NAEOTOM Alpha, Scan&GO Software

K220814 · Siemens Medical Solutions USA, Inc. · JAK · Jul 12, 2022 · Radiology

Device Facts

• Record ID: K220814
• Device Name: NAEOTOM Alpha, Scan&GO Software
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 12, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

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 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. This in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner. The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

Device Story

NAEOTOM Alpha is a dual-source CT scanner utilizing photon-counting detectors (Cadmium-Telluride) to generate cross-sectional images; inputs include x-ray transmission data. System features include VECTRON x-ray tubes, iterative reconstruction, and optional Scan&GO mobile application for in-room scan planning via wireless tablet. Scan&GO allows clinicians to select patients, protocols, and view scan parameters/images in close proximity to the patient; it cannot trigger radiation or store images. New features include MyNeedle Laser for CT-guided interventions, PURE Calcium for spectral image processing, and modified cardiac/perfusion modes. Device used in clinical settings by trained staff; output consists of DICOM images for diagnostic/therapeutic aid. Benefits include improved image quality, spectral data acquisition, and streamlined interventional workflows.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via phantom studies, image quality evaluations, and functional testing of new features (MyNeedle Laser accuracy, PURE Calcium spectral reconstruction, iMAR metal artifact reduction, and cardiac acquisition modes).

Technological Characteristics

Dual-source CT scanner; photon-counting detectors (CdTe); VECTRON x-ray tubes; 82cm bore; 2x120kW generator. Connectivity: DICOM, Wi-Fi for mobile tablet. Software: SOMARIS/10 syngo CT VA50 (command-based, Windows-based). Cybersecurity: IT hardening, encryption, authentication. Sterilization: N/A (non-invasive). Standards: IEC 60601-2-44, IEC 60601-1-2, DICOM PS 3.1-3.20.

Indications for Use

Indicated for patients requiring cross-sectional imaging via CT reconstruction for diagnostic or therapeutic purposes, including low-dose lung cancer screening in 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, Scan&GO (K211591)
• SOMATOM X.ceed, Scan&GO (K211373)

Submission Summary (Full Text)

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July 12, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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

Re: K220814

Trade/Device Name: NAEOTOM Alpha, Scan&GO Software Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: June 8, 2022 Received: June 9, 2022

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 (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 located 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.

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 803) for

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devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-regulatoryassistance/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,

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

Enclosure

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# Indications for Use

510(k) Number (if known)

#### K220814

Device Name NAEOTOM Alpha Scan&GO Software

#### Indications for Use (Describe) NAEOTOM Alpha

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.

#### Scan&GO

This in-room scan application is a planning and information system the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.

The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are using special protocols.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| <span style="font-family: Arial, sans-serif;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-family: Arial, sans-serif;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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## 510(k) Summary

FOR

## NAEOTOM Alpha CT Scanner System SOFTWARE VERSION SOMARIS/10 syngo CT VA50 (K220814) Submitted by: Siemens Medical Solutions USA, Inc. 810 Innovation Drive

Knoxville, TN 37932 Date Prepared: March 18, 2022

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 Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany Establishment Registration Number 3004977335

Note: Description in this submission use the short company name Siemens. It covers both manufacturing locations and names as listed above. Brand name on all products is Siemens Healthineers.

#### Contact Person:

Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. [phone] (work cell) [phone] FAX [e-mail]

### II. Device Name and Classification

NAEOTOM Alpha Product Name:

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

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| Product Name: | Scan&GO |
|--------------------------------|---------------------------------------------|
| Propriety Trade Name: | Scan&GO |
| Classification Name: | Computed Tomography X-ray System |
| Secondary Classification Name: | Picture Archiving and Communications System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Secondary CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | JAK |
| Secondary Product Code: | LLZ |

## III. Predicate Device

| Primary Predicate Device: | |
|-----------------------------|------------------------------------------------------------------------------------|
| Trade Name: | NAEOTOM Alpha, Scan&GO |
| 510(k) Number: | K211591 |
| Clearance Date: | September 30, 2021 |
| 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, Scan&GO |
| | |
| 510(k) Number: | K211373 |
| Clearance Date: | August 27, 2021 |
| 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: K211373 was a bundle submission with various Siemens CT Scanner Systems, including SOMATOM go.Now, SOMATOM go.Up, SOMATOM go.All, SOMATOM go.Top, SOMATOM go.Sim, SOMATOM go.Open Pro, SOMATOM X.cite, SOMATOM X.ceed and Scan&GO software.

In this submission, the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40 and the secondary predicate device SOMATOM X.ceed, both including Scan&GO, are being used, to demonstrate substantial equivalence of technological characteristics.

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# IV. Device Description

Siemens intends to update software version, SOMARIS/10 synqo CT VA50 for Siemens NAEOTOM Alpha Scanner Systems with unmodified mobile workflow options.

This update also includes optional hardware for CT guided intervention workflow.

### Dual Source CT Scanner System:

- NAEOTOM Alpha
- . Scan&GO Mobile Medical Application (optional mobile workflow component)

The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VA50 is a dual source Computed Tomography (CT) x-ray system featuring two detectors based on photon counting technology.

The CT scanner system algorithm is designed to allow image reconstruction by using photon counting data generated by the subject device. The reconstruction results are comparable with the primary and secondary predicate devices, but support with improved technological characteristics as described in Section 10.

The NAEOTOM Alpha with Software SOMARIS/10 syngo CT VA50 produces CT images in DICOM format, which can be used by trained staff for post-processing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post processing applications.

The Scan&GO mobile workflow is an optional planning and information software designed to perform the necessary functions required for planning and controlling of the workflow of the NAEOTOM Alpha. Scan&GO can be operated on a Siemens provided various tablet hardware that meets certain minimum technical requirements. It allows users to work in close proximity to the scanner and the patient. Specifically Scan&GO allows control/display of the following software interactions via a wireless tablet or personal computer with Wi-Fi connection that meets certain minimum requirements:

- . Selection of patients
- Selection of pre-defined protocols
- Scan parameter display
- Patient table position display and gantry tilt parameter display
- . Tools and instruction message area,
- Patient table position planning area
- . Physiological data display
- . Patient data display (e.g. date of birth, name)
- Display of acquired topogram and tomogram images
- Finalization of exam (close patient)
- Mobile Organizer
- Patient Instruction Language ("API languages")

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- . predefined workflow associated question/answer dialog
NOTE: Scan&GO does not support storage of images. Additionally, Scan&GO cannot trigger a scan or radiation release.

The software version for the NAEOTOM Alpha, syngo CT VA50 (SOMARIS/10 syngo CT VA50), 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 a software plugin interface that allows for the use of specific commercially available post processing software algorithms in an unmodified form from the cleared stand-alone post processing version.

New software version syngo CT VA50 (SOMARIS/10 syngo CT VA50) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the primary predicate device in K211591 and supports the same plugin interfaces for the subject device Scan&GO mobile workflow and integration of post-processing tasks as the primary predicate device.

# V. Indications for Use

### NAEOTOM Alpha:

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.

## Scan&GO:

This in-room scan application is a planning and information system designed to perform the necessary functions required for planning and controlling scans of supported SIEMENS CT scanners. It allows users to work in close proximity to the scanner.

The in-room scan application runs on standard information technology hardware and software, utilizing the standard information technology operating systems and user interface. Communication and data exchange are done using special protocols.

# VI. Comparison of Technological Characteristics with the Predicate Device

The NAEOTOM Alpha scanner provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the primary predicate device.

The subject device NAEOTOM Alpha is building on the dual-source CT system configuration of the primary predicate device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VA40.

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The predicate device and the subject device NAEOTOM Alpha features two photon counting detectors built from Cadmium-Telluride (CdTe).

Supported by the subject device, SOMARIS/10 syngo CT VA50 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211591.

lt reuses all unmodified software features of the legacy software syngo CT VA40 as described below in the section "Unmodified Features used in the Subject Devices".

The NAEOTOM Alpha with syngo CT VA50 also supports an optional laser component for a modified CT guided intervention workflow.

As with the primary device NAEOTOM Alpha with syngo CT VA40, the subject device NAEOTOM Alpha is supported by an optional mobile workflow, Scan&GO.

Software version SOMARIS/10 syngo CT VA50 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 remains unchanged from the cleared primary predicate device.

At a high level, the subject device NAEOTOM Alpha and the primary/secondary predicate device 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
- Tin filtration technology
- Vectron X-ray Tube
- Power Generator
- Mobile Medical application Software functionality (Scan&GO)
- Mobile workflow (Tablet)
- . Support 3D Camera operation for fast patient positioning workflow
- Scanner display and control functionality
- Remote Scan Control
- . Long scan range

The following technological differences exist between the subject device NAEOTOM Alpha and the primary predicate device NAEOTOM Alpha with syngo CT VA40 cleared in K211591:

- Software version SOMARIS/10 syngo CT VA50 ●
- . CT guided intervention – modified hardware and software application

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The following technological differences exist between the subject device Scan&GO mobile application software and the predicate device Scan&GO mobile application software cleared in K211591:

- Software version SOMARIS/10 syngo CT VA50 ●
- . CT guided intervention – modified hardware and software application

The NAEOTOM Alpha will support the following modifications/further developments in comparison to the primary/secondary predicate devices as listed in the tables below.

- 1) New/Modified Hardware
- Table 1: Overview of hardware modifications .
- 2) Software version SOMARIS/10 syngo CT VA50
- Table 2: Overview of software modifications

The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information:

Table 1: Overview of term definition.

| Term | Definition |
|----------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| N/A | The feature is not supported for the subject device |
| New | The feature is newly supported for Siemens CT Scanners and the subject<br>device |
| Modified | This feature is modified from the predicate / reference 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>VA50 and is substantially equivalent compared to the cleared version. |

#### New/modified hardware features:

Table 2: Overview of hardware modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.

| | Hardware properties | Subject device<br>NAEOTOM Alpha<br>SOMARIS/10 syngo CT VA50 |
|----|-----------------------------------------|-------------------------------------------------------------|
| 1. | CT guided intervention – MyNeedle Laser | enabled |
| 2. | Tablet dock for patient table | enabled |
| 3. | Interventional Joystick (IVJ) | enabled |
| 4. | Integrated Injector Arm | enabled |
| 5. | Tablet hardware for Scan&GO | modified |

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### New/modified software features:

Table 3: Overview of software modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VA50.

| | Software properties | NAEOTOM Alpha |
|-----|-----------------------------------------------------------|--------------------------|
| | | SOMARIS/10 syngo CT VA50 |
| | | (subject device) |
| 1. | CT guided intervention – MyNeedle Guide | enabled |
| 2. | Flex 4D Spiral – Neuro & Body Perfusion/ Dynamic<br>Angio | modified |
| 3. | Quantum 70 kV | modified |
| 4. | QuantumPlus UHR | modified |
| 5. | Flash Phase Spiral | modified |
| 6. | PURE Calcium | new |
| 7. | Iterative Metal Artifact Reduction (iMAR) | enabled |
| 8. | Automated Patient Instructions | modified |
| 9. | QuantumPlus Topo (Spectral Topo) | modified |
| 10. | Multi-Threshold Acquisition | modified |
| 11. | High Resolution Dual Source Cardiac Modes | modified |
| 12. | Additional ex-factory exam protocols | modified |

A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VA50 and primary/secondary predicate device are listed in Table 4 and Table 5 below (modifications are in gray shaded sections).

Table 4: Technical hardware characteristics for subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT VA50) compared to the predicate devices.

| Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA40<br>(K211591) | SOMATOM X.ceed<br>SOMARIS/10 syngo CT<br>VA40<br>(K211373) |
| Scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner | whole body X-ray<br>computed tomography<br>scanner |
| Scan Mode | Dual Source Dual Energy | Dual Source Dual Energy | Single Source Dual<br>Energy |
| Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA40<br>(K211591) | SOMATOM X.ceed<br>SOMARIS/10 syngo CT<br>VA40<br>(K211373) |
| Generator<br>max. power | 2x 120 kW | 2x 120 kW | 105 kW/ 120 kW |
| Detector<br>Technology | QuantaMax<br>Direct Conversion with<br>"Quantum Technology" | QuantaMax<br>Direct Conversion with<br>"Quantum Technology" | Stellarinfinity<br>Energy integrating |
| Detector<br>volume<br>coverage | 2 x 57.6 mm | 2 x 57.6 mm | 38.4 mm |
| Detector<br>physical rows | 2x 288 | 2x 288 | 64 |
| Detector slice<br>width | 0.2 mm | 0.2 mm | 0.6 mm |
| Detector<br>channel No. | 2752 (A system)<br>1984 (B system) | 2752 (A system)<br>1984 (B system) | 920 |
| X-ray Tube | VECTRON | VECTRON | VECTRON |
| Tube<br>kV steps | 70 kV, 90 kV, 100 kV,<br>120 kV, 140 kV | 90 kV, 100 kV, 120 kV,<br>140 kV | 70 kV to 150 kV<br>(in 10 kV steps) |
| Tube<br>max. current | 2 x 1300 mA | 2 x 1300 mA | 1200 mA; for 105 kW<br>1300 mA; for 120 kW |
| Tube<br>tube focus | 0.4 mm x 0.5 mm<br>0.6 mm x 0.7 mm<br>0.8 mm x 1.1 mm<br>(for both tubes) | 0.4 mm x 0.5 mm<br>0.6 mm x 0.7 mm<br>0.8 mm x 1.1 mm<br>(for both tubes) | min. 0.6 mm x 0,7 mm<br>(w/o comb)<br>min. 0.4 mm x 0.5 mm<br>(with comb) |
| Tube<br>heat capacity | higher than 30 MHU | higher than 30 MHU | higher than 30 MHU |
| Gantry<br>bore size | 82 cm | 82 cm | 82 cm |
| Gantry<br>Scan FoV | 50 cm | 50 cm | 50 cm |
| Gantry<br>rotation time [s] | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.5 s, 1.0 s | 0.25 s, 0.3 s, 0.5 s, 1.0 s |
| Gantry<br>Tilt [degree] | N/A | N/A | +/- 25<br>+/- 30 (only with Vitus) |
| Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA40<br>(K211591) | SOMATOM X.ceed<br>SOMARIS/10 syngo CT<br>VA40<br>(K211373) |
| Patient Table<br>type | Vario 2.D<br>Vitus | Vario 2.D<br>Vitus | Vario 2.D<br>Vitus<br>Vario RT |
| Max. Scan<br>length<br>Topogram | Vario 2.D: 2080 mm<br>Vitus: 2080 mm | Vario 2.D: 2080 mm<br>Vitus: 2080 mm | Vario 2.D: 2080 mm<br>Vitus: 2080 mm<br>Vario RT: 1680 mm |
| Max. Scan<br>length<br>Image<br>acquisition | Vario 2.D: 2000 mm<br>Vitus: 2000 mm | Vario 2.D: 2000 mm<br>Vitus: 2000 mm | Vario 2.D: 2000 mm<br>Vitus: 2000 mm<br>Vario RT: 1600 mm |
| Spectral<br>filtration<br>Option* | Tin Filter for both tubes | Tin Filter for both tubes | Combined Split Filter /<br>Tin Filter supported, plus<br>extra Tin Filter |
| 3D Camera<br>for patient<br>positioning | option for patient<br>positioning with 3D<br>Camera | option for patient<br>positioning with 3D<br>Camera | option for patient<br>positioning with 3D<br>Camera |
| Tablet dock for<br>patient table | Option for mounting of<br>the tablet on the patient<br>table. | N/A | Option for mounting of<br>the tablet on the patient<br>table. |
| Interventional<br>Joystick (IVJ) | Option to support the<br>tablet mobile workflow<br>including an electrical<br>connection for the tablet<br>dock which allows<br>charging the tablet<br>when mounted. | N/A | Option to support the<br>tablet mobile workflow<br>including an electrical<br>connection for the tablet<br>dock which allows<br>charging the tablet<br>when mounted. |
| Laser supported<br>workflow | Laser in combination<br>with FAST Isocentering<br>visualize coordinates for<br>patient isocenter<br>position;<br>myNeedle Laser<br>visualizes a planned<br>needle path for<br>interventions | N/A | Laser in combination<br>with FAST Isocentering<br>visualize coordinates for<br>patient isocenter<br>position;<br>myNeedle Laser<br>visualizes a planned<br>needle path for<br>interventions |
| Software<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA40<br>(K211591) | SOMATOM X.ceed<br>SOMARIS/10 syngo CT<br>VA40<br>(K211373) |
| Operating<br>System | Windows based<br>SOMARIS/10 syngo CT<br>VA50 | Windows based<br>SOMARIS/10 syngo CT<br>VA40 | Windows based<br>SOMARIS/10 syngo CT<br>VA40 |
| Acquisition<br>Workplace | syngo Acquisition<br>Workplace named as<br>"myExam Console"<br><br>syngo Viewing, syngo<br>Filming and syngo<br>Archiving & Networking<br><br>2nd Acquisition<br>Workplace named as<br>"myExam Satellite" | syngo Acquisition<br>Workplace named as<br>"myExam Console"<br><br>syngo Viewing, syngo<br>Filming and syngo<br>Archiving & Networking<br><br>2nd Acquisition<br>Workplace named as<br>"myExam Satellite" | syngo Acquisition<br>Workplace named as<br>"myExam Console"<br><br>syngo Viewing, syngo<br>Filming and syngo<br>Archiving & Networking<br><br>2nd Acquisition<br>Workplace named as<br>"myExam Satellite" |
| IRS | Image Reconstruction<br>for Quantum<br>Technology | Image Reconstruction<br>for Quantum<br>Technology | Image Reconstruction<br>for classic Siemens<br>single source CT scanner |
| Detector | QuantaMax detector<br>firmware supported | QuantaMax detector<br>firmware supported | Stellar detector<br>firmware supported |
| Teamplay | Support teamplay<br>Protocols | Support teamplay<br>Protocols | Support teamplay<br>Protocols |
| Protocols | Support of:<br>Protocol supporting<br>contrast bolus-<br>triggered data<br>acquisitionContrast media<br>protocols (including<br>coronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual Energy<br>acquisitionDynamic imaging<br>(Flex 4D Spiral) | Support of:<br>Protocol supporting<br>contrast bolus-<br>triggered data<br>acquisitionContrast media<br>protocols (including<br>coronary CTA)Pediatric ProtocolsFlex Dose ProfileTurbo Flash SpiralDual Energy<br>acquisitionProtocols supporting<br>Cardiac Scanning,<br>Spectral imaging for | Protocols for<br>Radiation Therapy<br>Planning support<br>patient markingProtocols that allow<br>scanning with<br>support of an<br>external respiratory<br>gating system<br>(ANZAI, Varian RGSC)Protocol supporting<br>contrast bolus-<br>triggered data<br>acquisition |
| Software<br>property | Subject device | Primary predicate device | Secondary predicate device |
| | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA40<br>(K211591)…