Who is the manufacturer of YSIO X.pree?

Siemens Medical Solutions filed the 510(k) submission for YSIO X.pree (K233543).

What is the FDA product code for YSIO X.pree?

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

What is the regulatory pathway for YSIO X.pree?

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

Does YSIO X.pree use AI or machine learning?

Yes. YSIO X.pree (K233543) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Who can help prepare an FDA 510(k) submission like YSIO X.pree?

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.

Can an AI/ML device like YSIO X.pree get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

YSIO X.pree

K233543 · Siemens Medical Solutions · KPR · May 21, 2024 · Radiology

Device Facts

Record ID	K233543
Device Name	YSIO X.pree
Applicant	Siemens Medical Solutions
Product Code	KPR · Radiology
Decision Date	May 21, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1680
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations.

Device Story

YSIO X.pree is a modular digital radiography X-ray system comprising a ceiling-suspended X-ray tube, Bucky wall stand, Bucky table, generator, and wireless/fixed detectors. Operated by healthcare professionals in clinical settings, it captures X-ray patterns and converts them into digital images for diagnostic/therapeutic decision-making. The system features AI-based auto-cropping and auto-collimation (including Auto Thorax and Auto Long-Leg/Full-Spine) using a collimator-mounted camera for patient positioning. The system processes images via the syngo XR platform, utilizing clinical protocols to select acquisition and processing parameters. The device provides visual/audible warnings and system blocks upon error detection to ensure safety. Benefits include optimized workflow, reduced radiation exposure via CARE (Combined Applications to Reduce Exposure) features, and high-quality imaging for diverse patient populations.

Clinical Evidence

A Customer Use Test (CUT) was conducted at Universitätsklinikum Augsburg, Germany. The study evaluated system function, clinical workflow, image quality, ease of use, and overall performance. Results confirmed the system met its intended use and clinical needs. The new wireless detectors were validated as acceptable for radiographic usage per FDA guidance for solid-state X-ray imaging devices.

Technological Characteristics

Modular stationary X-ray system; components include Polydoros R80 generator, OPTITOP X-ray tube, digital multileaf collimator, and Trixell pixium detectors. Connectivity via DICOM. Software platform: syngo XR (Windows 10). Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, and ISO 14971. Features AI-based auto-cropping and auto-collimation algorithms.

Indications for Use

Indicated for visualization of anatomical structures in human patients of all ages, including pediatric, adult, and bariatric populations, for whole-body radiographic imaging (skull, chest, abdomen, extremities). 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

YSIO X.pree (K201670)

Reference Devices

MULTIX Impact (VA21) (K213700)

Related Devices

K250738 — YSIO X.pree · Siemens Medical Solutions · Jul 31, 2025
K081722 — YSIO · Siemens Medical Solutions USA, Inc. · Aug 22, 2008
K250788 — Definium Tempo Select · Ge Hualun Medical Systems Co. , Ltd. · Aug 28, 2025
K133259 — YSIO MAX · Siemens Medical Solutions USA, Inc. · Jan 24, 2014
K251167 — uDR Aurora CX · Shanghai United Imaging Healthcare Co., Ltd. · Sep 19, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Siemens Medical Solutions USA, Inc. % Camila Rodriguez Valentin Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355 # Re: K233543 Trade/Device Name: YSIO X.pree Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary X-Ray System Regulatory Class: Class II Product Code: KPR Dated: November 3, 2023 Received: April 24, 2024 Dear Camila Rodriguez Valentin: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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, Image /page/1/Picture/6 description: The image shows the names Gabriela M. Rodal -S and Lu Jiang, Ph.D. The names are stacked on top of each other. The text is black and the background is white. Digitally signed by for Gabriela M. Rodal -S Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ # Indications for Use Submission Number (if known) ### K233543 Device Name YSIO X.pree Indications for Use (Describe) The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) ## 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." {3}------------------------------------------------ K233543 Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. | 510(k) Summary: | YSIO X.pree | |-----------------|----------------------------------------------------------------------------------| | 510(k) Number: | K233543 | | Company: | Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 | | Date Prepared: | May 20, 2024 | This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92. #### General Information: 1. ## Importer / Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869 ## Location of Manufacturing Site: Siemens Healthineers AG Siemensstr. 1 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Camila Rodriguez Valentin Regulatory Affairs Professional Siemens Medical Solutions USA, Inc.40 Liberty Boulevard Malvern, PA 19355, US camila.rodriguezvalentin@siemens-healthineers.com ### Alternate Contact Person: Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc.40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel @ siemens-healthineers.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots. #### 3. Subject Device Name and Classification: Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code: YSIO X.pree Stationary x-ray system Radiology 21 CFR §892.1680 II KPR #### 4. Legally Marketed Predicate Device: | Trade Name: | YSIO X.pree | |----------------------------|-------------------------| | Company: | Siemens Healthineers AG | | 510(k) Number: | K201670 | | Classification Name: | Stationary x-ray system | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | II | | Product Code: | KPR | #### ട. Legally Marketed Reference Device: | Trade Name: | MULTIX Impact (VA21) | |----------------------------|-----------------------------------------| | Company: | Siemens Shanghai Medical Equipment Ltd. | | 510(k) Number: | K213700 | | Classification Name: | Stationary x-ray system | | Classification Panel: | Radiology | | Classification Regulation: | 21 CFR §892.1680 | | Device Class: | II | | Product Code: | KPR | {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a cluster of orange dots of varying sizes. #### 6. Device Description: The YSIO X.pree is a radiography X-ray system. It is designed as a modular system with components such as a ceiling suspension with an X-ray tube, Bucky wall stand, Bucky table, X-ray generator, portable wireless, and fixed integrated detectors that may be combined into different configurations to meet specific customer needs. The following modifications have been made to the cleared predicate device: - -New Camera Model in Collimator - -New Auto Collimation Function: Auto Long-Leg/Full-Spine - -Two new wireless detectors #### 7. Indication for Use: The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations. #### 8. Technological Characteristics and Substantial Equivalence: The subject device is the same as the predicate device. The software was updated, and two new detectors have been added. The camera model for auto collimation was changed, and the reference device Multix Impact algorithm has been taken over. The new components and features have been tested and do not raise any new concerns of safety and effectiveness. The device remains within the same classification regulation for the same technology as the predicate device. The system software design was completed in accordance with Siemens Quality Management System Design Controls. The scope of internationally recognized standards compliance remains the same. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. # Table 8-1: Comparison of the Subject Device (YSIO X.pree VA20) to the PredicateDevice (YSIO X.pree VA10) | Feature | Predicate device YSIO X.pree VA10 | Subject device YSIO X.pree VA20 | Comment | |---------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| | Regulation Description | Stationary X-Ray System | Stationary X-Ray System | Same | | Regulation Number | 892.1680 | 892.1680 | Same | | Classification Product Code | KPR | KPR | Same | | Indications for use | YSIO X.pree is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. YSIO X.pree enables radiographic exposures of the whole body and may be used on pediatric, adult and bariatric patients. It can also be used for emergency applications. YSIO X.pree is not for mammography examinations. | The intended use of the device YSIO X.pree is to visualize anatomical structures of human beings by converting an X-ray pattern into a visible image. The device is a digital X-ray system to generate X-ray images from the whole body including the skull, chest, abdomen, and extremities. The acquired images support medical professionals to make diagnostic and/or therapeutic decisions. YSIO X.pree is not for mammography examinations. | Similar | | X-Ray | | | | | Generator | Polydoros R80 65/80 kW | Polydoros R80 65/80 kW | Same | | X-Ray tube | OPTITOP 150/40/80/HC-100 | OPTITOP 150/40/80/HC-100 | Same | | X-ray techniques | Radiography | Radiography | Same | | Collimator | Digital Multileaf Collimator N | Digital Multileaf Collimator N | Same | | Air kerma | Kerma X | Kerma X | Same | | CARE | Combined Applications to Reduce Exposure | Combined Applications to Reduce Exposure | Same | | Touch user interface on tube suspension Digital Imaging | touchscreen in landscape format | touchscreen in landscape format | Same | | Feature | Predicate device YSIO X.pree VA10 | Subject device YSIO X.pree VA20 | Comment | | Fixed detector for table and wall stand | Trixell pixium 4343RC "Max Static" | Trixell pixium 4343RC "Max Static" | Same | | | Trixell pixium 3543EZh, "MAX wi-D" | Trixell pixium 3543EZh, "MAX wi-D" | Same | | Large mobile detectors | N/A | Trixell pixium 3543EZ3 "X.wi-D 35" | New for YSIO X.pree VA20 | | | N/A | Trixell pixium 4343EZ3 "X.wi-D 43" | New for YSIO X.pree VA20 | | Small mobile detector | Trixell pixium 2430EZ "MAX mini" | Trixell pixium 2430EZ "MAX mini" | Same | | | syngo XR | syngo XR | Same | | | Operating system Windows 10 | Operating system Windows 10 | Same | | | Operated via touch screen | Operated via touch screen | Same | | Digital imaging system | Image processing with myExam IQ | Image processing with myExam IQ | Same | | | AI-based Auto Cropping | AI-based Auto Cropping | Same | | | Acquisition and Image processing parameters selected via clinical protocols | Acquisition and Image processing parameters selected via clinical protocols | Same | | Other Features and Components | | | | | Patient Table | Table with fixed detector and table with bucky | Table with fixed detector and table with bucky | Same | | | Standard tabletop and flat tabletop | Standard tabletop and flat tabletop | Same | | Wall stand | Wall stand with fixed detector and wall stand with bucky | Wall stand with fixed detector and wall stand with bucky | Same | | Camera | Live camera for patient positioning and collimation | Live camera for patient positioning and collimation | Similar New Camera Model, same functionality | | | Auto Thorax Collimation | Auto Thorax Collimation | Different. | | AI based Automatic collimation | N/A | Auto Long-Leg/Full-Spine collimation | Changed to new algorithm, Auto Long-Leg/Full- Spine collimation added | | Cropping | AI-based auto cropping | AI-based auto cropping | Same | | Wireless Remote Control | Yes, same type | Yes, same type | Same | | Feature | Predicate device MULTIX Impact | Subject device YSIO X.pree VA20 | Comment | | Camera | Live camera for patient positioning and collimation | Live camera for patient positioning and collimation | Same The camera, used for MULTIX Impact, is now used for YSIO X.pree VA20 | | AI based Automatic collimation | Auto Thorax, Auto Long- Leg/Full-Spine collimation | Auto Thorax, Auto Long- Leg/Full-Spine collimation | Same The algorithm, used in MULTIX Impact, is also used for YSIO X.pree VA20 | 40 Liberty Boulevard Malvern, PA 19355 USA {7}------------------------------------------------ Image /page/7/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 words is a graphic of orange dots. 40 Liberty Boulevard Malvern, PA 19355 USA Tel.: +1-888-826-9702 usa.siemens.com/healthineers {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. To the right of the words is a graphic of orange dots in a circular pattern. # Table 8-2: Comparison of the Subject Device (YSIO X.pree VA20) to the Reference Device (Multix Impact) – AI based Automatic Collimation #### Summary of Non-Clinical Tests: 9. The YSIO X.pree was tested and complies with the voluntary standards listed in the table below: | Table 9: Non-clinical performance testing | | | | |-------------------------------------------|--|--|--| |-------------------------------------------|--|--|--| | Standards Development Organization and Reference Number | Title of Standard | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ANSI AAMI 60601-1, 2012 Ed. 3.1 | Medical Electrical Equipment - Part 1: General Requirements for Safety | | IEC 60601-1-2 2014 Ed 4.1 | Medical Electrical Equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | IEC 60601-1-3: Edition 2.1, 2013 | Medical electrical equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment | | IEC 60601-2-28, 2017 | Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis | {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 below it. To the right of the word "Healthineers" is a graphic of orange dots. | IEC 60601-2-54 2018, Edition 1.2 | Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1-6 2020 Ed 3.2 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | IEC 62366-1 2020 Ed 1.1 | Medical devices – Application of usability engineering tomedical devices | | ISO 14971: 2019 | Medical devices - application of risk management tomedical devices | | IEC 62304 2015, Ed.1.1 | Medical device software - Software life cycle processes | | IEC 61910-1: 2014, Ed 1.0 | Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured reports for radiography and radioscopy | | NEMA PS 3.1 - 3.20 2021 | Digital Imaging and Communications in Medicine(DICOM) Set | | ISO EN ISO 10993-1 Fifth edition 2018 | Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process | The following quality assurance measures were applied to the development of the system: - Risk Analysis - Requirement Specification Reviews - Design Reviews - Integration testing (System verification and validation) {10}------------------------------------------------ Image /page/10/Picture/0 description: The image contains the logos for Siemens and Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. #### 10. Summary of Clinical Tests: A Customer Use Test (CUT) was performed at the "Universitätsklinikum Augsburg, Germany, to ensure the acceptance of the design and to gather feedback on the usability of the device on the clinical environment. The focus of the test was: - System function and performance-related clinical workflow - Image quality - Ease of use - Overall performance and stability The results of the clinical test stated that the intended use of the system was met, and the clinical need covered. #### General Safety and Effectiveness Concerns: 11. The Instructions for Use (IFU) are included within the device labeling, and the information provided enables the user to operate the device safely and effectively. Several safety features including visual and audible warnings are incorporated into the system design. In addition, the device is continually monitored, and if an error occurs, the system functions will be blocked, and an error message will be displayed. Furthermore, the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing. #### 12. Conclusion as to Substantial Equivalence: The YSIO X.pree, that is the subject of this 510(k), is the same as the predicate device. The operating environment is the same and the changes do not affectiveness. Siemens concludes, according to this submission material and the documentation provided, that the YSIO X.pree is substantially equivalent to the predicate device and reference device. The newly introduced wireless detectors (X.wi-D35 and X.wi D43) were tested during a Clinical Use Test (CUT) at University Hospital Augsburg in Germany according to "Guidance of Submission of 510(k)s for Solid State X-ray Imaging Devices" Document issued on: September 1, 2016. All images acquired with the new detectors were sufficiently acceptable for radiographic usage. Together with the non-clinical testing, it has met the objective of demonstrating substantial equivalence when comparing the Siemens YSIO X.pree VA20 to the Siemens YSIO X.pree VA10 detectors. {11}------------------------------------------------ Image /page/11/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 words is a graphic of orange dots. #### 13. Guidance documents The following FDA guidance documents were utilized in this Premarket Notification: Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography Document issued on October 20, 2006 Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submission - Guidance for Industry and Food and Drug Administration Staff Document Issued on September 27, 2023 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 Content of Premarket Submissions for Device Software Functions - Guidance for Industry and FDA Staff Document issued on June 14, 2023 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: Evaluation Substantial Equivalent in Premarket Notifications 510(k) - Guidance for Industry and Food and Drug Administration Staff Document issued on July 28, 2014. 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 Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff Document issue on August 13, 2013