The Siemens PET/CT systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

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

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

Device Description

Biograph Trinion PET/CT systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. This system is designed for whole body oncology, neurology and cardiology examinations. Biograph Trinion PET/CT systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph Trinion VK20 software is a command-based program used for patient management, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

Biograph PET/CT systems, which are the subject of this application, are substantially equivalent to the commercially available Biograph Trinion VK10 family of PET/CT systems (K233677). Differences compared to the commercially available Biograph Trinion systems include:

The commercially available SOMATOM go.All and go.Top systems with VB10 (K233650) software have been incorporated into the Biograph Trinion VK20 systems, including commercially available CT features.
Additional PET axial field of view (FoV) systems allowing for more scalability.
Additional patient communication and comfort features.
PET respiratory gating with an external gating device has been implemented.

The Biograph Trinion models may also use the names Biograph Mission, Biograph Wonder, Biograph Ambition and Biograph Devotion for marketing purposes.

AI/ML Overview

The provided FDA 510(k) clearance letter for the Biograph Trinion PET/CT system primarily focuses on demonstrating substantial equivalence to a predicate device and adherence to recognized performance standards. It indicates that "all performance testing met the predetermined acceptance values," but does not provide specific numerical acceptance criteria or reported device performance for an AI/algorithm component, nor does it detail a study proving the device meets AI-specific acceptance criteria. The context suggests the "performance testing" refers to general PET/CT system performance, not AI-driven diagnostic assistance.

Therefore, many of the requested details, particularly those related to a standalone AI algorithm's performance, human-in-the-loop studies, dataset characteristics (sample size, provenance), and ground truth establishment methods for an AI component, are not available in the provided text.

Based on the information available in the document, here's what can be extracted and inferred, with explicit notes where information is missing or not applicable in the context of an AI study.

Acceptance Criteria and Reported Device Performance

The document states that "all performance testing met the predetermined acceptance values." However, it does not specify what those acceptance values were or the precise reported performance metrics beyond this general statement. The tests conducted were primarily related to the physical performance of the PET/CT system as per NEMA NU 2:2024 and NEMA XR 25:2019 standards, not specifically an AI component for diagnostic aid.

Table of Acceptance Criteria and Reported Device Performance (Based on available information for the PET/CT system):

Performance Metric (PET/CT system)	Acceptance Criteria (Stated as "predetermined acceptance values")	Reported Device Performance
Spatial Resolution	Met acceptance values	Met acceptance values
Scatter Fraction, Count Losses, and Randoms	Met acceptance values	Met acceptance values
Sensitivity	Met acceptance values	Met acceptance values
Accuracy: Corrections for Count Losses and Randoms	Met acceptance values	Met acceptance values
Image Quality, Accuracy of Corrections	Met acceptance values	Met acceptance values
Time-of-Flight Resolution	Met acceptance values	Met acceptance values
PET-CT Coregistration Accuracy	Met acceptance values	Met acceptance values
No AI-specific performance metrics detailed	Not specified in document	Not specified in document

Study Details (Focusing on AI-related aspects where applicable, and general system testing otherwise)

Sample size used for the test set and the data provenance:
- For System Performance (NEMA tests): The document does not specify a "test set" in terms of patient data. NEMA tests typically involve phantom studies rather than patient data. Thus, sample size and data provenance are not applicable in the traditional sense for these tests.
- For AI Component: The document does not provide any information on a test set (patient cases, images) or data provenance (e.g., country of origin, retrospective/prospective) for validating an AI component for diagnostic assistance. The descriptions are entirely about the physical PET/CT system.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For System Performance: Ground truth for NEMA tests is established by physical measurements and calibration standards, not human experts.
- For AI Component: This information is not provided in the document as there's no mention of an AI-driven diagnostic aid requiring expert-established ground truth.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- For System Performance: Not applicable.
- For AI Component: This information is not provided in the document.
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- The document does not indicate that an MRMC study was performed for an AI component. The focus is on the substantial equivalence of the PET/CT hardware and software to a predicate device, and compliance with performance standards for the imaging system itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The document does not detail any standalone algorithm performance testing. The performance testing described is for the integrated PET/CT system's physical and functional characteristics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For System Performance: Ground truth for NEMA tests involves physical phantoms and established measurement protocols.
- For AI Component: This information is not provided in the document.
The sample size for the training set:
- This information is not provided in the document, as there is no mention of an AI model that undergoes a separate training process requiring a distinct training set.
How the ground truth for the training set was established:
- This information is not provided in the document, as there is no mention of an AI model's training set.

Summary of Device and Performance Information from Document:

The provided 510(k) clearance letter for the Biograph Trinion is for a PET/CT imaging system, not an AI-based diagnostic software. The "performance testing" described in the document pertains to the physical and functional aspects of the PET/CT scanner (e.g., spatial resolution, sensitivity, image quality) as measured against industry standards (NEMA NU 2:2024). The clearance is based on proving substantial equivalence to a predicate device and adherence to these well-established performance standards for imaging hardware.

Therefore, the detailed questions regarding AI acceptance criteria, AI test set characteristics, human-in-the-loop studies, and AI ground truth establishment are not addressed in this document because the device being cleared is the imaging system itself, not an AI software component for image analysis or diagnostic support. The document implies that the system can be used for certain clinical applications (like lung cancer screening), but it doesn't describe an automated AI system within the device that requires separate clinical validation with reader studies or large patient datasets.

Summary

FDA 510(k) Clearance Letter - Biograph Trinion

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 31, 2025

Siemens Medical Solutions USA, Inc.
Alaine Medio
Manager, Regulatory Affairs
Siemens Medical Solutions USA, Inc.
810 Innovation Drive, Knoxville, TN 37322 USA

Re: K251561
Trade/Device Name: Biograph Trinion
Regulation Number: 21 CFR 892.1200
Regulation Name: Emission computed tomography system
Regulatory Class: Class II
Product Code: KPS, JAK
Dated: July 2, 2025
Received: July 2, 2025

Dear Alaine Medio:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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K251561 - Alaine Medio
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K251561 - Alaine Medio
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Daniel M. Krainak, Ph.D.
Assistant Director
DHT8C: Division of Radiological
Imaging and Radiation Therapy Devices
OHT8: Office of Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

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

510(k) Number (if known): K251561

Device Name: Biograph Trinion

Indications for Use (Describe)

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging.

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

Type of Use (Select one or both, as applicable)

☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

510(k) Summary
as required by 21 CFR Part 807.87(h)

Identification of the Submitter

Submitter: Alaine Medio
Regulatory Affairs Manager
Siemens Medical Solutions USA, Inc.
Molecular Imaging
810 Innovation Drive
Knoxville, TN 37932

Alternative Contact: Tabitha Estes
Regulatory Affairs

Manufacturer: Siemens Medical Solutions USA, Inc.
Molecular Imaging
2501 North Barrington Road
Hoffman Estates, IL 60192

Telephone Number: (865)206-0337
Fax Number: (865)218-3019
Date of Submission: July 30, 2025

Identification of the product

Device Proprietary Name: Biograph Trinion

Common Name: Positron Emission Tomography (PET) System
Computed Tomography (CT) System

Classification Name: Emission Computed Tomography System per 21 CFR 892.1200
Computed Tomography X-Ray System per 21 CFR 892.1750

Product Code: KPS and JAK

Classification Panel: Radiology

Device Class: Class II

K251561

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Marketed Devices to which Equivalence is claimed

Primary Predicate Device:

Device Proprietary Name: Biograph Trinion PET/CT system

Manufacturer: Siemens Medical Solutions USA, Inc.

Product Code: KPS and JAK

Device Class: Class II

510(k) Number: K233677

Reference Predicate Devices:

Device	SOMATOM go.All and go.Top	Biograph Vision.X	MI View &Go
Manufacturer:	Siemens Medical Solutions USA, Inc.
Product Code:	JAK	KPS	QIH
Device Class:	Class II
510(k) Number:	K233650	K231833	K242300

Device Description:

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The commercially available SOMATOM go.All and go.Top systems with VB10 (K233650) software have been incorporated into the Biograph Trinion VK20 systems, including commercially available CT features.
Additional PET axial field of view (FoV) systems allowing for more scalability.
Additional patient communication and comfort features.
PET respiratory gating with an external gating device has been implemented.

The Biograph Trinion models may also use the names Biograph Mission, Biograph Wonder, Biograph Ambition and Biograph Devotion for marketing purposes.

Indications for Use:

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and/or PET diagnostic imaging.

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

There is no change to the Intended Use / Indications for use as compared to the commercially available Biograph Tinion PET/CT Scanners.

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Performance Testing / Safety and Effectiveness:

Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing.

PET Testing in accordance with NEMA NU 2: 2024 was conducted on the system and all performance testing met the predetermined acceptance values. The following NEMA performance tests were conducted:

Spatial Resolution
Scatter Fraction, Count Losses, and Randoms
Sensitivity
Accuracy: Corrections for Count Losses and Randoms
Image Quality, Accuracy of Corrections
Time-of-Flight Resolution
PET-CT Coregistration Accuracy

This testing performed the same as or better than the commercially available Biograph Trinion VK10 family of PET/CT systems (K233677).

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk Management is ensured via a risk analysis in compliance with ISO 14971 to identify and provide mitigation to potential hazards beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions, USA Inc. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.

Siemens Medical Solutions USA, Inc claims compliance with the following product standards for the Biograph Trinion VK20 PET/CT Systems:

IEC 60601-1: 2005+ A1:2012 +A2:2020-- [Rec #19-49]
IEC 60601-1-2: 2020 – [Rec #19-36]
IEC 60601-1-3: 2008 + A1:2013 – [Rec # 12-336]
IEC 60601-1-6:2010 +A1:2013 + A2:2020 – [Rec # 5-132]
IEC 60601-2-28:2017 – [Rec # 12-309]
IEC 60601-2-44: 2016 – [Rec # 12-302]
IEC 60825-1: 2007 – [Rec # 12-273]
IEC 62366-1: 2015 +A1:2020 – [Rec # 5-129]
ISO 10993-1: 2018 – [Rec # 2-258]
IEC 61223-3-5:2019 – [Rec # 12-328]

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NEMA NU 2: 2018 – [Rec # 12-326]
NEMA NU 2:2024
NEMA XR 25: 2019 – [Rec #12-325]
NEMA PS3.1-3.20 2023e – [Rec # 12-352]

Additionally, the Biograph systems have been developed in accordance with the requirements of the following standards:

IEC 62304:2015 – [Rec # 13-79]
ISO 14971:2019 – [Rec # 5-125]
ISO 13485:2015

Cybersecurity information in accordance with FDA Guidance documents has been provided. The Biograph software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph systems and external devices.

Verification and validation of Siemens Medical Solutions USA, Inc. systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

Statement regarding Substantial Equivalence:

There have been no changes implemented in the Biograph system that impacts either the fundamental technology or the indications for use as compared to the predicate. The Biograph PET/CT systems outlined in this Premarket Notification are substantially equivalent to the currently commercially available predicate devices.

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.