(56 days)
Not Found
No
The summary does not mention AI, ML, deep learning, or any related concepts in the device description, intended use, or performance studies. The focus is on the hardware (flat panel detector) and its basic image acquisition and digitization functions.
No
This device is an X-ray detector used for capturing radiographic images, not for treating conditions.
No
Explanation: The device captures and displays radiographic images, which are then interpreted by a human for diagnosis. The device itself does not perform the diagnostic function.
No
The device description explicitly states it is a "portable digital detector system" and mentions "detector models," indicating it includes hardware components beyond just software.
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. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, or tissue) outside of the body.
- Device Description: The description reinforces its use in standard radiographic systems for acquiring and digitizing X-ray exposures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other typical components or processes associated with in vitro diagnostics.
In vitro diagnostics are tests performed on samples taken from the human body to detect diseases, conditions, or infections. This device is used for capturing images of the internal structure of the body using X-rays.
N/A
Intended Use / Indications for Use
The FDR SE Lite 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 SE Lite is not intended for mammography, fluoroscopy, and angiography applications, as well as pediatric and neonatal exams.
Product codes
MQB
Device Description
Fujifilm's FDR SE Lite (DR-ID 330), is a portable digital detector system that interfaces with, and acquires and digitizes X-ray exposures from, standard radiographic systems. DR-ID 330 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, not for pediatrics and neonates. The detector models support only wireless data communication between the detector and the console. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
radiographic
Anatomical Site
human anatomy
Indicated Patient Age Range
adults, not for pediatrics and neonates
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
Non-clinical Performance Data: FDR SE Lite FPD System (DR-ID330) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366 and DICOM. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (August 14, 2013) was followed to test wireless features. As required by the risk analysis, necessary verification activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the FDR SE Lite system using MarsXF detectors is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 1, 2019
Fujifilm Corporation % Kamila Sak Specialist. Regulatory Affairs FuiiFilm Medical Systems U.S.A., Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
Re: K192440
Trade/Device Name: FDR SE Lite Flat Panel Detector System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: September 5, 2019 Received: September 6, 2019
Dear Kamila Sak:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K192440
Device Name FDR SE Lite Flat Panel Detector System
Indications for Use (Describe)
The FDR SE Lite 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 SE Lite is not intended for mammography, fluoroscopy, and angiography applications, as well as pediatric and neonatal exams.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo consists of the word "FUJIFILM" in large, bold, black letters. There is a red square above the second "I" in "FUJIFILM". Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller, black font.
510(k) Summary
FDR SE-Lite Flat Panel Detector System (DR-ID 330)
Date: September 5, 2019
Submitter's Information:
FUJIFILM Corporation
798 Miyanodai Kaisei-Machi
Ashigarakami-Gun, Kanagawa, 258-8538, Japan
FDA Establishment Registration Number: 3001722928
Contact Person:
| Name: | Kamila Sak |
|---|---|
| Title: | Specialist, Regulatory Affairs |
| Telephone: | (347) 577-2309 |
ldentification of the Device:
Proprietary:
Model Number: DR-ID330 Classification Name: Stationary X-ray system CFR Section: 21 CFR 892.1680 Product Codes: 90 MQB Device Class: Class II Review Panel: Radiologv Common Name: Flat Panel Digital Detector System
ldentification of the Legally Marketed Device:
FDR D-EVO II Flat Panel Detector System (DR-ID 1200), K142003 cleared 10/21/2014
FDR SE Lite Flat Panel Detector System
l. DEVICE DESCRIPTION
Fujifilm's FDR SE Lite (DR-ID 330), is a portable digital detector system that interfaces with, and acquires and digitizes X-ray exposures from, standard radiographic systems. DR-ID 330 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, not for pediatrics and neonates. The detector models support only wireless data communication between the detector and the console. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams.
II. INDICATIONS FOR USE
The FDR SE Lite 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 SE Lite is not intended for mammography, fluoroscopy, tomography, and angiography applications, as well as pediatric and neonatal exams.
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Image /page/4/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. There is a red square on top of the letter "I". Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA".
SUBSTANTIAL EQUIVALENCE ..............................................................................................................................................................................
Fujifilm FDR SE Lite FPD System (DR-ID 330) is substantially equivalent to the following legally marketed device.
| Legally Marketed Device | 510(k) # | Clearance Date |
|---|---|---|
| FDR D-EVO II Flat Panel Detector System (DR-ID1200) | K142003 | 10/21/2014 |
Both the subject device FDR SE Lite (DR-ID 330) and predicate device FDR D-EVO II (DR-ID 1200) in K142003 are portable digital detector systems that are intended to be used for the same purposes except for pediatric and neonatal use and wired communication. The most detector characteristics remain unchanged for FDR SE Lite, and the image quality is substantially equivalent to the predicate device. The design made for the FDR SE Lite have been successfully tested and validated as summarized below.
IV. SUMMARY OF STUDIES
Non-clinical Performance Data: FDR SE Lite FPD System (DR-ID330) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366 and DICOM. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (August 14, 2013) was followed to test wireless features. As required by the risk analysis, necessary verification activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the FDR SE Lite system using MarsXF detectors is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
> CONCLUSION
Based upon the supporting data summarized above, we concluded FDR SE Lite Flat Panel Detector System (DR-ID 330) is as safe and effective as the legally marketed device DR-ID 1200 (K142003), and do not raise different questions of safety and effectiveness than K142003.