SOMATOM Pro.Pulse

K232206 · Siemens Medical Solutions USA, Inc. · JAK · Dec 6, 2023 · Radiology

Device Facts

• Record ID: K232206
• Device Name: SOMATOM Pro.Pulse
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 6, 2023
• 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 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

Dual-source CT scanner; utilizes two continuously rotating tube-detector systems; operates on fan-beam principle. Inputs: X-ray transmission data. Transforms inputs via computer reconstruction into DICOM-format cross-sectional images. Used in professional healthcare facilities by trained staff (physicians, radiologists). Features include iterative reconstruction (ADMIRE, iMAR), spectral imaging, and automated workflow tools (myExam Companion, Recon&GO). Output: CT images for diagnosis, treatment planning, and interventional guidance. Healthcare providers use images to aid clinical decision-making in oncology, cardiology, and surgery. Benefits include high-speed scanning, reduced motion artifacts, and support for low-dose screening protocols.

Clinical Evidence

Bench testing only. Performance verified via phantom studies (ACR, Gammex) evaluating noise, homogeneity, high-contrast resolution, slice thickness, and CNR. Specific feature validation included ZeeFree (stack artifact correction), Dual Source Dual Energy spectral properties, FAST 3D Camera accuracy, and myNeedle Guide detection algorithm (90.76% detection rate). No clinical prospective/retrospective trials conducted for this submission; relies on established clinical literature (e.g., National Lung Screening Trial) for screening indications.

Technological Characteristics

Dual-source CT scanner; 150 kW generator (2x75 kW); Stellar detector (UFC ceramic); 2x64 physical rows. Connectivity: DICOM, networked. Software: SOMARIS/10 syngo CT VB10 (Windows-based). Features: Tin filtration, iterative reconstruction (ADMIRE, iMAR), spectral imaging, wireless remote control (Scan&GO). Sterilization: N/A (non-invasive). Cybersecurity: IT hardening, encryption, authentication.

Indications for Use

Indicated for generation and processing of cross-sectional patient images via computer reconstruction of x-ray transmission data. Used by trained staff 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

• SOMATOM go.Top (K211373)

Reference Devices

• SOMATOM Drive (K230421)

Submission Summary (Full Text)

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December 6, 2023

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

Re: K232206

Trade/Device Name: SOMATOM Pro.Pulse Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 8, 2023 Received: November 8, 2023

Dear Clayton Ginn:

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.

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).

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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.

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 mediation-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).

Sincerelv.

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

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## Indications for Use

510(k) Number (if known) K232206

Device Name SOMATOM Pro.Pulse

#### 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 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)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510(k) Summary

### for

## SOMATOM Pro.Pulse – Software Version SOMARIS/10 syngo CT VB10

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. Contact Details

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 (1) Siemens Healthcare GmbH Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

Location of Manufacturing Site (2) SIEMENS SHANGHAI, MEDICAL EQUIPMENT LTD 278 Zhou Zhu Rd Shanghai, CHINA, 201318 Establishment Registration Number: 3003202425

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.

#### Submitter Contact Person:

Clayton Ginn Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: [phone] [e-mail] Backup Contact

Alaine Medio Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: [phone] [e-mail]

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## II. Device Name and Classification

| Product name: | SOMATOM Pro.Pulse |
|-----------------------|----------------------------------|
| Trade name: | SOMATOM Pro.Pulse |
| 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: | SOMATOM go.Top |
|-----------------------|---------------------------------------------------------------------------------|
| 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 device design. |

### Reference device:

| Trade Name: | SOMATOM Drive |
|-----------------------|---------------------------------------------------------------------------------|
| 510(k) Number: | K230421 |
| Clearance Date: | June 16, 2023 |
| 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 device design. |

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## IV. Device Description Summary

Siemens intends to market a new Dual Source CT scanner system SOMATOM Pro.Pulse based on the SOMARIS/10 platform.

The subject device SOMATOM Pro.Pulse with software version SOMARIS/10 synqo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector system (dual source) and functions according to the fan beam principle. The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format. The images delivered by the system can be used by trained staff for post-processing applications commercially distributed by Siemens Healthcare and other vendors as an aid in diagnosis, treatment preparation, radiation therapy planning, and therapeutic interventions (including, 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. 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 SOMATOM Pro.Pulse is SOMARIS/10 syngo CT VB10. 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 VB10 (SOMARIS/10 syngo CT VB10) is a modified software version of the predicate device, syngo CT VA40 (SOMARIS/10 syngo CT VA40) cleared in K211373.

The subject device SOMATOM Pro.Pulse 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 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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## VI. Indications for Use Comparison

### 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 physician as an aid in diagnosis.

The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment preparation and radiation therapy planning.

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.

### 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 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:

1. The subject device Indications for Use is the exact same as the reference predicate's Indications for Use (K230421), however it is slightly different than the primary predicate's Indications for Use.

2. The sentence "The images delivered by the system can be used by a trained physician as an aid in diagnosis" was removed, since the subsequent sentence restates the same, replacing 'trained physician' with 'trained staff'. It can be assumed a trained physician is part of the trained staff.

Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists. 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.

3. The word 'preparation' has been removed from the phrase "treatment preparation and radiation therapy planning" since treatment planning better describes how the device is used.

4. The phrase "as well as for diagnostic and therapeutic interventions" was added to the second sentence. This was done to express use of the device in standard practice. The predicate device can and is commonly used as an aid in invasive procedures. The same is applicable to the subject device.

None of the intended use includes 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 SOMATOM CT System is not the principal means of guidance, because the CT System does not guide the invasive procedures, the needle orientation and the needle advance and handling is always done under the physicians control.

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## VII. Comparison of Technological Characteristics with the Predicate Device

Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA40 software version which is cleared in K211373.

The SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 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 SOMATOM Pro.Pulse have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices.

The intended use and fundamental scientific technology for the SOMATOM Pro.Pulse remain unchanged from the predicate devices.

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

- Scanner Principle- Whole body X-Ray Computed Tomography Scanner
- System Acquisition – Continuously rotating tube detector system
- Workplaces Support of workplaces that include reconstruction and image evaluation software ●
- Patient table
- Patient table foot switch for movement
- Tin filtration technology
- Stellar detector technology
- Athlon type X-ray tube
- Power generator
- High Power 80/ High Power 70
- . Iterative reconstruction methods
- Scan&GO
- Mobile workflow (Tablets)
- Optional injector arm
- . Support of CT guided intervention workflow (myNeedle Guide)
- Precision matrix (large image matrices)
- DirectDensity™ Reconstruction ●
- Cardiac CT imaging

The subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 will support the modifications/further developments in comparison to the predicate devices as listed in the tables under subsections 1) Modified Hardware and 2) Modified Software.

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 |
| enabled | This feature is currently supported by other cleared Siemens CT systems or cleared<br>Siemens stand-alone software applications. This feature will be supported for the |

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| Term | Definition |
|----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | subject device with software version SOMARIS/10 syngo CT VB10 and is substantially<br>equivalent compared to the cleared version of the predicate/reference device. |
| modified | This feature is a modified form of a feature cleared within the predicate and/ or<br>reference devices |
| new | The feature is newly supported for Siemens CT Scanners and the subject device |

#### 1) Modified Hardware

Table 2: Overview of hardware modifications for the subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CTVB10 compared to the predicate/reference devices.

| # | Hardware properties | SOMATOM Pro.Pulse<br>SOMARIS/10 syngo CT VB10 |
|----|-----------------------------|-----------------------------------------------|
| 1. | CARE Breathe | enabled |
| 2. | FAST 3D Camera | modified |
| 3. | Full-range CARE 2D Camera | modified |
| 4. | Moodlight | modified |
| 5. | CARE Moodlight | modified |
| 6. | Patient table configuration | modified |

#### 2) Modified Software (syngo CT VB10)

Table 3: Overview of software modifications for the subject device SOMATOM Pro.Pulse with SOMARIS/10 syngo CT VB10 compared to the predicate/reference devices.

| # | Software properties | SOMATOM Pro.Pulse<br>SOMARIS/10 syngo CT VB10 |
|----|-----------------------------------------------------|-----------------------------------------------|
| 1. | ZeeFree | new |
| 2. | Dual Source Dual Energy | enabled |
| 3. | FAST Integrated Workflow | modified |
| 4. | Automatic Patient Instruction | modified |
| 5. | myNeedle Guide (with MyNeedle Detection) | modified |
| 6. | CARE kV | modified |
| 7. | Recon&GO | modified |
| 8. | CT View&GO | modified |
| 9. | myExam Companion – myExam<br>Compass/myExam Cockpit | modified |

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| # | Software properties | SOMATOM Pro.Pulse<br>SOMARIS/10 syngo CT VB10 |
|-----|----------------------------|-----------------------------------------------|
| 10. | Scan&GO | enabled |
| 11. | Flex4D Spiral - Neuro/Body | modified |

A tabular summary of the comparable hardware properties between the subject and predicate/reference devices is provided in the following Table 4 and Table 5.

Table 4: Technical hardware characteristics for subject device SOMATOM Pro.Pulse (software version SOMARIS/10 syngo CT VB10) compared to the predicate/reference devices.

| Hardware<br>property | Subject device<br>SOMATOM Pro.Pulse<br>with SOMARIS/10 syngo<br>CT VB10 | Primary predicate device<br>SOMATOM go.Top<br>with SOMARIS/10 syngo<br>CT VA40<br>(K211373) | Reference device<br>SOMATOM Drive<br>with SOMARIS/7 syngo CT<br>VB30<br>(K230421) |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| scanner | Whole body Computed<br>Tomography (CT) Scanner<br>System | Whole body Computed<br>Tomography (CT) Scanner<br>System | Whole body Computed<br>Tomography (CT) Scanner<br>System |
| System<br>configuration | Dual Source | Single Source | Dual Source |
| Environment of<br>Use | Professional Healthcare<br>Facility | Professional Healthcare<br>Facility | Professional Healthcare<br>Facility |
| Generator<br>Max. power (kW) | 150 (2 × 75) | 75 | 200 (2 × 100) |
| Detector<br>technology | Stellar detector based on<br>Multislice UFC (Ultra Fast<br>Ceramic) | Stellar detector based on<br>Multislice UFC (Ultra Fast<br>Ceramic) | StellarInfinity Detector (UFC<br>detector)<br>with TrueSignal and Edge<br>technology |
| Detector<br>volume coverage | 38.4 mm | 38.4 mm | 32 mm |
| Detector<br>physical rows | 2 × 64 | 64 | 2 × 64 |
| Detector<br>Slice width | 0.6 mm | 0.6 mm | 0.5 mm |
| Detector | 840 (detector A) | 840 | 1472 (detector A) |
| Hardware<br>property | Subject device<br>SOMATOM Pro.Pulse<br>with SOMARIS/10 syngo<br>CT VB10 | Primary predicate device<br>SOMATOM go.Top<br>with SOMARIS/10 syngo<br>CT VA40<br>(K211373) | Reference device<br>SOMATOM Drive<br>with SOMARIS/7 syngo CT<br>VB30<br>(K230421) |
| DAS channel no. | 600 (detector B) | 600 (detector B) | 960 (detector B) |
| Detector | 2 x 128 | 128 | 2 x 128 |
| Image slices | (with Interleaved Volume<br>Reconstruction, IVR)<br>2 x 384 | (with Interleaved Volume<br>Reconstruction, IVR)<br>384 | (acquired slices through z-<br>Sharp technology)<br>2 x 384 |
| | (reconstructed slices) | (reconstructed slices) | (reconstructed slices) |
| Tube<br>technology | 2 x Athlon® DS X-ray tube | Athlon® X-ray tube | 2 x Straton MX Sigma X-ray<br>tubes |
| Tube<br>collimator | Tube collimator DS4-A,<br>DS4-B<br>• Equivalent to 0.5 mm Al<br>in the isocenter<br>• 1 mm Al with cardio<br>wedge | Tube collimator<br>• Equivalent to 0.5 mm Al<br>in the isocenter<br>• 1 mm Al with cardio<br>wedge | Detector Scatter<br>Collimator<br>For improved low-contrast<br>resolution, e.g., in neuro<br>and abdominal imaging |
| Tube<br>kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps | 70–140 kV in 10 kV steps |
| Tube<br>Max. current | Single Source: 13-825 mA<br>Dual Source: 26-1650 mA | Standard range: 13 - 825 mA | Single source 20-800 mA<br>Dual source 40–1600 mA |
| Tube | • 0.8 × 0.8 / 7° | • 0.8 × 0.8 / 7° | • 0.7 × 0.7/7° |
| focus | • 1.0 × 1.2 / 7° | • 1.0 × 1.2 / 7° | • 0.9 x 1.1/7° |
| Tube<br>Heat storage<br>capacity | 2 x 7.0 MHU | 7.0 MHU | 0 MHU (0.6 MHU capacity<br>combined with 7.3 MHU/min (5,400 kJ/min)<br>cooling rate is comparable<br>to the performance of a<br>conventional tube with<br>approximately 50 MHU<br>(37,000 kJ) anode heat<br>storage capacity) |
| Tube<br>Cooling rate<br>(MHU/ min) | up to 1.7 | up to 1.7 | 7.3 |

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| Hardware<br>property | Subject device<br>SOMATOM Pro.Pulse<br>with SOMARIS/10 syngo<br>CT VB10 | Primary predicate device<br>SOMATOM go.Top<br>with SOMARIS/10 syngo<br>CT VA40<br>(K211373) | Reference device<br>SOMATOM Drive<br>with SOMARIS/7 syngo CT<br>VB30<br>(K230421) |
|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Gantry<br>Bore size | 70 | 70 | 78 |
| Gantry<br>Scan FoV (cm) | 50 | 50 | 50 |
| Gantry<br>Extended FoV<br>(cm) | 70 | 70 | 78 |
| Gantry<br>Rot. time (sec) | 0.33 (optional), 0.5, 1.0 | 0.33 (optional), 0.5, 1.0 | 0.28, 0.33, 0.5, 1.0 |
| Gantry<br>Tilt (degree) | n.a. | + 30° | n.a. |
| Maximum<br>temporal<br>resolution in ECG<br>gated or triggered<br>examination<br>(ms) | 86 ms (mono-segment)<br>43 ms (bi-segment) | 165 ms (mono-segment)<br>82.5 ms (bi-segment) | 75 ms (mono-segment)<br>37.5 ms (bi-segment) |
| Maximum scan<br>speed at pitch<br>(mm/s at pitch x) | 372 mm/s at pitch 3.2 | 175 mm/s at pitch 1.5 | 458 mm/s at pitch 3.4 |
| Touch panels | Yes | Yes | Yes |
| Patient table<br>Type | Vario 2 (2000 mm)<br>Vario 2.D (2000 mm) | Vario1 (1600 mm)<br>Vario RT (1600 mm)<br>Vario 2 (2000mm) | PHS 2000 (type PHS4n)<br>Multi-purpose patient<br>(MPT) table (optional) |
| Patient table<br>Max. weight<br>capacity (kg) | 307 | 227<br>307 | 227<br>307 |
| Max. scan length<br>topogram | 2080 mm with table<br>extension | 1680 mm with table<br>extension<br>2080 mm with table<br>extension | 2000 mm |
| Hardware<br>property | Subject device<br>SOMATOM Pro.Pulse<br>with SOMARIS/10 syngo<br>CT VB10 | Primary predicate device<br>SOMATOM go.Top<br>with SOMARIS/10 syngo<br>CT VA40<br>(K211373) | Reference device<br>SOMATOM Drive<br>with SOMARIS/7 syngo CT<br>VB30<br>(K230421) |
| Max. scan length<br>Image acquisition | Max. 2000 mm with<br>patient table extension | Max. 1600 mm with<br>patient table extension<br>Max. 2000 mm with<br>patient table extension | Max. 1840 mm |
| Spectral filtration | Tin Filter | Combined Tin Filter / Split<br>Filter | Tin Filter |
| FAST 3D Camera | option for patient<br>positioning with 3D<br>Camera:<br>• Ceiling mounted<br>• Gantry mounted | option for patient<br>positioning with 3D<br>Camera:<br>• Ceiling mounted | option for patient<br>positioning with 3D<br>Camera:<br>• Ceiling mounted |
| High Power 70/<br>High Power 80 | up to 825 mA (@70 kV)<br>up to 825 mA (@80 kV) | up to 825 mA (@70 kV)<br>up to 825 mA (@80 kV) | 750 mA (@ 80 kV)<br>650 mA (@ 70 kV) |
| x-ray foot switch | Option to trigger hands-<br>free scanning | Option to trigger hands-<br>free scanning | Option to trigger hands-<br>free scanning |
| Table foot switch | Option for table patient<br>movement | Option for table patient<br>movement | N/A |
| i-joystick | Option for patient table<br>movements, including an<br>electrical connection for<br>the tablet dock which<br>allows charging the tablet<br>when mounted. | Option for patient table<br>movements, including an<br>electrical connection for<br>the tablet dock which<br>allows charging the tablet<br>when mounted. | i-control:<br>option to operate some of<br>the CT functions including<br>patient table movement as<br>an alternative to the<br>gantry operating panel and<br>the input units at the<br>console. |
| Tablet dock | Option for mounting of the<br>tablet on the patient table. | Option for mounting of the<br>tablet on the patient table. | N/A |
| Software<br>property | Subject device | Primary predicate device | Reference device |
| | SOMATOM Pro.Pulse<br>SOMARIS/10 syngo CT<br>VB10 | SOMATOM go.Top<br>SOMARIS/10 syngo CT<br>VA40<br>(K211373) | SOMATOM Drive<br>SOMARIS/7 syngo CT VB30<br>(K230421) |
| Operating System | Windows based<br>SOMARIS/10 syngo CT<br>VB10<br>Note: Note: the short<br>version syngo CT VB10 is<br>also used as labeling<br>information…