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

K243523 · Siemens Medical Solutions USA, Inc. · JAK · Feb 12, 2025 · Radiology

Device Facts

• Record ID: K243523
• Device Name: NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Feb 12, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: AI/ML

Intended 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.

Device Story

NAEOTOM Alpha/Alpha.Pro/Alpha.Prime are CT scanner systems using photon-counting detector technology (QuantaMax) to generate cross-sectional images. Inputs include X-ray transmission data; system transforms these via computer reconstruction into DICOM images. Used in professional healthcare facilities by physicians, radiologists, or technologists. Output images aid in diagnosis, treatment, and radiation therapy planning (e.g., Brachytherapy, Proton Therapy, Surgery). Features include dual-source (Alpha/Alpha.Pro) or single-source (Alpha.Prime) configurations, VECTRON X-ray tubes, and SOMARIS/10 syngo CT VB20 software. Supports advanced workflows like FAST 3D Camera positioning, myNeedle Guide for interventions, and respiratory gating. Output affects clinical decision-making by providing high-resolution anatomical data for therapy planning and diagnostic assessment. Benefits include improved image quality, reduced radiation dose, and streamlined clinical workflows.

Clinical Evidence

Bench testing only. Performance verified through phantom tests, integration/functional testing, and image quality evaluations. Testing confirmed accuracy of FAST 3D camera features, respiratory gating (Direct i4D, DirectBreathhold), and radiotherapy planning protocols. Low-dose lung cancer screening performance was compared to predicates via technical parameter analysis, demonstrating substantial equivalence.

Technological Characteristics

Whole-body CT scanner; photon-counting QuantaMax detector; VECTRON X-ray tube; dual-source (Alpha/Alpha.Pro) or single-source (Alpha.Prime) configurations. Connectivity: DICOM, networked. Software: SOMARIS/10 syngo CT VB20. Standards: IEC 60601-1, IEC 60601-2-44, IEC 61223-3-5, DICOM PS 3.1-3.20. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnosis, treatment, radiation therapy planning, and diagnostic/therapeutic interventions. Includes low-dose lung cancer screening for high-risk populations as defined by professional medical societies.

Regulatory Classification

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.

Predicate Devices

• NAEOTOM Alpha (K233657)
• SOMATOM X.ceed (K233650)

Reference Devices

• SOMATOM go. Platform (K233650)
• SOMATOM X. Platform (K233650)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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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. [phone] (work cell) [e-mail]

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Image /page/5/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" are several orange dots of varying sizes.

# II. Device Name and Classification

| Product name | Trade name |
|---------------------|-------------------------------------|
| NAEOTOM Alpha | NAEOTOM Alpha.Peak<br>NAEOTOM 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 subject<br>device 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 subject<br>device 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 subject<br>device 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.

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".

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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.

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.

## 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/or<br>secondary predicate devices |
| Enabled | This feature is currently supported by other cleared Siemens CT systems or<br>cleared Siemens stand-alone software applications. This feature will be<br>supported for the subject device with software version SOMARIS/10 syngo CT<br>VB20 and is substantially equivalent compared to the cleared version of the<br>primary/secondary predicate device. |
| n.a. | The feature is not supported by the subject device or by the primary and/or<br>secondary 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.

| | Technological<br>property | HW/<br>SW<br>change | Subject devices | | | Predicate devices | |
|-----|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--------------------------------------|------------------------------------------|--------------------------------------------|---------------------------------------------------|----------------------------------------------------|
| | | | Dual Source | | Single<br>source | Dual Source | Single<br>source |
| | | | NAEOTOM<br>Alpha | NAEOTOM<br>Alpha.Pro | NAEOTOM<br>Alpha.Prime | NAEOTOM<br>Alpha | SOMATOM<br>X.ceed |
| | | | syngo CT<br>VB20 | syngo CT<br>VB20 | syngo CT<br>VB20 | syngo CT<br>VB10 | syngo CT<br>VB10 |
| | | | | | | (K233657) | (K233650) |
| 1. | Respiratory Motion<br>Management -<br>Interfaces for<br>respiratory gating:<br>- Varian RGSC<br>- Anzai<br>- Open Interface<br>- Open Online<br>Interface | HW | modified¹ | modified¹ | modified¹ | n.a. | cleared |
| 2. | Respiratory Motion<br>Management -<br>FAST 4D | SW | enabled | enabled | enabled | n.a. | cleared |
| 3. | Respiratory Motion<br>Management -<br>Direct i4D | SW | enabled | enabled | enabled | n.a. | cleared |
| 4. | Respiratory Motion<br>Management -<br>DirectBreathhold | SW | enabled | enabled | enabled | n.a. | cleared |
| 5. | CT View&GO<br>- Sim&GO | SW | modified² | modified² | modified² | cleared | cleared |
| 6. | Direct Laser<br>Steering | HW/<br>SW | enabled | enabled | enabled | n.a. | cleared |
| 7. | Recon&GO | SW | modified² | modified² | modified² | cleared | cleared |
| | Technological<br>property | HW/<br>SW<br>change | Subject devices | | | Predicate devices | |
| | | | NAEOTOM<br>Alpha<br>syngo CT<br>VB20 | NAEOTOM<br>Alpha.Pro<br>syngo CT<br>VB20 | NAEOTOM<br>Alpha.Prime<br>syngo CT<br>VB20 | NAEOTOM<br>Alpha<br>syngo CT<br>VB10<br>(K233657) | SOMATOM<br>X.ceed<br>syngo CT<br>VB10<br>(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/<br>FAST Integrated<br>Workflow | SW/<br>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/<br>SW | new | new | new | n.a. | n.a. |
| 15. | Power Shaver | SW/<br>HW | n.a. | n.a. | new | n.a. | n.a. |
| 16. | myExam<br>Companion –<br>myExam<br>Compass/<br>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.

| Hardware<br>property | Subject device<br>(Dual source NAEOTOM CT systems) | | Primary predicate<br>device | Secondary predicate<br>device |
|------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM<br>Alpha.Pro<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB10<br>(K233657) | SOMATOM X.ceed<br>SOMARIS/10 syngo<br>CT VB10<br>(K233650) |
| Scanner | whole body X-ray<br>computed<br>tomography (CT)<br>scanner | whole body X-ray<br>computed<br>tomography (CT)<br>scanner | whole body X-ray<br>computed<br>tomography (CT)<br>scanner | whole body X-ray<br>computed<br>tomography (CT)<br>scanner |
| Product<br>name | NAEOTOM Alpha | NAEOTOM<br>Alpha.Pro | NAEOTOM Alpha | SOMATOM X.ceed |
| Trade name | • Ex-factory CT<br>systems:<br>NAEOTOM<br>Alpha.Peak<br>• Installed base CT<br>systems:<br>NAEOTOM Alpha | • Ex-factory CT<br>systems:<br>NAEOTOM<br>Alpha.Pro<br>• Installed base CT<br>systems:<br>n.a., new CT system | NAEOTOM Alpha | SOMATOM X.ceed |
| Design | without myNeedle<br>Laser:<br>Image: CT scanner | without myNeedle<br>Laser:<br>Image: CT scanner | without myNeedle<br>Laser:<br>Image: CT scanner | without myNeedle<br>Laser:<br>Image: CT scanner<br>with myNeedle Laser: |
| Hardware<br>property | Subject device<br>(Dual source NAEOTOM CT systems) | | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM<br>Alpha.Pro<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB10<br>(K233657) | SOMATOM X.ceed<br>SOMARIS/10 syngo<br>CT VB10<br>(K233650) |
| | with myNeedle<br>Laser:<br>Image: CT scanner | with myNeedle<br>Laser:<br>Image: CT scanner | with myNeedle<br>Laser:<br>Image: CT scanner | Image: CT scanner |
| System<br>configuration | Dual Source | Dual Source | Dual Source | Single Source |
| Environment<br>of Use | Professional<br>Healthcare Facility | Professional<br>Healthcare Facility | Professional<br>Healthcare Facility | Professional<br>Healthcare Facility |
| Generator<br>max. power<br>(kW) | 2x 120 | 2x 120 | 2x 120 | 105 or 120 |
| Detector<br>technology | QuantaMax<br>direct conversion<br>with "Quantum<br>Technology" | QuantaMax<br>direct conversion<br>with "Quantum<br>Technology" | QuantaMax<br>direct conversion<br>with "Quantum<br>Technology" | StellarInfinity<br>UFC (Ultra Fast<br>Ceramic) |
| Detector<br>volume<br>coverage<br>(mm) | 2x 57.6 | 2x 38.4 | 2x 57.6 | 38.4 |
| Detector<br>physical rows | 2x 288 | 2x 192 | 2x 288 | 64 |
| Detector<br>slice width<br>(mm) | 0.2 | 0.2 | 0.2 | 0.6 |
| Detector<br>DAS channel<br>no. | 2752 (A system)<br>1984 (B system) | 2752 (A system)<br>1984 (B system) | 2752 (A system)<br>1984 (B system) | 920 |
| Tube | VECTRON | VECTRON | VECTRON | VECTRON |
| Hardware<br>property | Subject device<br>(Dual source NAEOTOM CT systems) | | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM<br>Alpha.Pro<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB10<br>(K233657) | SOMATOM X.ceed<br>SOMARIS/10 syngo<br>CT VB10<br>(K233650) |
| technology | | | | |
| Tube<br>kV steps | 70, 90, 100, 120,<br>140, 150<br>(150 kV only<br>available on the<br>smaller tube-<br>detector system (B<br>system) and only in<br>combination with<br>the additional Sn<br>filter, 0.7 mm) | 70, 90, 100, 120,<br>140, 150<br>(150 kV only<br>available on the<br>smaller tube-<br>detector system (B<br>system) and only in<br>combination with<br>the additional Sn<br>filter, 0.7 mm) | 70, 90, 100, 120,<br>140, 150<br>(150 kV only<br>available on the<br>smaller tube-<br>detector system (B<br>system) and only in<br>combination with<br>the additional Sn<br>filter, 0.7 mm) | 70, 80, 90, 100, 110,<br>120, 130, 140, 150 |
| Tube<br>max. current<br>(mA) | 2x 1300 | 2x 1300 | 2x 1300 | 1200 mA (for 105<br>kW)<br>1300 mA (for 120<br>kW) |
| Tube<br>tube focus<br>(mm) | 0.4 x 0.5/8°<br>0.6 x 0.7/8°<br>0.8 x 1.1/8°<br>(for both tubes) | 0.4 x 0.5/8°<br>0.6 x 0.7/8°<br>0.8 x 1.1/8°<br>(for both tubes) | 0.4 x 0.5/8°<br>0.6 x 0.7/8°<br>0.8 x 1.1/8°<br>(for both tubes) | 0.4 x 0.5/8°<br>0.6 x 0.7/8°<br>0.8 x 1.1/8° |
| Tube<br>heat storage<br>capacity<br>(MHU) | higher than 30 | higher than 30 | higher than 30 | higher than 30 |
| Tube<br>cooling rate<br>(MHU/min) | 2.7 | 2.7 | 2.7 | 2.7 |
| Gantry<br>bore size<br>(cm) | 82 | 82 | 82 | 82 |
| Gantry<br>Scan FoV<br>(cm) | 50 | 50 | 50 | 50 |
| Gantry | 81.5 | 81.5 | 81.5 | 81.5 |
| Hardware<br>property | Subject device<br>(Dual source NAEOTOM CT systems) | | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM<br>Alpha.Pro<br>SOMARIS/10 syngo<br>CT VB20 | NAEOTOM Alpha<br>SOMARIS/10 syngo<br>CT VB10<br>(K233657) | SOMATOM X.ceed<br>SOMARIS/10 syngo<br>CT VB10<br>(K233650) |
| Extended FoV<br>(cm) | | | | |
| Gantry<br>rotation time<br>(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 |
| Gantry<br>Tilt (degree) | N/A | N/A | N/A | +/- 25<br>+/-30 (only with<br>Vitus) |
| Maximum<br>temporal<br>resolution in<br>ECG gated or<br>triggered<br>examination<br>(ms) | mono- mono-<br>segment: 66<br>bi-segment: 33 | mono- mono-<br>segment: 66<br>bi-segment: 33 | mono-segment: 66<br>bi-segment: 33 | mono-segment: 125<br>bi-segment: 66 |
| Maximum<br>scan speed at<br>pitch<br>(mm/s at<br>pitch x) | 737 mm/s at pitch<br>3.2 | 492 mm/s at pitch<br>3.2 | 737 mm/s at pitch<br>3.2 | 261 at pitch 1.7…