The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. Generic clinical benefits of radiographic examinations within the intended use are applicable for this device.

YSIO X.pree is not for mammography examinations.

Device Description

The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless and fixed integrated detectors that may be combined into different configurations to meet specific customer needs.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens YSIO X.pree X-ray system. It does not contain information about the acceptance criteria or a study proving the device meets specific performance criteria for an AI/CAD-related product.

The document primarily focuses on establishing substantial equivalence to a predicate device (Ysio Max) based on technological characteristics, intended use, and compliance with general safety and performance standards for X-ray systems.

Specifically, the document states:

"Al-based Auto Cropping" is a feature described as a "New Algorithm," but the comparison table explicitly states it "does not affect safety or effectiveness." This implies that its performance was not a critical factor in the substantial equivalence determination for this 510(k). The document does not provide any performance metrics or studies related to this AI feature.
The comparison tables highlight changes in DQE and MTF for the "MAX mini" detector, noting "small changes...does not affect safety and effectiveness." These are technical specifications of the detector, not overall system performance against clinical or perceptual criteria.

Therefore, since the document does not seem to describe an AI/CAD device that requires specific clinical performance testing against established acceptance criteria, I cannot fulfill the request for a table of acceptance criteria and associated study details from the provided text.

The information requested, such as sample size, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, is typically found in submissions for AI/CAD-assisted diagnostic devices where the AI's performance is central to the safety and effectiveness claim. This 510(k) notice is for a general radiographic X-ray system, where the primary focus is on the hardware and its general imaging capabilities.

Summary

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October 21, 2020

Image /page/0/Picture/1 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solutions USA, Inc. % Mr. Andrew Turner Regulatory Affairs Specialist 40 Liberty Boulevard, 65-1A MALVERN PA 19355

Re: K201670

Trade/Device Name: YSIO X.pree Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 17, 2020 Received: September 21, 2020

Dear Mr. Turner:

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/cfpmp/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 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

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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 medical devices and radiation-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,

For

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) K201670

Device Name YSIO X.Pree

Indications for Use (Describe)

YSIO X.pree is not for mammography examinations.

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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Image /page/3/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots. Below the words is the text "K201670".

510(k) Summary: YSIO X.pree

Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355

Date Prepared: August 5, 2020

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:

Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site

Siemens Healthcare GmbH Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Andrew Turner Requlatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Stop 65-1A Malvern, PA 19355, USA Phone: 610-850-5627 Email: andrew.turner@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: YSIO X.pree System, X-Ray, Stationary Classification Name: Classification Panel: Radiology Classification Regulation: 21 CFR § 892.1680 Device Class: Class II Product Code: KPR

4. Legally Marketed Predicate Device

Trade Name: Ysio Max 510(k) #: K181270 Classification Name: System, X-Ray, Stationary Classification Panel: Radiology

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Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

Classification Regulation: 21 CFR §892.1680 Device Class: Class II Product Code: KPR

5. Device Description:

New image system with touch user interface o
Added a camera at collimator to support clinical workflow o

Indications for Use: 6.

YSIO X.pree is not for mammography examinations.

7. Substantial Equivalence:

The YSIO X.pree with VA10 is substantially equivalent to the commercially available Ysio Max VF10 ( K181270 ).

8. Summary of Technological Characteristics of the Subiect Device as Compared with the Predicate Devices:

The YSIO X.pree is comparable in indications for use, design, material, functionality, technology, energy source and is substantially equivalent to the commercially available Ysio Max. It uses the same or similar components cleared with Ysio Max (e.g. tube, collimator, table, wallstand, detector or generator).

Many components of the subject device have the same technological characteristics as those from the predicate device.

Testing and validation have been successfully completed and test results show that the subject device YSIO X.pree with all of its components is comparable and therefore substantially equivalent to the predicate device.

The modifications made to the subject device YSIO X.pree are within the scope of intended use of 510(k) cleared predicate device Ysio Max (tomographic exposure is no longer available) and they also don't alter the fundamental scientific technology compared to predicate device.

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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Table 1: Comparison of the Subject to the Predicate

Attribute	Subject DeviceYSIO X.pree	Predicate DeviceYsio Max K181279	Comparison /Remarks
Intended use	YSIO X.pree is a deviceintended to visualizeanatomical structures byconverting an X-raypattern into a visibleimage. YSIO X.preeenables radiographicexposures of the wholebody and may be used onpediatric, adult andbariatric patients. It canalso be used foremergency applications.YSIO X.pree is not formammographyexaminations.	Ysio Max is a deviceintended to visualizeanatomical structures byconverting an X-ray patterninto a visible image. YsioMax enables radiographicand tomographic exposuresof the whole body and maybe used on pediatric, adultand bariatric patients. It canalso be used for emergencyapplications.Ysio Max is not formammographyexaminations.	The option fortomographicexposures is notavailable for thesubject devicedue to lowcustomer use inprevious devices.Ysio X.pree wasinitially developedwithout thisfeature andtherefore thisdoes not alter thesafety andeffectiveness.
Product Code	KPR	KPR	same
X-Ray
Generator	Polydoros R8065/80 kW	Polydoros R8065/80 kW	same
X-Ray tube	OPTITOP150/40/80/HC-100	OPTITOP150/40/80/HC-100	same
X-raytechniques	Radiography	Radiography	same
Collimator	Digital MultileafCollimator N	Digital MultileafCollimator N	same
Air kerma	Kerma X	Kerma X	same
CARE	CombinedApplications toReduce Exposure	CombinedApplications toReduce Exposure	same
Touch userinterface ontubesuspension	New touchscreen inlandscape format	Touchscreen in portraitformat.	New touchscreen
Digital Imaging
Fixed detectorfor table andwall stand	Trixell Pixium 4343RC"Max Static"	Trixell Pixium 4343RC"Max Static"	same
Large mobiledetector	Trixell Pixium3543EZh "MAX wi-D"	Trixell Pixium3543EZh "MAX wi-D"	same
Small mobiledetector	Pixium 2430EZ "MAXmini"	Pixium 2430EZ "MAX mini"	small changes inDQE and MTF,see table below,does not affectsafety andeffectiveness.
			effectiveness
Digital imagingsystem	syngo XR	Fluorospot Compact	Different, newimaging system
	Operating systemWindows 10	Operating system Windows10	same
	Operated via touch screen	Operated with mouse andkeyboard	Different, doesnot affect safetyor effectiveness
	Image processing withMyExam IQ	Image processing withDiamond View Plus	Slightly different,based on sameprocessingsoftware. Doesnot affect safetyor effectiveness
	Al-based Auto Cropping	Auto Cropping	New Algorithm,does not affectsafety oreffectiveness
	Acquisition and Imageprocessing parametersselected via clinicalprotocols	Acquisition and Imageprocessing parametersselected via OrganPrograms	Improved, doesnot affect safetyor effectiveness
Other Features and Components
	Table with fixed detectorand table with bucky	Table with fixed detectorand table with bucky	same
Patient table	Standard tabletop and flattabletop	Standard tabletop	Additional flattabletop for easierpatientpositioning, doesnot affect safetyor effectiveness
Wall stand	Wall stand with fixeddetector and wall standwith bucky	Wall stand with fixeddetector and wall stand withbucky	same
Camera	Live camera for patientpositioning and collimation	N/A	New, does notaffect safety oreffectiveness
WirelessRemoteControl	Yes, same type	Yes, same type	same

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Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots.

Table 2: Comparison of detector parameters for detector Pixium 2430EZ

Mobile Rad detector	YSIO X.pree	Ysio Max / K181279
Siemens Name	MAX mini	MAX mini
Trixell name	Pixium 2430EZ	Pixium 2430EZ
Dimensions (active area)	28.4 cm x 22.5 cm	28.4 cm x 22.5 cm

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Image /page/7/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are a series of orange dots arranged in a circular pattern.

Matrix size	1920 x 1520	1920 x 1520
DQE in %; 2 µGy	70 % at 0.05 lp/mm	66 % at 0.05 lp/mm
	51 % at 1 lp/mm	50 % at 1 lp/mm
	42 % at 2 lp/mm	40 % at 2 lp/mm
	29 % at 3 lp/mm	24 % at 3 lp/mm
	19 % at Nyquist	17 % at Nyquist
MTF in %	63 % at 1 lp/mm	61 % at 1 lp/mm
	35 % at 2 lp/mm	31 % at 2 lp/mm
	19 % at 3 lp/mm	15 % at 3 lp/mm
	15 % at Nyquist	12 % at Nyquist

The MAX mini has now the same image performance as the MAX Wi-D.

9. Summary of Non-Clinical Tests:

The YSIO X.pree was tested and complies with the voluntary standards listed in the table below:

Reference Number and Date	Title of Standard
IEC 60601-1Edition 3.1 (IEC 60601-1:2005+ Cor.:2006 + Cor.:2007 +A1:2012)	Medical Electrical Equipment - Part 1: General Requirementsfor Safety
IEC 60601-1-2Edition 4.0(IEC 60601-1-2:2014)	Medical Electrical Equipment - Part 1-2: General requirementsfor basic safety and essential performance - CollateralStandard: Electromagnetic Compatibility -- Requirements andTests
IEC 60601-1-3Edition 2.1(IEC 60601-1-3:2008 +A1:2013)	Medical electrical equipment - Part 1-3: General requirementsfor basic safety and essential performance - CollateralStandard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-28 Edition 3.0(IEC 60601-2-28: 2017)	Medical electrical equipment - Part 2-28: Particularrequirements for the basic safety and essential performance ofX-ray tube assemblies for medical diagnosis
IEC 60601-2-43Edition 2.1(IEC 60601-2-43:2010 +A1:2017)	Medical electrical equipment - Part 2-43: Particularrequirements for the safety of X-ray equipment forinterventional procedures
IEC 60601-2-54Edition 1.2(IEC 60601-2-54:2009 +Cor.:2010 + Cor.:2011 +A1:2015 + A2:2018)	Medical electrical equipment - Part 2-54: Particularrequirements for the basic safety and essential performance ofX-ray equipment for radiography and radioscopy

Table 3: Non-clinical performance testing

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IEC 62366-1Edition 1.0(IEC 62366-1:2015)	Medical devices - Application of usability engineering tomedical devices
ISO 14971:2019	medical devices - application of risk management to medicaldevices
IEC 62304Edition 1.1(IEC 62304:2006 + A1:2015)	Medical device software - Software life cycle processes
IEC 61910-1Edition 1.0(IEC 61910:2014)	Medical electrical equipment - Radiation dose documentation -Part 1: Radiation dose structured reports for radiography andradioscopy (IEC 61910-1:2014)
PS 3.1 - 3.20 2016	Digital Imaging and Communications in Medicine (DICOM) Set
ISO 10993-1: 2013	Biological evaluation of medical devices -- Part 1: Evaluationand testing within a risk management process

The following quality assurance measures were applied to the development of the system:

. Risk Analysis
Requirement Specification Reviews ●
. Design Reviews
Integration testing (System verification and validation) ●

10. General Safety and Effectiveness Concerns:

Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features, including visual and audible warnings, are incorporated into the system design. In addition, the YSIO X.pree is continuously monitored and if an error occurs the system functions will be blocked and an error message will be displaved.

Furthermore, the operators are health care professionals familiar with and responsible for the x-ray examinations to be performed. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and all equipment is subject to final performance testing.

11. Conclusion as to Substantial Equivalence:

The YSIO X.pree has the same fundamental scientific technology and performance characteristics as the predicate, Ysio Max (K181270). The YSIO X.pree has the same intended use and a simplified indications for use. Therefore, the YSIO X.pree is substantially equivalent to the predicate Ysio Max

12. Guidance documents

The following FDA guidance documents were utilized in this Premarket Notification:

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Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.

Content of Premarket Submissions for Management of Cyberse ● Devices Guidance for Industry and Food and Drug Administration Staff Document lssued on: October 2, 2014
. Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on July 11, 2016. The draft of this document was issued on November 2, 2015.
. Pediatric Information for X-ray Imaging Device Premarket Notifications Guidance for Industry and Food and Drug Administration Staff Document issued on November 28, 2017.
Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices . Guidance for Industry and Food and Drug Administration Staff Document issued on: September 1, 2016
Guidance for Industry and FDA Staff Guidance for the Content of Premarket ● Submissions for Software contained in Medical Devices, Document issued on: May 11, 2005
Guidance for Industry and FDA Staff Recognition and Use of Consensus . Standards Document issued on: September 17, 2007
. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] Guidance for Industry and Food and Drug Administration Staff Document issued on: July 28, 2014
. Radio Frequency Wireless Technology in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: August 14, 2013

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.