(111 days)
Not Found
No
The summary focuses on the hardware modifications (wired/wireless communication) and image acquisition technology, with no mention of AI or ML for image processing or analysis.
No
The device is described as a flat panel detector system that captures and displays radiographic images, which is for diagnostic imaging purposes, not for therapeutic intervention.
No
This device is an imaging system (flat panel detector system) used to capture radiographic images. While these images can be used by a clinician for diagnostic purposes, the device itself is a tool for image acquisition, not for automated diagnosis or interpretation.
No
The device description explicitly states it is a "flat panel detector system" and describes hardware components like a "flat panel sensor" and "detector," indicating it is a hardware device with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states 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 acquires and digitizes X-ray exposures. This is a component of a medical imaging system used for diagnostic imaging in vivo (within the living body).
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the living body) to provide information for diagnostic purposes. The provided information does not mention any interaction with biological specimens or analysis performed outside the body.
Therefore, the Wireless/Wired FDR D-EVO flat panel detector system is a medical imaging device used for diagnostic purposes in vivo, not an IVD.
N/A
Intended Use / Indications for Use
The Wireless/Wired 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
90 MQB
Device Description
The proposed device, Wireless/Wired FDR D-EVO flat panel detector system, is a modified version of our currently-cleared predicate device, (wired) FDR D-EVO fat panel detector system (DR-ID600), K100762. The predicate device includes the flat panel sensor (DR-ID600SE), which provides only a wired communication mode. The proposed device introduces a modified flat panel detector (DR-ID601SE), which provides both wired and wireless communication modes.
The indirect X-ray conversion method using GOS Scintillator, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device.
The proposed device is a portable digital detector system that acquires and digitizes xray exposures from standard radiographic systems, which is the same as the predicate device. The proposed device is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. All of which are also the same as the predicate device.
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
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 Wireless/Wired FDR D-EVO flat panel detector system successfully completed internal and 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.
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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 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.
MAR 2 9 2011
510(k) Summary Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System
Date: December 6, 2010
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
Contact Person:
| Name: | Katherine Y. Choi, RAC |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Telephone: | (203) 602-3568 |
| Facsimile: | (203) 363-3950 |
Identification of the Proposed Device:
Proprietary/Trade Name:
Classification Name: Regulations Number: Product Codes: Device Class: Review Panel: Common Name:
Wireless/Wired FDR D-EVO Fiat Panel Detector System (DR-ID600 w/DR-ID601SE) Solid State X-ray Imager (Flat Panel/Digital Imager) 21 CFR 892.1650 90 MQB Class II Radiology Flat Panel Digital Detector
l. INDICATIONS FOR USE
The Wireless/Wired 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 is not interest Johnsmonal limitscieen of CK System tomography, and angiography applications.
II. DEVICE DESCRIPTION
The proposed device, Wireless/Wired FDR D-EVO flat panel detector system, is a modified version of our currently-cleared predicate device, (wired) FDR D-EVO fat panel detector system (DR-ID600), K100762. The predicate device includes the flat panel sensor (DR-ID600SE), which provides only a wired communication mode. The
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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 and features the word "FUJIFILM" in large, bold letters. Below the main logo is the text "Fujifilm Medical Systems, USA" in a smaller font.
proposed device introduces a modified flat panel detector (DR-ID601SE), which provides both wired and wireless communication modes.
The indirect X-ray conversion method using GOS Scintillator, and FUJIFILM's unique Irradiated Side Sampling design, delivering high image quality, remained unchanged in the proposed device."
The proposed device is a portable digital detector system that acquires and digitizes xray exposures from standard radiographic systems, which is the same as the predicate device. The proposed device is designed to be used in any environment that would typically use a radiographic cassette. It can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. All of which are also the same as the predicate device.
III. SUMMARY OF STUDIES
The Wireless/Wired FDR D-EVO flat panel detector system successfully completed internal and 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 Wireless/Wired FDR D-EVO flat panel detector system is substantially equivalent to the predicate device, (wired) FDR D-EVO system (K100762). The proposed Wireless/Wired FDR D-EVO system has similar Indications for Use, functional and technical requirements as the currently-cleared predicate device, (wired) FDR D-EVO system (K100762). In addition, wireless communication specifications are substantially equivalent to the predicate Canon CXDI-70C Wireless (K102012).
V. CONCLUSION-
The Wireless/Mired FDR D-EVO 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 Department of Health & Human Services. The logo includes the department's seal on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The seal features an abstract design with a stylized human figure.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Katherine Y. Choi. RAC Regulatory Affairs Specialist Fuji Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902
AUG 2 3 2013
Re: K103596
Trade/Device Name: Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System
Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 1. 2010 Received: February 2, 2010
Dear Ms. Choi:
This letter corrects our substantially equivalent letter of March 29, 2011.
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your beceeemined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encreate)76, the enactment date of the Medical Device Amendments, or to commerce pror to May 20, 1976, the eccordance 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 Tou may, dicrerore, market the Act include requirements for annual registration, listing of general controls provisioning 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 catal 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
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice inclical dovice rolated at reloc ovelity 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 predication. THE I Drivinalig sification 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 If you desire specific antilo for your aver in Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 2 1561 Thises promotions 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 Tour 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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Indications for Use
510(k) Number (if known): ما 35 ما 35 1
Device Name: Wireless/Wired FDR D-EVO (DR-ID600 w/DR-ID601SE) Flat Panel Detector System
Indications for Use:
The WirelessMired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human analomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Prescription Use X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use AND/OR (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)
Mury Spatil
on of Redintonical Office of In Vitro Diagnostic Device Evaluation and Sefety
510K. K103596
CONFIDENTIAL
FDR D-EVO Wireless 510(k)-
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