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.

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.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the "RADspeed fit" device, which is a stationary X-ray system. The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (K152244 RADspeed Pro) and a digital radiography system (K170332 Digital Radiography CXDI-710C Wireless / CXDI-810C Wireless).

The document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or non-clinical evaluation comparing the device's output to ground truth, as typically seen for AI/ML-based medical devices or devices where image quality itself is the primary novelty.

Instead, the submission focuses on demonstrating substantial equivalence through:

Comparison of Technological Characteristics: Showing that the new device shares fundamental technology with the predicate devices and that modifications (removed functions, added features like FPD rotation tray and calculated dose-area product display) do not affect safety or essential effectiveness.
Compliance with Standards: Stating that the new device conforms to relevant IEC standards (IEC60601-1, IEC60601-1-2, IEC60601-1-3) and CFR, which are general safety and performance standards for medical electrical equipment and X-ray systems.
Software Verification and Validation: Showing that these processes were conducted according to FDA guidance, assuring safety and effectiveness for the software modifications related to interface adaptation.
Claim of Substantial Equivalence for Image Quality: Since the digital radiography system (detectors) used in the new device is "exactly the same as the predicate device (K170332)," the submission argues that "the output image is substantially equivalent to the predicate device as long as the quality and profile of input X-ray are similar." The compliance of X-ray generators with IEC60601-1 is cited to ensure similar X-ray quality.

Therefore, many of the requested details regarding acceptance criteria, test set characteristics, expert involvement, and specific performance metrics (like sensitivity, specificity, or MRMC results) are not applicable or not present in this type of 510(k) submission, which relies on demonstrating equivalence through design similarity, functional comparison, and adherence to general safety standards rather than a de novo performance study against a specified ground truth for a novel function.

However, I can extract the information that is present and explain why other points are not detailed.

Summary of Device Acceptance Criteria and Performance Data (Based on provided document):

The acceptance criteria are not presented in a quantitative table with specific metrics (e.g., sensitivity, specificity, accuracy). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices by ensuring:

Safety and Effectiveness: The device is as safe, as effective, and performs as well as the predicate device(s).
Technological Equivalence: Key technological elements (energy emission, X-ray generation mechanism, image data acquisition/processing, hardware/software components) are the same or comparable.
Compliance with Standards: Adherence to relevant IEC standards (IEC60601-1, 60601-1-2, 60601-1-3) and CFR for electrical, mechanical, chemical, thermal, and radiation safety, and electromagnetic compatibility.
Software Verification and Validation: Software risks are analyzed, and V&V testing is conducted per FDA guidance to ensure its safety and effectiveness, despite modifications to adapt interfaces.
Image Quality Equivalence: The digital radiography system (detector) is identical to a legally marketed predicate (K170332), thus ensuring "substantially equivalent" output image quality when combined with X-ray generators complying with relevant IEC standards.
Non-introduction of New Safety/Effectiveness Concerns: Modifications (removed functions, added minor features) do not adversely impact safety or effectiveness.

The "study" proving this device meets its "acceptance criteria" is primarily the comparative analysis of its design, technology, and compliance with standards against established predicate devices, as documented in the 510(k) submission.

Breakdown of Requested Information based on the provided text:

A table of acceptance criteria and the reported device performance
- Acceptance Criteria (Implicit - Substantial Equivalence):
  - Device is as safe, as effective, and performs as well as predicate device (K152244 RADspeed Pro).
  - Digital Radiography system (Canon CXDI-710C/810C) is identical to a legally marketed device (K170332).
  - Compliance with IEC 60601-1, 60601-1-2, 60601-1-3, and CFR (for radiation safety).
  - Software V&V conducted per FDA guidance, showing no new risks.
  - No new safety or effectiveness concerns due to modifications.
- Reported Device Performance (as stated in the document):
  - Electromagnetic compatibility: In conformity with IEC60601-1-2.
  - Materials and Bio-compatibility: In conformity with IEC 10993-1. All materials in clinical use by other commercial products.
  - Sterility: Not sterilized (same as predicate).
  - Electrical, Mechanical, Chemical and Thermal safety: Substantially equivalent to predicate by conformed standards.
  - Software: Risk Analysis and V&V testing conducted; identified level of concern, documentation consistent. "Difference does not affect its safety and effectiveness."
  - Non-clinical Image Performance: "Substantially equivalent to the predicate device" because the Digital Radiography system is identical to K170332, and X-ray generators comply with IEC60601-1.
  - Clinical Performance: "Substantially equivalent to the predicate device" for the same reasons as non-clinical performance.
  - Radiation safety: Substantially equivalent by conformities of CFR and IEC60601-1-3.
(Note: This is not a quantitative performance table but a qualitative statement of equivalence and compliance.)
Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable/Not provided in this document. This submission primarily relies on design comparison, compliance with general standards, and leveraging the prior clearance of the identical digital detector system. There is no specific test set of patient images with ground truth described for "proving" the device's image quality or diagnostic performance via a clinical trial.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable/Not provided. As there is no described test set with ground truth established, no experts for this purpose are mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No MRMC study was done or mentioned. This device is a basic X-ray system, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not done. This device is an X-ray imaging system, not an algorithm providing a standalone diagnostic output.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable/Not provided. No specific "ground truth" for diagnostic accuracy or image quality assessment (beyond compliance with technical standards) is detailed in this type of submission. The ground truth in this context is implicitly the "known good performance" of the predicate devices and the established performance of the identical digital detector.
The sample size for the training set
- Not applicable/Not provided. This is a hardware device submission. While software V&V is mentioned, it's about system integration and safety, not an AI/ML algorithm that requires a "training set."
How the ground truth for the training set was established
- Not applicable/Not provided. (See point 8).

Summary

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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.

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(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)

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	SHIMADZUCORPORATON
Secondary	K170332	MQB	Digital RadiographyCXDI-710C WirelessDigital RadiographyCXDI-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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510(k) Notification Submission, RADspeed fit

510(k) Summary

8) Device Description

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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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 DeviceRADspeed fit	Predicate DeviceRADspeed Pro < K152244>
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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510(k) Notification Submission, RADspeed fit

510(k) Summary

Specification	New DeviceRADspeed fit	Secondary Predicate Device
Application	Same as predicate	General Radiography
Scintillator type	Same as predicate	CsI(TI)[Cesium lodide doped withThallium]
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 mm810C: 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 Detectorand: 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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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

Radiation safety

New device and primary predicate device is substantially equivalent by their conformities of CFR and IEC60601-1-3.

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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).

Regulation Number and Section

§ 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.