This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

Siemens intends to market a new Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform.

Siemens also intends to market updated software version, SOMARIS/10 syngo CT VB20, for the new NAEOTOM CT scanner systems and for the NAEOTOM Alpha cleared in K233657 (clearance date March 28th, 2024). The updated software version SOMARIS/10 syngo CT VB20 incorporates mainly features for radiotherapy planning support.

With the new software version SOMARIS/10 syngo CT VB20, the trade name of NAEOTOM Alpha cleared in K233657 has been changed to NAEOTOM Alpha.Peak for ex-factory systems. Systems already installed will receive the software update without change of the trade name. The system label keeps the product name NAEOTOM Alpha. System label information and UDI are not changed and remain the same as the original submitted.

For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.

The subject devices NAEOTOM Alpha (trade name ex-factory CT systems: NAEOTOM Alpha.Peak) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 are Computed Tomography X-ray systems which feature two continuously rotating tube-detector systems, denominated as Aand B-systems respectively (dual source NAEOTOM CT scanner system).

The subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 is a Computed Tomography X-ray system which features one continuously rotating tube-detector systems, denominated as A-system (single source NAEOTOM Alpha CT scanner system).

The detectors' function is based on photon-counting technology.

In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM CT scanner systems".

The NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 produce CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors. The CT images can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. The radiation therapy planning support includes, but not limited to, Brachytherapy, Particle including Proton Therapy, External Beam Radiation Therapy, Surgery. The computer system delivered with the CT scanner is able to run optional post-processing applications.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system.

The platform software for the NAEOTOM CT scanner systems is syngo CT VB20 (SOMARIS/10 syngo CT VB20). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version.

Software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657.

Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. All subject devices will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use remains unchanged compared to the predicate devices.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens NAEOTOM CT Scanner Systems, specifically addressing the updated software version SOMARIS/10 syngo CT VB20 and new system configurations (NAEOTOM Alpha.Pro and NAEOTOM Alpha.Prime).

The document does not contain a multi-reader, multi-case (MRMC) comparative effectiveness study with human readers improving with AI vs. without AI assistance. The device described is a Computed Tomography (CT) X-ray system, which is a medical imaging hardware device, not an AI software intended for image interpretation assistance to human readers in the way an MRMC study would typically evaluate. The software features described primarily relate to system control, image reconstruction, and workflow efficiency, some of which are automated ("FAST" technologies) but do not indicate an "AI assistance" that augments a human reader's diagnostic performance in a comparative study design. Therefore, the questions related to MRMC studies and human reader improvement are not applicable to the information provided in this 510(k) summary.

Additionally, the document describes non-clinical performance testing (bench testing), which evaluates the technical performance of the device and its features, rather than a clinical study evaluating diagnostic accuracy against a ground truth from expert readers or pathology. The performance data presented is based on phantom tests and technical assessments rather than a clinical study. Therefore, several of the requested elements (number of experts, adjudication methods, type of ground truth for test sets/training sets, sample sizes for training/test sets as they pertain to clinical data) are not directly addressed in the context of a clinical performance study as typically understood for AI/CADe devices.

The acceptance criteria and reported device performance are generally stated in terms of comparable or improved accuracy to predicate devices and successful completion of verification and validation testing against internal specifications and recognized standards.

Here's an attempt to answer the questions based on the provided document, noting the limitations regarding the type of device and performance data presented:

Acceptance Criteria and Device Performance Study Summary

The device in question is a Computed Tomography (CT) X-ray System (NAEOTOM CT Scanner Systems) with software version SOMARIS/10 syngo CT VB20. The performance data provided are primarily from non-clinical bench testing to demonstrate the device's technical capabilities and comparability to predicate devices. The focus is on functionality verification and image quality evaluation, particularly for new and modified features.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific, quantifiable table of "acceptance criteria" for features in the typical sense of a clinical trial (e.g., sensitivity/specificity thresholds). Instead, "acceptance criteria" are referenced as being "related to the corresponding requirements" for various verification and validation tests. The reported performance is generally qualitative, stating that features meet expectations or are comparable/improved to predicate devices.

Feature/Non-clinical Supportive Testing	Acceptance Criteria (Implicit from text)	Reported Device Performance
Direct i4D	The functionality should enable acquisition of a complete breathing cycle at every planned position, even with changing respiratory rates during data acquisition, successfully avoiding interpolation artifacts seen in conventional 4DCT.	"The test results show that with Direct i4D it is possible to acquire data for a full breathing cycle at every position of the patient even if the respiratory rate changes during the data acquisition. Compared to the conventional 4DCT scan mode interpolation artifacts (which occur because not for every position a complete breathing cycle could be acquired) can successfully be avoided with Direct i4D."
DirectBreathhold	The functionality should correctly trigger a spiral scan automatically from an external respiratory gating device, ensuring the scan remains unchanged and the object is accurately depicted.	"The test results show that using the Direct Breathhold functionality, a spiral scan can automatically be triggered from an external respiratory gating device. The actual scan remains unchanged, and the object is correctly depicted in the resulting image."
Recon&GO – RT planning	The introduction of RTP scan protocols should enable time and imaging dose savings by allowing spectral post-processing to provide task-specific images, eliminating the need for additional Single Energy scan ranges.	"The bench test underpins the possibility that with the introduction of the RTP scan protocols in the subject devices NAEOTOM CT scanner systems with syngo CT VB20, time and imaging dose can be saved, since each RTP scan range allows for spectral post-processing to provide task-specific images for an end-to-end radiotherapy workflow and thus no additional scan range with Single Energy is needed."
FAST 3D Camera/FAST Integrated Workflow	The optimized sub-features (Isocentering, Range, Direction) should demonstrate comparable or better accuracy for adults and adolescents as the predicate device for adults.	"Overall, the subject devices with syngo CT VB20 delivers comparable or improved accuracy to the predicate devices with syngo CT VB10 predicate device for adults and extends the support to adolescents." (Specific improvements for adolescents and maintained accuracy for adults)
Flex 4D Spiral	The functionality should demonstrate proper function and assess the image quality of Flex 4D Spiral with NAEOTOM CT scanners.	"The performed bench test report describes the technical background of Flex 4D Spiral and its functionalities with NAEOTOM CT scanners, demonstrate the proper function of those, and assess the image quality of Flex 4D Spiral." (No specific quantifiable results given in summary, just that a report describes and assesses).
FAST Planning	The algorithm should have a high fraction (percentage) of correct ranges that can be applied without change and meet interactive speed requirements for calculation time.	"For more than 90% of the ranges no editing action was necessary to cover standard ranges. For more than 95%, the speed of the algorithm was sufficient." (Meets objective for reducing editing actions and meeting speed requirements).
Low-Dose Lung Cancer Screening (NAEOTOM Alpha.Pro & Alpha.Prime)	Technical parameters specific to Low-Dose Lung Cancer Screening should be comparable to predicate devices.	"It can be concluded that the subject and predicate devices are substantially equivalent for the task of Low-Dose Lung Cancer Screening since the bench test results showed comparable technical parameters."

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

The "test set" in this context refers to phantom test data used for non-clinical bench testing.

Sample Size: Not explicitly quantified as a number of "cases" or "patients" in the way a clinical study would. The descriptions indicate testing was performed on "a dynamic phantom" for Direct i4D, and "additional data from adults and adolescence patients" for FAST 3D Camera accuracy (though this data was for optimizing the feature, not for an independent test set as typically understood for a clinical performance evaluation). For FAST Planning, testing was done on "patient data" but no sample size is given. For Low-Dose Lung Cancer Screening, "technical parameters" were compared, implying phantom or engineering data. The overall testing framework includes "System Validation test" and "System Verification test" with various activities, but no specific human subject test set is detailed.
Data Provenance: The data is from non-clinical bench testing and internal verification/validation activities. There is no mention of data origin in terms of "country of origin" as it is not a clinical study involving patient data from specific geographical locations. The testing is described as part of product development, implying internal company testing. It is inherently retrospective in the sense that it's testing a developed product against its specifications.

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

This information is not provided as the performance data is from non-clinical bench testing, not from a clinical study with a ground truth established by medical experts interpreting images. The "ground truth" for these tests would be the pre-defined technical specifications and expected physical behavior of the system, verified by engineering and quality assurance personnel.

4. Adjudication Method for the Test Set

Since there is no clinical test set involving human expert interpretations and potential discrepancies, an "adjudication method" is not applicable. The "acceptance criteria" for the non-clinical tests are against internal requirements and performance metrics (e.g., accuracy against a known phantom truth, successful triggering of functions).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done according to the provided information. This submission is for a CT scanner system (hardware and associated control/reconstruction software), not an AI software intended to assist human readers in image interpretation. The performance data focuses on the technical capabilities of the CT system itself.

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

The "performance data" section describes the technical performance and functionality of various software and hardware features, which can be considered "standalone" in the sense of evaluating the algorithm/system's output against a known input (e.g., phantom data). For instance:

Direct i4D: Performance evaluated based on data acquisition and artifact avoidance.
FAST Planning: Assessed the algorithm's ability to calculate ranges correctly and its speed.
Low-Dose Lung Cancer Screening: Compared technical parameters.

However, this is not a "standalone performance" measure for diagnostic accuracy of an AI algorithm in the context of interpreting medical images compared to a clinical ground truth, but rather the technical performance of the imaging device and its embedded functionalities.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" is technical/physical ground truth based on phantom properties, defined test conditions, and engineering specifications. For instance:

For Direct i4D, the ground truth is the "breathing pattern of a thorax phantom."
For FAST 3D Camera, the ground truth for accuracy would be the known physical position/orientation relative to the scanner.
For FAST Planning, the ground truth involves "correct" calculated ranges based on anatomical rules or system design.

There is no mention of ground truth established via expert consensus, pathology, or outcomes data, as these are non-clinical hardware/software performance tests.

8. The Sample Size for the Training Set

The document does not provide information on a "training set" in the context of machine learning or AI models with labelled clinical data. The software features described are primarily rule-based or optimized algorithms, not deep learning models that require large labelled training datasets. While some features like FAST 3D camera were "optimized using additional data," this refers to data used for algorithm refinement (development/internal testing) and not a distinct "training set" for an AI model that would then be tested on an independent "test set."

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

Since no explicit "training set" for AI/ML algorithms is described in the provided context, this question is not applicable. The development and optimization of the system's features rely on engineering specifications, physical models, and potentially iterative refinement using internal test data (phantoms, potentially anonymized patient data for feature optimization) where the "truth" is either known by design or derived from highly controlled measurements.

Summary

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February 12, 2025

Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE, TN 37932

Re: K243523

Trade/Device Name: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 14, 2024 Received: November 14, 2024

Dear Tabitha Estes:

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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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 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.

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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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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,

Lu Jiang

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

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K243523

Device Name

NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime

Indications for Use (Describe)

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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."

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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 word "Healthineers" is an orange graphic of a cluster of circles.

K243523

510(k) Summary for

NAEOTOM CT Scanner Systems

with software version SOMARIS/10 syngo CT VB20

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

I. Submitter

Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number: 1034973

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 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers.

Submitter Contact Person: Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) tabitha.estes@Siemens-healthineers.com

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II. Device Name and Classification

Product name	Trade name
NAEOTOM Alpha	NAEOTOM Alpha.PeakNAEOTOM Alpha
NAEOTOM Alpha.Pro	NAEOTOM Alpha.Pro
NAEOTOM Alpha.Prime	NAEOTOM Alpha.Prime

Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

III. Predicate Device

Primary Predicate Device:
Trade Name:	NAEOTOM Alpha
510(k) Number:	K233657
Clearance Date:	March 28, 2024
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subjectdevice design.

Secondary Predicate Device:
Trade Name:	SOMATOM X.ceed
510(k) Number:	K233650
Clearance Date:	March 26, 2024
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subjectdevice design.

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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 word "Healthineers" is a cluster of orange dots.

Reference Predicate Device:
Trade Name:	SOMATOM go. Platform
510(k) Number:	K233650
Clearance Date:	March 26, 2024
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
Regulation Number:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	All predicate device recalls have been considered in the subjectdevice design.

Note: K233650 was a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).

IV. Device Description

Siemens intends to market a new Single source CT system NAEOTOM Alpha.Prime and a new Dual Source CT system NAEOTOM Alpha.Pro based on the SOMARIS/10 software platform.

For simplicity, the product name of NAEOTOM Alpha will be used throughout this submission instead of the trade name NAEOTOM Alpha.Peak.

The detectors' function is based on photon-counting technology.

In this submission, the above-mentioned CT scanner systems are jointly referred to as subject devices by "NAEOTOM CT scanner systems".

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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 word "Healthineers" is a graphic of orange dots arranged in a circular pattern.

Software version syngo CT VB20 (SOMARIS/10 syngo CT VB20) is a modified software version of the primary predicate device NAEOTOM Alpha, syngo CT VB10 (SOMARIS/10 syngo CT VB10) cleared in K233657.

Software version SOMARIS/10 syngo CT VB20 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems.

V. Indications for Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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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 word "Healthineers" is a cluster of orange dots that are arranged in a circular pattern.

VI. Indications for Use Comparison

Subject Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Primary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations*.

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Secondary Predicate Device Indications for Use:

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data.

The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.

This CT system can be used for low dose lung cancer screening in high risk populations.*

*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Comparison:

The subject device Indications for Use is the exact same as the secondary predicate device Indications for Use (K233650).

Compared to the primary predicate device, the indications for Use of the subject devices have been extended with the phrase "radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions.". The extension of the indications for use reflects the support for radiotherapy planning introduced with the software version syngo CT VB20 of the subject devices.

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Image /page/9/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.

None of the intended uses include computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient).

The subject devices NAEOTOM CT scanner systems are not the principal means of guidance, because the CT Systems do not guide the invasive procedures, the needle orientation and the needle advance and handling are always done under the physician's control.

VII. Comparison of Technological Characteristics with the Predicate Device

Supported by the subject device, SOMARIS/10 syngo CT VB20 software version is a further development of the SOMARIS/10 syngo CT VB10 software version which is cleared in K233657.

The subject devices NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of the NAEOTOM CT scanner systems have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

The new syngo CT VB20 software reuses all unmodified software features of the legacy software syngo CT VB10 cleared in K233657. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB20 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications.

The intended use and fundamental scientific technology for the NAEOTOM Alpha remain unchanged from the predicate devices.

At a high level, the subject and predicate devices are based on the same subset of technological elements:

Scanner Principle Whole body X-Ray Computed Tomography Scanner ●
. System Acquisition - Continuously rotating tube detector system
. Iterative Reconstruction – Support of various iterative reconstruction principles
Workplaces – Support of workplaces that include reconstruction and image evaluation software
. Patient table
. Patient table foot switch for movement
QuantaMax Detector
Tin filtration technology
Vectron X-ray Tube
Power Generator
Scan&GO
. Mobile workflow (Tablet)
Optional injector arm
Optional support of CT guided intervention workflow (myNeedle Guide)
Optional support of FAST 3D Camera operation for fast patient positioning workflow
Scanner display and control functionality
Remote Scan Control
Long scan range

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Image /page/10/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 word "Healthineers" is a cluster of orange dots of varying sizes.

The subject devices NAEOTOM CT scanner systems with SOMARIS/10 syngo CT VB20 will support hardware and software modifications/further developments in comparison to the predicate devices as listed in the Table 2. The column "HW/ SW change" in the table contains reference to a hardware (HW) or/and software (SW) change. The columns under "Predicate devices" of the Table 2 indicate the clearance of the technological properties in the corresponding predicate device.

The modification overview in Table 2 uses the terms "new, modified, or enabled" to describe various technological characteristics of the subject devices in comparison to the primary and secondary predicate devices. The definition of the above-mentioned terms is provided in the following Table 1.

Term	Definition
New	The feature is newly supported for Siemens CT scanners and the subject device
Modified	This feature is a modified form of a feature cleared within the primary and/orsecondary predicate devices
Enabled	This feature is currently supported by other cleared Siemens CT systems orcleared Siemens stand-alone software applications. This feature will besupported for the subject device with software version SOMARIS/10 syngo CTVB20 and is substantially equivalent compared to the cleared version of theprimary/secondary predicate device.
n.a.	The feature is not supported by the subject device or by the primary and/orsecondary predicate device.

Table 1: Overview of term definition.

The following Table 2 provides a modification overview of the subject devices at a high-level.

Table 2: High-level overview of key hardware (HW) and software (SW) modifications of the Dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and

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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 below it. To the right of the word "Healthineers" is a graphic of several orange dots arranged in a pattern.

NAEOTOM Alpha.Pro and the Single source subject device NAEOTOM Alpha.Prime with software version SOMARIS/10 syngo CT VB20 compared to the predicate devices.

	Technologicalproperty	HW/SWchange	Subject devices			Predicate devices
			Dual Source		Singlesource	Dual Source	Singlesource
			NAEOTOMAlpha	NAEOTOMAlpha.Pro	NAEOTOMAlpha.Prime	NAEOTOMAlpha	SOMATOMX.ceed
			syngo CTVB20	syngo CTVB20	syngo CTVB20	syngo CTVB10	syngo CTVB10
						(K233657)	(K233650)
1.	Respiratory MotionManagement -Interfaces forrespiratory gating:- Varian RGSC- Anzai- Open Interface- Open OnlineInterface	HW	modified¹	modified¹	modified¹	n.a.	cleared
2.	Respiratory MotionManagement -FAST 4D	SW	enabled	enabled	enabled	n.a.	cleared
3.	Respiratory MotionManagement -Direct i4D	SW	enabled	enabled	enabled	n.a.	cleared
4.	Respiratory MotionManagement -DirectBreathhold	SW	enabled	enabled	enabled	n.a.	cleared
5.	CT View&GO- Sim&GO	SW	modified²	modified²	modified²	cleared	cleared
6.	Direct LaserSteering	HW/SW	enabled	enabled	enabled	n.a.	cleared
7.	Recon&GO	SW	modified²	modified²	modified²	cleared	cleared
	Technologicalproperty	HW/SWchange	Subject devices			Predicate devices
			NAEOTOMAlphasyngo CTVB20	NAEOTOMAlpha.Prosyngo CTVB20	NAEOTOMAlpha.Primesyngo CTVB20	NAEOTOMAlphasyngo CTVB10(K233657)	SOMATOMX.ceedsyngo CTVB10(K233650)
	- RT planning
8.	Oncology Exchange	SW	new	new	new	n.a.	n.a.
9.	DirectSetupNotes	SW	enabled3	enabled3	enabled3	n.a.	cleared
10.	FAST 3D Camera/FAST IntegratedWorkflow	SW/HW	modified4	modified4	modified4	cleared	cleared
11.	Flex 4D Spiral	SW	modified4	modified4	modified4	cleared	cleared
12.	FAST Planning	SW	modified4	modified4	modified4	cleared	cleared
13.	CARE Moodlight	HW	enabled5	enabled5	enabled5	n.a.	n.a.
14.	Eco Power Mode	HW/SW	new	new	new	n.a.	n.a.
15.	Power Shaver	SW/HW	n.a.	n.a.	new	n.a.	n.a.
16.	myExamCompanion –myExamCompass/myExam Cockpit	SW	modified4	modified4	modified4	cleared	cleared

1 The listed interfaces for respiratory gating are implemented unchanged in the subject devices compared to the secondary predicate device SOMATOM X.ceed with exception of Open Online Interface is not available on the predicate devices and the interface is new for this submission.

2 In the subject devices NAEOTOM Alpha, NAEOTOM Alpha.Pro, and NAEOTOM Alpha.Prime with syngo CT VB20, the functionalities Recon&GO Inline Results and CT View&GO support the same functions as cleared in the secondary predicate device SOMATOM X.ceed but are modified compared to the primary predicate device NAEOTOM Alpha with software version syngo CT VB10.

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Image /page/12/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 word "Healthineers" is a cluster of orange dots arranged in a circular pattern.

A tabular summary of the comparable hardware and software properties between the subject devices NAEOTOM CT scanner systems with software version syngo CT VB20 and the

Siemens Healthineers AG

3 DirectSetupNotes is cleared in K233650 for the SOMATOM go.Open Pro. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X.cite and SOMATOM X.cite and SOMATOM X.ceed).

4 These features are modified compared to the same feature cleared in the primary and secondary predicate device.

5 CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).

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Image /page/13/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

primary/secondary predicate devices are listed in the following tables (modifications are in gray shaded sections).

Table 3 compares the hardware properties of the dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and NAEOTOM Alpha.Pro with the primary/secondary predicate devices.

Table 4 provides a comparison of the hardware properties between the single source subject device NAEOTOM Alpha.Prime and the primary/secondary predicate devices.

Table 5 compares the software technological characteristics of the subject devices and the predicate devices.

Table 3: Hardware characteristics for the dual source subject devices NAEOTOM Alpha (trade name ex-factory: NAEOTOM Alpha.Peak; trade name installed base: NAEOTOM Alpha) and NAEOTOM Alpha.Pro with software version SOMARIS/10 syngo CT VB20 compared to the predicate devices.

Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
Scanner	whole body X-raycomputedtomography (CT)scanner	whole body X-raycomputedtomography (CT)scanner	whole body X-raycomputedtomography (CT)scanner	whole body X-raycomputedtomography (CT)scanner
Productname	NAEOTOM Alpha	NAEOTOMAlpha.Pro	NAEOTOM Alpha	SOMATOM X.ceed
Trade name	• Ex-factory CTsystems:NAEOTOMAlpha.Peak• Installed base CTsystems:NAEOTOM Alpha	• Ex-factory CTsystems:NAEOTOMAlpha.Pro• Installed base CTsystems:n.a., new CT system	NAEOTOM Alpha	SOMATOM X.ceed
Design	without myNeedleLaser:Image: CT scanner	without myNeedleLaser:Image: CT scanner	without myNeedleLaser:Image: CT scanner	without myNeedleLaser:Image: CT scannerwith myNeedle Laser:
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
	with myNeedleLaser:Image: CT scanner	with myNeedleLaser:Image: CT scanner	with myNeedleLaser:Image: CT scanner	Image: CT scanner
Systemconfiguration	Dual Source	Dual Source	Dual Source	Single Source
Environmentof Use	ProfessionalHealthcare Facility	ProfessionalHealthcare Facility	ProfessionalHealthcare Facility	ProfessionalHealthcare Facility
Generatormax. power(kW)	2x 120	2x 120	2x 120	105 or 120
Detectortechnology	QuantaMaxdirect conversionwith "QuantumTechnology"	QuantaMaxdirect conversionwith "QuantumTechnology"	QuantaMaxdirect conversionwith "QuantumTechnology"	StellarInfinityUFC (Ultra FastCeramic)
Detectorvolumecoverage(mm)	2x 57.6	2x 38.4	2x 57.6	38.4
Detectorphysical rows	2x 288	2x 192	2x 288	64
Detectorslice width(mm)	0.2	0.2	0.2	0.6
DetectorDAS channelno.	2752 (A system)1984 (B system)	2752 (A system)1984 (B system)	2752 (A system)1984 (B system)	920
Tube	VECTRON	VECTRON	VECTRON	VECTRON
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
technology
TubekV steps	70, 90, 100, 120,140, 150(150 kV onlyavailable on thesmaller tube-detector system (Bsystem) and only incombination withthe additional Snfilter, 0.7 mm)	70, 90, 100, 120,140, 150(150 kV onlyavailable on thesmaller tube-detector system (Bsystem) and only incombination withthe additional Snfilter, 0.7 mm)	70, 90, 100, 120,140, 150(150 kV onlyavailable on thesmaller tube-detector system (Bsystem) and only incombination withthe additional Snfilter, 0.7 mm)	70, 80, 90, 100, 110,120, 130, 140, 150
Tubemax. current(mA)	2x 1300	2x 1300	2x 1300	1200 mA (for 105kW)1300 mA (for 120kW)
Tubetube focus(mm)	0.4 x 0.5/8°0.6 x 0.7/8°0.8 x 1.1/8°(for both tubes)	0.4 x 0.5/8°0.6 x 0.7/8°0.8 x 1.1/8°(for both tubes)	0.4 x 0.5/8°0.6 x 0.7/8°0.8 x 1.1/8°(for both tubes)	0.4 x 0.5/8°0.6 x 0.7/8°0.8 x 1.1/8°
Tubeheat storagecapacity(MHU)	higher than 30	higher than 30	higher than 30	higher than 30
Tubecooling rate(MHU/min)	2.7	2.7	2.7	2.7
Gantrybore size(cm)	82	82	82	82
GantryScan FoV(cm)	50	50	50	50
Gantry	81.5	81.5	81.5	81.5
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
Extended FoV(cm)
Gantryrotation time(sec)	0.25, 0.5, 1.0	0.25, 0.5, 1.0	0.25, 0.5, 1.0	0.25, 0.3, 0.5, 1.0
GantryTilt (degree)	N/A	N/A	N/A	+/- 25+/-30 (only withVitus)
Maximumtemporalresolution inECG gated ortriggeredexamination(ms)	mono- mono-segment: 66bi-segment: 33	mono- mono-segment: 66bi-segment: 33	mono-segment: 66bi-segment: 33	mono-segment: 125bi-segment: 66
Maximumscan speed atpitch(mm/s atpitch x)	737 mm/s at pitch3.2	492 mm/s at pitch3.2	737 mm/s at pitch3.2	261 at pitch 1.7
Patient TableType	Vario 2.DVitusInstallation optionwith extendeddistance (Vitus)	Vario 2.DVitusInstallation optionwith extendeddistance (Vitus)	Vario 2.DVitusInstallation optionwith extendeddistance (Vitus)	Vario RTVitusVario 2.D
Max. ScanlengthTopogram(mm)	Vario 2.D: 2080Vitus: 2080	Vario 2.D: 2080Vitus: 2080	Vario 2.D: 2080Vitus: 2080	Vario 2.D: 2080Vitus: 2080Vario RT: 1680
Max. ScanlengthImageacquisition(mm)	Vario 2.D: 2000Vitus: 2000	Vario 2.D: 2000Vitus: 2000	Vario 2.D: 2000Vitus: 2000	Vario 2.D: 2000Vitus: 2000Vario RT: 1600
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
Patient tableMax. weightcapacity (kg)	Vario 2.D: 307Vitus: 307 or 340	Vario 2.D: 307Vitus: 340	Vario 2.D: 307Vitus: 307 or 340	Vario 2.D: 307Vitus: 307Vario RT: 227
Spectralfiltration	Tin Filter for bothtubes: 0.4 mmadditional Tin Filterfor the smallertube-detectorsystem (B-system)only: 0.7 mm	Tin Filter for bothtubes: 0.4 mmadditional Tin Filterfor the smallertube-detectorsystem (B-system)only: 0.7 mm	Tin Filter for bothtubes: 0.4 mmadditional Tin Filterfor the smaller tube-detector system (B-system) only: 0.7mm	Combined Tin Filter /Split Filter, and extraTin Filter
FAST 3DCamera	option for patientpositioning withFAST 3D Camerainstallation options:• ceiling mounted	option for patientpositioning withFAST 3D Camerainstallation options:• ceiling mounted	option for patientpositioning withFAST 3D Camerainstallation options:• ceiling mounted	option for patientpositioning with FAST3D Camerainstallation options:• ceiling mounted
X-ray footswitch	Option to triggerhands-free scanning	Option to triggerhands-free scanning	Option to triggerhands-free scanning	Option to triggerhands-free scanning
Table footswitch	Option for tablepatient movement	Option for tablepatient movement	Option for tablepatient movement	Option for tablepatient movement
Tablet dockfor patienttable	Option formounting of thetablet on thepatient table.	Option formounting of thetablet on thepatient table.	Option for mountingof the tablet on thepatient table.	Option for mountingof the tablet on thepatient table.
Interventional Joystick(IVJ)	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electricalconnection for thetablet dock whichallows charging thetablet whenmounted.	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electricalconnection for thetablet dock whichallows charging thetablet whenmounted.	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electrical connectionfor the tablet dockwhich allowscharging the tabletwhen mounted.	Option to move thetable duringmyNeedle Guideprocedures in theexamination room.electrical connectionfor the tablet dockwhich allowscharging the tabletwhen mounted.
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
Lasersupportedworkflow	Laser incombination withFAST Isocenteringvisualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser incombination withFAST Isocenteringvisualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combinationwith FASTIsocentering visualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combinationwith FASTIsocentering visualizecoordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions
CAREMoodlight	LED lightsintegrated on thegantry front toindicate the systemstatus:· System startup• Scan countdown• Radiation on	LED lightsintegrated on thegantry front toindicate the systemstatus:· System startup• Scan countdown· Radiation on	n.a.6	n.a.6
RespiratoryMotionmanagement- Interfacesforrespiratorygating	acquisition ofrespiration-correlated scanssupportedInterfaceconnectors for:• Anzai respiratorygating system• Varian RGSCrespiratory gatingsystem• Open interfacecompatible	acquisition ofrespiration-correlated scanssupportedInterfaceconnectors for:• Anzai respiratorygating system• Varian RGSCrespiratory gatingsystem· Open interfacecompatible	n.a.	acquisition ofrespiration-correlated scanssupportedInterface connectorsfor:• Anzai respiratorygating system• Varian RGSCrespiratory gatingsystem• Open interfacecompatible
Hardwareproperty	Subject device(Dual source NAEOTOM CT systems)		Primary predicatedevice	Secondary predicatedevice
	NAEOTOM AlphaSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
	respiratory gatingsystems• Open OnlineInterface	respiratory gatingsystems• Open OnlineInterface		respiratory gatingsystems

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Image /page/14/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the word "Healthineers" is a graphic of orange dots that are arranged in a pattern.

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Image /page/15/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 word "Healthineers" is a series of orange dots that form an arrow shape.

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Image /page/16/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

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Image /page/17/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 word "Healthineers" is a series of orange dots that get progressively larger.

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Image /page/18/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots.

რ CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).

{19}------------------------------------------------

Image /page/19/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 word "Healthineers" is a series of orange dots that are arranged in a circular pattern. The logo is simple and modern.

Table 4: Hardware characteristics for the single source subject device NAEOTOM Alpha.Prime (software version SOMARIS/10 syngo CT VB20) compared to the predicate devices.

Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.PrimeSOMARIS/10 syngo CTVB20	NAEOTOM AlphaSOMARIS/10 syngo CTVB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngo CTVB10(K233650)
Scanner	whole body X-raycomputed tomographyscanner	whole body X-raycomputed tomographyscanner	whole body X-raycomputed tomographyscanner
Design	without myNeedleLaser:Image: CT scanner without myNeedle Laser	without myNeedleLaser:Image: CT scanner without myNeedle Laser	without myNeedleLaser:Image: CT scanner without myNeedle Laser
	with myNeedle Laser:Image: CT scanner with myNeedle Laser	with myNeedle Laser:Image: CT scanner with myNeedle Laser	with myNeedle Laser:Image: CT scanner with myNeedle Laser
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.PrimeSOMARIS/10 syngo CT VB20	NAEOTOM AlphaSOMARIS/10 syngo CT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngo CT VB10(K233650)
Systemconfiguration	Single Source	Dual Source	Single Source
Environment ofUse	Professional HealthcareFacility	Professional HealthcareFacility	Professional HealthcareFacility
Generatormax. power (kW)	105 or 120	2x 120	105 or 120
Detectortechnology	QuantaMaxDirect Conversion with"Quantum Technology"	QuantaMaxDirect Conversion with"Quantum Technology"	UFC(Ultra Fast Ceramic)
Detectorvolume coverage(mm)	57.6	2x 57.6	38.4
Detectorphysical rows	288	2x 288	64
Detectorslice width (mm)	0.2	0.2	0.6
DetectorDAS channel no.	2752	2752 (A system)1984 (B system)	920
Tubetechnology	VECTRON	VECTRON	VECTRON
TubekV steps	70, 90, 100, 120, 140	70, 90, 100, 120, 140,150(150 kV only availableon the smaller tube-detector system (Bsystem) and only incombination with the	70, 80, 90, 100, 110,120, 130, 140, 150
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.Prime	NAEOTOM Alpha	SOMATOM X.ceed
	SOMARIS/10 syngo CTVB20	SOMARIS/10 syngo CTVB10(K233657)	SOMARIS/10 syngo CTVB10(K233650)
		additional Sn filter, 0.7mm)
Tubemax. current (mA)	1200 (for 105 kWGenerator)	2x 1300	1200 (for 105 kWGenerator)
	1300 (for 120 kWGenerator)		1300 (for 120 kWGenerator)
Tubetube focus (mm)	0.4 x 0.5/8°	0.4 x 0.5/8°	0.4 x 0.5/8°
	0.6 x 0.7/8°	0.6 x 0.7/8°	0.6 x 0.7/8°
	0.8 x 1.1/8°	0.8 x 1.1/8°	0.8 x 1.1/8°
		(for both tubes)
Tubeheat capacity	higher than 30 MHU	higher than 30 MHU	higher than 30 MHU

Tubecooling rate(MHU/min)	2.7	2.7	2.7

Gantrybore size (cm)	82	82	82

GantryScan FoV (cm)	50	50	50

GantryExtended FoV(cm)	81.5	81.5	81.5

Gantryrotation time (sec)	0.25, 0.5, 1.0	0.25, 0.5, 1.0	0.25, 0.3, 0.5, 1.0

GantryTilt (degree)	N/A	N/A	+/- 25+/-30 (only with Vitus)

Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.PrimeSOMARIS/10 syngo CTVB20	NAEOTOM AlphaSOMARIS/10 syngo CTVB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngo CTVB10(K233650)
Maximumtemporalresolution in ECGgated or triggeredexamination (ms)	mono-segment: 125bi-segment: 66	mono-segment: 66bi-segment: 33	mono-segment: 125bi-segment: 66
Maximum scanspeed at pitch(mm/s at pitch x)	345 mm/s at pitch 1.5	737 mm/s at pitch 3.2	261 mm/s at pitch 1.7
Patient TableType	Vario 2.DVitus	Vario 2.DVitusInstallation option withextended distance(Vitus)	Vario RTVario 2.DVitus
Max. Scan lengthTopogram (mm)	Vario 2.D: 2080Vitus: 2080	Vario 2.D: 2080Vitus: 2080	Vario RT: 1680Vario 2.D: 2080Vitus: 2080
Max. Scan lengthImage acquisition(mm)	Vario 2.D: 2000Vitus: 2000	Vario 2.D: 2000Vitus: 2000	Vario RT: 1600Vario 2.D: 2000Vitus: 2000
Patient tableMax. weightcapacity (kg)	Vario 2.D: 307Vitus: 340	Vario 2.D: 307Vitus: 307 or 340	Vario RT: 227Vario 2.D: 307Vitus: 307 or 340
Spectral filtration	Tin Filter: 0.4 mm	Tin Filter for both tubes:0.4 mmadditional Tin Filter forthe smaller tube-detectorsystem (B-system) only:0.7 mm	Combined Tin Filter / SplitFilter, and extraTin Filter
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.PrimeSOMARIS/10 syngo CTVB20	NAEOTOM AlphaSOMARIS/10 syngo CTVB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngo CTVB10(K233650)
FAST 3D Camera	option for patientpositioning with FAST3D Camerainstallation options:• ceiling mounted	option for patientpositioning with FAST3D Camerainstallation options:• ceiling mounted	option for patientpositioning with FAST3D Camerainstallation options:• ceiling mounted
X-ray foot switch	Option to trigger hands-free scanning	Option to trigger hands-free scanning	Option to trigger hands-free scanning
Table foot switch	Option for table patientmovement	Option for table patientmovement	Option for table patientmovement
Tablet dock forpatient table	Option for mounting ofthe tablet on thepatient table.	Option for mounting ofthe tablet on thepatient table.	Option for mounting ofthe tablet on thepatient table.
InterventionalJoystick (IVJ)	Option to move thetable during myNeedleGuide procedures in theexamination room.electrical connection forthe tablet dock whichallows charging thetablet when mounted.	Option to move thetable during myNeedleGuide procedures in theexamination room.electrical connection forthe tablet dock whichallows charging thetablet when mounted.	Option to move thetable during myNeedleGuide procedures in theexamination room.electrical connection forthe tablet dock whichallows charging thetablet when mounted.
Laser supportedworkflow	Laser in combinationwith FAST Isocenteringvisualize coordinates forpatient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combinationwith FAST Isocenteringvisualize coordinatesfor patient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions	Laser in combinationwith FAST Isocenteringvisualize coordinatesfor patient isocenterposition;myNeedle Laservisualizes a plannedneedle path forinterventions
Hardwareproperty	Subject device	Primary predicatedevice	Secondary predicatedevice
	NAEOTOM Alpha.PrimeSOMARIS/10 syngo CTVB20	NAEOTOM AlphaSOMARIS/10 syngo CTVB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngo CTVB10(K233650)
CARE Moodlight	LED lights integrated onthe gantry front toindicate the systemstatus:• System startup• Scan countdown• Radiation on	n.a.7	n.a.7
RespiratoryMotionmanagement -Interfaces forrespiratory gating	acquisition ofrespiration-correlatedscans supported	n.a.	acquisition ofrespiration-correlatedscans supported
	Interface connectorsfor:• Anzai respiratorygating system• Varian RGSCrespiratory gatingsystem• Open interfacecompatiblerespiratory gatingsystems• Open Online Interface		Interface connectorsfor:• Anzai respiratorygating system• Varian RGSCrespiratory gatingsystem• Open interfacecompatiblerespiratory gatingsystems
Power Shaver	energy storageassembly to reducemains peak currenttowards mains	n.a.	n.a.

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7 CARE Moodlight is cleared in K233650 for the SOMATOM go.Now, SOMATOM go.Top and SOMATOM go.All. K233650 is a bundle 510(k) including the SOMATOM go. Platform (SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim and SOMATOM go.Open Pro) and the SOMATOM X. Platform (SOMATOM X.cite and SOMATOM X.ceed).

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Table 5: Software characteristics for the dual source subject devices NAEOTOM Alpha and NAEOTOM Alpha.Pro and single source subject device NAEOTOM Alpha.Prime (software version SOMARIS/10 syngo CT VB20) compared to the predicate devices.

Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
	NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
OperatingSystem	Windows basedSOMARIS/10 syngoCT VB20Note: the shortversion syngo CTVB20 is also used aslabelinginformation	Windows basedSOMARIS/10 syngoCT VB20Note: the shortversion syngo CTVB20 is also used aslabelinginformation	Windows basedSOMARIS/10 syngoCT VB10Note: the shortversion syngo CTVB10 is also used aslabelinginformation	Windows basedSOMARIS/10 syngoCT VB10Note: the shortversion syngo CTVB10 is also used aslabelinginformation
Workplace	syngo AcquisitionWorkplace (ICS)named as "myExamConsole"ImageReconstruction forQuantumTechnology (IRS)2nd workplaceoption named as"myExam Satellite"with Remote Reconfunction	syngo AcquisitionWorkplace (ICS)named as "myExamConsole"ImageReconstruction forQuantumTechnology (IRS)2nd workplaceoption named as"myExam Satellite"with Remote Reconfunction	syngo AcquisitionWorkplace (ICS)named as "myExamConsole"ImageReconstruction forQuantumTechnology (IRS)2nd workplaceoption named as"myExam Satellite"with Remote Reconfunction	syngo AcquisitionWorkplace (ICS)named as "myExamConsole"ImageReconstruction forQuantumTechnology (IRS)2nd workplaceoption named as"myExam Satellite"with Remote Reconfunction
Standard systemsoftware	• syngoExamination• syngo Viewing• syngo Filming• syngo Archiving &Network	• syngoExamination• syngo Viewing• syngo Filming• syngo Archiving &Network	• syngoExamination• syngo Viewing• syngo Filming• syngo Archiving &Network	• syngoExamination• syngo Viewing• syngo Filming• syngo Archiving &Network
Detectorfirmware	QuantaMaxdetector firmwaresupported	QuantaMaxdetector firmwaresupported	QuantaMaxdetector firmwaresupported	Stellar detectorfirmware supported
Teamplay	Support ofteamplay Protocols	Support ofteamplay Protocols	Support ofteamplay Protocols	Support ofteamplay Protocols
Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
	NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
Protocols	Support of:• Protocol supportingcontrast bolus-triggered dataacquisition• Contrast mediaprotocols(includingcoronary CTA)• PediatricProtocols• Flex Dose Profile• Turbo FlashSpiral• Dual Energyacquisition• Protocolssupporting CTIntervention,CardiacScanning,Spectral imagingfor childexamination,Spectral imagingwith highresolution• Protocols forQuantumImaging modes:- Quantum- Quantumplus- QuantumHD- QuantumHD Cardiac- Quantumpeak• Dynamic	Support of:• Protocolsupportingcontrast bolus-triggered dataacquisition• Contrast mediaprotocols(includingcoronary CTA)• PediatricProtocols• Flex Dose Profile• Turbo FlashSpiral• Dual Energyacquisition• Protocolssupporting CTIntervention,CardiacScanning,Spectral imagingfor childexamination,Spectral imagingwith highresolution• Protocols forQuantumImaging modes:- Quantum- Quantumplus- QuantumHD- QuantumHD Cardiac• Dynamic	Support of:• Protocolsupportingcontrast bolus-triggered dataacquisition• Contrast mediaprotocols(includingcoronary CTA)• PediatricProtocols• Flex Dose Profile• Turbo FlashSpiral• Dual Energyacquisition• Protocolssupporting CTIntervention,CardiacScanning,Spectral imagingfor childexamination,Spectral imagingwith highresolution• Protocols forQuantumImaging modes:- Quantum- Quantumplus- QuantumHD- QuantumHD Cardiac- Quantumpeak• Dynamic	Support of:• Protocolsupportingcontrast bolus-triggered dataacquisition• Contrast mediaprotocols(includingcoronary CTA)• PediatricProtocols• Flex Dose Profile• Turbo FlashSpiral• Dual Energyacquisition(TwinBeam DEand TwinSpiralDE)• Protocolssupporting CTIntervention,CardiacScanning
Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
	NAEOTOM AlphaNAEOTOMAlpha.Pro	NAEOTOMAlpha.Prime	NAEOTOM Alpha	SOMATOM X.ceed
	SOMARIS/10 syngoCT VB20	SOMARIS/10 syngoCT VB20	SOMARIS/10 syngoCT VB10(K233657)	SOMARIS/10 syngoCT VB10(K233650)
	Spiral withseparationfactor drivenscan range)• Protocols forRadiationTherapyPlanningsupport patientmarking• Protocols forDirectBreathhold• Protocols forFAST 4D• Protocols thatallow scanningwith support ofan externalrespiratorygating system(Anzai, VarianRGSC, Openinterface, OpenOnlineInterface)	Spiral withseparationfactor drivenscan range)• Protocols forRadiationTherapyPlanningsupport patientmarking• Protocols forDirectBreathhold• Protocols forFAST 4D• Protocols thatallow scanningwith support ofan externalrespiratorygating system(Anzai, VarianRGSC, Openinterface, OpenOnlineInterface)	Spiral with cycletime driven scanrange)	• Dynamicimaging (Flex 4DSpiral Flex 4DSpiral with cycletime driven scanrange)• Protocols forRadiationTherapyPlanningsupport patientmarking• Protocols forDirectBreathhold• Protocols forFAST 4D• Protocols thatallow scanningwith support ofan externalrespiratorygating system(ANZAI, VarianRGSC, Openinterface)
AdvancedReconstruction	Recon&GO:	Recon&GO:	Recon&GO:	Recon&GO:
	- Spectral Recon	- Spectral Recon	- Spectral Recon	- Spectral Recon
	- Inline Results - DESPP	- Inline Results – DESPP	- Inline Results - DESPP	- Inline Results - DESPP
	- Inline Results -Anatomical ranges(Parallel/Radial)incl. VirtualUnenhanced,Monoenergetic plus	- Inline Results -Anatomical ranges(Parallel/Radial)incl. VirtualUnenhanced,Monoenergetic plus	- Inline Results -Anatomical ranges(Parallel/Radial)incl. VirtualUnenhanced,Monoenergetic plus	- Inline Results -Anatomical ranges(Parallel/Radial)incl. VirtualUnenhanced,Monoenergetic plus
	- Inline Results -Spine and RibRanges	- Inline Results -Spine and RibRanges	- Inline Results -Spine and RibRanges	- Inline Results -Spine and RibRanges
Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
	NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
	- Inline Results –table and boneremoval	- Inline Results –table and boneremoval	- Inline Results –table and boneremoval	- Inline Results –table and boneremoval
	Image viewing	CT View&GO:- basic post-processing viewer(CT View&GO)- 2D and 3D (MPR,VRT, MIP andminIP)- Evaluation tools,Filming, Printing- InteractiveSpectral Imaging(ISI)- Basic visualizationtools: Endo View- Basicmanipulation tools:DE ROI, ROI HUThreshold, Average- Automated tableand bone removal	CT View&GO:- basic post-processing viewer(CT View&GO)- 2D and 3D (MPR,VRT, MIP andminIP)- Evaluation tools,Filming, Printing- InteractiveSpectral Imaging(ISI)- Basic visualizationtools: Endo View- Basicmanipulation tools:DE ROI, ROI HUThreshold, Average- Automated tableand bone removal	CT View&GO:- basic post-processing viewer(CT View&GO)- 2D and 3D (MPR,VRT, MIP andminIP)- Evaluation tools,Filming, Printing- InteractiveSpectral Imaging(ISI)- Basic visualizationtools: Endo View- Basicmanipulation tools:DE ROI, ROI HUThreshold, Average- Automated tableand bone removal
		Post-Processinginterface	• Recon&GOInline Results:Software interfaceto post-processingalgorithms whichare unmodifiedwhen loaded ontothe CT scanners and510(k) cleared asmedical devices,Inline Results – RT-Planning introduced	• Recon&GOInline Results:Software interfaceto post-processingalgorithms whichare unmodifiedwhen loaded ontothe CT scanners and510(k) cleared asmedical devices,Inline Results – RT-Planning introduced	• Recon&GOInline Results:Software interfaceto post-processingalgorithms whichare unmodifiedwhen loaded ontothe CT scanners and510(k) cleared asmedical devices	• Recon&GOInline Results:Software interfaceto post-processingalgorithms whichare unmodifiedwhen loaded ontothe CT scanners and510(k) cleared asmedical devices,including theinterface InlineResults – RT-Planning
			Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice
		NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
		• CT View&GOplug-ininterface:designed forstandalone plug-inswhich arerepresented by thecleared medicaldevice by its owncalled syngo.CTExtendedFunctionality,plug-in CTView&GO –Sim&GO introduced	• CT View&GOplug-ininterface:designed forstandalone plug-inswhich arerepresented by thecleared medicaldevice by its owncalled syngo.CTExtendedFunctionality,plug-in CTView&GO –Sim&GO introduced	• CT View&GOplug-ininterface:designed forstandalone plug-inswhich arerepresented by thecleared medicaldevice by its owncalled syngo.CTExtendedFunctionality	• CT View&GOplug-ininterface:designed forstandalone plug-inswhich arerepresented by thecleared medicaldevice by its owncalled syngo.CTExtendedFunctionality,including the plug-in CT View&GO –Sim&GO
		• CT View&GOsoftwareinterface forAdvancedVisualizationApps:Software interfacesfor post-processingfunctionalities toprovide advancedvisualization toolsto prepare andprocess medical	• CT View&GOsoftwareinterface forAdvancedVisualizationApps:Software interfacesfor post-processingfunctionalities toprovide advancedvisualization toolsto prepare andprocess medical	• CT View&GOsoftwareinterface forAdvancedVisualizationApps:Software interfacesfor post-processingfunctionalities toprovide advancedvisualization toolsto prepare andprocess medicalimages for	• CT View&GOsoftwareinterface forAdvancedVisualizationApps:Software interfacesfor post-processingfunctionalities toprovide advancedvisualization toolsto prepare andprocess medical
		images fordiagnostic purpose.Note: The clearanceof standaloneAdvancedVisualizationApplicationsoftware ismandatoryprecondition.	images fordiagnostic purpose.Note: The clearanceof standaloneAdvancedVisualizationApplicationsoftware ismandatoryprecondition.	diagnostic purpose.Note: The clearanceof standaloneAdvancedVisualizationApplicationsoftware ismandatoryprecondition.These advancedvisualization tools	images fordiagnostic purpose.Note: The clearanceof standaloneAdvancedVisualizationApplicationsoftware ismandatoryprecondition.These advancedvisualization tools
Softwareproperty		Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
		NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
	These advancedvisualization toolsare designed tosupport thetechnician &physician in thequalitative andquantitativemeasurement &analysis of clinicaldata acquired andreconstructed byComputedTomographyscanners.	These advancedvisualization toolsare designed tosupport thetechnician &physician in thequalitative andquantitativemeasurement &analysis of clinicaldata acquired andreconstructed byComputedTomographyscanners.	are designed tosupport thetechnician &physician in thequalitative andquantitativemeasurement &analysis of clinicaldata acquired andreconstructed byComputedTomographyscanners.	are designed tosupport thetechnician &physician in thequalitative andquantitativemeasurement &analysis of clinicaldata acquired andreconstructed byComputedTomographyscanners.
Cybersecurity	IT Hardening	IT Hardening	IT Hardening	IT Hardening
HD FoV	supported	supported	supported	supported
Standardtechnologies	• FASTtechnologies• CAREtechnologies• GO technologies• CARE keV	• FASTtechnologies• CAREtechnologies• GO technologies• CARE keV	• FASTtechnologies• CAREtechnologies• GO technologies• CARE keV	• FASTtechnologies• CAREtechnologies• GO technologies• CARE keV
RespiratoryMotionmanagement(workflows)	Workflows forrespiration-correlated scans forradiation therapyplanning:- FAST 4D- Direct i4D- DirectBreathhold	Workflows forrespiration-correlated scans forradiation therapyplanning:- FAST 4D- Direct i4D- DirectBreathhold	n.a.	Workflows forrespiration-correlated scans forradiation therapyplanning:- FAST 4D- Direct i4D- DirectBreathhold
Direct LaserSteering	software interfaceto control 3rd partylasers (LAP lasers)to support amarkerlessworkflow forpatient marking in	software interfaceto control 3rd partylasers (LAP lasers)to support amarkerlessworkflow forpatient marking in	n.a.	software interfaceto control 3rd partylasers (LAP lasers)to support amarkerlessworkflow forpatient marking in
Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
	NAEOTOM AlphaNAEOTOM Alpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.PrimeSOMARIS/10 syngoCT VB20	NAEOTOM AlphaSOMARIS/10 syngoCT VB10(K233657)	SOMATOM X.ceedSOMARIS/10 syngoCT VB10(K233650)
	radiation therapyplanning (RTP).	radiation therapyplanning (RTP).	radiation therapyplanning (RTP).	radiation therapyplanning (RTP).
FAST IntegratedWorkflow (FAST3D Camera)	FAST integratedworkflow:• FAST Range• FAST Isocentering• FAST Direction• CollisionIndication• Centerline/GridOverlay	FAST integratedworkflow:• FAST Range• FAST Isocentering• FAST Direction• CollisionIndication• Centerline/ GridOverlay	FAST integratedworkflow:• FAST Range• FAST Isocentering• FAST Direction	FAST integratedworkflow:• FAST Range• FAST Isocentering• FAST Direction
DirectSetupNotes	patient andaccessory setupdocumentation inthe Scan&GOworkflow	patient andaccessory setupdocumentation inthe Scan&GOworkflow	n.a.	n.a.
Oncologyexchange	transfer ofprescriptioninformation fromthe ARIA OncologyInformation System(OIS) to the CTscanner	transfer ofprescriptioninformation fromthe ARIA OncologyInformation System(OIS) to the CTscanner	n.a.	n.a.
FAST Planning	detects globallyused scan andrecon ranges fromthe topogramimageadditional bodyregions:- Head/Neck(Vascular),Lateral/APPA- Vascular - RunoffKnee	detects globallyused scan andrecon ranges fromthe topogramimageadditional bodyregions:- Head/Neck(Vascular),Lateral/APPA- Vascular - RunoffKnee	detects globallyused scan andrecon ranges fromthe topogramimage	detects globallyused scan andrecon ranges fromthe topogramimage
Softwareproperty	Subject device(Dual Source)	Subject device(Single Source)	Primary predicatedevice	Secondarypredicate device
NAEOTOM AlphaNAEOTOMAlpha.ProSOMARIS/10 syngoCT VB20	NAEOTOMAlpha.Prime	NAEOTOM Alpha	SOMATOM X.ceed
	SOMARIS/10 syngoCT VB20	SOMARIS/10 syngoCT VB10(K233657)	SOMARIS/10 syngoCT VB10(K233650)
	- Neck and chest- Neck and Lung- Extremities -Both knees	- Neck and chest- Neck and Lung- Extremities -Both knees
Eco Power Mode	reduce the energyconsumption duringidle times.	reduce the energyconsumption duringidle times.	n.a.	n.a.
IterativeReconstructionMethods	Quantum IterativeReconstructioniMAR	Quantum IterativeReconstructioniMAR	Quantum IterativeReconstructioniMAR	ADMIRESAFIREiMAR
Matrix sizes	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels(Precision Matrix)	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels(Precision Matrix)	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels(Precision Matrix)	256 x 256 pixels512 x 512 pixels768 x 768 pixels1024 x 1024 pixels(Precision Matrix)

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Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject devices, the NAEOTOM CT scanner systems with syngo CT VB20, is comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VIII. Performance Data

Non-Clinical Testing

Non-clinical testing (integration and functional) including phantom tests were conducted for the subject devices NAEOTOM CT scanner systems during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

The general purpose of each test is to verify and validate the functionality of the subject device modifications.

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and

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acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

Acceptance test (workflow and user manual test) ●
Legal and Regulatory test

System Verification test:

System Integration Test (functional)
. Functionality verification
Image Quality (IQ) Evaluation

Tests are conducted for all software components developed in product development and for the complete product itself. Several activities are considered for this process, including creation of test specifications that relate to software/hardware requirements including tests to address risk mitigations that are identified, documented, and traced by hazard keys.

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 6 below.

Feature/Non-clinicalsupportive testing	Bench Testing performed for new and modified features
Direct i4D	The target of the bench test is to perform a respiratory sequence scanusing a dynamic phantom where at every planned position of the scanrange at least one complete breathing cycle is acquired.
	Objective of the test is to compare a conventional respiratory 4DCT scan(spiral scan) with the breathing pattern of a thorax phantom and theresult of Direct i4D with the same breathing pattern.
	The test results show that with Direct i4D it is possible to acquire data fora full breathing cycle at every position of the patient even if therespiratory rate changes during the data acquisition. Compared to theconventional 4DCT scan mode interpolation artifacts (which occurbecause not for every position a complete breathing cycle could beacquired) can successfully be avoided with Direct i4D.
DirectBreathhold	The test results show that using the Direct Breathhold functionality, aspiral scan can automatically be triggered from an external respiratorygating device. The actual scan remains unchanged, and the object iscorrectly depicted in the resulting image.
Recon&GO – RTplanning	The bench test underpins the possibility that with the introduction of theRTP scan protocols in the subject devices NAEOTOM CT scanner systemswith syngo CT VB20, time and imaging dose can be saved, since each RTPscan range allows for spectral post-processing to provide task-specificimages for an end-to-end radiotherapy workflow and thus no additionalscan range with Single Energy is needed.
Feature/Non-clinicalsupportive testing	Bench Testing performed for new and modified features
FAST 3D Camera/FAST IntegratedWorkflow	The FAST 3D camera sub-features FAST Isocentering, FAST Range, andFAST Direction have been optimized using additional data from adultsand adolescence patients. The bench test evaluates and compares theaccuracy of the three sub-features in software version syngo CT VB20 tothe accuracy of the predicate devices with syngo CT VB10.The objectives of the bench tests are to demonstrate that the FAST 3Dcamera achieves comparable or better results for both, adults andadolescents, as the predicate device for adults.Overall, the subject devices with syngo CT VB20 delivers comparable orimproved accuracy to the predicate devices with syngo CT VB10predicate device for adults and extends the support to adolescents.
Flex 4D Spiral	The performed bench test report describes the technical background ofFlex 4D Spiral and its functionalities with NAEOTOM CT scanners,demonstrate the proper function of those, and assess the image qualityof Flex 4D Spiral.
FAST Planning	The purpose of the test is to provide a clear reporting on the appliedalgorithm, its product development, validation, and verification onpatient data, which enable the claims.Objective of the test is to assess the fraction (percentage) of rangescalculated by the FAST Planning algorithm that are correct and can beapplied without change. Additionally, calculation time was measured tocheck whether it meets interactive requirements.The test results show that the editing actions for the scanner techniciancan be reduced to a minimum and that the calculation time is fastenough for interactive speed during scanning. For more than 90% of theranges no editing action was necessary to cover standard ranges. Formore than 95%, the speed of the algorithm was sufficient.
Low-Dose Lung CancerScreening –NAEOTOM Alpha.Pro	The bench test provides a comparison of technical parameters specific toLow-Dose Lung Cancer Screening of the predicate and subject devices,following the established concept of our previous 510(k) submissions.It can be concluded that the subject and predicate devices aresubstantially equivalent for the task of Low-Dose Lung Cancer Screeningsince the bench test results showed comparable technical parameters.
Low-Dose Lung CancerScreening –NAEOTOMAlpha.Prime	The bench test provides a comparison of technical parameters specific toLow-Dose Lung Cancer Screening of the predicate and subject devices,following the established concept of our previous 510(k) submissions.It can be concluded that the subject and predicate devices aresubstantially equivalent for the task of Low-Dose Lung Cancer Screeningsince the bench test results showed comparable technical parameters.

Table 6: Non-clinical performance testing (bench testing).

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A list of recognized and general consensus standards considered for the subject devices is provided as Table 7 and Table 8 below.

	Table 7: Recognized Consensus Standards.

Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
12/19/2022	12-349	NEMA	PS 3.1 - 3.20 2022d	Digital Imaging andCommunications inMedicine (DICOM) Set
07/06/2020	12-325	NEMA	XR 25-2019	ComputedTomography DoseCheck
07/06/2020	12-330	NEMA	XR 28-2018	SupplementalRequirements for UserInformation andSystem FunctionRelated to Dose in CT
12/23/2019	12-328	IEC	61223-3-5 Edition 2.02019-09	Evaluation and routinetesting in medicalimaging departments -Part 3-5: Acceptancetests and constancytests - Imagingperformance ofcomputed tomographyX-ray equipment[Including: TechnicalCorrigendum 1 (2006)]
03/14/2011	12-226	IEC	61223-2-6 SecondEdition 2006-11	Evaluation and routinetesting in medicalimaging departments -Part 2-6: Constancytests - Imagingperformance ofcomputed tomographyX-ray equipment
01/14/2014	12-269	IEC	60601-1-3 Edition 2.12013-04	Medical electricalequipment - Part 1-3:General requirementsfor basic safety andessential performance– Collateral Standard:Radiation protection indiagnostic X-rayequipment
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
06/27/2016	12-302	IEC	60601-2-44 Edition3.2: 2016	Medical electricalequipment - Part 2-44:Particularrequirements for thebasic safety andessential performanceof x-ray equipment forcomputed tomography
12/23/2019	5-125	ANSI AAMIISO	14971: 2019	Medical devices -Applications of riskmanagement tomedical devices
		ISO	14971 Third Edition2019-12	Medical devices -Application of riskmanagement tomedical devices
01/14/2019	13-79	ANSI AAMIIEC	62304:2006/A1:2016	Medical devicesoftware - Softwarelife cycle processes[Including Amendment1 (2016)]
		IEC	62304 Edition 1.12015-06CONSOLIDATEDVERSION	Medical devicesoftware - Softwarelife cycle processes
07/09/2014	19-46	ANSI AAMI	ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012(Cons. Text) [Incl.AMD2:2021]	Medical electricalequipment - Part 1:General requirementsfor basic safety andessential performance(IEC 60601-1:2005,MOD) [IncludingAmendment 2 (2021)]
09/17/2018	19-36	ANSI AAMIIEC	60601-1-2:2014[Including AMD1:2021]	Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
		IEC	60601-1-2 Edition 4.12020-09CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-2:General requirementsfor basic safety andessential performance- Collateral Standard:Electromagneticdisturbances -Requirements andtests
12/23/2016	5-129	ANSI AAMIIEC	62366-1:2015+AMD1:2020(Consolidated Text)	Medical devices Part 1:Application of usabilityengineering to medicaldevices, includingAmendment 1
		IEC	62366-1 Edition 1.12020-06CONSOLIDATEDVERSION	Medical devices - Part1: Application ofusability engineeringto medical devices
07/09/2014	12-273	IEC	60825-1 Edition 2.02007-03	Safety of laserproducts - Part 1:Equipmentclassification, andrequirements
12/21/2020	5-132	IEC	60601-1-6 Edition 3.22020-07CONSOLIDATEDVERSION	Medical electricalequipment - Part 1-6:General requirementsfor basic safety andessential performance- Collateral standard:Usability
12/23/2019	12-309	IEC	60601-2-28 Edition3.0 2017-06	Medical electricalequipment - Part 2-28:Particularrequirements for thebasic safety andessential performanceof X-ray tubeassemblies for medicaldiagnosis
12/20/2021	12-341	IEC	62563-1 Edition 1.22021-07	Medical electricalequipment - Medicalimage display systems
Date of Entry	RecognitionNumber	StandardDevelopingOrganization	StandardDesignation Numberand Date	Title of Standard
			CONSOLIDATEDVERSION	- Part 1: Evaluationmethods

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Image /page/37/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

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Table 8: General Use Consensus Standards.

StandardDevelopingOrganization	Standard DesignationNumber and Date	Title of Standard	How was Standard Used
IEC	60601-1:2005+A1:2012+A2:2020	Medical electricalequipment - part 1:general requirementsfor basic safety andessential performance	ANSI AAMI ES60601-1:2005/(R)2012 &A1:2012,C1:2009/(R)2012 &A2:2010/(R)2012 (Cons.Text) [Incl. AMD2:2021]
IEC/ISO	17050-1	Conformity Assessment– Supplier's declarationof conformity – Part 1:General requirements	Declaration ofconformance to FDArecognized consensusstandards.
IEC/ISO	17050-2	Conformity assessment– Supplier's declarationof conformity - Part 2:Supportingdocumentation.	General consensusstandards not currentlyrecognized by FDA.

A list of applicable guidance documents considered for this submission is provided as Table 9 below. Table 9: FDA Guidance Document and Effective Date

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s	10/05/2022
Refuse to Accept Policy for 510(k)s	04/21/2022
Electronic Submission Template for Medical Device 510(k) Submissions	10/2/2023
Deciding When to Submit a 510(k) for a Change to an Existing Device	10/25/2017
The 510(k) Program: Evaluating Substantial Equivalence in PremarketNotifications [510(k)]	07/28/2014
Content of Premarket Submissions for Device Software Functions	06/14/2023
Off-The-Shelf Software Use in Medical Devices	09/27/2019
Applying Human Factors and Usability Engineering to Medical Devices	02/03/2016
Pediatric Information for X-ray Imaging Device Premarket Notifications	11/28/2017

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FDA Guidance Document	Issue date
Cybersecurity in Medical Devices: Quality System Considerations and Contentof Premarket Submissions	09/27/2023
Electromagnetic Compatibility (EMC) of Medical Devices	06/06/2022
Design Considerations and Pre-market Submission Recommendations forInteroperable Medical Devices	09/06/2017
Appropriate Use of Voluntary Consensus Standards in Premarket Submissionsfor Medical Devices	09/14/2018

Verification and Validation

The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

Cybersecurity

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient.

Wireless Coexistence Testing

Additionally, Siemens conforms to the requirements for Radio Frequency Wireless Technology as defined in FDA guidance document "Radio Frequency Wireless Technology in Medical Devices, Guidance for Industry and Food and Drug Administration Staff, issued on August 14, 2013" by adhering to the EMC and risk based verification and validation requirements in design, testing, and labeling of the wireless remote control components of the subject devices.

The Radio Frequency Wireless Technology of the optional Remote Scan Control and supporting Control Device iPad for Scan&GO complies to 47 CFR part 15 subpart c – Intentional Radiators. All Radio device labels will show an FCC ID code to show compliance. Shielding requirement applicable to the NAEOTOM Alpha and respective Scatter Radiation diagrams for typical room installations are provided in the User Documentation and Planning Guide of the intended Scanners in accordance with IEC60601-2-44.

Siemens has considered several measures to address wireless coexistence by design to ensure the safe operation of the wireless components in combination with the applicable system supported functionality. Wireless technology in the system setup to perform a task in a given shared environment where other systems have an ability to perform their tasks and may or may not be using the same set of rules has been considered. According to FDA guidance 'Radio Frequency Wireless Technology in Medical Devices" Siemens has addressed the safety, effectiveness, and high likelihood of coexistence with other devices of this technology in our product design by our Risk Management Process, Failure Mode and Effects Analysis (FMEA) Process, and Requirement Engineering Process. As part of the risk management process, hazardous situations associated with the Scan&GO and its connection to the host system via Wi-Fi were addressed as part of the Risk Management process.

Testing for co-existence considered for following scenarios:

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Co-Channel Testing
. Adjacent Channel Testing
RF Interference Testing
Separation Distance/Location Testing .

Scan&GO is designed to allow dynamic frequency selection and transmission power control by default in accordance with IEEE 802.11h. Adjacent channel testing is addressed by the fact that Scan&GO does not support shared medium access to Siemens Wi-Fi network. RF interference was tested by successfully ensuring that wireless communications were actively transmitting in situations where possible interference may exist. Recommended distance and router locations requirements are documented in the user documentation.

Summary

The features described in this premarket notification are supported with verification and validation testing, dosimetry and imaging performance, and analysis of phantom images to assess device and feature performance during product development. The risk analysis was completed, and risk control implemented to mitigate identified hazards. The test results show that all of the software specifications have met the acceptance criteria. Verification testing of the device was found acceptable to support the claim of substantial equivalence.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use as well as necessary cautions and warnings to provide for safe and effective use of the device. Risk management is ensured via a system related risk analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing according to the risk management process. In order to minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

IX. Conclusions

The non-clinical data supports the safety of the devices and the hardware and software verification and validation demonstrates that the NAEOTOM CT scanner systems perform as intended in the specified use conditions. Verification and validation, clinical/patient and phantom testing were performed. The data included in this submission demonstrates that the NAEOTOM CT scanner systems with described modifications performs comparably to the predicate devices currently marketed for the same intended use. The conclusions drawn from the nonclinical tests demonstrate that the subject devices are as safe, as effective, and perform as well as or better than the predicate devices.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.