MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact is not intended for mammography.

MULTIX Impact uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact C is not intended for mammography.

MULTIX Impact C uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact C is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.

Device Description

The MULTIX Impact (VA21) Radiography X-ray system is a floor mounted, modular system of x-ray components (x-ray tube, bucky wall stand, patient table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (VA20, K203345).

The MULTIX Impact C (VA21) Radiography X-ray system is a ceiling suspended, modular system of x-ray components (x-ray tube, bucky wall stand, patient table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact C (VA20, K203340).

The following modifications have been made to the predicate devices:

1. Upgrade software version from VA20 to VA21 to support the new features: Auto TOD Measurement, Auto Thorax Collimation, Virtual Collimation, Hybrid Image Documentation (HID).
1. New mobile UI: Smart Remote Control (SRC).
1. New accessory: myExam 3D Camera, to support the new software features. The myExam 3D Camera has been cleared in YSIO X.pree (K201670).

AI/ML Overview

The provided document is a 510(k) Summary for the Siemens MULTIX Impact and MULTIX Impact C radiographic systems. This document primarily focuses on demonstrating substantial equivalence to predicate devices based on modifications in software and accessories, rather than presenting a standalone clinical study for an AI-powered diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design for AI performance, and ground truth establishment is not present in this document.

However, based on the information provided, here's what can be extracted and what cannot:

General Statement:
The document does not describe an AI-powered diagnostic device that requires specific clinical performance acceptance criteria based on accuracy, sensitivity, or specificity. Instead, it describes a radiographic system (X-ray machine) with new software features (Auto TOD Measurement, Auto Thorax Collimation, Virtual Collimation, Hybrid Image Documentation (HID)), a new mobile UI (Smart Remote Control), and a new accessory (myExam 3D Camera), and demonstrates its substantial equivalence to previously cleared predicate devices. The "acceptance criteria" discussed are related to the safety and functional performance of the radiographic system itself, and its consistency with regulatory standards and previous versions.

Detailed Breakdown based on your Request:

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

The document does not provide a table of performance acceptance criteria in the context of an AI diagnostic study (e.g., specific thresholds for sensitivity, specificity, or AUC). The "acceptance criteria" it refers to are regulatory compliance and functional testing for the X-ray system.

Acceptance Criteria Category (Implied)	Reported Device Performance (Implied)
Regulatory Compliance	Conforms to recognized standards (e.g., ANSI ES60601-1, IEC 60601-1-2, ISO 14971, IEC 62304). Software documentation for Moderate Level of Concern is included.
Software Functionality	Test results support that all software specifications have met the acceptance criteria. New features (Auto TOD Measurement, Auto Thorax Collimation, Virtual Collimation, HID) and new UI (Smart Remote Control) are supported.
Risk Management	Risk analysis completed, risk controls implemented, hazards mitigated.
Safety	Instructions for use enable safe operation. Visual and audible warnings. System monitoring and error blocking. Adherence to industry practice for electrical and radiation hazards.
Substantial Equivalence	Device maintains same indications for use, similar operating environment and mechanical design as predicate devices. Performance is comparable to predicate, introduces no new safety risks.
New Camera Functionality	myExam 3D Camera (Intel® RealSenseTM D400 series) and associated features (Auto Thorax Collimation, Virtual Collimation) are similar in functionality to reference device (YSIO X.pree, K201670) and bench testing concluded no impact on safety and effectiveness.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document describes "non-clinical tests" (integration and functional) and "bench testing" to support the modifications and substantial equivalence. It does not mention a "test set" in the context of diagnostic image data for performance evaluation.

3. 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)

This information is not provided in the document. Ground truth establishment by experts is relevant for diagnostic AI performance evaluation, which is not the subject of this 510(k) summary.

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

This information is not provided in the document. Adjudication methods are relevant for establishing ground truth in diagnostic studies, which is not described.

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

There is no indication that an MRMC comparative effectiveness study was done. The device is an X-ray system, not an AI-assisted diagnostic software that directly affects human reader performance in interpreting images. The software updates relate to workflow and system operation (e.g., collimation, measurement, documentation) rather than diagnostic image interpretation assistance.

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

There is no indication that a standalone algorithm performance study was done. The device is an X-ray imaging system, not a standalone diagnostic algorithm.

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

This information is not provided in the document, as it is not an AI diagnostic device requiring such ground truth for performance evaluation. The "ground truth" in this context would be related to the functional correctness and safety of the X-ray system and its new features.

8. The sample size for the training set

This information is not provided in the document. Training sets are relevant for machine learning models, which are not explicitly described as part of the "software version: VA21" updates in a way that suggests a need for specific training set sizes for diagnostic performance claims. The software changes appear to be for operational enhancements of the X-Ray system rather than a diagnostic AI.

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

This information is not provided in the document, for the reasons mentioned above.

Summary

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December 13, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a seal on the left and the FDA acronym with the agency's name on the right. The seal includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA". The FDA acronym is in blue, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue as well.

Siemens Medical Solutions USA, Inc. % Ms. Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355

Re: K213700

Trade/Device Name: MULTIX Impact; MULTIX Impact C Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: November 18, 2021 Received: November 23, 2021

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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 (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) K213700

Device Name MULTIX Impact; MULTIX Impact C

Indications for Use (Describe)

MULTIX Impact is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, or in the prone position. MULTIX Impact is not intended for mammography.

MULTIX Impact C is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact C enables radiographic exposures of the whole body including: skull, chest, abdomen, and may be used on pediatric, adult and bariatric patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact C is not intended for mammography.

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 Siemens Healthineers logo. 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.

510(k) Summary: MULTIX Impact / MULTIX Impact C K213700

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

Date Prepared: December 7, 2021

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 Malvern, PA 19355 Establishment Registration Number: 2240869

Location of Manufacturing Site

Siemens Shanghai Medical Equipment Ltd. 278 Zhou Zhu Road Shanghai, 201318, China Establishment Registration Number: 3003202425

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

2. Contact Person

Denise Adams Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 610-944-2184 adams.denise@siemens-healthineers.com

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3. Subject Device Name and Classification

Trade Name:	MULTIX Impact (VA21)
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR
Trade Name:	MULTIX Impact C (VA21)
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II

4. Legally Marketed Predicate/Reference Devices

Trade Name:	MULTIX Impact (VA20)
510(k) #:	K203345
Clearance Date:	January 07, 2021
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR
Trade Name:	MULTIX Impact C (VA20)
510(k) #:	K203340
Clearance Date:	January 06, 2021
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR
Trade Name:	YSIO X.pree
510(k) #:	K201670
Clearance Date:	October 21, 2020
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680

Siemens Medical Solutions USA, Inc.

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Device Class:	Class II
Product Code:	KPR

5. Device Description

The following modifications have been made to the predicate devices:

1. Upgrade software version from VA20 to VA21 to support the new features: Auto TOD Measurement, Auto Thorax Collimation, Virtual Collimation, Hybrid Image Documentation (HID).
1. New mobile UI: Smart Remote Control (SRC).
1. New accessory: myExam 3D Camera, to support the new software features. The myExam 3D Camera has been cleared in YSIO X.pree (K201670).

6. Indications for Use

MULTIX Impact:

MULTIX Impact C:

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard Malvern. PA 19355 USA

Tel +1-888-826-9702 usa.siemens.com/healthineers

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7. Substantial Equivalence

MULTIX Impact (VA21):

MULTIX Impact (VA21) is a modification of the predicate device, the MULTIX Impact (VA20), cleared via K203345. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact (VA21) is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.

MULTIX Impact C (VA21):

MULTIX Impact C (VA21) is a modification of the predicate device, the MULTIX Impact C (VA20), cleared via K203340. The subject device is within the same classification regulation, has the same indications for use, and the same mechanical design as the predicate device. The MULTIX Impact C (VA21) is substantially equivalent to the predicate device and documentation is provided to support a claim of substantial equivalence.

8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device

The subject devices are substantially equivalent to the predicate devices in terms of the indications for use, design, material, functionality, technology, and energy source. The subject devices use the same or similar components cleared in the predicate devices.

The components of the subject device have many of the same technological characteristics as those in the predicate device. Some technological characteristics that differ slightly are shown in attached comparison table. Verification and validation testing have been successfully completed and test results show that the subject devices with all its components, is substantially equivalent to the predicate devices.

The modifications made to the subject devices do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate devices.

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

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Attribute	MULTIX Impact (VA21)(Subject)	MULTIX Impact (VA20)K203345(Predicate)	ComparisonResults
Indicationsfor Use	MULTIX Impact is a radiographicsystem used in hospitals, clinics, andmedical practices. MULTIX Impactenables radiographic exposures ofthe whole body including: skull,chest, abdomen, and extremities andmay be used on pediatric, adult andbariatric patients. Exposures may betaken with the patient sitting,standing, or in the prone position.MULTIX Impact is not intended formammography.MULTIX Impact uses digitaldetectors for generating diagnosticimages by converting X- rays intoimage signals.MULTIX Impact is also designed tobe used with conventional film/screenor Computed Radiography (CR)cassettes.	MULTIX Impact is a radiographicsystem used in hospitals, clinics, andmedical practices. MULTIX Impactenables radiographic exposures ofthe whole body including: skull,chest, abdomen, and extremities andmay be used on pediatric, adult andbariatric patients. Exposures may betaken with the patient sitting,standing, or in the prone position.MULTIX Impact is not intended formammography.MULTIX Impact uses digitaldetectors for generating diagnosticimages by converting X- rays intoimage signals.MULTIX Impact is also designed tobe used with conventional film/screenor Computed Radiography (CR)cassettes	Same

Table 1: Indications for Use Comparison:

Attribute	MULTIX Impact C (VA21)(Subject)	MULTIX Impact C (VA20)K203340(Predicate)	Comparison Results
Indications for Use	MULTIX Impact C is a radiographicsystem used in hospitals, clinics, andmedical practices. MULTIX ImpactC enables radiographic exposures ofthe whole body including: skull,chest, abdomen, and extremities andmay be used on pediatric, adult andbariatric patients. Exposures may betaken with the patient sitting,standing, or in the prone position.MULTIX Impact C is not intendedfor mammography.MULTIX Impact C uses digital	MULTIX Impact C is a radiographicsystem used in hospitals, clinics, andmedical practices. MULTIX ImpactC enables radiographic exposures ofthe whole body including: skull,chest, abdomen, and extremities andmay be used on pediatric, adult andbariatric patients. Exposures may betaken with the patient sitting,standing, or in the prone position.MULTIX Impact C is not intendedfor mammography.MULTIX Impact C uses digital	Same
Siemens Medical Solutions USA, Inc.		40 Liberty BoulevardMalvern, PA 19355USA	Tel.: +1-888-826-9702usa.siemens.com/healthineers

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detectors for generating diagnosticimages by converting X- rays intoimage signals.	detectors for generating diagnosticimages by converting X- rays intoimage signals.
MULTIX Impact C is also designedto be used with conventionalfilm/screen or ComputedRadiography (CR) cassettes.	MULTIX Impact C is also designed tobe used with conventional film/screenor Computed Radiography (CR)cassettes.

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Table 2: Subject Device Compared to Predicate Device
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MULTIX Impact (VA21)(Subject)	MULTIX Impact (VA20)K203345(Predicate)	ComparisonResults
MULTIX Impact C (VA21)(Subject)	MULTIX Impact C (VA20)K203340(Predicate)
Polydoros RFX	Polydoros RFX	Same
RAY-14S_3F	RAY-14S_3F	Same
- Collimator ML03- Collimator ML04- Collimator RFU	- Collimator ML03- Collimator ML04- Collimator RFU	Same
- Collimator ML04- Collimator RFU	- Collimator ML04- Collimator RFU
- Trixell Pixium 3543EZH(MAX wi-D)- iRay Mars1717VS (Core XL)- iRay Venu1717X (Core Static)	- Trixell Pixium 3543EZH(MAX wi-D)- iRay Mars1717VS (Core XL)- iRay Venu1717X (Core Static)	Same
Manual or motorized verticalmodule	Manual or motorized verticalmodule	Same
- Motorized vertical module- Manual tilting module	- Motorized vertical module- Manual tilting module
Floor mounted semi-motorized -- Manual tube tilting- Manual longitudinal movementFloor mounted fully motorized- Manual tube tilting- Motorized tube lifting- Manual longitudinal movement- Motorized tube tilting- Motorized longitudinal	Floor mounted semi-motorized- Manual tube tilting- Manual longitudinal movementFloor mounted fully motorized- Manual tube tilting- Motorized tube lifting- Manual longitudinal movement- Motorized tube tilting- Motorized longitudinal	Same
Attribute	MULTIX Impact (VA21)(Subject)MULTIX Impact C (VA21)(Subject)	MULTIX Impact (VA20)K203345(Predicate)MULTIX Impact C (VA20)K203340(Predicate)	ComparisonResults
Ceilingsuspensiontube stand(MULTXImpact C)	Ceiling suspension manual- Manual tube tilting- Motorized tube liftingCeiling suspension motorized- Motorized tube tilting- Motorized tube lifting	Ceiling suspension manual- Manual tube tilting- Motorized tube liftingCeiling suspension motorized- Motorized tube tilting- Motorized tube lifting	Same
All-in-onePC	- With touch screen- With non-touch screen	- With touch screen- With non-touch screen	Same
Patienttable	Elevating patient table with trayfor wireless or fixed detector	Elevating patient table with trayfor wireless or fixed detector	Same
ImagingSystem	Software version: VA21including new software features:Auto TOD Measurement, AutoThorax Collimation, VirtualCollimation, and Hybrid ImageDocumentation (HID).	Software version: VA20	DifferentImproved to supportmore operationalpossibilities. Benchtesting concluded noimpact on safety andeffectiveness.
HMI(HumanMachineInterface)	Smart Remote Control (SRC)supported by Siemens providedPhone that meets minimumrequirements.	Remote Interface supported bySiemens provided tablet thatmeets minimum requirements.	SimilarSame software withsimilar hardware.Bench testingconcluded no impact onsafety andeffectiveness.
Attribute	MULTIX Impact (VA21)(Subject)MULTIX Impact C (VA21)(Subject)	MULTIX Impact (VA20)K203345(Predicate)MULTIX Impact C (VA20)K203340(Predicate)	ComparisonResults
Camera	3D Camera	2D Camera	DifferentImproved to support thenew features of AutoTOD Measurement,Auto ThoraxCollimation, VirtualCollimation, andHybrid ImageDocumentation (HID).Bench testingconcluded no impact onsafety andeffectiveness.

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Table 3: Comparison of new feature to reference device

TechnicalSpecifications	MULTIX Impact /MULTIX Impact C(VA21)(subject)	YSIO X.pree(K201670)(reference)	Comparison Results
myExam 3DCamera	- Accessory- Model: Intel®RealSenseTM D400series	- Accessory- Model: Intel®RealSenseTM D400series	SimilarSame model series;Same functionality;Bench testing concluded noimpact on safety andeffectiveness.
Auto ThoraxCollimation	Exam rangeautomatically plannedfor Thorax by 3Dcamera with manualadjustment	Exam range automaticallyplanned for Thorax by 3Dcamera with manualadjustment	DifferentSame functionality;Similar clinical workflow;Bench testing concluded noimpact on safety andeffectiveness.
VirtualCollimation	Manually adjustcollimation size onimaging system by 3Dcamera	Manually adjustcollimation size onimaging system by 3Dcamera	DifferentSame functionality;Similar clinical workflow;Bench testing concluded noimpact on safety andeffectiveness.

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9. Nonclinical Performance Testing

Non-clinical tests were conducted for the MULTIX Impact (VA21) and MULTIX Impact C (VA21) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.

MULTIX Impact (VA21) and MULTIX Impact C (VA21) conforms to the following standards: ANSI ES60601-1:2005/(R)2012 and A1:2012 IEC 60601-1-2 Edition 4.0 2014-02 IEC 60601-1-3 Edition 2.1 2013-04 IEC 62366-1 Edition 1.0 2015-02 ISO 14971 Second edition 2007-03-01 IEC 60601-1-6 Edition 3.1 2013-10 IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION IEC 60601-2-28 Edition 3.0 2017-06 IEC 60601-2-54 Edition 1.2 2018-06 CONSOLIDATED VERSION NEMA PS 3.1 - 3.20 (2016) ISO 10993-1 Fifth edition 2018-08

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005, is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests (integration and functional) were conducted on the MULTIX Impact (VA21) and MULTIX Impact C (VA21) during product development.

The risk analysis was completed and risk controls were implemented to mitigate identified hazards. The test results support that all the software specifications have met the acceptance criteria. Verification and validation testing were found acceptable to support the claim of substantial equivalence.

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, MULTIX Impact (VA21) and MULTIX Impact C (VA21) Radiography Xray system are continually monitored and if an error occurs the system functions will be blocked and an error message will be displayed.

Risk management is ensured via a hazard analysis which is used to identify potential hazards. These potential hazards are controlled via software development, verification, and validation testing. To minimize electrical, and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. Furthermore, the operators are healthcare professionals familiar with and responsible for the x-ray examinations to be performed.

Siemens Medical Solutions USA, Inc.

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Conclusion as to Substantial Equivalence 11.

The MULTIX Impact (VA21) / MULTIX Impact C (VA21) has the same indications for use as the predicate device, MULTIX Impact (VA20, K203345) / MULTIX Impact C (VA20, K203340). The operating environment and mechanical design are similar.

Verification and validation testing demonstrate that the MULTIX Impact (VA21) and MULTIX Impact (VA21) performs as intended. The non-clinical test data demonstrate that the MULTIX Impact (VA21) and MULTIX Impact C (VA21) device performance is comparable to the predicate device that is currently marketed for the same intended use.

In summary, Siemens concludes that the MULTIX Impact (VA21) and MULTIX Impact (VA21) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate device, MULTIX Impact (VA20, K203345) and MULTIX Impact C (VA20, K203340).

12. Guidance documents

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

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.
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

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Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices Guidance for Industry and Food and Drug Administration Staff Document issued on: September 14, 2018
• 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.