Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

Yes
The document explicitly mentions "Al-based needle tip detection" as part of the myNeedle Guide feature.

Therapeutic

No.
The device is a diagnostic imaging system (CT scanner) used to generate images for diagnosis, treatment planning, and guidance, rather than directly providing therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states that 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 directly indicates its role as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device is a software version for existing Computed Tomography (CT) Scanner Systems, which are hardware devices. While the submission focuses on the software modifications, the device itself is the CT system with the new software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: This device is a Computed Tomography (CT) system. It generates images of the inside of the body using X-rays. It does not perform tests on biological samples.
Intended Use: The intended use is to generate and process images for diagnosis, treatment planning, and interventions. This is an in vivo (within the living body) imaging process, not an in vitro diagnostic test.

Therefore, this CT system falls under the category of medical imaging devices, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The section for "Control Plan Authorized (PCCP) and relevant text" explicitly states "Not Found", meaning there is no mention of PCCP approval or clearance in the provided text.

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

JAK

Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

. SOMATOM go.Up
. SOMATOM go.Now
SOMATOM go.All
SOMATOM go.Top
. SOMATOM go.Sim
. SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

. SOMATOM X.cite
. SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which 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 and therapy planning support (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, 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 SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray 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.

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

No

Input Imaging Modality

Computed Tomography X-ray System

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.
Professional Healthcare Facility

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM go. Platform and SOMATOM X. Platform during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

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

Testing will cover all related subsystems that contribute to the device modifications. Test levels are defined. For each test level several test activities are performed. The test specification and acceptance criteria are related to the corresponding requirements. Various test activities are performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

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

System Verification test:

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

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

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 10 below. Image /page/31/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 of varying sizes.

| Feature/Non-clinical

supportive testing	Bench Testing performed
FAST 3D Camera /
FAST Integrated
Workflow	The bench test evaluates and compares the accuracy of the three sub-
features FAST Isocentering, FAST Range, and FAST Direction to the
accuracy of the predicate device with syngo CT VA40 using the old
camera hardware and the then only available ceiling mount. The objectives of the bench test are to demonstrate that the FAST 3D
Camera feature of the subject device with SOMARIS/10 syngo CT VB10,
where the algorithms have been optimized for a new camera hardware
in two mounting positions, achieves comparable results as the predicate
device with syngo CT VA40. The FAST Isocentering accuracy of the subject device with syngo CT VB10
is comparable to the predicate device with syngo CT VA40, regardless of
the camera mounting position. For the FAST Range feature, the detection accuracy of all body region
boundaries is comparable between the subject device with syngo CT
VB10 and predicate device with syngo CT VA40. In the gantry mounting
position, the legs are often occluded by the torso when the patient is
lying head-first on the table. This is not a severe limitation, as leg
examinations are usually performed feet-first. The FAST Direction pose detection results are of comparable accuracy for
subject and predicate device, regardless of the camera mounting
position. Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to
the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera
hardware, also in the new gantry position.
Multi-Purpose Table	A CT system with extended distance between CT gantry and patient table
base plus a mobile C-arm system were combined to evaluate the
technical feasibility and possible limitations of this combination.
The range of possible movement for the mobile C-arm in different
positions between CT gantry and patient table was tested and
documented by measurement of angles.
Based on the test results it can be concluded that a CT scanner, equipped
with a Multi-Purpose (Vitus) Patient Table, which is installed with
enhanced distance (674 mm) to the CT gantry and offers the iCT mode
functionality, provides sufficient freedom of movement for a mobile C-
arm X-ray system to be used for clinical routine without any significant
limitations for the myNeedle Lasers or FAST 3D Camera.
Direct Breathhold	The test results showed that using the Direct Breathhold functionality, a
spiral scan can automatically be triggered from an external respiratory
gating device. The actual scan remains unchanged, and the object is
correctly depicted in the resulting image.
ZeeFree	The bench tests evaluate the performance of ZeeFree reconstruction.
The objectives of the tests are to demonstrate:
that the number of artefacts which can be attributed to a stack
misalignment (e.g. discontinuities in vessel structures,
anatomical steps at air-soft-tissue interfaces, doubling of vessel
or other anatomy) and which are often caused by incomplete
patient breath-hold can be reduced in a "Cardiac Stack Artefact
Correction" (SAC) reconstruction compared to the standard
reconstruction with otherwise matching reconstruction
parameters. that no artefacts are introduced by a SAC reconstruction. The test results show: If misalignment artefacts are identified in non-corrected
standard ECG-gated reconstructed sequence or spiral images,
the feature "Cardiac Stack Artefact Correction" (SAC, marketing
name: ZeeFree) enables optional stack artefact corrected
images, which reduce the number of alignment artefacts. The SAC reconstruction does not introduce new artefacts, which
were previously not present in the non-corrected standard
reconstruction. The SAC reconstruction does realize equivalent image quality in
quantitative standard physics phantom-based measurements
(ACR, Gammex phantom) in terms of noise, homogeneity, high-
contrast resolution, slice thickness and CNR compared to a non-
corrected standard reconstruction The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data
myNeedle Guide
(with myNeedle
Detection)	Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed. It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases. Further, the results of this bench test clearly show that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW. With successful Al-based needle tip detection, no user interaction is needed to achieve needle-aligned view during needle progression. Additional manual adjustment (fine tuning) of the needle-aligned view is always possible.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The non-clinical and clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject devices SOMATOM go. Platform and SOMATOM X. Platform perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go. Platform and SOMATOM X. Platform with described modifications perform comparably to the predicate devices currently marketed for the same intended use. Siemens believes that the data generated from the SOMATOM go. Platform and SOMATOM X. Platform testing supports a finding of substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K211373

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K230421

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

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

Summary

0

Image /page/0/Picture/0 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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

March 26, 2024

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

Re: K233650

Trade/Device Name: SOMATOM go.Up: SOMATOM go.Now: SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM X.cite; SOMATOM X.ceed Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 23, 2024 Received: February 23, 2024

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).

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

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

2

Indications for Use

Submission Number (if known)

K233650
Device Name
SOMATOM go.Up;
SOMATOM go.Now;
SOMATOM go.All;
SOMATOM go.Top;
SOMATOM go.Sim;
SOMATOM go.Open Pro;
SOMATOM X.cite;
SOMATOM X.ceed
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/3/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 in a pattern.

510(k) Summary for K233650

SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems

with 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: Descriptions 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.

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Image /page/4/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 orange dots arranged in a circular pattern.

Submitter Contact Person:

Clayton Ginn Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865) 898-2692 clayton.ginn@siemens-healthineers.com Backup Contact: Kenny Bello Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (205) 856-6099 monsuru.bello@siemens-healthineers.com

II. Device Name and Classification

Table 1: Subject Device Names

Product Name	Trade Name
SOMATOM go.Up	SOMATOM go.Up
SOMATOM go.Now	SOMATOM go.Now
SOMATOM go.All	SOMATOM go.All
SOMATOM go.Top	SOMATOM go.Top
SOMATOM go.Sim	SOMATOM go.Sim
SOMATOM go.Open Pro	SOMATOM go.Open Pro
SOMATOM X.cite	SOMATOM X.cite
SOMATOM X.ceed	SOMATOM X.ceed
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 CT Scanner Systems with SOMARIS/10 syngo CT VA40
software
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.

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Image /page/5/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots arranged in a pattern.

Reference device:
Trade Name:	SOMATOM CT Scanner Systems with SOMARIS/7 syngo CT VB30
software
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.

Note:

K211373 was a bundle submission with various Siemens CT Scanner Systems, including the CT scanner systems 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.

K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open.

IV. Device Description

Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10 for the following SOMATOM Computed Tomography (CT) Scanner Systems:

SOMATOM go. Platform CT scanner systems:

. SOMATOM go.Up
. SOMATOM go.Now
SOMATOM go.All
SOMATOM go.Top
. SOMATOM go.Sim
. SOMATOM go.Open Pro

SOMATOM X. Platform CT scanner systems:

. SOMATOM X.cite
. SOMATOM X.ceed

In this submission, the above listed CT scanner systems are jointly referred to as subject devices by "SOMATOM go. Platform" and "SOMATOM X. Platform" CT scanner systems.

The subject devices SOMATOM go. Platform and SOMATOM X. Platform with SOMARIS/10 syngo CT VB10 are Computed Tomography X-ray Systems which feature one continuously rotating tubedetector system and function according to the fan beam principle (single source). The SOMATOM go. Platform and SOMATOM X. Platform with software SOMARIS/10 syngo CT VB10 produces CT

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Image /page/6/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 cluster of orange dots of varying sizes.

images in DICOM format, which 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 and therapy planning support (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, 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 SOMATOM go. Platform and SOMATOM X. Platform, SOMARIS/10 synqo CT VB10, is a command-based program used for patient management, data management, Xray 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.

New software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version based on syngo CT VA40 (SOMARIS/10 syngo CT VA40) which was cleared for the predicate device in K211373.

Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as an optional upgrade for the applicable existing SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems.

The bundle approach is feasible for this submission since the subject devices have similar technological characteristics, software operating platform, and supported software characteristics. The supporting data are similar, primarily one review division/group will be involved, and the indications for use is the same between the devices. 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/7/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" are several orange dots 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 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.

High risk populations are 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 reference predicate's Indications for Use (K230421), however it is slightly different than the primary predicate's Indications for Use.

1. 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.
  To consider that in the US, the standard of care is for physicians to perform diagnosis/treatment, Siemens added the following statement in the Device Description above and an equivalent warning exists in the labeling:

"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."

1. 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.

8

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 graphic of orange dots arranged in a circular pattern.

1. 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. This device can and is commonly used as an aid in invasive procedures.
  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 subject devices SOMATOM go. Platform and SOMATOM X. Platform 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 is always done under the physicians control.

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 go. Platform and the SOMATOM X. Platform 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 go. Platform and SOMATOM X. Platform 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 VB10 software reuses all unmodified software features of the legacy software syngo CT VA40 cleared in K211373. Additionally, no features present in the predicate device are descoped.

Software version SOMARIS/10 syngo CT VB10 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 SOMATOM go. Platform and SOMATOM X. Platform 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
Stellar Detector technology
. Tin filtration technology
. Vectron/Athlon/Chronon X-ray Tube depending on the CT system
Power Generator
Scan&GO
Mobile workflow (Tablet)
Optional injector arm

9

Image /page/9/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 cluster of orange dots that are arranged in a circular pattern.

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
. Respiratory Gating Devices
. Standard CARE technologies
Standard FAST technologies
Standard GO technologies
. Precision matrix (large image matrices)
HD FoV
DirectDensity™ ●

Compared to the primary predicate device referenced in this submission, the subject devices SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10 support the modifications provided in the Table 3 under subsection 1) Modified Hardware and Table 4 under subsection 2) Modified Software.

The configuration table and comparison table use the following terms in Table 2 to describe various technological characteristics in comparison to the primary and secondary predicate devices information:

Term	Definition
N/A	The feature is not supported for the subject device
New	The feature is newly supported for Siemens CT Scanners and newly introduced
within the subject device submission
Unmodified	The feature remains unchanged from that within the predicate device. The
relevant modification was already present within the predicate device.
Modified	This feature is modified from the predicate / reference devices
Enabled	This feature is currently supported by other cleared Siemens CT systems or
cleared Siemens stand-alone software applications. This feature will be
supported for the subject device with software version SOMARIS/10 syngo CT
VB10 and is substantially equivalent compared to the cleared version of the
primary/reference predicate device.

Table 2: Overview of term definition.

10

Image /page/10/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. To the right of the word "Healthineers" is a graphic of orange dots.

1) Modified Hardware

Table 3: Overview of hardware modifications of SOMATOM go. Platform and SOMATOM X. Platform CT scanner systems with SOMARIS/10 syngo CT VB10.

| # | Hardware
property | Subject devices
with SOMARIS/10 syngo CT VB10 | | |
|----|--------------------------------|---------------------------------------------------------------------|---------------------------------------|----------------------------------|
| | | SOMATOM go. Platform | | SOMATOM X. Platform |
| | | 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 |
| 1. | FAST 3D Camera | enabled | enabled | enabled |
| 2. | CARE Breathe | enabled | N/A | unmodified |
| 3. | CARE 2D Camera | enabled | unmodified | unmodified |
| 4. | Moodlight | enabled | unmodified | unmodified |
| 5. | CARE Moodlight | enabled | N/A | N/A |
| 6. | Multi-Purpose
Table (Vitus) | N/A | N/A | modified |

2) Modified Software (syngo CT VB10)

Table 4: Overview of software modifications of SOMATOM go. Platform and SOMATOM X. Platform CT Scanner Systems with SOMARIS/10 syngo CT VB10.

| # | Software property | Subject devices
with SOMARIS/10 syngo CT VB10 | | | | | |
|----|-----------------------------------|--------------------------------------------------|------------------|----------------------------------------|-------------------|------------------------|----------------------------------------|
| | | SOMATOM go. Platform | | | | SOMATOM
X. Platform | |
| | | 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 |
| 1. | DirectBreathhold | N/A | enabled | enabled | enabled | enabled | enabled |
| 2. | ZeeFree | N/A | N/A | enabled | enabled | enabled | enabled |
| 3. | myNeedle Guide | enabled | enabled | enabled | enabled | enabled | enabled |
| 4. | FAST Integrated
Workflow | enabled | enabled | enabled | enabled | enabled | enabled |
| 5. | Direct i4D | N/A | N/A | N/A | N/A | modified | modified |
| 6. | myExam
Companion | enabled | modified | modified | modified | modified | modified |
| 7. | myExam Satelite
(Remote Recon) | enabled | enabled | enabled | enabled | enabled | enabled |
| 8. | Recon&GO | modified | modified | modified | modified | modified | modified |

11

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 cluster of orange dots that are arranged in a circular pattern.

| # | Software property | Subject devices
with SOMARIS/10 syngo CT VB10 | | | | | |
|-----|----------------------------------|--------------------------------------------------|------------------|----------------------------------------|-------------------|------------------------|----------------------------------------|
| | | SOMATOM go. Platform | | | | | SOMATOM
X. Platform |
| | | 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 |
| 9. | CT View&GO | enabled | enabled | enabled | enabled | enabled | enabled |
| 10. | Scan&GO | enabled | enabled | enabled | enabled | enabled | enabled |
| 11. | Automatic Patient
instruction | enabled | enabled | enabled | enabled | enabled | enabled |
| 12. | DirectSetup Notes | N/A | N/A | N/A | new | new | N/A |
| 13. | ADMIRE | N/A | N/A | unmodified | enabled | enabled | unmodified |

A tabular summary of the comparable hardware and software properties between the subject devices SOMATOM go. Platform and SOMATOM X. Platform with software version syngo CT VB10 and primary/reference predicate devices are listed in Table 9 below (modifications are in gray shaded sections).

Table 5: Comparison of technical hardware characteristics between subject devices SOMATOM go.Now and SOMATOM go.Up with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.Now | SOMATOM
go.Up |
| scanner | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System |
| System
Configuration | Single Source | | Single Source | |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | |
| Generator
Max. power (kW) | 32 | | 32 | |
| Detector
technology | Stellar
based on UFC (Ultra Fast Ceramic) | | Stellar
based on UFC (Ultra Fast Ceramic) | |
| Detector
volume coverage
(mm) | 11.2 | 22.4 | 11.2 | 22.4 |
| Detector | 16 | 32 | 16 | 32 |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.Now | SOMATOM
go.Up |
| physical rows | | | | |
| Detector
Slice width (mm) | 0.7 | | 0.7 | |
| Detector
DAS channel no. | 768 | | 768 | |
| Detector
Image slices | 32 | 64 | 32 | 64 |
| Tube
technology | Chronon | | Chronon | |
| Tube
kV steps | 80, 110, 130 | | 80, 110, 130 | |
| Tube
Max. current (mA) | 400 | | 400 | |
| Tube
focus | • 0.8 x 0.4 / 8°
• 0.8 x 0.7 / 8° | | • 0.8 x 0.4 / 8°
• 0.8 x 0.7 / 8° | |
| Tube
Heat storage
capacity (MHU) | 3.5 | | 3.5 | |
| Tube
Cooling rate (kHU/
min) | 915 | | 915 | |
| Gantry
Bore size | 70 | | 70 | |
| Gantry
Scan FoV (cm) | 50 | | 50 | |
| Gantry
Extended FoV (cm) | 70 | | 70 | |
| Gantry
Rot. time (sec) | 0.5, 0.8, 1.0, 1.5 | | 0.8, 1.0, 1.5 | |
| Gantry
Tilt (degree) | N/A | +/- 30°
-30° to +28° with
optional 307 kg | N/A | +/- 30°
-30° to +28° with
optional 307 kg |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.Now | SOMATOM
go.Up |
| | | patient table | | patient table |
| Patient table
Type | Vector (1250
mm),
Vario 1 (1600
mm),
Vario RT (1600
mm)
with table
extension | Vario 1 (1600
mm),
Vario 2 (2000
mm),
Vario RT (1600
mm)
with table
extension | Vector (1250
mm),
Vario 1 (1600
mm),
Vario RT (1600
mm)
with table
extension | Vario 1 (1600
mm),
Vario 2 (2000
mm),
Vario RT (1600
mm)
with table
extension |
| Patient table
Max. weight
capacity (kg) | Vector: 160
Vario 1: 227
Vario RT: 227 | Vario 1: 227
Vario 2: 307
Vario RT: 227 | Vector: 160
Vario 1: 227
Vario RT: 227 | Vario 1: 227
Vario 2: 307
Vario RT: 227 |
| Max. scan length
topogram | 1680 mm with
table extension | 1680 mm with
table extension
2080 mm with
table extension | 1680 mm with
table extension | 1680 mm with
table extension
2080 mm with
table extension |
| Max. scan length
Image acquisition | Max. 1600 mm
with patient
table extension | Max. 1600 mm
with patient
table extension
Max. 2000 mm
with patient
table extension | Max. 1600 mm
with patient
table extension | Max. 1600 mm
with patient
table extension
Max. 2000 mm
with patient
table extension |
| Spectral filtration | Tin Filter | | Tin Filter | |
| High Power 80 | yes | yes | yes | yes |
| FAST 3D Camera | option for
patient
positioning with
3D Camera:
• gantry
mounted,
modified
design | option for
patient
positioning with
3D Camera:
• ceiling
mounted,
modified
design
• gantry
mounted,
modified
design | n.a. | option for
patient
positioning with
3D Camera:
• ceiling
mounted |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.Now | SOMATOM
go.Up |
| x-ray foot switch | Option to trigger hands-free
scanning | Option to trigger hands-free
scanning | Option to trigger hands-free
scanning | Option to trigger hands-free
scanning |
| Table foot switch | Option for table patient movement | Option for table patient movement | Option for table patient movement | Option for table patient movement |
| i-joystick | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. |
| Tablet dock | Option for mounting of the tablet
on the patient table. | Option for mounting of the tablet
on the patient table. | Option for mounting of the tablet
on the patient table. | Option for mounting of the tablet
on the patient table. |
| CARE Breathe | visualization of breathing
instructions to support three
messages in respiratory motion
management:
• free breathing
• preparation for breath hold
• breath hold itself in
combination with the
visualization of a countdown
visual patient instruction unit is
placed on the gantry front and
gantry back in the gantry funnel | | visual countdown indicator to
provide visual instruction in
respiratory motion management:
• free breathing
• preparation for hold breath
• breath hold
visual countdown indicator is placed
on the halo | |
| CARE 2D camera | one integrated into the gantry front
and one mounted on the gantry
back to monitor the patient during
examination | | 2D camera* integrated on the halo
plate
*in syngo CT VA40 known as patient
observation camera | |
| Moodlight | Illumination Moodlight to enhance
patient comfort supported
integrated as a ring with LED light
into the gantry front | | Illumination Moodlight to enhance
patient comfort supported
Integrated on the Halo | |
| CARE Moodlight | LED lights integrated on the gantry
front cover indicating:
• System startup | | n.a. | |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Now | SOMATOM
go.Up | SOMATOM
go.Now | SOMATOM
go.Up |
| | • Scan countdown
• Radiation on | | | |

12

Image /page/12/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

13

Image /page/13/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots that are arranged in a curved line.

14

Image /page/14/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 graphic of orange dots that are arranged in a pattern.

15

Image /page/15/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a series of orange dots arranged in a circular pattern.

Table 6: Comparison of technical hardware characteristics between subject devices SOMATOM go.All and SOMATOM go.Top with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | SOMATOM
go.Top | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | SOMATOM
go. Top |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|
| | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.All | SOMATOM
go.Top |
| scanner | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System | Whole body Computed Tomography
(CT) Scanner System |
| System
Configuration | Single Source | Single Source | Single Source | Single Source |
| Environment of Use | Professional Healthcare Facility | Professional Healthcare Facility | Professional Healthcare Facility | Professional Healthcare Facility |
| Generator
Max. power (kW) | 75 | 75 | 75 | 75 |
| Detector
technology | Stellar
based on UFC (Ultra Fast Ceramic) | Stellar
based on UFC (Ultra Fast Ceramic) | Stellar
based on UFC (Ultra Fast Ceramic) | Stellar
based on UFC (Ultra Fast Ceramic) |
| Detector
volume coverage
(mm) | 22.4 | 38.4 | 22.4 | 38.4 |
| Detector
physical rows | 32 | 64 | 32 | 64 |
| Detector
Slice width (mm) | 0.7 | 0.6 | 0.7 | 0.6 |
| Detector
DAS channel no. | 768 | 840 | 768 | 840 |
| Detector
Image slices | 64 | 128 | 64 | 128 |
| Tube | Athlon | Athlon | Athlon | Athlon |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.All | SOMATOM
go.Top |
| technology | | | | |
| Tube
kV steps | 70 to 140 (in 10 kV steps) | | 70 to 140 (in 10 kV steps) | |
| Tube
Max. current (mA) | 825 | | 825 | |
| Tube
focus | • 1.1 x 1.2 / 8°
• 0.8 x 0.8 / 8° | | • 1.1 x 1.2 / 8°
• 0.8 x 0.8 / 8° | |
| Tube
Heat storage
capacity (MHU) | 7 | | 7 | |
| Tube
Cooling rate (kHU/
min) | Up to 1700 | | Up to 1700 | |
| Gantry
Bore size | 70 | | 70 | |
| Gantry
Scan FoV (cm) | 50 | | 50 | |
| Gantry
Extended FoV (cm) | 70 | | 70 | |
| Gantry
Rot. time (sec) | 0.33, 0.5, 1.0 | | 0.33, 0.5, 1.0 | |
| Gantry
Tilt (degree) | +/- 30°
-30° to +28° with optional 307 kg
patient table | | +/- 30°
-30° to +28° with optional 307 kg
patient table | |
| Patient table
Type | Vario 1 (1600 mm)
Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Vario 1 (1600 mm)
Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | |
| Patient table
Max. weight
capacity (kg) | Vario 1: 227
Vario 2: 307
Vario RT: 227 | | Vario 1: 227
Vario 2: 307
Vario RT: 227 | |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.All | SOMATOM
go.Top |
| Max. scan length
topogram | 1680 mm with table extension
2080 mm with table extension | | 1680 mm with table extension
2080 mm with table extension | |
| Max. scan length
Image acquisition | Max. 1600 mm with patient table
extension
Max. 2000 mm with patient table
extension | | Max. 1600 mm with patient table
extension
Max. 2000 mm with patient table
extension | |
| Spectral filtration | Tin Filter | Combined Tin
Filter/Split filter | Tin Filter | Combined Tin
Filter/Split filter |
| High Power 70/
High Power 80 | 825 (@70 kV)
825 (@ 80 kV) | | 825 (@70 kV)
825 (@ 80 kV) | |
| FAST 3D Camera | option for patient positioning with
FAST 3D Camera:
• ceiling mounted, modified design
• gantry mounted, modified design | | option for patient positioning with
FAST 3D Camera:
• ceiling mounted | |
| x-ray foot switch | Option to trigger hands-free
scanning | | Option to trigger hands-free
scanning | |
| Table foot switch | Option for table patient movement | | Option for table patient movement | |
| i-joystick | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | |
| Tablet dock | Option for mounting of the tablet
on the patient table. | | Option for mounting of the tablet
on the patient table. | |
| CARE Breathe | visualization of breathing
instructions to support three
messages in respiratory motion
management:
• free breathing
• preparation for breath hold
• breath hold itself in
combination with the
visualization of a countdown | | visual countdown indicator to
provide visual instruction in
respiratory motion management:
• free breathing
• preparation for hold breath
• breath hold
visual countdown indicator is placed
on the halo | |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.All | SOMATOM
go.Top | SOMATOM
go.All | SOMATOM
go.Top |
| | visual patient instruction unit is
placed on the gantry front and
gantry back in the gantry funnel | | | |
| CARE 2D camera | one integrated into the gantry front
and one mounted on the gantry
back to monitor the patient during
examination | | 2D camera* integrated on the halo
plate
in syngo CT VA40 known as Patient
observation camera | |
| Moodlight | Illumination Moodlight to enhance
patient comfort supported
integrated as a ring with LED light
into the gantry front | | Illumination Moodlight to enhance
patient comfort supported
Integrated on the Halo | |
| CARE Moodlight | LED lights integrated on the gantry
front cover indicating:
• System startup
• Scan countdown
• Radiation on | | n.a. | |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Sim | SOMATOM
go.Open Pro | SOMATOM
go.Sim | SOMATOM
go.Open Pro |
| scanner | Whole body Computed Tomography
(CT) Scanner System | | Whole body Computed Tomography
(CT) Scanner System | |
| System
Configuration | Single Source | | Single Source | |
| Environment of Use | Professional Healthcare Facility | | Professional Healthcare Facility | |
| Generator
Max. power (kW) | 75 | | 75 | |
| Detector | Stellar | | Stellar | |
| technology | based on UFC (Ultra Fast Ceramic) | | based on UFC (Ultra Fast Ceramic) | |
| Detector
volume coverage
(mm) | 19.2 | 38.4 | 19.2 | 38.4 |
| Detector
physical rows | 32 | 64 | 32 | 64 |
| Detector
Slice width (mm) | 0.6 | 0.6 | 0.6 | 0.6 |
| Detector
DAS channel no. | 920 | 920 | 920 | 920 |
| Detector
Image slices | 64 | 128 | 64 | 128 |
| Tube
technology | Athlon | | Athlon | |
| Tube
kV steps | 70 to 140 (in 10 kV steps) | | 70 to 140 (in 10 kV steps) | |
| Tube
Max. current (mA) | 825 | | 825 | |
| Tube | • 1.1 x 1.2 / 7°
• 0.8 x 0.8 / 7° | | • 1.1 x 1.2 / 7°
• 0.8 x 0.8 / 7° | |
| focus | • 0.8 x 0.8 / 7° | | • 0.8 x 0.8 / 7° | |
| Tube | 7 | | 7 | |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Sim | SOMATOM
go.Open Pro | SOMATOM
go.Sim | SOMATOM
go.Open Pro |
| Heat storage
capacity (MHU) | | | | |
| Tube
Cooling rate (kHU/
min) | Up to 1700 | | Up to 1700 | |
| Gantry
Bore size | 85 | | 85 | |
| Gantry
Scan FoV (cm) | 60 | | 60 | |
| Gantry
Extended FoV (cm) | 85 | | 85 | |
| Gantry
Rot. time (sec) | 0.35, 0.5, 1.0 | | 0.35, 0.5, 1.0 | |
| Gantry
Tilt (degree) | +/- 30
-30° to +25° with optional 307 kg
patient table | | +/- 30
-30° to +25° with optional 307 kg
patient table | |
| Patient table
Type | Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | | Vario 2 (2000 mm)
Vario RT (1600 mm)
with table extension | |
| Patient table
Max. weight
capacity (kg) | Vario 2: 307
Vario RT: 227 | | Vario 2: 307
Vario RT: 227 | |
| Max. scan length
topogram | 1680 mm with table extension
2080 mm with table extension | | 1680 mm with table extension
2080 mm with table extension | |
| Max. scan length
Image acquisition | Max. 1600 mm with patient table
extension
Max. 2000 mm with patient table
extension | | Max. 1600 mm with patient table
extension
Max. 2000 mm with patient table
extension | |
| Spectral filtration | Tin Filter | Combined Tin
Filter/Split filter | Tin Filter | Combined Tin
Filter/Split filter |
| High Power 70/
High Power 80 | 825 (@70 kV)
825 (@ 80 kV) | Combined Tin
Filter/Split filter | 825 (@70 kV)
825 (@ 80 kV) | Combined Tin
Filter/Split filter |
| Hardware property | Subject device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM go. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
go.Sim | SOMATOM
go.Open Pro | SOMATOM
go.Sim | SOMATOM
go.Open Pro |
| FAST 3D Camera | option for patient positioning with
FAST 3D Camera:
• ceiling mounted, modified design | | option for patient positioning with
FAST 3D Camera:
• ceiling mounted | |
| x-ray foot switch | Option to trigger hands-free
scanning | | Option to trigger hands-free
scanning | |
| Table foot switch | Option for table patient movement | | Option for table patient movement | |
| i-joystick | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | | Option for patient table
movements, including an electrical
connection for the tablet dock
which allows charging the tablet
when mounted. | |
| Tablet dock | Option for mounting of the tablet
on the patient table. | | Option for mounting of the tablet
on the patient table. | |
| CARE Breathe | n.a. | | n.a. | |
| CARE 2D camera | Patient observation camera
integrated on gantry front
*in syngo CT VB10 the patient
observation camera is renamed as
CARE 2D camera | | Patient observation camera
integrated on gantry front | |

16

Image /page/16/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 cluster of orange dots.

17

Image /page/17/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

18

Image /page/18/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" are several orange dots of varying sizes.

19

Image /page/19/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots.

Table 7: Comparison of technical hardware characteristics between subject devices SOMATOM go.Sim and SOMATOM go.Open Pro with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40.

20

Image /page/20/Picture/0 description: The image contains 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 text is a series of orange dots arranged in a circular pattern.

21

Image /page/21/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

22

Image /page/22/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.

Table 8: Comparison of technical hardware characteristics between subject devices SOMATOM X.ceed with software version syngo CT VB10 and the primary predicate devices with software version syngo CT VA40 (K211373).

| Hardware
property | Subject device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| | | | SOMATOM
X.cite | SOMATOM
X.ceed |
| scanner | Whole body Computed Tomography
(CT) Scanner System | | Whole body Computed Tomography
(CT) Scanner System | |
| System
Configuration | Single Source | | Single Source | |
| Environment of
Use | Professional Healthcare Facility | | Professional Healthcare Facility | |
| Generator
Max. power (kW) | 90 kW or 105 kW | 105 kW or 120
kW | 90 kW or 105 kW | 105 kW or 120
kW |
| Detector
technology | StellarInfinity | | StellarInfinity | |
| Detector
volume coverage | 38.4 mm | | 38.4 mm | |
| Detector
physical rows | 64rows | | 64 | |
| Detector
Slice width | 0.6 mm | | 0.6 mm | |
| Detector
DAS channel no. | 840 | 920 | 840 | 920 |
| Detector
Image slices | 128 | | 128 | |
| Tube
technology | Vectron | | Vectron | |
| Tube
kV steps | 70–140 kV in 10 kV steps | | 70–140 kV in 10 kV steps | |
| Tube
Max. current | 1100 mA (for 90
kW)
1200 mA (for 105
kW) | 1200 mA (for 90
kW)
1300 mA (for 105
kW) | 1100 mA (for 90
kW)
1200 mA (for 105
kW) | 1200 mA (for 90
kW)
1300 mA (for 105
kW) |
| Tube
focus | • 0.6 x 0.7 / 8°
• 0.8 x 1.1 / 8° | • 0.4 x 0.5 / 8°
• 0.6 x 0.7 / 8° | • 0.6 x 0.7 / 8°
• 0.8 x 1.1 / 8° | • 0.4 x 0.5 / 8°
• 0.6 x 0.7 / 8° |
| Hardware
property | Subject device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
X.cite | SOMATOM
X.ceed | SOMATOM
X.cite | SOMATOM
X.ceed |
| | | • 0.8 x 1.1 / 8° | | • 0.8 x 1.1 / 8° |
| Tube
Heat storage
capacity | higher than 30 MHU | | higher than 30 MHU | |
| Tube
Cooling rate
(MHU/ min) | 2.7 MHU / min | 2.7 MHU / min | 2.7 MHU / min | 2.7 MHU / min |
| Gantry
Bore size | 82 | | 82 | |
| Gantry
Scan FoV (cm) | 50 | | 50 | |
| Gantry
Extended FoV
(cm) | 81.5 | | 81.5 | |
| Gantry
Rot. time (sec) | 0.3, 0.5, 1.0 | 0,25, 0.3, 0.5, 1.0 | 0.3, 0.5, 1.0 | 0,25, 0.3, 0.5, 1.0 |
| Gantry
Tilt (degree) | +/- 25
+/-30 (only with Vitus) | | +/- 25
+/-30 (only with Vitus) | |
| Patient table
Type | Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2 (2000
mm) | Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2.D (2000
mm) | Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2 (2000
mm) | Vario RT (1600
mm)
Vitus (2000 mm)
Vario 2.D (2000
mm) |
| Patient table
Installation
option | Regular
installation
(Vario RT, Vario 2
and Vitus):
474 mm
Installation
option with
extended
distance (Vitus):
674 mm (474 mm) | Regular
installation
(Vario RT, Vario 2
and Vitus):
474 mm
Installation
option with
extended
distance (Vitus):
674 mm (474 mm) | Regular
installation
(Vario RT, Vario 2
and Vitus):
474 mm | Regular
installation
(Vario RT, Vario 2
and Vitus):
474 mm |
| Hardware
property | Subject device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
X.cite | SOMATOM
X.ceed | SOMATOM
X.cite | SOMATOM
X.ceed |
| Patient table
Max. weight
capacity (kg) | 227 (Vario RT)
340 (Vitus)
307 (Vario 2) | 227 (Vario RT)
340 (Vitus)
307 (Vario 2.D) | 227 (Vario RT)
307 (Vitus)
307 (Vario 2) | 227 (Vario RT)
307 (Vitus)
307 (Vario 2.D) |
| Max. scan length
topogram | 1680 mm (Vario
RT)
2080 mm with
table extension
(Vario 2)
2080 mm (Vitus) | 1680 mm (Vario
RT)
2080 mm with
table extension
(Vario 2.D)
2080 mm (Vitus) | 1680 mm (Vario
RT)
2080 mm with
table extension
(Vario 2)
2080 mm (Vitus) | 1680 mm (Vario
RT)
2080 mm with
table extension
(Vario 2.D)
2080 mm (Vitus) |
| Max. scan length
Image acquisition | 1600 mm (Vario
RT)
2000 mm (Vitus)
2000 mm (Vario
2)
with table
extension | 1600 mm (Vario
RT)
2000 mm (Vitus)
2000 mm (Vario
2.D)
with table
extension | 1600 mm (Vario
RT)
2000 mm (Vitus)
2000 mm (Vario
2)
with table
extension | 1600 mm (Vario
RT)
2000 mm (Vitus)
2000 mm (Vario
2.D)
with table
extension |
| Spectral filtration | Combined Tin
Filter / Split
Filter, and extra
Tin Filter | Combined Tin
Filter / Split
Filter, and extra
Tin Filter | Combined Tin
Filter / Split
Filter, and extra
Tin Filter | Combined Tin
Filter / Split
Filter, and extra
Tin Filter |
| FAST 3D Camera | option for patient positioning with
FAST 3D Camera:
ceiling mounted, new design | | option for patient positioning with
FAST 3D Camera:
ceiling mounted | |
| High Power 70/
High Power 80 | Generator 90
kW:
up to 1100 mA
(@70 kV)
up to 1100 mA
(@80 kV)
Generator 105
kW:
up to 1200 mA
(@70 kV) | Generator 105
kW:
up to 1200 mA
(@70 kV)
up to 1200 mA
(@80 kV)
Generator 120
kW:
up to 1300 mA
(@70 kV) | Generator 90
kW:
up to 1100 mA
(@70 kV)
up to 1100 mA
(@80 kV)
Generator 105
kW:
up to 1200 mA
(@70 kV) | Generator 105
kW:
up to 1200 mA
(@70 kV)
up to 1200 mA
(@80 kV)
Generator 120
kW:
up to 1300 mA
(@70 kV) |
| Hardware
property | Subject device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VB10 | | Primary predicate device
SOMATOM X. Platform
with SOMARIS/10 syngo CT VA40
(K211373) | |
| | SOMATOM
X.cite | SOMATOM
X.ceed | SOMATOM
X.cite | SOMATOM
X.ceed |
| | up to 1200 mA
(@80 kV) | up to 1300 mA
(@80 kV) | up to 1200 mA
(@80 kV) | up to 1300 mA
(@80 kV) |
| x-ray foot switch | Option to trigger hands-free scanning | | Option to trigger hands-free scanning | |
| Table foot switch | Option for table patient movement | | Option for table patient movement | |
| i-joystick | Option for patient table movements,
including an electrical connection for
the tablet dock which allows charging
the tablet when mounted. | | Option for patient table movements,
including an electrical connection for
the tablet dock which allows charging
the tablet when mounted. | |
| Tablet dock | Option for mounting of the tablet on
the patient table. | | Option for mounting of the tablet on
the patient table. | |
| CARE 2D camera | Patient observation camera*
integrated on gantry front
*in syngo CT VB10 the patient
observation camera is renamed as
CARE 2D camera | | Patient observation camera
integrated on gantry front | |

23

Image /page/23/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a circular pattern.

24

Image /page/24/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

25

Image /page/25/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a series of orange dots that are arranged in a pattern.

26

Image /page/26/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 text is a graphic of orange dots arranged in a pattern.

Table 9: Comparison of software characteristics between the subject with software version syngo CT VB10 and predicate devices with software version syngo CT VA40 of the SOMATOM go. Platform.

Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40
(K211373)
Operating System	Windows based
SOMARIS/10 syngo CT VB10
Note: the short version syngo CT VB10 is also used as labeling information	Windows based
SOMARIS/10 syngo CT VA40
Note: the short version syngo CT VA40 is also used as labeling information
Workplace	syngo Acquisition Workplace (ICS) named as "myExam Console"
Image Reconstruction System (IRS)
2nd workplace option named as "myExam Satellite" with Remote Recon function	syngo Acquisition Workplace (ICS) named as "myExam Console"
Image Reconstruction System (IRS)
2nd workplace option named as "myExam Satellite"
Standard system
software	• syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network	• syngo Examination
• syngo Viewing
• syngo Filming
• syngo Archiving & Network
Detector firmware	Stellar detector firmware supported	Stellar detector firmware supported
Teamplay	Support of Teamplay protocols	Support of Teamplay protocols
Protocols	Support of:
• Protocols for Radiation Therapy Planning support patient marking
• Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian RGSC)	Support of:
• Protocols for Radiation Therapy Planning support patient marking
• Protocols that allow scanning with support of an external respiratory gating system (ANZAI, Varian RGSC)
Software property	Subject device	Primary predicate device
	SOMATOM go.Now	SOMATOM go.Now
	SOMATOM go.Up	SOMATOM go.Up
	SOMATOM go.All	SOMATOM go.All
	SOMATOM go.Top	SOMATOM go.Top
	SOMATOM go.Sim	SOMATOM go.Sim
	SOMATOM go.Open Pro	SOMATOM go.Open Pro
	SOMATOM X.cite	SOMATOM X.cite
	SOMATOM X.ceed	SOMATOM X.ceed
	with SOMARIS/10 syngo CT VB10	with SOMARIS/10 syngo CT VA40
(K211373)
	Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention (scan modes: i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning Protocols for DirectBreathhold	Protocol supporting contrast bolus-triggered data acquisition Contrast media protocols (including coronary CTA) Pediatric Protocols Flex Dose Profile Turbo Flash Spiral Dual Energy acquisition (TwinBeam DE and TwinSpiral DE) Dynamic imaging (Flex 4D Spiral) Protocols supporting CT Intervention (scan modes: i-sequence, i-spiral, i-Fluoro) Protocols supporting Cardiac Scanning
Advanced Reconstruction	Recon&GO:

Spectral Recon (Dual Energy
Reconstruction from photon-
counting data) / including Virtual
Unenhanced, Monoenergetic plus
Inline Results DE SPP (Spectral
Post-Processing with photon-
counting image data)
Inline Anatomical ranges
(Parallel/Radial) incl. Virtual
Unenhanced, Monoenergetic plus
Inline Spine and Rib Ranges
Inline table and bone removal | Recon&GO:
Spectral Recon (Dual Energy
Reconstruction from photon-
counting data) / including Virtual
Unenhanced, Monoenergetic plus
Inline Results DE SPP (Spectral
Post-Processing with photon-
counting image data) |
| Image viewing | CT View&GO offers: | CT View&GO offers: |
| Software property | Subject device | Primary predicate device |
| | SOMATOM go.Now | SOMATOM go.Now |
| | SOMATOM go.Up | SOMATOM go.Up |
| | SOMATOM go.All | SOMATOM go.All |
| | SOMATOM go.Top | SOMATOM go.Top |
| | SOMATOM go.Sim | SOMATOM go.Sim |
| | SOMATOM go.Open Pro | SOMATOM go.Open Pro |
| | SOMATOM X.cite | SOMATOM X.cite |
| | SOMATOM X.ceed | SOMATOM X.ceed |
| | with SOMARIS/10 syngo CT VB10 | with SOMARIS/10 syngo CT VA40
(K211373) |
| | - basic post-processing viewer (CT
View&GO) | - basic post-processing viewer (CT
View&GO) |
| | - 2D and 3D (MPR, VRT, MIP and
minIP) | - 2D and 3D (MPR, VRT, MIP and
minIP) |
| | - Evaluation tools, Filming, Printing | - Evaluation tools, Filming, Printing |
| | - Interactive Spectral Imaging (ISI) | |
| | - Basic visualization tools: Endo
View | |
| | - Basic manipulation tools: DE ROI,
ROI HU, Average | |
| Post-
Processing
interface | • Recon&GO Inline Results
Software interface to post-
processing algorithms which are
unmodified when loaded onto the
CT scanners and 510(k) cleared as
medical devices in their own right. | • Recon&GO Inline Results
Software interface to post-
processing algorithms which are
unmodified when loaded onto the
CT scanners and 510(k) cleared as
medical devices in their own right. |
| | • software interfaces for post-
processing functionalities to
provide advanced visualization
tools to prepare and process
medical images for diagnostic
purpose. | • software interfaces for post-
processing functionalities to
provide advanced visualization
tools to prepare and process
medical images for diagnostic
purpose. |
| | Note: The clearance of standalone
Advanced Visualization Application
software is mandatory precondition. | Note: The clearance of standalone
Advanced Visualization Application
software is mandatory precondition. |
| | These advanced visualization tools
are designed to support the
technician & physician in the
qualitative and quantitative
measurement & analysis of clinical
data acquired and reconstructed by | These advanced visualization tools
are designed to support the
technician & physician in the
qualitative and quantitative
measurement & analysis of clinical
data acquired and reconstructed by |
| Software property | Subject device | Primary predicate device |
| | SOMATOM go.Now | SOMATOM go.Now |
| | SOMATOM go.Up | SOMATOM go.Up |
| | SOMATOM go.All | SOMATOM go.All |
| | SOMATOM go.Top | SOMATOM go.Top |
| | SOMATOM go.Sim | SOMATOM go.Sim |
| | SOMATOM go.Open Pro | SOMATOM go.Open Pro |
| | SOMATOM X.cite | SOMATOM X.cite |
| | SOMATOM X.ceed | SOMATOM X.ceed |
| | with SOMARIS/10 syngo CT VB10 | with SOMARIS/10 syngo CT VA40
(K211373) |
| | Computed Tomography scanners.
Additional information regarding
the points of interface and inputs
for this feature is provided in
Section 16. | Computed Tomography scanners.
Additional information regarding
the points of interface and inputs
for this feature is provided in
Section 16. |
| Cybersecurity | IT Hardening | IT Hardening |
| HD FoV | HD FoV 4.0 | HD FoV 4.0 |
| Standard
technologies | • FAST technologies
• CARE technologies
• GO technologies | • FAST technologies
• CARE technologies
• GO technologies |
| Iterative
Reconstruction
Methods | ADMIRE*
SAFIRE
iMAR | ADMIRE*
SAFIRE
iMAR |
| | *supported in SOMATOM go.All,
SOMATOM go.Top, SOMATOM
go.Sim, SOMATOM go.Open Pro,
SOMATOM X.cite and SOMATOM
X.ceed | *supported in SOMATOM
go.All,SOMATOM go.Top,
SOMATOM X.cite and SOMATOM
X.ceed |
| Matrix sizes | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels (Precision
Matrix) | 256 x 256 pixels
512 x 512 pixels
768 x 768 pixels
1024 x 1024 pixels (Precision
Matrix) |
| DirectDensity™ | DirectDensity™ | DirectDensity™ |
| Software property | Subject device | Primary predicate device |
| | SOMATOM go.Now | SOMATOM go.Now |
| | SOMATOM go.Up | SOMATOM go.Up |
| | SOMATOM go.All | SOMATOM go.All |
| | SOMATOM go.Top | SOMATOM go.Top |
| | SOMATOM go.Sim | SOMATOM go.Sim |
| | SOMATOM go.Open Pro | SOMATOM go.Open Pro |
| | SOMATOM X.cite | SOMATOM X.cite |
| | SOMATOM X.ceed | SOMATOM X.ceed |
| | with SOMARIS/10 syngo CT VB10 | with SOMARIS/10 syngo CT VA40
(K211373) |
| | (including relative electron density
and relative mass density) | (including relative electron density
and relative mass density) |
| Breath-hold
technique | Respiratory Motion Management
support breath hold triggered spiral
scans with manual breath hold
triggered examinations. | Respiratory Motion Management
support breath hold triggered spiral
scans with manual breath hold
triggered examinations. |
| | Direct Breathold: externally
triggered workflow to start a spiral
scan by receiving a trigger signal
from an external gating device. | |
| | *Note: Direct Breathold is not
available for SOMATOM go.Now | |

27

Image /page/27/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 series of orange dots that are arranged in a curved line.

28

Image /page/28/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 graphic of orange dots that are arranged in a pattern.

29

Image /page/29/Picture/0 description: The image contains 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.

30

Image /page/30/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.

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject devices, the SOMATOM go. Platform and SOMATOM X. Platform with syngo CT VB10, are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VIII. Performance Data

Non-Clinical Testing

Non-clinical testing, (integration and functional) including phantom tests were conducted for the SOMATOM go. Platform and SOMATOM X. Platform during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.

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

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

31

Image /page/31/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 of varying sizes.

performed to specific modifications on different test levels to ensure safe and effective integration in the system. Three test levels are defined:

System Validation test:

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

System Verification test:

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

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

Additional evaluation tests are performed as bench tests to support the new device or device modification on Non-Clinical Performance Testing as listed in Table 10 below.

Table 10: Non-clinical performance testing (bench testing).
-------------------------------------------------------------	--	--	--	--

| Feature/Non-clinical

supportive testing	Bench Testing performed
FAST 3D Camera /
FAST Integrated
Workflow	The bench test evaluates and compares the accuracy of the three sub-
features FAST Isocentering, FAST Range, and FAST Direction to the
accuracy of the predicate device with syngo CT VA40 using the old
camera hardware and the then only available ceiling mount.
	The objectives of the bench test are to demonstrate that the FAST 3D
Camera feature of the subject device with SOMARIS/10 syngo CT VB10,
where the algorithms have been optimized for a new camera hardware
in two mounting positions, achieves comparable results as the predicate
device with syngo CT VA40.
	The FAST Isocentering accuracy of the subject device with syngo CT VB10
is comparable to the predicate device with syngo CT VA40, regardless of
the camera mounting position.
	For the FAST Range feature, the detection accuracy of all body region
boundaries is comparable between the subject device with syngo CT
VB10 and predicate device with syngo CT VA40. In the gantry mounting
position, the legs are often occluded by the torso when the patient is
lying head-first on the table. This is not a severe limitation, as leg
examinations are usually performed feet-first.
	The FAST Direction pose detection results are of comparable accuracy for
subject and predicate device, regardless of the camera mounting
position.
	Overall, the SOMARIS/10 syngo CT VB10 delivers comparable accuracy to
the SOMARIS/10 syngo CT VA40 predicate for the new FAST 3D Camera
hardware, also in the new gantry position.
Feature/Non-clinical
supportive testing	Bench Testing performed
Multi-Purpose Table	A CT system with extended distance between CT gantry and patient table
base plus a mobile C-arm system were combined to evaluate the
technical feasibility and possible limitations of this combination.
The range of possible movement for the mobile C-arm in different
positions between CT gantry and patient table was tested and
documented by measurement of angles.
Based on the test results it can be concluded that a CT scanner, equipped
with a Multi-Purpose (Vitus) Patient Table, which is installed with
enhanced distance (674 mm) to the CT gantry and offers the iCT mode
functionality, provides sufficient freedom of movement for a mobile C-
arm X-ray system to be used for clinical routine without any significant
limitations for the myNeedle Lasers or FAST 3D Camera.
Direct Breathhold	The test results showed that using the Direct Breathhold functionality, a
spiral scan can automatically be triggered from an external respiratory
gating device. The actual scan remains unchanged, and the object is
correctly depicted in the resulting image.
ZeeFree	The bench tests evaluate the performance of ZeeFree reconstruction.
The objectives of the tests are to demonstrate:
that the number of artefacts which can be attributed to a stack
misalignment (e.g. discontinuities in vessel structures,
anatomical steps at air-soft-tissue interfaces, doubling of vessel
or other anatomy) and which are often caused by incomplete
patient breath-hold can be reduced in a "Cardiac Stack Artefact
Correction" (SAC) reconstruction compared to the standard
reconstruction with otherwise matching reconstruction
parameters. that no artefacts are introduced by a SAC reconstruction. The test results show: If misalignment artefacts are identified in non-corrected
standard ECG-gated reconstructed sequence or spiral images,
the feature "Cardiac Stack Artefact Correction" (SAC, marketing
name: ZeeFree) enables optional stack artefact corrected
images, which reduce the number of alignment artefacts. The SAC reconstruction does not introduce new artefacts, which
were previously not present in the non-corrected standard
reconstruction. The SAC reconstruction does realize equivalent image quality in
quantitative standard physics phantom-based measurements
(ACR, Gammex phantom) in terms of noise, homogeneity, high-
contrast resolution, slice thickness and CNR compared to a non-
corrected standard reconstruction
Feature/Non-clinical
supportive testing	Bench Testing performed
	The SAC reconstruction does realize equivalent image quality in quantitative and qualitative phantom-based measurements with respect to metal objects compared to a non-corrected standard reconstruction. The SAC algorithm can be successfully applied to phantom data if derived from a suitable motion phantom demonstrating its correct technical function on the tested device. The SAC algorithm is independent from the physical detector width of the acquired data
myNeedle Guide
(with myNeedle
Detection)	Tests were performed to ensure clinical usability of the myNeedle Guide needle detection algorithm. Two individual tests were performed. The accuracy of the automatic needle detection algorithm was tested. The reduction of necessary user interactions for navigating to a needle-oriented view with and without the support of the automatic needle detection algorithm was analyzed.

It has been shown that the algorithm was able to consistently detect needle-tips over a wide variety of scans in 90.76% of cases.

Further, the results of this bench test clearly show that the auto needle detection functionality reduces the number of interactions steps needed to generate a needle-aligned view in the CT Intervention SW.

With successful Al-based needle tip detection, no user interaction is needed to achieve needle-aligned view during needle progression. Additional manual adjustment (fine tuning) of the needle-aligned view is always possible. |

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A list of recognized and general consensus standards considered for the subject devices is provided as Table 11 and Table 12 below.

Table 11: Recognized Consensus Standards.

| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
|------------------|-----------------------|----------------------------------------|-----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 12/19/2022 | 12-349 | NEMA | PS 3.1 - 3.20 2022d | Digital Imaging and
Communications in Medicine
(DICOM) Set |
| 07/06/2020 | 12-325 | NEMA | XR 25-2019 | Computed Tomography Dose
Check |
| 07/06/2020 | 12-330 | NEMA | XR 28-2018 | Supplemental Requirements
for User Information and
System Function Related to
Dose in CT |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| 12/23/2019 | 12-328 | IEC | 61223-3-5 Edition
2.0 2019-09 | Evaluation and routine testing
in medical imaging
departments - Part 3-5:
Acceptance tests and
constancy tests - Imaging
performance of computed
tomography X-ray equipment
[Including: Technical
Corrigendum 1 (2006)] |
| 03/14/2011 | 12-226 | IEC | 61223-2-6 Second
Edition 2006-11 | Evaluation and routine testing
in medical imaging
departments - Part 2-6:
Constancy tests - Imaging
performance of computed
tomography X-ray equipment |
| 01/14/2014 | 12-269 | IEC | 60601-1-3 Edition
2.1 2013-04 | Medical electrical equipment

Part 1-3: General
requirements for basic safety
and essential performance -
Collateral Standard: Radiation
protection in diagnostic X-ray
equipment |
| 06/27/2016 | 12-302 | IEC | 60601-2-44 Edition
3.2: 2016 | Medical electrical equipment
Part 2-44: Particular
requirements for the basic
safety and essential
performance of x-ray
equipment for computed
tomography |
| 12/23/2019 | 5-125 | ANSI AAMI
ISO | 14971: 2019 | Medical devices - Applications
of risk management to
medical devices |
| | | ISO | 14971 Third Edition
2019-12 | Medical devices - Application
of risk management to
medical devices |
| 01/14/2019 | 13-79 | ANSI AAMI
IEC | 62304:2006/A1:2016 | Medical device software -
Software life cycle processes
[Including Amendment 1
(2016)] |
| | | IEC | 62304 Edition 1.1
2015-06 | Medical device software -
Software life cycle processes |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| | | | CONSOLIDATED
VERSION | |
| 07/09/2014 | 19-46 | ANSI AAMI | ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012
(Cons. Text) [Incl.
AMD2:2021] | Medical electrical equipment
Part 1: General
requirements for basic safety
and essential performance
(IEC 60601-1:2005, MOD)
[Including Amendment 2
(2021)] |
| 09/17/2018 | 19-36 | ANSI AAMI
IEC | 60601-1-2:2014
[Including AMD
1:2021] | Medical electrical equipment
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances
Requirements and tests |
| | | IEC | 60601-1-2 Edition
4.1 2020-09
CONSOLIDATED
VERSION | Medical electrical equipment
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances
Requirements and tests |
| 12/23/2016 | 5-129 | ANSI AAMI
IEC | 62366-
1:2015+AMD1:2020
(Consolidated Text) | Medical devices Part 1:
Application of usability
engineering to medical
devices, including
Amendment 1 |
| | | IEC | 62366-1 Edition 1.1
2020-06
CONSOLIDATED
VERSION | Medical devices - Part 1:
Application of usability
engineering to medical
devices |
| 07/09/2014 | 12-273 | IEC | 60825-1 Edition 2.0
2007-03 | Safety of laser products - Part
1: Equipment classification,
and requirements |
| 12/21/2020 | 5-132 | IEC | 60601-1-6 Edition
3.2 2020-07
CONSOLIDATED
VERSION | Medical electrical equipment
Part 1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability |
| 12/23/2019 | 12-309 | IEC | 60601-2-28 Edition
2.0 2017-06 | Medical electrical equipment
Part 2-28: Particular |
| Date of
Entry | Recognition
Number | Standard
Developing
Organization | Standard
Designation Number
and Date | Title of Standard |
| | | | | requirements for the basic
safety and essential
performance of X-ray tube
assemblies for medical
diagnosis |
| 12/20/2021 | 12-341 | IEC | 62563-1 Edition 1.2
2021-07
CONSOLIDATED
VERSION | Medical electrical equipment
Medical image display
systems - Part 1: Evaluation
methods |

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Image /page/34/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 pattern of orange dots.

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Image /page/35/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" are several orange dots of varying sizes.

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Image /page/36/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.

Table 12: General Use Consensus Standards.

| Standard
Developing
Organization | Standard Designation
Number and Date | Title of Standard | How was Standard Used |
|----------------------------------------|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| IEC | 60601-
1:2005+A1:2012+A2:2020 | Medical electrical
equipment - part 1:
general requirements
for basic safety and
essential performance | ANSI AAMI ES60601-
1:2005/(R)2012 &
A1:2012,
C1:2009/(R)2012 &
A2:2010/(R)2012 (Cons.
Text) [Incl. AMD2:2021] |
| IEC/ISO | 17050-1 | Conformity Assessment
– Supplier's declaration
of conformity – Part 1:
General requirements | Declaration of
conformance to FDA
recognized consensus
standards. |
| IEC/ISO | 17050-2 | Conformity assessment
– Supplier's declaration
of conformity – Part 2:
Supporting
documentation. | General consensus
standards not currently
recognized by FDA. |

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A list of applicable guidance documents considered for this submission is provided as Table 13 below.

Table 13: FDA Guidance Document and Effective Date

FDA Guidance Document	Issue date
User Fees and Refunds for Premarket Notification Submissions (510(k)s)	10/05/2022
Refuse to Accept Policy for 510(k)s	04/21/2022
Electronic Submission Template for Medical Device 510(k) Submissions	10/2/2023
Deciding When to Submit a 510(k) for a Change to an Existing Device	10/25/2017
Deciding When to Submit a 510(k) for a Software Change to an Existing
Device	10/25/2017
The 510(k) Program: Evaluating Substantial Equivalence in Premarket
Notifications [510(k)]	07/28/2014
Content of Premarket Submissions for Software Contained in Medical
Devices	06/14/2023
Off-The-Shelf Software Use in Medical Devices	08/11/2023
Applying Human Factors and Usability Engineering to Medical Devices	02/03/2016
Pediatric Information for X-ray Imaging Device Premarket Notifications	11/28/2017
Cybersecurity in Medical Devices: Quality System Considerations and
Content of Premarket Submissions	09/27/2023
Electromagnetic Compatibility (EMC) of Medical Devices	06/06/2022
Design Considerations and Pre-market Submission Recommendations for
Interoperable Medical Devices	09/06/2017
Appropriate Use of Voluntary Consensus Standards in Premarket
Submissions for Medical Devices	09/14/2018

Verification and Validation

Software documentation at an Enhanced Documentation level per FDA's Guidance Document "Content of Premarket Submissions for Software Contained in Medical Devices" issued on June 14, 2023 is included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. The Risk Analysis was completed, and risk control implemented to mitigate identified hazards. The testing supports that all software specifications have met the acceptance criteria. Testing for verification and validation support the claims of substantial equivalence.

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Cybersecurity

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" issued on September 27, 2023 is included within this submission.

Wireless Coexistence Testing

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

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

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

Testing for co-existence considered for following scenarios:

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

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

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Summary

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

General Safety and Effectiveness Concerns

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

IX. Conclusions

The predicate/secondary devices were cleared based on the results of non-clinical and clinical testing including verification and validation, phantom tests, validation on clinical images, and supportive literature. The non-clinical and clinical data supports the safety of the device and the hardware and software verification and validation demonstrates that the subject devices SOMATOM go. Platform and SOMATOM X. Platform perform as intended in the specified use conditions. The data included in this submission demonstrates that the SOMATOM go. Platform and SOMATOM X. Platform with described modifications perform comparably to the predicate devices currently marketed for the same intended use. Siemens believes that the data generated from the SOMATOM go. Platform and SOMATOM X. Platform testing supports a finding of substantial equivalence.