K103596, cleared by CDRH on 03/29/11. This feature is the only difference between the proposed and predicate device.
IV. CONCLUSION
The Wired/Wireless FDR D-EVO with X-ray Detection Feature is substantially equivalent to the cleared predicate Wired/Wireless FDR D-EVO Flat Panel Detector and conforms to applicable medical device safety standards
(
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo includes the department's emblem on the left, which features a stylized human figure. To the right of the emblem, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" is displayed in a clear, sans-serif font. The overall design is simple and professional, reflecting the department's role in public health and human services.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Debra A. Peacock Regulatory Affairs Manager Fuji Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902
AUG 2 3 2013
Re: K11865
Trade/Device Name: Wireless/Wireless FDR D-EVO with X-ray Detection Feature Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: August 16, 2011 Received: August 17, 2011
Dear Ms. Peacock:
This letter corrects our substantially equivalent letter of September 30, 2011.
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 encreated 776, 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 I va may, morelore, mains 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 or any I cuttar statutes and reguirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device 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 notheation. The FDF imanis of fication 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 done specific de rice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket s 150. Thise, process now are roganized on 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 Totallay 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
4
Indications for Use
510(k) Number (if known): Kl (845
Device Name: Wired/Wireless FDR D-EVO with X-ray Detection Feature
Indications for Use:
ess
The Wired/Wireless FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications wherever conventional film/screen or CR systems may be used. The FDR D-EVO (DR-ID 600) is not intended for mammography, fluoroscopy, tomography and angiography applications.
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 Device (OIVD)
Mary Stattl
Division Sign-Off
Office of In Vi
510K K111865