The MULTIX Impact system 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. The MULTIX Impact system is not meant for mammography.

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

Device Description

The MULTIX Impact (VA11) Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless and fixed detectors) based on the predicate device, the MULTIX Impact (K182517). The following modifications have been made to the predicate device:

1. A new 43*43cm wireless detector, Mars1717VS manufactured by iRay
A new 43*43cm fixed detector, Venu1717X manufactured by iRay 2.
1. A new Remote Interface used for patient examination management
1. Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface.
న. New Bucky Wall Stands
1. New patient table

The new system will be branded as the MULTIX Impact.

AI/ML Overview

This is an FDA 510(k) summary for the MULTIX Impact (VA11) radiography x-ray system, which is a modification of an existing device (MULTIX Impact, K182517). The submission aims to demonstrate substantial equivalence to the predicate device, rather than proving the device meets a new set of performance acceptance criteria through a comparative clinical study.

Therefore, many of the typical acceptance criteria and study details for novel AI medical devices are not explicitly stated in this document. The focus is on demonstrating that the modifications made do not negatively impact safety and effectiveness and that the new device performs comparably to the predicate.

However, I can extract the relevant information regarding performance aspects that were tested and compared.

Here's a breakdown based on the provided text:

1. Table of "Acceptance Criteria" and Reported Device Performance

Since this is a substantial equivalence submission for modifications to an existing device, there aren't new specific quantifiable acceptance criteria in the typical sense for a brand new AI device. Instead, the "acceptance criteria" are implied to be at least equivalent or improved performance compared to the predicate device in key technical specifications.

Characteristic Measured/Compared	Acceptance Criteria (Implied: Equivalent or Improved vs. Predicate)	Reported Device Performance (Subject Device - MULTIX Impact VA11)	Notes/Comparison Results
Indications for Use	Same as predicate	Same as predicate	Same
Imaging Detectors (for RAD imaging)	Performance equivalent or improved; no impact on image quality.	Introduces iRay Mars1717VS (wireless) and iRay Venu1717X (fixed) detectors.	Different. Performance testing and co-existence testing concluded no impact on image quality.
HMI (Human Machine Interface)	Same as predicate	Touch user interface (same as predicate)	Same
Remote Interface	No impact on safety and effectiveness (as this is a new option)	Supported by Siemens provided tablet meeting minimum requirements.	Different. Performance testing and co-existence testing concluded no impact on safety and effectiveness.
UI (User Interface) on Imaging System	No impact on safety and effectiveness.	Color scheme is grey (dark); Button shape is rounded or pill-shaped.	Different. Performance testing concluded no impact on safety and effectiveness.
Software Version	No impact on safety and effectiveness.	VA11	Different. Improved to support hardware modifications and Remote Interface; performance testing concluded no impact on safety and effectiveness.
Bucky Wall Stand (BWS)	No impact on safety and effectiveness; performance unchanged.	For Pixium 3543 EZH: BWS with motorized height adjustment with new functions (option for fixed/selectable left/right detector loading direction). For Mars1717VS: BWS with manual/motorized height adjustment with new functions and new tray. For Venu1717X: BWS with motorized height adjustment with new functions, new tray, additional emergency button and motion switch.	Different. Improved/modified to support new detectors/operational possibilities. Performance testing concluded no impact on safety and effectiveness.
Patient Table	No impact on safety and effectiveness; performance unchanged.	Elevating Patient table in z-axis for Pixium 3543 EZH (same as predicate). Fixed and elevating Patient tables in z-axis for Mars1717VS with new tray.	Different (for Mars1717VS due to new tray). Modification to support new detector. Performance is unchanged. Testing concluded no impact on safety and effectiveness.
Detector Active Area	Equivalent or Improved (larger dimensions, no impact on safety/effectiveness).	iRay Mars1717VS: 426mm x 426mm; 3070x3070 pixels. iRay Venu1717X: 426mm x 426mm; 3070x3070 pixels.	Different. Improved active area (larger dimensions) no impact on safety and effectiveness.
Detector Pixel Size	Equivalent or Improved; no impact on safety/effectiveness.	iRay Mars1717VS: 139 µm. iRay Venu1717X: 139 µm.	Different. Minor change only; no impact on safety and effectiveness.
Detector Material	Same as predicate.	Amorphous Silicon.	Same.
Scintillator	Same as predicate.	Cesium iodide (CsI) 16 bit.	Same.
DQE (Detective Quantum Efficiency) @ 1 lp/mm (2 μGy)	Equivalent or improved.	iRay Mars1717VS: 65%. iRay Venu1717X: 65%.	Different. Minor improvement to DQE; no impact on safety and effectiveness.
MTF (Modulation Transfer Function) @ 1 lp/mm	Equivalent or improved.	iRay Mars1717VS: 64%. iRay Venu1717X: 64%.	Different. Minor improvement to MTF; no impact on safety and effectiveness.
General Safety and Effectiveness Concerns (Overall System)	Conformance to standards; risk mitigation; no new potential safety risk.	Conforms to IEC 60601-1:2012, IEC 60601-1-2:2014, etc. Risk analysis completed, controls implemented. Visual/audible warnings incorporated.	Test results support all software specifications met acceptance criteria. Verification/validation acceptable. Device performs as intended and is comparable to predicate.

2. Sample Sizes Used for the Test Set and Data Provenance

This document describes a 510(k) submission for modifications to a hardware device (X-ray system), not an AI software. The testing mentioned is primarily non-clinical performance testing (integration, functional, regulatory compliance, risk analysis) rather than clinical studies with patient data.

Test Set Sample Size: Not applicable in the context of patient image data for an AI algorithm. The testing involves hardware components and integrated system performance. No specific "test set" of patient images is referenced for algorithm evaluation.
Data Provenance: Not applicable for an AI algorithm. The testing would have occurred internally at Siemens manufacturing and R&D facilities.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This is not applicable as the submission focuses on hardware and software modifications of an X-ray system, not an AI algorithm that requires expert-established ground truth for performance evaluation.

4. Adjudication Method for the Test Set

Not applicable for this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not performed and not applicable. This is not an AI-assisted diagnostic device undergoing a comparative effectiveness study with human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not performed and not applicable. This is not an AI algorithm but a hardware X-ray system with embedded software.

7. Type of Ground Truth Used

Not applicable for an AI algorithm. The "ground truth" in this context refers to engineering specifications, regulatory standards compliance, and functional performance benchmarks for hardware and system software.

8. Sample Size for the Training Set

Not applicable as this is not an AI algorithm that requires a training set of patient data.

9. How the Ground Truth for the Training Set was Established

Not applicable as there is no mention of a training set or AI algorithm in the provided document.

Summary

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

Re: K193089

Trade/Device Name: MULTIX Impact Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: February 11, 2020 Received: February 12, 2020

Dear Mr. Rajchel:

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

March 20, 2020

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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) K193089

Device Name MULTIX Impact

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: MULTIX Impact

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

Date Prepared: November 5, 2019

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 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

Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355 610-448-6545 martin.rajchel@siemens-healthineers.com

Siemens Medical Solutions USA, Inc.

40 I iberty Boulevard Mail Code 65-1A Malvern, PA 19355 USA

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3. Subject Device Name and Classification

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

4. Legally Marketed Predicate Device

Trade Name:	MULTIX Impact
510(k) #:	K182517
Clearance Date:	January 11, 2019
Classification Name:	Stationary X-Ray System
Classification Panel:	Radiology
Classification Regulation:	21 CFR §892.1680
Device Class:	Class II
Product Code:	KPR

5. Device Description

1. A new 43*43cm wireless detector, Mars1717VS manufactured by iRay
A new 43*43cm fixed detector, Venu1717X manufactured by iRay 2.
1. A new Remote Interface used for patient examination management
1. Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface.
న. New Bucky Wall Stands
1. New patient table

The new system will be branded as the MULTIX Impact.

6. Indications for Use

The MULTIX Impact uses digital detectors for generating diagnostic images by converting X-

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355

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rays into image signals. The MULTIX Impact is also designed to be u film/screen or Computed Radiography (CR) cassettes.

7. Substantial Equivalence

The MULTIX Impact (VA11) is a modification of the predicate device, the MULTIX Impact, cleared via K182517. 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 (VA11) 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 MULTIX Impact (VA11) is substantially equivalent to the commercially available MULTIX Impact (K182517) in terms of the indications for use, design, material, functionality, technology, and energy source. The subject device uses the same or similar components cleared in the MULTIX Impact (e.g. tube, generator, collimator, patient table, Bucky Wall Stand, and imaging system).

The components of the subject device have many of the same technological characteristics as the ones from the predicate device. There are some technological characteristics that differ slightly as shown in the comparison tables below. Verification and validation testing have been successfully completed and test results show that the subject device, MULTIX Impact (VA11) with all its components, is substantially equivalent to the predicate device.

The modifications made to the subject device, MULTIX Impact (VA11), do not affect the intended use of the device nor do they alter its fundamental scientific technology compared to the predicate device, the MULTIX Impact (K182517).

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

Siemens Medical Solutions USA. Inc

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

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	MULTIX ImpactVA11 (Subject)	MULTIX ImpactK182517(Predicate)	ComparisonResults
Indicationsfor Use	The MULTIX Impact systemis a radiographic system usedin hospitals, clinics, andmedical practices. MULTIXImpact enables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremities andmay be used on pediatric,adult and bariatric patients.Exposures may be taken withthe patient sitting, standing, orin the prone position. TheMULTIX Impact system isnot meant for mammography.	The MULTIX Impact systemis a radiographic system usedin hospitals, clinics, andmedical practices. MULTIXImpact enables radiographicexposures of the whole bodyincluding: skull, chest,abdomen, and extremities andmay be used on pediatric,adult and bariatric patients.Exposures may be taken withthe patient sitting, standing,or in the prone position. TheMULTIX Impact system isnot meant for mammography.	Same
	The MULTIX Impact usesdigital detectors for generatingdiagnostic images byconverting x-rays into imagesignals.	The MULTIX Impact usesdigital detectors forgenerating diagnostic imagesby converting X-rays intoimage signals.
	The MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes.	The MULTIX Impact is alsodesigned to be used withconventional film/screen orComputed Radiography (CR)cassettes.

			Table 1: Indications for Use Comparison:
--	--	--	------------------------------------------

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

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Attribute	MULTIX ImpactVA11 (Subject)	MULTIX ImpactK182517(Predicate)	ComparisonResults
SSXI forRADimaging	Trixell Pixium 3543EZH	Trixell Pixium 3543EZH	Same
	iRay Mars1717VSwith corresponding tray inbucky wall stand and patienttable		Different.New flat detectors.Performance testingand co-existencetesting concluded noimpact on imagequality.
	iRay Venu1717Xwith corresponding tray inbucky wall stand
HMI(HumanMachineInterface)	Touch user interface	Touch user interface	Same
	Remote Interface supported bySiemens provided tablet thatmeets minimum requirements.	N.A.	Different.New option.Performance testingand co-existencetesting concluded noimpact on safety andeffectiveness.
UI (UserInteface) onImagingSystem	Color scheme is grey (dark)Button shape is rounded orpill-shaped	Color scheme is blue(dark)Button shape issquare	Different.Performance testingconcluded no impacton safety andeffectiveness.
Softwareversion	VA11	VA10	Different.Improved to supporthardwaremodifications andRemote Interface;Performance testingconcluded no impacton safety andeffectiveness.
Other minor modifications
	MULTIX ImpactVA11 (Subject)	K182517(Predicate)	ComparisonResults
Bucky WallStand(BWS)	For Pixium 3543 EZH:BWS with motorized heightadjustment with new functions:- Option for fixed left or rightdirection to load the detector- Option for selectable left orright direction to loaddetector during installation	For Pixium 3543 EZH:BWS with motorizedheight adjustment- Standardconfiguration forfixed left or rightdirection to loaddetector	Different.Improved to supportmore operationalpossibilities.Performance testingconcluded no impacton safety andeffectiveness.
	For Mars1717VS:BWS with manual andmotorized height adjustmentwith new functions- New tray for Mars1717VS- Option for fixed left or rightdirection to load detector- Option for selectable left orright direction to loaddetector during installation		Different.Modification tosupport the newdetectors.Performance isunchanged. Testingconcluded no impacton safety andeffectiveness.
	For Venu1717X:BWS with motorized heightadjustment with new functions- New tray for Venu1717X- Option for fixed left or rightdirection to load detector- Option for selectable left orright direction to loaddetector during installation- Additional emergency buttonand motion switch
Patient table	Elevating Patient table in z-axisfor Pixium 3543 EZH	Elevating Patient table inz-axis for Pixium 3543	Same
MULTIX ImpactVA11 (Subject)	K182517(Predicate)	ComparisonResults
Fixed and elevating Patienttables in z-axis forMars1717VS:- new tray for new detector	EZH	Different.Modification tosupport the newdetector. Performanceis unchanged. Testingconcluded no impacton safety andeffectiveness.

Table 2: Subject Device Compared to Predicate

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

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Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

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Table 3: Comparison of iRay Flat Detectors to the predicate Trixell Pixium 3543EZh

TechnicalSpecifications	iRay Mars1717VS(wireless)(Subject)	iRay Venu1717X(fixed) (Subject)	Trixell Pixium3543EZHdetector (wireless)(Predicate)	ComparisonResults
	426 mm x 426mm	426 mm x 426mm	348 mm x 424mm	Different.Minor change tosize dimensiononly; no impact onsafety andeffectiveness.
	3070 x 3070 pixels	3070 x 3070pixels	2350 x 2866pixels	Different.Improved activearea (larger)larger dimensions;no impact onsafety andeffectiveness.
	139 µm	139 µm	148 um	Different.Minor change topixel size only; noimpact on safetyand effectiveness.
Material	Amorphous	Amorphous	Amorphous	Same

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

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	Cesium iodide(CsI)16 bit	Cesium iodide(CsI)16 bit	Cesium iodide(CsI)16 bit	Same
QuantumEfficiency)	DQE @ 1lp/mm (2 μGy),65%	DQE @ 1lp/mm (2 μGy),65%	DQE @ 1lp/mm (2 μGy),51%	Different.Minorimprovement toDQE; no impacton safety andeffectiveness.
(Modulationstransferfunction)	MTF @ 1lp/mm, 64%	MTF @ 1lp/mm, 64%	MTF @ 1lp/mm, 63%	Different.Minorimprovement toMTF; no impacton safety andeffectiveness.

9. Nonclinical Performance Testing

Non-clinical tests were conducted for the MULTIX Impact (VA11) during product development. The modifications described in this Premarket Notification are supported with verification and validation testing.

MULTIX Impact (VA11) conforms to the following standards: IEC 60601-1:2012; IEC 60601-1-2:2014; IEC 60601-1-3:2008+A1:2013; IEC 62366-1:2015; ISO 14971:2007; IEC 60601-1-6:2013; IEC 62304:2015; IEC 60601-2-28:2017; IEC 60601-2-54:2015; NEMA PS 3.1-3.20 (2016) and ISO 10993-1:2009.

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 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 was found acceptable to support the claim of substantial equivalence.

General Safety and Effectiveness Concerns 10.

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

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355

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MULTIX Impact (VA11) Radiography X-ray system is continually monitor 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.

11. Conclusion as to Substantial Equivalence

The MULTIX Impact (VA11) has the same indications for use as the predicate device, MULTIX Impact. The operating environment and mechanical design are similar. It is Siemens opinion that the MULTIX Impact (VA11) is substantially equivalent to the MULTIX Impact, cleared in K182517 on January 11, 2019.

Verification and validation testing demonstrate that the MULTIX Impact (VA11) performs as intended. The non-clinical test data demonstrate that the MULTIX Impact (VA11) device performance is comparable to the predicate device that is currently marketed for the same intended use.

In summary, Siemens is of the opinion that the MULTIX Impact (VA11) does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate device.

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

Siemens Medical Solutions USA. Inc.

40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355
USA

Tel · +1-888-826-9702 isa siemens com/healthineer

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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
. 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

Siemens Medical Solutions USA, Inc.

40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 IISA

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.