YSIO X.pree

K250738 · Siemens Medical Solutions · KPR · Jul 31, 2025 · Radiology

Device Facts

• Record ID: K250738
• Device Name: YSIO X.pree
• Applicant: Siemens Medical Solutions
• Product Code: KPR · Radiology
• Decision Date: Jul 31, 2025
• 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. It captures X-ray patterns, converting them into digital images for diagnostic/therapeutic decision-making. Operated by healthcare professionals in clinical settings. Features include AI-based auto-cropping and auto-collimation (Thorax, Long-Leg/Full-Spine). New features in this version include an updated generator, collimator, patient table, Bucky wall stand, status indicator lights, and the X.wi-D 24 portable wireless detector. Virtual AEC selection allows field selection via a virtual overlay on the camera image. The system uses the syngo XR platform for image processing (myExam IQ). Output is viewed by clinicians to support clinical decisions, potentially improving diagnostic accuracy and workflow efficiency.

Clinical Evidence

Customer Use Test (CUT) conducted at two clinical sites in Germany evaluated system stability, usability, performance, and image quality, confirming clinical needs were met. Additionally, a US board-certified radiologist performed a clinical image quality evaluation of the new X.wi-D24 wireless detector; all images were deemed adequate for radiographic usage.

Technological Characteristics

Stationary digital X-ray system. Components: Polydoros RFX UG generator, Digital Multileaf Collimator RFU, Trixell pixium detectors (Amorphous Silicon/CsI scintillator). Connectivity: DICOM compliant. Software: syngo XR on Windows 10. Standards: ANSI AAMI 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-54, ISO 10993-1, ISO 14971, IEC 62304.

Indications for Use

Indicated for visualization of anatomical structures in human patients of all ages and genders for diagnostic or therapeutic purposes. Covers whole-body imaging including skull, chest, abdomen, and extremities. Contraindicated for mammography examinations.

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 (K233543)

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

July 31, 2025

Siemens Medical Solutions
c/o Camila Rodriguez Valentin
Regulatory Affairs Professional
40 Liberty Boulevard
MALVERN, PA 19355

Re: K250738
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: April 8, 2025
Received: July 3, 2025

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.

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K250738 - Camila Rodriguez Valentin
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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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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.

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K250738 - Camila Rodriguez Valentin
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See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,


for

Lu Jiang, Ph.D.
Assistant Director
Diagnostic X-Ray Systems Team
DHT8B: Division of Radiological Imaging Devices and Electronic Products
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services [phone]
EF

| DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use | Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. |
| --- | --- |
| 510(k) Number (if known) K250738 | |
| 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 [e-mail] "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." | |

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SIEMENS Healthineers

# 510(k) Summary

Device Name: YSIO X.pree

510(k) Number: K250738

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

Date Prepared: July 29, 2025

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.

## 1. General Information:

Importer/Distributor:
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355

Establishment Registration Number: 2240869

Location of Manufacturing Site:
Siemens Healthineers AG
Siemensstr. 1
91301 Forchheim, Germany

Establishment Registration Number: 3004977335

## 2. Contact Person:

Camila Rodriguez Valentin
Sr.Regulatory Affairs Professional
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, US
[e-mail]

Alternate Contact Person:
Martin Rajchel
Senior Regulatory Affairs Manager
Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, US
[e-mail]

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## 3. Subject Device Name and Classification:

| Trade Name: | YSIO X.pree |
| --- | --- |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR§892.1680 |
| Device Class: | II |
| Product Code: | KPR |

## 4. Legally Marketed Predicate Device:

| Trade Name: | YSIO X.pree |
| --- | --- |
| Company: | Siemens Healthineers AG |
| 510(k) Number: | K233543 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR§892.1680 |
| Device Class: | II |
| Product Code: | KPR |

## 5. 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:

- Updated generator
- Updated collimator
- Updated patient table
- Updated Bucky Wall Stand
- New X.wi-D 24 portable wireless detector
- New virtual AEC selection
- New status indicator lights

Siemens Medical Solutions USA, Inc.
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USA
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## 6. 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.

## 7. Technological Characteristics and Substantial Equivalence:

The subject device’s technological characteristics are same as the predicate device, with modifications to hardware and software features that do not impact the safety and effectiveness of the device. The new components have been tested and do not raise any new concerns about 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.

Table 7-1: Comparison of the Subject Device (YSIO X.pree VA20 Gen2) to the Predicate Device (YSIO X.pree VA20)

| Feature | Predicate device YSIO X.pree VA20 | Subject device YSIO X.pree VA20 Gen2 | 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 |
| Model Number | 11107464 | 11574001 | Changed |

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USA

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Healthineers

| Feature | Predicate device YSIO X.pree VA20 | Subject device YSIO X.pree VA20 Gen2 | Comment |
| --- | --- | --- | --- |
| Indications 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. | 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. | Same |
| X-Ray | | | |
| Generator | Polydoros R 65/80 kW | Polydoros RFX UG R 65/80 kW | Updated state-of-the-art generator with equal performance |
| 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 RFU | Updated collimator with equal performance |
| 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 | touchscreen in landscape format | touchscreen in landscape format | Same |
| Automatic Exposure Control | Field selection via touch user interface | Field selection via touch user interface and virtual AEC overlay on the camera image | New virtual AEC selection |
| Digital Imaging | | | |
| Fixed detector for table and wall stand | Trixell pixium 4343RC “Max Static” | Trixell pixium 4343RC “Max Static” | Same |

Siemens Medical Solutions USA, Inc.
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| Feature | Predicate device YSIO X.pree VA20 | Subject device YSIO X.pree VA20 Gen2 | Comment |
| --- | --- | --- | --- |
| Large mobile detectors | Trixell pixium 3543EZh „MAX wi-D“ | Trixell pixium 3543EZh „MAX wi-D“ | Same |
| | Trixell pixium 3543EZ3 “X.wi-D 35” | Trixell pixium 3543EZ3 “X.wi-D 35” | Same |
| | Trixell pixium 4343EZ3 “X.wi-D 43” | Trixell pixium 4343EZ3 “X.wi-D 43” | Same |
| Small mobile detectors | Trixell pixium 2430EZ “MAX mini” | Trixell pixium 2430EZ “MAX mini” | Same |
| | N/A | Trixell pixium 2430EZ3 “X.wi-D 24” | New small mobile detector |
| Digital imaging system | syngo XR | syngo XR | Same |
| | Operating system Windows 10 | Operating system Windows 10 | Same |
| | Operated via touch screen | Operated via touch screen | Same |
| | 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 | Updated table hardware with equal performance |
| | 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 | Updated wall stand hardware, new wireless detector configurations |
| Camera | Live camera for patient positioning and collimation | Live camera for patient positioning and collimation | Same |
| AI based Automatic collimation | Auto Thorax Collimation | Auto Thorax Collimation | Same |
| | Auto Long-Leg/Full-Spine collimation | Auto Long-Leg/Full-Spine collimation | |
| Cropping | AI-based auto-cropping | AI-based auto-cropping | Same |
| Wireless Remote Control | Yes, same type | Yes, same type | Same |
| Status Indicator Lights | N/A | Status Indicator Lights at tube stand and wall stand | New |

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# 8. Summary of Non-Clinical Tests:

The YSIO X.pree was tested and complies with the voluntary standards listed in the table below:

Table 8: Non-clinical performance testing

| Standards Development Organization and Reference Number | Title of Standard |
| --- | --- |
| ANSI AAMI
60601-1, 2020 Ed. 3.2 | Medical Electrical Equipment - Part 1: General Requirements for Safety |
| IEC 60601-1-2 2020 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 2.2, 2021 | 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 |
| 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 2023e | 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 |

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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)

Table 8-2: Comparison of the new detector X.wi-D24 (Pixium 2430EZ3) to the predicates detectors

| | Pixium 3543EZ3 (predicate detector) | Pixium 2430EZ (predicate detector) | Pixium 2430EZ3 (subject detector) | Comparison to predicate |
| --- | --- | --- | --- | --- |
| Sensor Technology | Amorphous Silicon | Amorphous Silicon | Amorphous Silicon | same |
| Scintillator | Cesium Iodide (CsI) | Cesium Iodide (CsI) | Cesium Iodide (CsI) | same |
| Pixel pitch | 99 μm | 148 μm | 99 μm | same as 3543EZ3 |
| Pixel area - full IQ | 345.1 mm x 424.4 mm | 284.2 mm x 225.0 mm | 229.0 mm x 284.3 mm | similar to 2430EZ |
| Pixel matrix - full IQ | 3495 x 4298 pixels | 1920 x 1520 pixels | 2319 x 2879 pixels | higher than for 2430EZ |
| Pixel matrix - active | 3520 x 4316 pixels | 1920 x 1560 pixels | 2336 x 2880 pixels | higher than for 2430EZ |
| Maximum resolution | 5 lp/mm | 3.4 lp/mm | 5 lp/mm | same as 3543EZ3 |
| Detector dimensions (mm) | 384.5 x 460.5 x 16.0 | 268.5 x 328.5 x 16.0 | 268.5 x 328.5 x 16.0 | same as 2430EZ |
| Sensitivity (RQA5) | 450/560/680 lsb/μGy (min/typ/max) | 450/550/700 lsb/μGy (min/typ/max) | 450/560/680 lsb/μGy (min/typ/max) | same as 3543EZ3 |
| Maximal linear dose range (RQA5) [μGy] | 50 | 50 | 50 | |
| Electronic Noise [lsb] | 8.2 | 3.6 | 8.2 | |
| DQE @ 0 lp/mm (2.5μGy, RQA5) [%] | 70 | 70 | 70 | |
| DQE @ 1 lp/mm (2.5μGy, RQA5) [%] | 53 | 51 | 53 | |
| DQE @ 2 lp/mm (2.5μGy, RQA5) [%] | 45 | 42 | 45 | |
| DQE @ 3 lp/mm (2.5μGy, RQA5) [%] | 38 | 29 | 38 | |
| DQE @ 4 lp/mm (2.5μGy, RQA5) [%] | 27 | n.a. | 27 | |
| DQE @ 5 lp/mm (2.5μGy, RQA5) [%] | 14 | n.a. | 14 | |
| MTF @ 0.5 lp/mm | 84 | 81 | 84 | |

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| (IEC 62220) [%] | | | |
| --- | --- | --- | --- |
| MTF @ 1 lp/mm
(IEC 62220) [%] | 68 | 63 | 68 |
| MTF @ 2 lp/mm
(IEC 62220) [%] | 43 | 35 | 43 |
| MTF @ 3 lp/mm
(IEC 62220) [%] | 27 | 19 | 27 |
| MTF @ 4 lp/mm
(IEC 62220) [%] | 16 | n.a. | 16 |
| MTF @ 5 lp/mm
(IEC 62220) [%] | 10 | n.a. | 10 |

## 9. Summary of Clinical Tests:

A Customer Use Test (CUT) was performed at the “Universitätsklinikum Augsburg” in Augsburg, Germany, and at the “Klinikum rechts der Isar, Technische Universität München” in Muchich, 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 on:

- Stability check of the system
- Usability
- Performance
- Image Quality

The clinical test results stated that the system's intended use was met, and the clinical needs were covered.

The newly introduced wireless detector (X.wi-D24) was evaluated in a clinical image quality evaluation by a US board-certified radiologist. All images acquired with the new detector were adequate and considered to be of adequate radiographic quality.

## 10. General Safety and Effectiveness Concerns:

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 healthcare 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 practices, and all equipment is subject to final performance testing.

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## 11. Conclusion as to Substantial Equivalence:

The YSIO X.pree, the subject of this 510(k), is similar to the predicate device. The operating environment is the same, and the changes do not affect safety and effectiveness. Siemens concludes that the YSIO X.pree is substantially equivalent to the predicate device.

The newly introduced wireless detector (X.wi-D24) was evaluated in a clinical image quality evaluation by a US board-certified radiologist. All images acquired with the new detector 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 Gen2 to the Siemens YSIO X.pree VA20 detectors.

## 12. 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

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SIEMENS Healthineers

Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Document issue on August 13, 2013

Siemens Medical Solutions USA, Inc.
Page 10 of 10

40 Liberty Boulevard
Malvern, PA19355
USA

Tel.: [phone]
usa.siemens.com/healthineers