(136 days)
Not Found
No
The summary describes a standard X-ray radiography system and does not mention any AI or ML capabilities. The focus is on the hardware components and image acquisition/processing, which are typical for such devices.
No
The device is an X-ray radiography system intended for generating diagnostic images, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is intended to "generate diagnostic images by converting x-rays into electronic signals." The device is a radiographic imaging system, and radiographic images are used for diagnostic purposes.
No
The device description explicitly states that the RADspeed fit consists of hardware components such as an X-ray high voltage generator, X-ray tube unit, X-ray tube support, and collimator, and can be configured with a radiographic table, stand, and digital radiography system. While it includes software for communication and image processing, it is fundamentally a hardware-based X-ray system.
Based on the provided information, the RADspeed fit is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for generating radiographic images of various body parts for diagnostic purposes. This involves imaging the human body directly, not testing samples taken from the body (which is the core of in vitro diagnostics).
- Device Description: The description details an X-ray radiography system, which is a medical imaging device used to visualize internal structures of the body.
- Input Imaging Modality: The input is X-ray, which is a form of radiation used for imaging, not for analyzing biological samples.
- Anatomical Site: The device is used on various anatomical sites of the human body.
- Mechanism: The mechanism involves acquiring, processing, and storing image data, which is typical for imaging devices.
IVD devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The RADspeed fit does not perform this function. It is a medical imaging device.
N/A
Intended Use / Indications for Use
The RADspeed fit 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 RADspeed fit enables radiographic exposure 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 RADspeed fit 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 device is not intended for mammographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.
Product codes
KPR, MQB
Device Description
The RADspeed fit 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 RADspeed fit can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed fit consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. The X-ray generator of RADspeed fit has the capability to communicate with the digital radiography system to synchronize exposure timing, receive a code to select an anatomical program and to send X-ray technique factors and dose information after exposure.
Mentions image processing
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Electromagnetic compatibility: Both new device and primary predicate device are in conformity with IEC60601-1-2.
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.
Sterility: Both new device and primary predicate device are not sterilized.
Electrical, Mechanical, Chemical and Thermal safety: New device and primary predicate device are substantially equivalent by their conformed standards.
Software Verification and Validation Testing: 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.
Non-clinical Performance Testing: Since the Digital radiography system is exactly the same as the predicate device (K170332), the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar. The criteria for the connectability of X-ray generators are the compliance with IEC60601-1. Since the subject device complies with IEC60601-1 and IEC60601-1-3(collateral standard), it was concluded that the non-clinical image Performance and its data are substantially equivalent to the predicate device.
Clinical Performance Testing: Since the Digital radiography system is exactly the same as the predicate device (K170332), the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar. The criteria for the connectability of X-ray generators are the compliance with IEC60601-1. Since the subject device complies with IEC60601-1 and IEC60601-1-3(collateral standard), it was concluded that the clinical Performance and its data are substantially equivalent to the predicate device.
Radiation safety: New device and primary predicate device is substantially equivalent by their conformities of CFR and IEC60601-1-3.
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
SHIMADZU CORPORATION % Mr. Jeffrey Seiler Manager, National Service Business Shimadzu Medical Systems 20101 South Vermont Avenue TORRANCE CA 90502
Re: K173517
Trade/Device Name: RADspeed fit Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: February 19, 2018 Received: February 21, 2018
Dear Mr. Seiler:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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
(1-800-638-2041 or 301-796-7100).
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
Sincerely,
Robert Sauer 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) K173517
Device Name RADspeed fit
Indications for Use (Describe)
The RADspeed fit 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 RADspeed fit enables radiographic exposure 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 RADspeed fit 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 device is not intended for mammographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.
WARNING: United States Federal Law restricts this device to sale by or on the order of a physician.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Notification Submission, RADspeed fit
510(k) Summary
The following information is submitted in accordance with the requirements of 21 CFR§807.92.
1) Date of Submission
October 30th, 2017
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
Kimihiro Takahama SHIMADZU MEDICAL SYSTEMS USA 20101 South Vermont Ave., Torrance, CA 90502 USA Phone: 310-217-8855 ext 180 Email: takahama@shimadzu-usa.com
5) Device
| Name of Device | : RADspeed fit |
|---|---|
| Common Name | : General 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 | K152244 | KPR | RADspeed Pro | SHIMADZU
CORPORATON |
|-----------|---------|-----|----------------------------------------------------------------------------------------|------------------------|
| Secondary | K170332 | MQB | Digital Radiography
CXDI-710C Wireless
Digital Radiography
CXDI-810C Wireless | Canon, Inc. |
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, K152244 RADspeed Pro manufactured by SHIMADZU CORPORATON. And as the Digital Radiography system, the legally marketed device, K170332 Digital Radiography CXDI-710C Wireless / Digital Radiography CXDI-810C Wireless by Canon, inc. is configured.
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Image /page/4/Picture/0 description: The image shows the Shimadzu logo. The logo consists of a black square with a white cross inside, followed by the word "SHIMADZU" in bold, black letters. The font used for the wordmark is sans-serif and appears to be slightly italicized.
510(k) Notification Submission, RADspeed fit
510(k) Summary
8) Device Description
The RADspeed fit 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 RADspeed fit can be used in a wide range of applications from general radiography using X-ray film or Computed Radiography (CR) cassettes, to digital radiography. The RADspeed fit consists of an X-ray high voltage generator, X-ray tube unit, X-ray tube support and collimator. The system can be configured with radiographic table, radiographic stand and digital radiography system as well. The X-ray generator of RADspeed fit has the capability to communicate with the digital radiography system to synchronize exposure timing, receive a code to select an anatomical program and to send X-ray technique factors and dose information after exposure.
9) Intended Use
The RADspeed fit is a stationary X-ray system for taking general radiographic 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 RADspeed fit 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 RADspeed fit enables radiographic exposure 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 RADspeed fit 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 device is not intended for mammographic applications or tomographic techniques. The indications for use remain the same as those for the predicate, except for the removal of tomographic technique.
WARNING: United States Federal Law restricts this device to sale by or on the order of a physician.
11) Comparison of Technological Characteristics with the predicate devices
At a high level, new device and its predicate device 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
- Use of software processing
The modifications to its predicate device K152244 are as follows,
- Removed "Fluoroscopy" function ●
- Removed "Long View Radiography" function
- Removed "Energy subtraction radiography" function
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Image /page/5/Picture/0 description: The image shows the Shimadzu logo. The logo consists of a black square with a white circle and cross inside, followed by the word "SHIMADZU" in bold, black letters. The logo is simple and modern, and it is likely used to represent the company's brand.
510(k) Notification Submission. RADspeed fit
510(k) Summary
- Removed "Tomography function" ●
- Removed "Tomosynthesis radiography" function
- Removed "Side Station RAD" from the configuration
- As the Digital Radiography system, the legally marketed device, K170332 Digital Radiography CXDI-710C Wireless / Digital Radiography CXDI-810C Wireless by Canon, inc. is configured.
- Added Calculated Dose-Area Product Display Function
- Added FPD Rotation Tray
Since all removed functions mentioned above are for the optional and additional applications of the predicate device, they do not affect safety and essential effectiveness even though they do not exist. And since the Digital Radiography system is completely the same as the predicate device K170332 Digital Radiography CXDI-710C Wireless / Digital Radiography CXDI-810C Wireless by Canon, Inc, there is no difference in image quality performance. The Calculated Dose-Area Product Display Function (added above) is a new feature to indicate calculated dose-area product values as reference purpose only. FPD rotation tray is also an optional item for the user to change the orientation of FPD without detaching from the tray. These added functions and features do not affect safety or overall system effectiveness.
Comparison charts of items which are relevant to image quality are described as follows, especially X-ray High Voltage Generator and Digital Radiography system. As for X-ray High Voltage Generator; Technology, design and specification of the X-ray high voltage generator of new device are substantially equivalent to the one of primary predicate device, except Nominal electric power, Tube current and mAs of new device. It does not affect safety and effectiveness. As for Digital Radiography system, Technology, design and specification of digital radiography system of new device are exactly the same as those of secondary predicate device.
| Specification | | New Device
RADspeed fit | Predicate Device
RADspeed Pro |
|------------------------|---------------|-------------------------------------------|--------------------------------------------------------------------|
| Radiography technique | | Same as predicate | General radiography |
| | | Same as predicate | Bucky radiography |
| | | Not Available | Tomosynthesis / Tomography |
| | | Same as predicate | Digital radiography |
| Nominal electric power | | 32kW/56kW | 80 kW / 65 kW / 50 kW |
| Radiography setting | Tube voltage | Same as predicate | 40 to 150 kV |
| | Tube current | 10 to 500 mA (32kW)
10 to 630 mA(56kW) | 10 to 1000 mA (80kW)
10 to 800 mA (65kW)
10 to 630 mA (50kW) |
| | mAs | 0.5 to 500mAs | 0.5 to 800 mAs |
| | Exposure time | Same as predicate | 0.001 to 10 sec |
- X-ray High Voltage Generator ●
- Digital Radiography system ●
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Image /page/6/Picture/0 description: The image shows the Shimadzu logo. The logo consists of a square with a circle and cross inside it, followed by the word "SHIMADZU" in bold, sans-serif font. The logo is black and white.
510(k) Notification Submission, RADspeed fit
510(k) Summary
| Specification | New Device
RADspeed fit | Secondary Predicate Device |
|---------------------|----------------------------|--------------------------------------------------------------------|
| Application | Same as predicate | General Radiography |
| Scintillator type | Same as predicate | CsI(TI)
[Cesium lodide doped with
Thallium] |
| Pixel Pitch | Same as predicate | 125 μm |
| Pixels | Same as predicate | 710C: 2,800 x 3,408 (≈ 9.5 mil)
810C: 2,800 x 2,192 (≈ 6.1 mil) |
| External Dimensions | Same as predicate | 710C: 384 x 460 x 15.7 mm
810C: 307.5 x 384 x 15.7 mm |
| Weight | Same as predicate | 710C: 2.3 kg 810C: 1.8 kg |
| Spatial Resolution | Same as predicate | 35% [MTF@2lp/mm] |
| Control SW | Same as predicate | CXDI Control Software |
| Device FW | Same as predicate | PCA - FE - 710 |
| Wireless Functions | Same as predicate | Communication between Detector
and: Multi Box Control PC |
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 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.
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Image /page/7/Picture/0 description: The image shows the Shimadzu logo. The logo consists of a square with a white cross and circle inside, followed by the word "SHIMADZU" in bold, sans-serif font. The logo is black and white.
510(k) Notification Submission. RADspeed fit
510(k) Summary
Software Verification and Validation Testing
Digital radiography system is exactly the same as the predicate (K170332). In order to adapt to the interface of the components and Digital radiography system, we modified the interface specification of the system software. However, this modification of software does not indicate the new technological characteristics. But in this submission, 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
Since the Digital radiography system is exactly the same as the predicate device (K170332), the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar. The criteria for the connectability of X-ray generators are the compliance with IEC60601-1. This means that the quality and profile of X-ray generation are ensured and are substantially equivalent as long as the both X-ray generators comply with IEC60601-1. Since the subject device complies with IEC60601-1 and IEC60601-1-3(collateral standard), we concluded that the non-clinical image Performance and its data are substantially equivalent to the predicate device. Plus, the entire system performance is ensured by verification and validation of software, risk management, and the conformity of IEC standards. The verification and validation of software and risk management are documented and are attached to this submission. IEC standards including IEC60601-1, 60601-1-2 ensure the conformity of Electrical safety and Electromagnetic Compatibility performance by the testing based on IEC standards. Therefore, IEC standards and verification and validation of software and risk management ensure the safety and effectiveness of the subject device.
Clinical Performance Testing
Since the Digital radiography system is exactly the same as the predicate device (K170332), the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar. The criteria for the connectability of X-ray generators are the compliance with IEC60601-1. This means that the quality and profile of X-ray generation are ensured and are substantially equivalent as long as the both X-ray generators comply with IEC60601-1. Since the subject device complies with IEC60601-1 and IEC60601-1-3(collateral standard), we concluded that the clinical Performance and its data are substantially equivalent to the predicate device.
Radiation safety
New device and primary predicate device is substantially equivalent by their conformities of CFR and IEC60601-1-3.
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Image /page/8/Picture/0 description: The image shows the Shimadzu logo. The logo consists of a black square with a white cross inside, followed by the word "SHIMADZU" in bold, black letters. The font used for the wordmark is sans-serif and appears to be slightly italicized.
510(k) Notification Submission, RADspeed fit
510(k) Summary
13) Conclusion
The non-clinical performance and the clinical performance are the substantially equivalent, which ensure the safety and effectiveness of the hardware and software verification and validation demonstrate that new device should perform as intended in the specified use. Based on our risk analysis, the differences do not affect its clinical safety or effectiveness.
From the result of our risk analysis, software verification and validation, discussed above, it is our conclusion that,
- -New device is substantially equivalent to the legally marketed predicate devices, K152244 RADspeed Pro manufactured by SHIMADZU CORPORATON and K170332 Digital Radiography CXDI-710C Wireless / Digital Radiography CXDI-810C Wireless.
- -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 the predicate device(s).