Who is the manufacturer of MULTIX Impact?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MULTIX Impact (K193089).

What is the FDA product code for MULTIX Impact?

KPR. It is classified under 21 CFR 892.1680 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MULTIX Impact?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MULTIX Impact?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTIX Impact

K193089 · Siemens Medical Solutions USA, Inc. · KPR · Mar 20, 2020 · Radiology

Device Facts

Record ID	K193089
Device Name	MULTIX Impact
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	KPR · Radiology
Decision Date	Mar 20, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	Pediatric

Intended Use

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 Story

MULTIX Impact is a modular stationary X-ray system for hospitals/clinics; operated by healthcare professionals. System components include floor-mounted X-ray tube, bucky wall stand, patient table, X-ray generator, and digital detectors (wireless/fixed). Input: X-ray radiation; Output: diagnostic images via digital detectors or CR/film cassettes. VA11 software update supports new iRay detectors (Mars1717VS, Venu1717X) and a new Remote Interface for patient management. System provides visual/audible warnings and monitors functions to ensure safety. Benefits include improved imaging performance (DQE/MTF) and operational flexibility (motorized Bucky Wall Stand adjustments).

Clinical Evidence

Bench testing only. Verification and validation testing conducted to support hardware and software modifications. Performance testing included image quality assessment (DQE, MTF) and co-existence testing for new detectors. Software testing performed per moderate level of concern requirements. No clinical data presented.

Technological Characteristics

Stationary X-ray system; floor-mounted tube; digital detectors (Amorphous Silicon/Cesium Iodide); motorized Bucky Wall Stand; elevating patient table. Connectivity: DICOM (NEMA PS 3.1-3.20). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 62366-1, ISO 14971, IEC 60601-1-6, IEC 62304, IEC 60601-2-28, IEC 60601-2-54, ISO 10993-1.

Indications for Use

Indicated for radiographic imaging of the whole body (skull, chest, abdomen, extremities) in pediatric, adult, and bariatric patients. Not indicated for mammography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

MULTIX Impact (K182517)

Related Devices

K203345 — MULTIX Impact · Siemens Medical Solutions USA, Inc. · Jan 7, 2021
K233532 — MULTIX Impact E · Siemens Medical Solutions · Nov 29, 2023
K213700 — MULTIX Impact, MULTIX Impact C · Siemens Medical Solutions USA, Inc. · Dec 13, 2021
K162971 — Multix Fusion Max · Siemens Medical Solutions USA, Inc. · Nov 22, 2016
K220919 — MULTIX Impact E · Siemens Medical Solutions USA, Inc. · May 17, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration". 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193089 ### Device Name MULTIX Impact ## Indications for Use (Describe) 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. 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) ## 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, to: > 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 OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. {3}------------------------------------------------ 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. There is a graphic to the right of the words that consists of a cluster of orange dots. Below the logo is the text "K193089". # 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 {4}------------------------------------------------ Image /page/4/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. To the right of the word "Healthineers" is a graphic of orange dots. #### 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 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. - 3. A new Remote Interface used for patient examination management - 4. Upgraded software version from VA10 to VA11 to support hardware modifications and Remote Interface. - న. New Bucky Wall Stands - 6. New patient table The new system will be branded as the MULTIX Impact. #### 6. Indications for Use 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- Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots. 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 {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. | | MULTIX Impact VA11 (Subject) | MULTIX Impact K182517 (Predicate) | Comparison Results | |------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Indications for Use | 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 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. | Same | | | The MULTIX Impact uses digital detectors for generating diagnostic images by converting x-rays into image signals. | 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. | The MULTIX Impact is also designed to be used with conventional film/screen or Computed 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 {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots. | Attribute | MULTIX Impact VA11 (Subject) | MULTIX Impact K182517 (Predicate) | Comparison Results | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | SSXI for RAD imaging | Trixell Pixium 3543EZH | Trixell Pixium 3543EZH | Same | | | iRay Mars1717VS with corresponding tray in bucky wall stand and patient table | | Different. New flat detectors. Performance testing and co-existence testing concluded no impact on image quality. | | | iRay Venu1717X with corresponding tray in bucky wall stand | | | | HMI (Human Machine Interface) | Touch user interface | Touch user interface | Same | | | Remote Interface supported by Siemens provided tablet that meets minimum requirements. | N.A. | Different. New option. Performance testing and co-existence testing concluded no impact on safety and effectiveness. | | UI (User Inteface) on Imaging System | Color scheme is grey (dark) Button shape is rounded or pill-shaped | Color scheme is blue (dark) Button shape is square | Different. Performance testing concluded no impact on safety and effectiveness. | | Software version | VA11 | VA10 | Different. Improved to support hardware modifications and Remote Interface; Performance testing concluded no impact on safety and effectiveness. | | Other minor modifications | | | | | | MULTIX Impact VA11 (Subject) | K182517 (Predicate) | Comparison Results | | Bucky Wall Stand (BWS) | For Pixium 3543 EZH: BWS with motorized height adjustment with new functions: - Option for fixed left or right direction to load the detector - Option for selectable left or right direction to load detector during installation | For Pixium 3543 EZH: BWS with motorized height adjustment - Standard configuration for fixed left or right direction to load detector | Different. Improved to support more operational possibilities. Performance testing concluded no impact on safety and effectiveness. | | | For Mars1717VS: BWS with manual and motorized height adjustment with new functions - New tray for Mars1717VS - Option for fixed left or right direction to load detector - Option for selectable left or right direction to load detector during installation | | Different. Modification to support the new detectors. Performance is unchanged. Testing concluded no impact on safety and effectiveness. | | | For Venu1717X: BWS with motorized height adjustment with new functions - New tray for Venu1717X - Option for fixed left or right direction to load detector - Option for selectable left or right direction to load detector during installation - Additional emergency button and motion switch | | | | Patient table | Elevating Patient table in z-axis for Pixium 3543 EZH | Elevating Patient table in z-axis for Pixium 3543 | Same | | MULTIX Impact VA11 (Subject) | K182517 (Predicate) | Comparison Results | | | Fixed and elevating Patient tables in z-axis for Mars1717VS: - new tray for new detector | EZH | Different. Modification to support the new detector. Performance is unchanged. Testing concluded no impact on safety and effectiveness. | | ## Table 2: Subject Device Compared to Predicate Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 USA {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. There are also some orange dots to the right of the words. Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 USA {9}------------------------------------------------ Image /page/9/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots. # Table 3: Comparison of iRay Flat Detectors to the predicate Trixell Pixium 3543EZh | Technical Specifications | iRay Mars1717VS (wireless) (Subject) | iRay Venu1717X (fixed) (Subject) | Trixell Pixium 3543EZH detector (wireless) (Predicate) | Comparison Results | |-----------------------------|--------------------------------------------|-------------------------------------|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------| | | 426 mm x 426 mm | 426 mm x 426 mm | 348 mm x 424 mm | Different. Minor change to size dimension only; no impact on safety and effectiveness. | | | 3070 x 3070 pixels | 3070 x 3070 pixels | 2350 x 2866 pixels | Different. Improved active area (larger) larger dimensions; no impact on safety and effectiveness. | | | 139 µm | 139 µm | 148 um | Different. Minor change to pixel size only; no impact on safety and effectiveness. | | Material | Amorphous | Amorphous | Amorphous | Same | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail Code 65-1A Malvern, PA 19355 USA {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. | | Cesium iodide (CsI) 16 bit | Cesium iodide (CsI) 16 bit | Cesium iodide (CsI) 16 bit | Same | |---------------------------------------|----------------------------------|----------------------------------|----------------------------------|--------------------------------------------------------------------------------------------| | Quantum Efficiency) | DQE @ 1 lp/mm (2 μGy), 65% | DQE @ 1 lp/mm (2 μGy), 65% | DQE @ 1 lp/mm (2 μGy), 51% | Different. Minor improvement to DQE; no impact on safety and effectiveness. | | (Modulations transfer function) | MTF @ 1 lp/mm, 64% | MTF @ 1 lp/mm, 64% | MTF @ 1 lp/mm, 63% | Different. Minor improvement to MTF; no impact on safety and effectiveness. | ## 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 {11}------------------------------------------------ Image /page/11/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. 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 {12}------------------------------------------------ Image /page/12/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. 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