(337 days)
No reference devices were used in this submission.
No
The document describes standard X-ray and tomosynthesis technology with image processing, but there is no mention of AI or ML algorithms being used for image analysis, reconstruction beyond standard methods (FBP, SA), or any other function. The performance studies focus on image quality and equivalence to predicate devices, not on AI/ML performance metrics.
No
The device is described as an X-ray radiography system intended to generate diagnostic images of various body parts. Its purpose is to aid in diagnosis, not to provide therapy or treatment.
Yes
The device is described as generating "diagnostic images" by converting x-rays into electronic signals, and the tomosynthesis option is also described as producing reconstructed images for diagnostic purposes (though with a caveat for SA mode).
No
The device description explicitly states it consists of hardware components such as an X-ray high voltage generator, X-ray tube unit, X-ray tube support, collimator, and digital radiography system, in addition to software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the living body (in vitro).
- Device Function: The FDR Visionary Suite is an X-ray radiography system. It generates images of the internal structures of the body by passing X-rays through the patient. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states it's for generating radiographic images of various body parts for diagnostic purposes. It does not involve the analysis of biological specimens.
Therefore, based on the provided information, the FDR Visionary Suite falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes.
The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.
The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/ trained professionals.
The device is not intended for mammographic applications.
Product codes
KPR
Device Description
The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The device can be used in a wide range of applications of digital radiography. The device consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support, collimator and digital radiography system. The system can be configured with radiographic table and/or radiographic stand as well.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies
Indicated Patient Age Range
all ages including pediatric patients
Intended User / Care Setting
hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/ trained professionals.
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 Testing:
Performed non clinical performance testing between new device and predicate devices, in accordance with the FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging(SSXI) Devices" issued on Aug. 6, 1999.
Conducted performance bench test and image quality evaluate substantial equivalence of image processing technique to each predicate device respectively.
Performed phantom tests using several different anatomical body phantoms.
For Dual Energy Subtraction, additional test report was submitted to assure the distinction of lesion overlying bones to calcification or tubercle shade.
For metal artifact reduction function of tomosynthesis option, conducted performance testing. The result indicated that FBP (filtered back-projection) mode of new device has a same level of metal artifact reduction capability as the mode with artifact reduction of its predicate device.
Result: The result of non-clinical performance data demonstrates substantial equivalence of new device to the predicate devices in aspect of image acquisition, image processing as well as image quality capabilities.
Clinical Performance Testing:
The result of non-clinical bench testing demonstrates substantial equivalence to the predicate devices. Therefore, it is our understanding that clinical testing is not required in this case.
Key Metrics
Not Found
Predicate Device(s)
K093427, K121499, K101686, K122454
Reference Device(s)
No reference devices were used in this submission.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 15, 2016
SHIMADZU CORPORATION % Mr. Don Karle Manager, Customer Service Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502-1328
Re: K152294
Trade/Device Name: FDR Visionary Suite Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 10, 2016 Received: June 16, 2016
Dear Mr. Karle:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152294
Device Name FDR Visionary Suite
Indications for Use (Describe)
The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations. The FDR Visionary Suite enables radiographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position. The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes.
The Tomosynthesis option is intended to generate tomographic images of human anatomies. Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.
The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/ trained professionals.
The device is not intended for mammographic applications.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
The following information is submitted in accordance with the requirements of 21 CFR§807.92.
1) Date of Submission
August 5th, 2015
2) Submitter
SHIMADZU CORPORATION 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto, 604-8511, Japan Registration Number: 8030233 Phone: +81-75-823-1305 Fax : +81-75-823-1377
3) Primary Contact Person
Toshio Kadowaki Phone: +81-75-823-1920 E-mail: kadowaki@shimadzu.co.jp
4) Secondary Contact Person
Jeffrey Seiler SHIMADZU MEDICAL SYSTEMS USA 20101 South Vermont Ave., Torrance, CA 90502 USA Phone: 310-217-8855 ext 174 Email: seiler@shimadzu-usa.com
5) Device
| Name of Device | : FDR Visionary Suite |
|---|---|
| Common Name | : Digital Radiography System |
| Classification Name | : Stationary x-ray system (21 CFR§892.1680) |
| Classification Panel | : Radiology |
| Regulatory Class | : Class II |
| Product Code | : KPR |
6) Predicate Device
| Primary | K093427 | FDR ACSELERATE SYSTEM, DR-ID 200
FLAT PANEL DETECTOR | FUJIFILM
CORPORATION |
|------------|---------|--------------------------------------------------------------------------------|-------------------------|
| Secondary | K121499 | FUJIFILM TOMOSYNTHESIS OPTION
FOR FDR ACSELERATE STATIONARY
X-RAY SYSTEM | FUJIFILM
CORPORATION |
| Tertiary | K101686 | FDR IMAGE STITCHING OPTION | FUJIFILM
CORPORATION |
| Quaternary | K122454 | FUJIFILM DUAL ENERGY SUBTRACTION
(DES) SOFTWARE OPTION | FUJIFILM
CORPORATION |
No reference devices were used in this submission.
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7) Purpose of Submission
The purpose of this submission is to notify FDA of our intent to introduce a modified device of legally marketed devices, K093427 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR, K121499 FUJIFILM Tomosynthesis Option for FDR ACSELERATE STATIONARY X-RAY SYSTEM, K101686 FDR IMAGE STITCHING OPTION and K122454 FUJIFILM DUAL ENERGY SUBTRACTION (DES) SOFTWARE OPTION. The last three predicate devices are image processing options for the primary predicate device. All predicate devices are manufactured by FUJIFILM CORPORATION, Japan.
8) Device Description
The FDR Visionary Suite is an X-ray radiography system that is mainly used for the radiography of various regions of the patient's body in a standing or recumbent position. The device can be used in a wide range of applications of digital radiography. The device consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support, collimator and digital radiography system. The system can be configured with radiographic table and/or radiographic stand as well.
Major hardware components of new device are substantially equivalent to those of primary predicate device as below, even though some of components are optional in new device.
The difference is seen in below tables.
| | FDR Visionary Suite
(New Device) | AcSelerate Tomosynthesis
(K121499) |
|-----------------|--------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| Available type | Stand, Table | Stand, Table |
| Shot Interval | 200msec | 200msec |
| Exposure number | Maximum 60 exposures | Maximum 60 exposures |
| Angulation | Table : Maximum 60 degree
Wall stand : Maximum 40 degree | Table : Maximum 60 degree
Wall stand : Maximum 40 degree |
| Slice Interval | Minimum 1mm | Minimum 1mm |
| Pixel Size | 150um | 150um |
| Processing | FUJIFILM Tomosynthesis processing (DR-ID 900CL) With Pre-Processing Unit (PPU) | FUJIFILM Tomosynthesis processing (DR-ID 300CL same as DR-ID 900CL) With Pre-Processing Unit (PPU) |
Tomosynthesis Comparison Table
Optionally, the device is also used to perform tomosynthesis radiography by two different reconstruction modes, e.g. Filtered Back-Projection (FBP) mode and Shift-and-Add (SA) mode. SA reconstructed images are intended to be used alongside FBP reconstructed images and not for stand-alone diagnostic purpose.
9) Intended Use
5
SECTION V:
The FDR Visionary Suite is a stationary X-ray system for taking general radiographic and tomographic images of the whole body. The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals.
10) Indications for Use
- The FDR Visionary Suite is intended to generate digital or conventional radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts of human anatomies in all routine radiography examinations.
- . The FDR Visionary Suite enables radiographic or tomographic exposures of the whole body of all ages including pediatric patients. Exposures may be taken with the patient sitting, standing, or lying in the prone or supine position.
- · The FDR Visionary Suite uses portable or integrated flat panel detectors to generate diagnostic images by converting x-rays into electronic signals. The device is also designed to be used with conventional film/screen or computed radiography (CR) cassettes.
- The Tomosynthesis option is intended to generate tomographic images of human anatomies. . Tomosynthesis technique is used to produce a specific cross-sectional plane of the body by reconstruction of tomographic acquisition.
- · The device is intended to be used in hospitals, clinics, imaging centers, and/or other healthcare facilities by qualified/trained professionals.
- . The device is not intended for mammographic applications.
11) Comparison of Technological Characteristics with the predicate devices
At a high level, new device and its predicate devices are based on the following same technological elements:
- · Energy emission to the patient X-ray
- . Power requirement, Environmental requirement
- Mechanism to generate X-ray ●
- Mechanism to acquire, process and store image data
- Use of the hardware components
The following technological differences exist between new and its predicate devices.
- Use of software processing
12) Performance Data
The following performance data were provided in support of the substantial equivalence determination.
Electromagnetic compatibility
Both new device and primary predicate device are in conformity with IEC60601-1-2. The
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SECTION V:
510(k) Summary
difference is edition of the standard. Difference of edition of the standard does not affect safety and effectiveness.
Materials and Bio-compatibility testing
All materials and components of new device are in conformity with IEC10993-1. All materials and components of new device are in clinical use by other commercial products. Difference between new device and primary predicate device does not affect safety and effectiveness.
Sterility
Both new device and primary predicate device are not sterilized.
Electrical, Mechanical, Chemical and Thermal safety
As to these safeties, new device and primary predicate device are substantially equivalent by their conformed standards.
Software Verification and Validation Testing
Digital radiography system is using similar, but different software processing method. Therefore, Software Risk Analysis and Verification and Validation testing were conducted as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" to assure substantial equivalence.
As a result, we identified the level of concern associated with new device and provided documentation consistent with that level. Based on our risk analysis of software, the difference does not affect its safety and effectiveness.
Non-clinical Performance Testing
For the difference of software processing methods which is different from primary predicate device, we performed non clinical performance testing between new device and predicate devices, in accordance with the FDA Guidance "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging(SSXI) Devices" issued on Aug. 6, 1999.
We conducted performance bench test and image quality evaluate substantial equivalence of image processing technique to each predicate device respectively.
We also performed phantom tests using several different anatomical body phantoms.
For Dual Energy Subtraction, additional test report was submitted to assure the distinction of lesion overlying bones to calcification or tubercle shade.
For metal artifact reduction function of tomosynthesis option, we conducted performance testing.
7
SECTION V: 510(k) Summary
The result indicates that FBP(filtered back-projection) mode of new device has a same level of metal artifact reduction capability as the mode with artifact reduction of its predicate device.
Considering all these aspects, the result of non-clinical performance data demonstrates substantial equivalence of new device to the predicate devices in aspect of image acquisition, image processing as well as image quality capabilities.
Clinical Performance Testing
The result of non-clinical bench testing demonstrates substantial equivalence to the predicate devices. Therefore, it is our understanding that clinical testing is not required in this case.
Radiation safety
New device and primary predicate device is substantially equivalent by their conformities of CFR and IEC60601-1-3.
13) Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that new device should perform as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness.
From the result of our risk analysis, software verification, and nonclinical testing discussed above, it is our conclusion that,
- -New device is substantially equivalent to the legally marketed predicate devices, K093427 FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR, K121499 FUJIFILM Tomosynthesis Option for FDR ACSELERATE STATINOARY X-RAY SYSTEM, K101686 IMAGE STITCHING OPTION and K122454 FUJIFILM DUAL ENERGY FDR SUBTRACTION (DES) SOFTWARE OPTION.
- -Additional Indication for Use of new device does not introduce any new safety and effectiveness concern.
- -Therefore, new device is as safe, as effective, and performs as well as or better than the predicate device(s).