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 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

AI/ML Overview

The provided 510(k) clearance letter and summary for the YSIO X.pree device (K250738) indicate that the device is substantially equivalent to a predicate device (K233543). The submission primarily focuses on hardware and minor software updates, asserting that these changes do not impact the device's fundamental safety and effectiveness.

However, the provided text does not contain the detailed information typically found in a clinical study report regarding acceptance criteria, sample sizes, ground truth establishment, or expert adjudication for an AI-enabled medical device. This submission appears to be for a conventional X-ray system with some "AI-based" features like auto-cropping and auto-collimation, which are presented as functionalities that assist the user rather than standalone diagnostic algorithms requiring extensive efficacy studies for regulatory clearance.

Based on the provided document, here's an attempt to answer your questions, highlighting where information is absent or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., sensitivity, specificity, or image quality scores) with corresponding reported device performance values for the AI features. The "acceptance" appears to be qualitative and based on demonstrating equivalence to the predicate device and satisfactory usability/image quality.

If we infer acceptance criteria from the "Summary of Clinical Tests" and "Conclusion as to Substantial Equivalence," the criteria seem to be:

Acceptance Criteria (Inferred)	Reported Device Performance (as stated in document)
Overall System: Intended use met, clinical needs covered, stability, usability, performance, and image quality are satisfactory.	"The clinical test results stated that the system's intended use was met, and the clinical needs were covered."
New Wireless Detector (X.wi-D24): Images acquired are of adequate radiographic quality and sufficiently acceptable for radiographic usage.	"All images acquired with the new detector were adequate and considered to be of adequate radiographic quality." and "All images acquired with the new detector were sufficiently acceptable for radiographic usage."
Substantial Equivalence: Safety and effectiveness are not affected by changes.	"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." and "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."

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

Sample Size: Not explicitly stated as a number of cases or images. The "Customer Use Test (CUT)" was performed at two university hospitals.
Data Provenance: The Customer Use Test (CUT) was performed at "Universitätsklinikum Augsburg" in Augsburg, Germany, and "Klinikum rechts der Isar, Technische Universität München" in Munich, Germany. The document states "clinical image quality evaluation by a US board-certified radiologist" for the new detector, implying that the images themselves might have originated from the German sites but were reviewed by a US expert. The study design appears to be prospective in the sense that the new device was evaluated in a clinical setting in use rather than historical data being analyzed.

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

Number of Experts: For the overall system testing (CUT), it's not specified how many clinicians/radiologists were involved in assessing "usability," "performance," and "image quality." For the new wireless detector (X.wi-D24), it states "a US board-certified radiologist."
Qualifications of Experts: For the new wireless detector's image quality evaluation, the expert was a "US board-certified radiologist." No specific experience level (e.g., years of experience) is provided.

4. Adjudication Method for the Test Set

No explicit adjudication method (e.g., 2+1, 3+1 consensus) is described for the clinical evaluation or image quality assessment. The review of the new detector was done by a single US board-certified radiologist, not multiple independent readers with adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs. without AI assistance.

MRMC Study: No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance was evaluated. The AI features mentioned (Auto Cropping, Auto Thorax Collimation, Auto Long-Leg/Full-Spine collimation) appear to be automatic workflow enhancements rather than diagnostic AI intended to directly influence reader diagnostic accuracy.
Effect Size: Not applicable, as no such study was conducted or reported.

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

The document does not describe any standalone performance metrics for the AI-based features (Auto Cropping, Auto Collimation). These features seem to be integrated into the device's operation to assist the user, rather than providing a diagnostic output that would typically be evaluated in a standalone study. The performance of these AI functions would likely be assessed as part of the overall "usability" and "performance" checks.

7. The Type of Ground Truth Used

For the overall system and the new detector, the "ground truth" seems to be expert opinion/consensus (qualitative clinical assessment) on the system's performance, usability, and the adequacy of image quality for radiographic use. There is no mention of pathology, outcomes data, or other definitive "true" states related to findings on the images.

8. The Sample Size for the Training Set

The document does not provide any information about a training set size for the AI-based auto-cropping and auto-collimation features. This is typical for 510(k) submissions of X-ray systems where such AI features are considered ancillary workflow tools rather than primary diagnostic aids.

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

Since no training set information is provided, there is no information on how ground truth was established for any training data.

In summary: The 510(k) submission for the YSIO X.pree focuses on demonstrating substantial equivalence for an updated X-ray system. The "AI-based" features appear to be workflow automation tools that were assessed as part of general system usability and image quality in a "Customer Use Test" and a limited clinical image quality evaluation for the new detector. It does not contain the rigorous quantitative performance evaluation data for AI software as might be seen for a diagnostic AI algorithm that requires a detailed clinical study for clearance.

Summary

FDA 510(k) Clearance Letter - YSIO X.pree

Page 1

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

Doc ID # 04017.07.05

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.

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K250738 - Camila Rodriguez Valentin Page 2

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 Page 3

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

Page 4

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.

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:

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"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 FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

Page 5

Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355
USA
Tel.: +1-888-826-9702
usa.siemens.com/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
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

Page 6

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 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

Page 7

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.

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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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

Page 9

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

Feature	Predicate device YSIO X.pree VA20	Subject device YSIO X.pree VA20 Gen2	Comment
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

Feature	Predicate device YSIO X.pree VA20	Subject device YSIO X.pree VA20 Gen2	Comment
Fixed detector for table and wall stand	Trixell pixium 4343RC "Max Static"	Trixell pixium 4343RC "Max Static"	Same

Page 10

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

Feature	Predicate device YSIO X.pree VA20	Subject device YSIO X.pree VA20 Gen2	Comment
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	Wallstand with fixed detector and wall stand with bucky	Wallstand with fixed detector and wall stand with bucky	Updated wallstand 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	Same
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

Page 11

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 to medical devices
ISO 14971: 2019	Medical devices – application of risk management to medical 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

Page 12

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

Page 13

(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 Munich, 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.

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.

Page 14

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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Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
Document issue on August 13, 2013

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.