Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max is not for mammography examinations.

Device Description

The Ysio Max is a stationary X-ray system for radiography. The main components are the X-ray generator, the X-ray tube with collimator supported by a ceiling rail system. The Ysio Max comes with SSXIs (Solid State X-ray Imagers) that can be mobile or fixed in the Bucky tray. An image processing and data management system (syngo FLC) completes the radiographic suite.

The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features:

The operating system will be MS Windows 10
New cybersecurity features
Additional pediatric programs
Implementing a "Virtual Machine" that supports hospital IT
The SSXIs have been updated
The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition)
. The image processing algorithms (Diamond view Plus) will be used for exposures without grid.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called Ysio Max. It focuses on demonstrating substantial equivalence to a predicate device after a software upgrade (VF10) and minor hardware changes.

Based on the provided document, the device (Ysio Max with VF10 software) is a stationary X-ray system, not an AI/ML-powered device for which acceptance criteria typically involve performance metrics like sensitivity, specificity, or AUC.

Therefore, the acceptance criteria and study detailed in the document are primarily related to demonstrating that the updated device maintains the same safety and effectiveness as its predicate device and complies with relevant performance standards, rather than proving a specific diagnostic accuracy or improvement in human reader performance using AI assistance.

Here's a breakdown of the information as it applies to this specific submission, addressing your points where relevant:

1. A table of acceptance criteria and the reported device performance:

The acceptance criteria are implicitly tied to demonstrating continued substantial equivalence to the predicate device and compliance with applicable industry standards and FDA regulations. Performance is reported through comparisons to the predicate and confirmation of adherence to standards.

Feature	Acceptance Criteria (Implied)	Reported Device Performance
Intended Use	Maintain same intended use as predicate.	"Ysio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. Ysio Max is not for mammography examinations." (Identical to predicate, "reworded to simplify").
Technological Characteristics	Maintain comparable technological characteristics to predicate.	X-ray Generator: Same (Polydoros 65/80 kW)X-ray tube: Same (OPTITOP 150/40/80/HC-100)Collimator: Same (Digital Multileaf Collimator N)Air kerma: Same (Kerma X)X-ray techniques: Same (Radiography)Organ programs: Same functionality (X-ray parameters, Imaging processing parameters).Digital Imaging System: Same (Fluorospot Compact aka syngo FLC).Image processing: Same (Diamond View Plus, "made user friendly").
Detector Performance	Detectors (SSXI) must be similar in performance to predicates and comply with guidance (e.g., DQE, MTF).	Trixell Pixium 4343RCE (MAX static): DQE @ 0.05 lp/mm (2 uGy), 67% (Predicate: 65%); MTF @ 1 lp/mm, 62% (Predicate: 63%). "Difference not significant".Trixell Pixium 3543 EZh (MAX wi-D): DQE @ 1 lp/mm (2 µGy), 51% (Predicate: 50%); MTF @ 1 lp/mm, 63% (Predicate: 61%). "Difference not significant".Trixell Pixium 2430 EZ (MAX mini): DQE @ 1 lp/mm (2 µGy), 50% (Predicate: 50%); MTF @ 1 lp/mm, 61% (Predicate: 61%). "Same".
Software Functionality	Correctly perform as designed, fulfill software requirements, and align with user needs.	"the verification/validation activities successfully confirmed that the software requirements have been fulfilled and that system functionality is consistent with the user needs and intended uses. The VF10 software correctly performs as designed and raises no new questions regarding safety or effectiveness."
Cybersecurity	Improved cybersecurity.	"New cybersecurity features" and "Security package based on MS Win 10" (Predicate: MS Win 7). "Improved".
Operating System	Update to current OS.	"MS Windows 10" (Predicate: Windows 7).
Compliance with Standards	Adherence to relevant IEC, ISO, NEMA, and FDA performance standards.	Compliance confirmed for IEC 60601 series, IEC 62366, ISO 14971, IEC 62304, IEC 61910-1, NEMA PS 3.1 - 3.20 (DICOM), ISO 10993-1. Specifically, IEC 60601-1-2:2007 Edition 4.0 for EMC testing was applied ("Testing according to current IEC test scope").
FDA Performance Standards	Compliance with 21 CFR 1020.30-31.	"Performance testing confirmed that the Ysio Max with VF10 complies with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray equipment." Specific sections are listed.

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a "test set" in the context of an AI/ML algorithm being evaluated on a dataset of patient cases. Instead, the testing is described as verification and validation (V&V) testing of the software and hardware components, and performance measurements of the X-ray detectors against technical specifications. These are engineering and performance tests, not clinical studies on a patient cohort for diagnostic AI.
Data Provenance: Not applicable in the context of diagnostic data for AI. The testing is internal to the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI/ML diagnostic system requiring expert interpretation as ground truth. The "ground truth" for the device's performance is adherence to engineering specifications and regulatory standards.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable. This is not a study involving human reader interpretations of medical images that would require adjudication.

5. 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, an MRMC study was not done. The document explicitly states: "For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as X-ray technology; geometry and SSXI changes are minor." This device is an X-ray system itself, not an AI assistant intended to improve human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The Ysio Max is a medical imaging device (a stationary X-ray system), not a standalone diagnostic algorithm. Its performance is measured by its ability to generate images and comply with technical and safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this submission is based on engineering specifications, compliance with standardized test methods (e.g., IEC standards for electrical safety, EMC, radiation protection), and measurable physical characteristics of the detectors (DQE, MTF). It's a technical "ground truth" rather than a clinical diagnostic one.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set of data.

9. How the ground truth for the training set was established:

Not applicable for the same reason mentioned above.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

June 13, 2018

Siemens Medical Solutions, Inc. % Ms. Denise Adams Regulatory Affairs Specialist 40 Liberty Boulevard 65-1A MALVERN PA 19355

Re: K181279

Trade/Device Name: Ysio Max Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: May 14, 2018 Received: May 15, 2018

Dear Ms. Adams:

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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K181279

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 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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Hol 2. Mild

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181279

Device Name

Ysio Max

Indications for Use (Describe)

Y sio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max 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) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, tor

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid QMB number."

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Image /page/3/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.

Special 510(k) Summary: Ysio Max

Company:

Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: June 12, 2018

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

1. General Information:

Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard 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:

Denise Adams, RAC Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355 adams.denise@siemens-healthineers.com

Alternate Contact Person:

Patricia D. Jones Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65 - 1A Malvern, PA 19355 patricia.d.jones@siemens-healthineers.com

3. Device Name and Classification:

Trade Name: Ysio Max

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Classification Name: Stationary x-ray System Classification Panel: Radiology Classification Regulation: 21 CFR §892.1680 Device Class: II Product Codes: KPR

4. Legally Marketed Predicate Device:

Trade Name: Ysio Max 510(k) Number: K133259 Device Classification Name: Stationary x-ray System Regulation Medical Specialty: Radiology Review Panel: Radiology Product Code: KPR Submission Type: Special 510(k) Regulation Number: 892.1680 Device Class: II

5. Device Description:

The purpose of this submission is the upgrade to a new software version VF10 and minor hardware changes. The modified Yisio Max will introduce the following new features:

The operating system will be MS Windows 10 ●
New cybersecurity features
Additional pediatric programs ●
Implementing a "Virtual Machine" that supports hospital IT ●
The SSXIs have been updated ●
The EMC (Electromagnetic Compatibility was tested according to the IEC . 4th edition)
. The image processing algorithms (Diamond view Plus) will be used for exposures without grid.

6. Indications for Use:

Y sio Max is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. Ysio Max enables radiographic and tomographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications.

Ysio Max is not for mammography examinations.

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7. Substantial Equivalence:

The new system software VF10 does not alter the intended use or the fundamental scientific technology. The device remains within the same classification regulation for the same intended use as the predicate device. The new system software design was completed in accordance with Siemens Quality Management System Design Controls comparable to the processes available for the predicate device. The scope of internationally recognized standards compliance was updated to the standards recognized at the time of the design of the new software. Verification and Validation testing was the same or similar to the testing being used with the predicate device.

The new system software version VF10 controls solid state X-ray imagers (SSXI) similar to the imagers being used with the predicate device. The updated MAX wi-D and Max mini detectors have been previously cleared in K173639.

1. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device:
  The subject device with the new software version VF10 uses the same X-ray generator, the same X-ray tube and similar SSXIs with the same digital imaging system and similar image processing software as the predicate device. There are no changes in the patient environment or the type of user interface.

The following tables compare the main performance data of the subject device with the predicate device to substantiate equivalence.

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	Subject Device	Predicate Device
Feature	Ysio Max	Ysio MaxK133259	Comparison Results
Indications for Use Comparison
Indicationsfor Usestatement	Ysio Max is a deviceintended to visualizeanatomical structuresby converting an X-ray pattern into avisible image. YsioMax enablesradiographic andtomographicexposures of thewhole body and maybe used on pediatric,adult and bariatricpatients. It can also beused for emergencyapplications.Ysio Max is notformammographyexaminations.	The Ysio Max is a radio-graphic system used inhospitals, clinics, andmedical practices. YsioMax enables radiographicand tomographic expo-sures of the whole bodyincluding: skull, chest,abdomen, and extremitiesand may be used onpediatric, adult andbariatric patients. It canalso be used for intrave-nous, small interventions(like biopsy, punctures,etc.) and emergency(trauma, critical ill)applications.Exposures may be takenwith the patient sitting,standing, or in the proneposition.The Ysio Max system isnot meant formammography.The Ysio Max usesintegrated or portabledigital detectors forgenerating diagnosticimages by converting x-rays into electronicsignals. Ysio Max is alsodesigned to be used withconventional film/screenor Computed Radiography	Intendeduse is thesame.Indicationsfor usehave beenrewordedtosimplify.

Table 1: Comparison of the Subject Device Ysio Max to the Predicate

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Technical Comparison
X-ray
Generator	Polydoros65/80 kW	Polydoros65/80 kW
X-ray tube	OPTITOP150/40/80/HC-100	OPTITOP150/40/80/HC-100	Same
Collimator	Digital MultileafCollimator N	Digital MultileafCollimator N
Air kerma	Kerma X	Kerma X
X-ray techniques	Radiography	Radiography
Organ programs	X-ray parametersImaging processingparameters	X-ray parametersImaging processingparameters
Testing
IEC Compliance	IEC 4th edition forEMC testing	IEC 3rd edition forEMC testing	Testing according tocurrent IEC test scope
Digital Imaging
SSXI for Radimaging	Trixell PixiumMAX wi-D =3543EZhMAX mini = 2430EZMAX Static =4343RC	Trixell PixiumMAX wi-D =3543EZhMAX mini = 2430EZMAX Static =4343RC	Image Chainis similar to predicatedeviceDetector Performancedata according ToSSXI guidance areprovided
Digital imagingsystem	Fluorospot Compactaka syngo FLC	Fluorospot Compact
Image processing	Diamond View Plus	Diamond View Plus	Same processingmade user friendly
MS Operatingsystem	Windows 10	Windows 7	New Operatingsystem
Cybersecurity	Security packagebased on MS Win 10	Security packagebased on MS Win 7	Improved
Integration ofhospital IT	Hospital/RadiologyInformation System	Hospital/RadiologyInformation System	Improved
Pediatric package	Increased number oforgan programs	Organ programs	Increased number andvariability

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Table 2: Comparison of Trixell Pixium 4343RCE to the predicate Pixium 4343RC
(MAX static)

TechnicalSpecifications	Trixell Pixium4343RCE detector(MAX static) (fixed)(subject)	Trixell Pixium4343RC detector(fixed) (predicate)	ComparisonResults
Dimensions	423.3mm x 425.4 mm	424.6 mm x 425.5 mm	Difference notsignificant
Resolution	2860 x 2874 pixels	2869 x 2874 pixels	Difference notsignificant
Pixel size	148 um	148 um	Same
SemiconductorMaterial	Amorphous silicon,a-Si	Amorphous silicon,a-Si	Same
Scintillator	Cesium iodide (CsI)	Cesium iodide (CsI)	Same
Acquisitiondenth	16 bit	16 bit	Same
DQE (Detective	DQE @ 0.05 lp/mm (2uGy), 67%	DQE @ 0.05 lp/mm (2uGy), 65%	Difference notsignificant
nlations	MTF @ 1 lp/mm, 62%	MTF @ 1 lp/mm, 63%	Difference notsignificant

Table 3: Comparison of Trixell Pixium 3543 EZh to the predicate Pixium 3543EZh
(MAX wi-D)

TechnicalSpecifications	Trixell Pixium 3543EZh detector(wireless)(subject)	Trixell Pixium 3543EZh detector (MAXwi-D) (wireless)(predicate)	ComparisonResults
Dimensions	348 mm x 424 mm	349 mm x 425 mm	Difference notsignificant
Resolution	2350 x 2866 pixels	2356 x 2872 pixels	Difference notsignificant
Pixel size	148 µm	148 µm	Same
SemiconductorMaterial	Amorphous silicon,a-Si	Amorphous silicon,a-Si	Same
Scintillator	Cesium iodide (CsI)	Cesium iodide (CsI)	Same
Acquisition depth	16 bit	16 bit	Same
DQE (DetectiveQuantumEfficiency)	DQE @ 1 lp/mm (2µGy), 51%	DQE @ 1 lp/mm (2µGy), 50%	Difference notsignificant
MTF(Modulationstransferfunction)	MTF @1 lp/mm,63%	MTF @1 lp/mm,61%	Difference notsignificant

Siemens Medical Solutions USA, Ino.

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Image /page/9/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots. The logo is simple and modern.

Table 4: Comparison of Trixell Pixium 2430 EZ to the predicate Pixium 2430 EZ
(MAX mini)

TechnicalSpecifications	Trixell Pixium2430EZ detector(wireless)(subject)	TrixellPixium 2430EZ detector(MAX mini)(wireless)(predicate)	ComparisonResults
Dimensions	225 mm x 284mm	228 mm x 284mm	Difference notsignificant
Resolution	1520 x 1920pixels	1560 x 1920pixels	Difference notsignificant
Pixel size	148 µm	148 µm	Same
SemiconductorMaterial	Amorphoussilicon, a-Si	Amorphoussilicon, a-Si	Same
Scintillator	Cesium iodide(CsI)	Cesium iodide(CsI)	Same
Acquisitiondepth	16 bit	16 bit	Same
DQE(DetectiveQuantumEfficiency)	DQE @ 1lp/mm (2 µGy),50%	DQE @ 1lp/mm (2 µGy),50%	Same
MTF(Modulationstransferfunction)	MTF @ 1lp/mm,61%	MTF @ 1lp/mm,61%	Same

Summary of Non-Clinical Test Data:

The software VF10 design was completed in accordance with Siemens Quality Management System Design Controls and verification and validation testing were successfully conducted. Non-clinical performance data are provided for the updated detectors. The new IEC 4th edition has been applied for the compliance to the IEC 60601-1-2 electromagnetic compatibility standard.

The tests were performed on the new software VF10 demonstrating that the device is safe and effective, performs comparably to the predicate device, and is substantially equivalent to the predicate device.

Documentation provided demonstrates compliance of the subject device to all FDA requirements stated in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests of software requirements and software risk hazards.

Performance testing confirmed that the five devices comply with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray Fluoroscopic equipment

The software VF10 controls solid state X-ray imagers (SSXI) that are similar in performance to the predicates. Performance data are provided according to the "Guidance

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for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on: September 1, 2016''. X-ray geometry and techniques are the same so that clinical image comparisons involving SSXI were not conducted.

Together, the verification/validation activities successfully confirmed that the software requirements have been fulfilled and that system functionality is consistent with the user needs and intended uses. The VF10 software correctly performs as designed and raises no new questions regarding safety or effectiveness. Therefore, when compared to the predicate device the Ysio Max with the new software VF10 support a determination of substantial equivalence to the predicate device.

9. Summary of Non-Clinical Tests

The devices operating with software VF10 comply with the voluntary standards as listed in the following table:

DevelopmentOrganization andReference Number	Title of Standard
IEC 60601-1:2012,Edition 3.1	Medical Electrical Equipment - Part 1: GeneralRequirements for Safety
IEC 60601-1-2:2007Edition 4.0	Medical Electrical Equipment - Part 1-2: Generalrequirements for basic safety and essentialperformance - Collateral Standard: ElectromagneticCompatibility -- Requirements and Tests
IEC 60601-1-3: 2012,Edition 2.1	Medical electrical equipment - Part 1-3: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Radiationprotection in diagnostic X-ray equipment
IEC 62366:2014Edition 1.1	Medical devices – Application of usabilityengineering to medical devices
ISO 14971, 2007	Medical devices – application of risk managementto medical devices
IEC 62304 Ed. 1.0,2006	Medical device software - Software life cycleprocesses
IEC 60601-2-28:2010Edition 2.0	Medical electrical equipment - Part 2-28: Particularrequirements for the basic safety and essentialperformance of X-ray tube assemblies for medicaldiagnosis
IEC 60601-2-54, 2009Edition 1.0	Medical electrical equipment - Part 2-54: Particularrequirements for the basic safety and essentialperformance of X-ray equipment for radiographyand radioscopy
IEC 61910-1, 2014	Medical electrical equipment - Radiation dosedocumentation - Part 1: Radiation dose structuredreports for radiography and radioscopy (IEC 61910-1:2014)

Table 5: Standards

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NEMA PS 3.1 - 3.20,2011	Digital Imaging and Communications in Medicine(DICOM) Set
ISO 10993-1, 2009	Biological evaluation of medical devices -- Part 1:Evaluation and testing within a risk managementprocess

Documentation provided demonstrates compliance of the subject devices to all FDA requirements stated in the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, including results of verification/validation tests of software requirements and software risk hazards.

Performance testing confirmed that the Ysio Max with VF10 complies with 21 CFR 1020.30-31 Federal Performance Standards for X-Ray equipment. The applicable sections include:

1020.30(c)	Manufacturer's Responsibility (Certification)
1020.30(e)	Identification of X-ray components
1020.30(g)	Information to be provided to assemblers
1020.30(h)	Information to be provided to users
1020.31(k)	Leakage Radiation
1020.30(m)	Beam Quality
1020.31(a)	Peak Tube Potential
1020.31 (d)(2)(i, iii)	Alignment of visually defined X-ray fields and contrastof light defined X-ray field.
1020.31 (e)(1)(i)	Alignment of the center of the radiographic X-ray fieldwith the center of the image receptor
1020.31 (e)(1)(ii, iii)	Radiography X-ray field size and image receptor size

The software VF10 controls solid state X-ray imagers (SSXI) that are similar in performance to the predicates. Performance data are provided according to the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices, issued on: September 1, 2016".

10. Summary of Clinical Tests:

For the subject of this premarket submission, Siemens did not do an evaluation of the clinical image quality as X-ray technology; geometry and SSXI changes are minor.

11. 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 devices are continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.

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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.

12. Conclusion as to Substantial Equivalence:

The Ysio Max with VF10 software has the same intended use as the predicate device. The operating environment is the same and the technology differences do not affect safety and effectiveness. Siemens concludes via the documentation provided in this 510(k) submission that the radiology device Ysio Max with VF10 is substantially equivalent to the predicate device Ysio Max.

13. Guidance documents

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

Guidance for Industry and FDA Staff ●
Bundling Multiple Devices or Multiple Indications in a Single Submission Document issued on: June 22, 2007
Content of Premarket Submissions for Management of Cybersecurity in . Medical Devices
Guidance for Industry and Food and Drug Administration Staff Document Issued 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 1 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

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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.