The Spectral CT system is a Computed Tomography X-ray system intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment support, component parts, and accessories.

The Spectral CT system acquires one CT dataset – composed of data from a higher-energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and to provide information about the chemical composition of the body materials and/or contrast agents.

Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This information may be used by a trained healthcare professional as a diagnostic tool for the visualization and analysis of anatomical and pathological structures in patients of all ages, and to be used for diagnostic imaging in radiology, interventional radiology, and cardiology and in oncology as part of treatment preparation and radiation therapy planning. The Extended field of view images and respiratory correlated scanning (4DCT) are for treatment preparation and radiation therapy planning/simulation usage only.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

The system is also intended to be used for low dose CT lung cancer screening for the early detection of lung nodules that may represent cancer*. The screening must be performed within the established inclusion criteria of programs / protocols that have been approved and published by either a governmental body or professional medical society.

*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

Spectral CT system is a whole-body computed tomography (CT) X-ray system featuring a continuously rotating X-ray tube and detectors gantry, and multi slice capability. The acquired X-ray transmission data is reconstructed by computer into cross-sectional images of the body taken at different angles and planes. This system also includes signals analysis and display equipment, patient and equipment support, components, and accessories.

The Spectral CT system acquires one CT dataset – composed of data from a higher energy detected X-ray spectrum and a lower- energy detected X-ray spectrum. The two spectra may be used to analyze the differences in the energy dependence of the attenuation coefficient of different materials. This allows for the generation of images at energies selected from the available spectrum and provides information about the chemical composition of the body materials and/or contrast agents. Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

The Spectral CT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system.

The fundamental design and characteristics of the main components used in the proposed Spectral CT system are identical to the currently marketed primary predicate device, Spectral CT system (K203020).

AI/ML Overview

This document is a 510(k) clearance letter for a Spectral CT System, indicating its substantial equivalence to previously cleared predicate devices. While it focuses heavily on design features and compliance with general safety and performance standards for CT systems, it does not contain the detailed clinical study information typically found in submissions for AI/ML-based medical devices that require specific performance metrics and human reader studies.

The provided text only briefly mentions "Clinical Image Evaluation" and "Comparison of performance data against internal performance requirements" as supporting the evaluation of new features. It does not provide specific acceptance criteria or performance results for these "new features" (Pulmonary Gating 4DCT and Extended Field of View (EFOV)) in the context of a clinical study, nor does it detail how substantial equivalence was demonstrated clinically for these features beyond a generic statement.

Therefore, many of the requested items cannot be extracted from this document, as it primarily covers the device's technical specifications and regulatory compliance for a general CT system, rather than specific performance studies for new AI/ML functionalities.

Given the information provided, here's what can be extracted and what cannot:

Acceptance Criteria and Study for Spectral CT System (K244008)

Based on the provided FDA 510(k) clearance letter, the primary method for demonstrating the device meets acceptance criteria and proving its performance is through substantial equivalence to predicate devices and adherence to recognized consensus standards and guidance documents. The document does not detail specific performance metrics, acceptance criteria, or a clinical study for the new features (Pulmonary Gating 4DCT and Extended Field of View (EFOV)) in the format requested for AI/ML device performance.

The document states:

"Non-clinical performance testing has been performed on the proposed Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s)..."
"Design verification planning and testing were conducted at the system level. The system is tested against the System Requirements Specifications (SRS)."
"Design Validation tests the user needs and intended use that are documented in the top-level User Requirement Specification (PRS)."
"All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements."
"Non-clinical design validation testing demonstrates that the proposed Spectral CT system can be used as defined in its clinical workflow and intended use."
"To support the evaluation of the new features, the submission includes: - Phantom-based image quality (IQ) testing, assessing parameters such as noise, resolution, and artifacts - A representative clinical image assessment - Comparison of performance data against internal performance requirements"

This indicates that the "acceptance criteria" are primarily framed around compliance with established engineering and regulatory standards and internal performance requirements verified through non-clinical and limited clinical assessment, rather than a specific clinical trial with defined performance endpoints for the new features.

Information Extracted from the Document:

A table of acceptance criteria and the reported device performance:

The document does not provide a table of specific quantitative acceptance criteria and corresponding reported device performance metrics from a clinical study for the new features (Pulmonary Gating 4DCT and Extended Field of View (EFOV)). Instead, it states that "All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements." without detailing these.
The primary "performance" discussed is the technological equivalence to predicate devices. Below is a summary of the technological characteristics being presented as "met" by being identical or substantially equivalent to the predicate.

Table: Technological Characteristics (Implicit Acceptance Criteria - Equivalence to Predicate)

Design Feature	Acceptance Criteria (Equivalent to K203020/K240844)	Reported Performance (Proposed Device)
Design and Fundamental Scientific Technology
Application	Head, Body and Cardiac	Head, Body and Cardiac
Scan regime	Continuous Rotation	Continuous Rotation
Scan Field of View (SFOV)	Up to 500 mm (Identical to K203020)	Up to 500 mm
Extended Field of View (EFOV)	Up to 800 mm (Identical to K240844)	Up to 800 mm (for non-gated Helical scans, RT planning)
No. of slices	Up to 128 slices of 0.625 mm	Up to 128 slices of 0.625 mm
Scan modes	Surview, Axial-after-Axial Dynamic Scan, Helical Scan	Surview, Axial-after-Axial Dynamic Scan, Helical Scan
Spatial Resolution	16 lp/cm max (high mode), 13 lp/cm max (standard mode)	16 lp/cm max (high mode), 13 lp/cm max (standard mode)
Minimum Scan time	0.18 sec for 240° rotation, 0.27 sec for 360° rotation	0.18 sec for 240° rotation, 0.27 sec for 360° rotation
Scan coverage	Scanner Center of Rotation (COR) is up to 80 mm	Scanner Center of Rotation (COR) is up to 80 mm
Low contrast resolution (32cm body CTDI phantom)	4 mm @ 0.3% @ 25 mGy CTDIvol	4 mm @ 0.3% @ 25 mGy CTDIvol
Noise in (as standard mode measured on 21.6 cm water-equivalent)	0.27% at 27 mGy	0.27% at 27 mGy
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024
Display	1024 x 1280	1024 x 1280
Communication	Compliance with DICOM 3.0	Compliance with DICOM 3.0
Detectors
Type	Nano Panel Prism	Nano Panel Prism
Material	Solid-state yttrium-based scintillator, GOS + Photodiode	Solid-state yttrium-based scintillator, GOS + Photodiode
DMS Detector Spectral CT 7500	8 cm - Dual-Layer scintillator, up to 128 detector rows	8 cm - Dual-Layer scintillator, up to 128 detector rows
DMS structure	Spherical DMS structure	Spherical DMS structure
Collimation	0.625 mm and various combinations	0.625 mm and various combinations
Gantry
Gantry rotation speed	0.27 sec -1.5 sec (360° rotation), 0.18 sec, 0.2 sec (240° rotation)	0.27 sec -1.5 sec (360° rotation), 0.18 sec, 0.2 sec (240° rotation)
Bore size	800 mm	800 mm
Operator Controls located on Gantry	Touch Panel Controls	Touch Panel Controls
Eclipse Collimation	A-Plane	A-Plane
Generator and Tube Performance
Power	120kW	120kW
kV Setting	80, 100, 120, 140	80, 100, 120, 140
mA Range	10-1000	10-1000
Couch
Couch	Noah Couch	Noah Couch
Couch Vertical Range	Minimum Height – 430 mm	Minimum Height – 430 mm
Couch Horizontal Range	-2143 mm	-2143 mm
Scannable Surview Range	1940mm	1940mm
Scannable axial Range	2000mm	2000mm
Scannable helical Range	1900mm	1900mm
Couch Speed Range	1 mm/sec – 600 mm/sec	1 mm/sec – 600 mm/sec
Acceleration	800 mm/Sec^2	800 mm/Sec^2
Couch Max Load Capacity	High Performance: 675 lbs. (307 kg), RTP Tabletop: 628 lbs. (285 kg)	High Performance: 675 lbs. (307 kg), RTP Tabletop: 628 lbs. (285 kg)
Couch accessories	Infant Cradle, Paper roller, Varian Camera Adaptor, Oncology flat tabletop	Infant Cradle, Paper roller, Varian Camera Adaptor, Oncology flat tabletop
Clinical Applications: Dose Tools
Cardiac reconstruction method	Standard ECG Gated Reconstruction, Motion Compensated Reconstruction (optional)	Standard ECG Gated Reconstruction, Motion Compensated Reconstruction (optional)
Virtual Tilt Viewer (VTV) (optional)	Yes	Yes
Pulmo & 4DCT	Feature introduced, deemed substantially equivalent to K240844	Pulmonary gated scanning for RT planning procedures
General
Technical Basis for Collection of two CT Spectral	Dual Layer DMS (Spectral Detector)	Dual Layer DMS (Spectral Detector)
Spectral Base Images	Low energy, High-energy, Photoelectric, Compton Scatter	Low energy, High-energy, Photoelectric, Compton Scatter
Spectral results available [kVp]	100kVp, 120kVp, 140kVp	100kVp, 120kVp, 140kVp
Spectral Results Images	Monoenergetic, Materials Basis/Density Pairs, Electron Density, etc.	Monoenergetic, Materials Basis/Density Pairs, Electron Density, etc.
Host Drives	256GB OS disk Plus one 7.68TB PCIE NVMe SSD	256GB OS disk Plus one 7.68TB PCIE NVMe SSD
Host Infrastructure	Windows 10	Windows 10
CIRS Computers	CIRS Rack with two HP Z8 servers (option for two additional)	CIRS Rack with two HP Z8 servers (option for two additional)
CIRS CPUs	Dual Intel Gold 6230 with 20 cores at 2.1GHz each	Dual Intel Gold 6230 with 20 cores at 2.1GHz each
CIRS Drives	512GB NVMe SSD for OS/software, Two 2TB NVMe SSDs for raw data	512GB NVMe SSD for OS/software, Two 2TB NVMe SSDs for raw data
Interventional Controls	Yes	Yes

Sample sizes used for the test set and the data provenance:

Not explicitly stated in the provided text. The document refers to "Phantom-based image quality (IQ) testing" and "A representative clinical image assessment" but does not give sample sizes or provenance (country/retrospective/prospective) for these.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not explicitly stated. The document refers to "A representative clinical image assessment" but does not detail how ground truth was established or the experts involved.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not explicitly stated.
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:

Not explicitly stated. This type of study is typically done for AI/ML diagnostic tools where human interpretation of medical images is directly affected by the AI output. This 510(k) is for a CT system itself, with new acquisition and reconstruction features (4DCT, EFOV) that are likely intended to provide better images for human interpretation, rather than an AI reading a dataset. The document's statements about "clinical image evaluation" do not elaborate on how this was conducted or whether it involved comparative effectiveness with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is more applicable to diagnostic algorithms. For a CT system with new acquisition/reconstruction capabilities, the "standalone" performance would typically refer to the "Phantom-based image quality (IQ) testing," where the system's output (images) are assessed against objective physical metrics (noise, resolution, artifacts) without human interpretation of clinical findings. The document states this was done: "Phantom-based image quality (IQ) testing, assessing parameters such as noise, resolution, and artifacts."
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Phantom-based IQ testing," the ground truth would be the known physical properties and measurements of the phantoms.
For the "representative clinical image assessment," the type of ground truth is not specified.
The sample size for the training set:

Not applicable. This 510(k) is for a CT hardware and software system, not an AI/ML diagnostic algorithm that would typically have a "training set" in the machine learning sense. The "new features" (Pulmonary Gating 4DCT and EFOV) are descriptions of how the system acquires and processes data, not separate AI algorithms trained on massive datasets to perform a diagnostic task.
How the ground truth for the training set was established:

Not applicable, as there's no mention of a "training set" in the context of an AI/ML algorithm.

Summary

FDA 510(k) Clearance Letter - Spectral CT System

Page 1

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

Doc ID # 04017.07.05

May 16, 2025

Philips Medical Systems Technologies Ltd.
℅ Carmit Shmuel
Regulatory Affairs Manager and Site Lead
Advanced Technology Center, Building 34, MATAM
HAIFA, 3100202
ISRAEL

Re: K244008
Trade/Device Name: Spectral CT
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system
Regulatory Class: Class II
Product Code: JAK
Dated: February 3, 2025
Received: April 14, 2025

Dear Carmit Shmuel:

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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K244008 - Carmit Shmuel Page 2

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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K244008 - Carmit Shmuel Page 3

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,

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

Enclosure

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FORM FDA 3881 (8/23) Page 1 of 1

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): K244008
Device Name: Spectral CT

Indications for Use (Describe)

Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

*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.

Based on the information provided above, the proposed Spectral CT system is considered substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of Indications for Use.

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:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"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

K244008 510(k) Summary

This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR §807.92.

Date Prepared: February 03, 2025

Manufacturer: Philips Medical Systems Nederland B.V.
Veenpluis 6,
5684 PC BEST
The Netherlands
Establishment Registration Number: 3015777306

Primary Contact Person:
Rachel Shalit
Regulatory Affairs Specialist
Phone: +972-54-9988057
E-Mail: rachel.shalit@philips.com

Secondary Contact Person:
Carmit Shmuel
Regulatory Affairs Manager and Site Lead
Phone: +972-54-2109054
E-Mail: Carmit.Shmuel@philips.com

Device Information

Trade Name: Spectral CT
Common name: Computed Tomography X-ray System
Classification Name: Computed Tomography X-ray System
Classification Regulation: 21CFR 892.1750
Classification Panel: Radiology
Device Class: II
Product Code: JAK

Primary Predicate Device

Trade Name: Spectral CT
Manufacturer: Philips Medical Systems Nederland B.V.
510(k) Clearance: K203020
Classification Name: Computed Tomography X-ray System
Classification Regulation: 21 CFR 892.1750
Classification Panel: Radiology
Device Class: Class II
Product Code: JAK

Secondary Predicate Device

Trade Name: Spectral CT 7500 RT
Manufacturer: Philips Medical Systems Nederland B.V.
510(k) Clearance: K240844
Classification Name: Computed Tomography X-ray System
Classification Regulation: 21 CFR 892.1750
Classification Panel: Radiology
Device Class: Class II
Product Code: JAK

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Device Description

Indications for Use

Additionally, materials analysis provides for the quantification and graphical display of attenuation, material density, and effective atomic number.

This device is indicated for head, whole body, cardiac and vascular X-ray Computed Tomography applications in patients of all ages.

*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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Technological Characteristics

The proposed Spectral CT system consists of three main components – a scanner system that includes a rotating gantry, a movable patient couch, and an operator console for control and image reconstruction; a Spectral Reconstruction System; and a Spectral CT Viewer. On the gantry, the main active components are the X-ray high voltage (HV) power supply, the X-ray tube, and the detection system.

The design/fundamental scientific technology of the proposed Spectral CT system and the currently marketed primary predicate device, Spectral CT system (K203020) and recently cleared secondary predicate device Spectral CT 7500 RT system (K240844) are the same. The design changes (e.g. new software version and additional software features) do not change the fundamental scientific technology of the proposed Spectral CT system.

The following table 1 lists the technological characteristics differences for the proposed Spectral CT system:

Table 01 Modifications made to the proposed device, Spectral CT system as compared to the currently marketed primary predicate device, Spectral CT system (K203020)

Design Feature	Description
Pulmonary Gating 4DCT	Pulmonary gated scanning is a new feature that allows CT scan data to be collected along with the patient's breathing signal in order to allow the CT data to be reconstructed into specific phases of breathing. This allows patient anatomy to be visualized during a breathing cycle usually to allow for breathing motion of both the target as well as organs at risk to be compensated for during radiation therapy treatment planning.
Extended Field of View (EFOV)	EFOV is a feature that allows for a maximum reconstructed FOV of up to 800mm for non-gated Helical scans only.

Design Feature

Description

Pulmonary Gating 4DCT

Pulmonary gated scanning is a new feature that allows CT scan data to be collected along with the patient's breathing signal in order to allow the CT data to be reconstructed into specific phases of breathing. This allows patient anatomy to be visualized during a breathing cycle usually to allow for breathing motion of both the target as well as organs at risk to be compensated for during radiation therapy treatment planning.

Extended Field of View (EFOV)

EFOV is a feature that allows for a maximum reconstructed FOV of up to 800mm for non-gated Helical scans only.

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Table 2 – Technological Characteristics Comparison

Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
Design and Fundamental Scientific Technology
Application	Head, Body and Cardiac	Head, Body and Cardiac	Head, Body and Cardiac	Identical, therefore substantially equivalent.
Scan regime	Continuous Rotation	Continuous Rotation	Continuous Rotation	Identical, therefore substantially equivalent.
Scan Field of View	Up to 500 mm	Up to 800 mm	Up to 800 mm	Substantially Equivalent. Both the proposed device and the primary predicate device include a Scannable Field of View (SFOV) of 500mm used for reconstructed images. The improvement of the FOV in the proposed device for up to 800mm (Extended Field of View (EFOV)) is planned for Radiation Therapy Planning procedure and is identical from a technology perspective to the recently cleared secondary predicate device, Spectral CT 7500 RT (K240844). The SFOV was successfully verified and validated and does not raise new questions on safety and/or effectiveness.
No. of slices	Up to 128 slices of 0.625 mm	Up to 128 slices of 0.625 mm	Up to 128 slices of 0.625 mm	Identical, therefore, substantially equivalent
Scan modes	Surview, Axial-after-Axial Dynamic Scan, Helical Scan	Surview, Axial-after-Axial Dynamic Scan, Helical Scan	Surview, Axial-after-Axial Dynamic Scan, Helical Scan	Identical, therefore, substantially equivalent
Spatial Resolution	16 lp/cm max (high mode), 13 lp/cm max (standard mode)	16 lp/cm max (high mode), 13 lp/cm max (standard mode)	16 lp/cm max (high mode), 13 lp/cm max (standard mode)	Identical, therefore, substantially equivalent

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
Minimum Scan time	0.18 sec for 240° rotation, 0.27 sec for 360° rotation	0.18 sec for 240° rotation, 0.27 sec for 360° rotation	0.18 sec for 240° rotation, 0.27 sec for 360° rotation	Identical, therefore, substantially equivalent
Scan coverage	Scanner Center of Rotation (COR) is up to 80 mm	Scanner Center of Rotation (COR) is up to 80 mm	Scanner Center of Rotation (COR) is up to 80 mm	Identical, therefore, substantially equivalent
Low contrast resolution (32cm body CTDI phantom)	4 mm @ 0.3% @ 25 mGy CTDIvol	4 mm @ 0.3% @ 25 mGy CTDIvol	4 mm @ 0.3% @ 25 mGy CTDIvol	Identical, therefore, substantially equivalent
Noise in (as standard mode measured on 21.6 cm water-equivalent)	0.27% at 27 mGy	0.27% at 27 mGy	0.27% at 27 mGy	Identical, therefore, substantially equivalent
Image Matrix	Up to 1024 x 1024	Up to 1024 x 1024	Up to 1024 x 1024	Identical, therefore, substantially equivalent
Display	1024 x 1280	1024 x 1280	1024 x 1280	Identical, therefore, substantially equivalent
Communication	Compliance with DICOM 3.0	Compliance with DICOM 3.0	Compliance with DICOM 3.0	Identical, therefore, substantially equivalent
Detectors
Type	Nano Panel Prism	Nano Panel Prism	Nano Panel Prism	Identical, therefore, substantially equivalent
Material	Solid-state yttrium-based scintillator, GOS + Photodiode	Solid-state yttrium-based scintillator, GOS + Photodiode	Solid-state yttrium-based scintillator, GOS + Photodiode	Identical, therefore, substantially equivalent
DMS Detector Spectral CT 7500	8 cm - Dual-Layer scintillator, up to 128 detector rows	8 cm - Dual-Layer scintillator, up to 128 detector rows	8 cm - Dual-Layer scintillator, up to 128 detector rows	Identical, therefore, substantially equivalent
DMS structure	Spherical DMS structure	Spherical DMS structure	Spherical DMS structure	Identical, therefore, substantially equivalent
Collimation	0.625 mm and various combinations, such as:	0.625 mm and various combinations, such as:	0.625 mm and various combinations, such as:	Identical, therefore, substantially equivalent

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
	2x0.625, 16x0.625, 32x0.625, 64x0.625, 96x0.625, 112x0.625, 128x0.625 mm	2x0.625, 16x0.625, 32x0.625, 64x0.625, 96x0.625, 112x0.625, 128x0.625 mm	2x0.625, 16x0.625, 32x0.625, 64x0.625, 96x0.625, 112x0.625, 128x0.625 mm
Gantry
Gantry rotation speed	0.27 sec -1.5 sec (360° rotation), 0.18 sec, 0.2 sec (240° rotation)	0.27 sec -1.5 sec (360° rotation), 0.18 sec, 0.2 sec (240° rotation)	0.27 sec -1.5 sec (360° rotation), 0.18 sec, 0.2 sec (240° rotation)	Identical, therefore, substantially equivalent
Bore size	800 mm	800 mm	800 mm	Identical, therefore, substantially equivalent
Operator Controls located on Gantry	Touch Panel Controls	Touch Panel Controls	Touch Panel Controls	Identical, therefore, substantially equivalent
Eclipse Collimation	A-Plane	A-Plane	A-Plane	Identical, therefore, substantially equivalent
Generator and Tube Performance
Power	120kW	120kW	120kW	Identical, therefore, substantially equivalent
kV Setting	• 80 • 100 • 120 • 140	• 80 • 100 • 120 • 140	• 80 • 100 • 120 • 140	Identical, therefore, substantially equivalent
mA Range	10-1000	10-1000	10-1000	Identical, therefore, substantially equivalent
Couch
Couch	Noah Couch	Noah Couch	Noah Couch	Identical, therefore, substantially equivalent
Couch Vertical Range	Minimum Height – 430 mm	Minimum Height – 430 mm	Minimum Height – 430 mm	Identical, therefore, substantially equivalent
Couch Horizontal Range	-2143 mm	-2143 mm	-2143 mm	Identical, therefore, substantially equivalent
Scannable Surview Range	1940mm	1940mm	1940mm	Identical, therefore, substantially equivalent

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
Scannable axial Range	2000mm	2000mm	2000mm	Identical, therefore, substantially equivalent
Scannable helical Range	1900mm	1900mm	1900mm	Identical, therefore, substantially equivalent
Couch Speed Range	1 mm/sec – 600 mm/sec	1 mm/sec – 600 mm/sec	1 mm/sec – 600 mm/sec	Identical, therefore, substantially equivalent
Acceleration	800 mm/Sec^2	800 mm/Sec^2	800 mm/Sec^2	Identical, therefore, substantially equivalent
Couch Max Load Capacity	High Performance: 675 lbs. (307 kg), Utilizing RTP flat tabletop optional accessory: 628 lbs. (285 kg)	High Performance: 675 lbs. (307 kg), Utilizing RTP flat tabletop optional accessory: 628 lbs. (285 kg)	High Performance: 675 lbs. (307 kg), Utilizing RTP flat tabletop optional accessory: 628 lbs. (285 kg)	Identical, therefore, substantially equivalent
Couch accessories	Infant Cradle, Paper roller, Varian Camera Adaptor, Oncology flat tabletop	Infant Cradle, Paper roller, Varian Camera Adaptor, Oncology flat tabletop	Infant Cradle, Paper roller, Varian Camera Adaptor, Oncology flat tabletop	Identical, therefore, substantially equivalent
Clinical Applications: Dose Tools
Cardiac reconstruction method	Standard ECG Gated Reconstruction method, Motion Compensated Reconstruction (MCR) (optional feature)	Standard ECG Gated Reconstruction method, Motion Compensated Reconstruction (MCR) (optional feature)	Standard ECG Gated Reconstruction method, Motion Compensated Reconstruction (MCR) (optional feature)	Identical, therefore substantially equivalent.
Virtual Tilt Viewer (VTV) (optional feature)	Yes	Yes	Yes	Identical, therefore substantially equivalent.
Pulmo & 4DCT (Four- Dimension Computed Tomography)	No	Yes	Yes	Substantially Equivalent. The proposed device, Spectral CT system introduces Pulmonary gated scanning which allows image acquisition of the esophagus and abdomen area while the patient is breathing. The Pulmonary gated scan

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
				feature is planned for Radiation Therapy Planning procedures and is similar from a technological perspective to the secondary recently marketed secondary predicate device, Spectral CT 7500 RT system (K240844). The Pulmonary gating was successfully verified and validated and does not raise new questions on safety and/or effectiveness
General
Technical Basis for Collection of two CT Spectral	Dual Layer DMS (Spectral Detector)	Dual Layer DMS (Spectral Detector)	Dual Layer DMS (Spectral Detector)	Identical, therefore, substantially equivalent
Spectral Base Images	Low energy, High-energy, Photoelectric, Compton Scatter	Low energy, High-energy, Photoelectric, Compton Scatter	Low energy, High-energy, Photoelectric, Compton Scatter	Identical, therefore, substantially equivalent
Spectral results available [kVp]	100kVp, 120kVp, 140kVp	100kVp, 120kVp, 140kVp	100kVp, 120kVp, 140kVp	Identical, therefore, substantially equivalent
Spectral Results Images	Monoenergetic, Materials Basis/Density Pairs, such as I / H20, I / Ca, Ca / Uric Acid, Effective Atomic Number, Material Separation/ Differentiation, Attenuation Curves, Density Measurements/Visualization	Monoenergetic, Materials Basis/Density Pairs, such as I / H20, I / Ca, Ca / Uric Acid, Effective Atomic Number, Material Separation/ Differentiation, Attenuation Curves, Density Measurements/Visualization	Monoenergetic, Materials Basis/Density Pairs, such as I / H20, I / Ca, Ca / Uric Acid, Effective Atomic Number, Material Separation/ Differentiation, Attenuation Curves, Density Measurements/Visualization	Identical, therefore, substantially equivalent

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
	Reduction of Beam Hardening, Reduction of Calcium Blooming, Calcium Suppression Index, Electron Density, Spectral results for Cardiac	Reduction of Beam Hardening, Reduction of Calcium Blooming, Calcium Suppression Index, Electron Density, Spectral results for Cardiac	Reduction of Beam Hardening, Reduction of Calcium Blooming, Calcium Suppression Index, Electron Density, Spectral results for Cardiac
Host Drives	256GB OS disk Plus one 7.68TB PCIE NVMe SSD	256GB OS disk plus one 7.68TB PCIE NVMe SSD	256GB OS disk plus one 7.68TB PCIE NVMe SSD	Identical, therefore, substantially equivalent
Host Infrastructure	Windows 10	Windows 10	Windows 10	Identical, therefore, substantially equivalent
CIRS Computers	CIRS Rack that contains two HP Z8 servers. Option for two additional HP Z8 Servers in the same rack	CIRS Rack that contains two HP Z8 servers. Option for two additional HP Z8 Servers in the same rack	CIRS Rack that contains two HP Z8 servers. Option for two additional HP Z8 Servers in the same rack	Identical, therefore, substantially equivalent
CIRS CPUs	In each HP Z8: Dual Intel Gold 6230 with 20 cores at 2.1GHz each.	In each HP Z8: Dual Intel Gold 6230 with 20 cores at 2.1GHz each.	In each HP Z8: Dual Intel Gold 6230 with 20 cores at 2.1GHz each.	Identical, therefore, substantially equivalent
CIRS Drives	In each HP Z8: 512GB NVMe SSD for OS and CIRS software, Two 2TB NVMe SSDs for raw data.	In each HP Z8: 512GB NVMe SSD for OS and CIRS software, Two 2TB NVMe SSDs for raw data.	In each HP Z8: 512GB NVMe SSD for OS and CIRS software, Two 2TB NVMe SSDs for raw data.	Identical, therefore, substantially equivalent

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Design Feature	Currently Marketed Primary Predicate Device: Spectral CT system (K203020)	Currently approved Secondary Predicate Device: Spectral CT 7500 RT system (K240844)	Proposed Device: Spectral CT system	Conclusion
Interventional Controls	Yes	Yes	Yes	Identical, therefore, substantially equivalent

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Summary of Non-Clinical Performance Data

Non-clinical performance testing has been performed on the proposed Spectral CT system and demonstrates compliance with the following International and FDA recognized consensus standards and FDA guidance document(s): (e.g., see below)

IEC 60601-1:2005 A1:2012 A2:2020: Medical electrical equipment -- Part 1: General requirements for safety and essential performance (FDA recognition number: 19-49).
IEC 60601-1-2:2014 A1:2020: Medical electrical equipment -- Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests (FDA recognition number: 19-36).
IEC 60601-1-3:2008 A2:2021: Medical electrical equipment -- Part 1: General requirements for safety -- 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment. (FDA recognition number: 12-336).
IEC 60601-1-6:2010 A1:2013 A2:2020: Medical electrical equipment -- Part 1-6: General requirements for safety - Collateral standard: Usability (FDA recognition number: 5-132).
IEC 60601-2-28:2017: Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-ray Source Assemblies and X-ray Tube Assemblies for Medical Diagnosis (FDA recognition number: 12-309).
IEC 60601-2-44:2009 A1:2012 A2:2016: Medical electrical equipment -- Part 2-44: Particular requirements for the basic safety and essential performance of X-ray equipment for computed tomography (FDA recognition number: 12-302).
IEC 60825-1:2014 ISH1:2017 ISH2:2017: Safety measures, Light hazards, Lasers, Wavelengths, Eyes, Warning devices, Mathematical calculations, Medical equipment, Light emission, Marking, Hazards, Symbols, Instructions for use, Physiological effects (human body), Skin (body), Classification systems, Definitions, Occupational safety (FDA recognition number: 12-273).
IEC 62304:2006 + A1:2015: Medical device software - Software life-cycle processes (FDA recognition number: 13-79).
IEC 62366-1:2015 A1:2020: Medical devices - Application of usability engineering to medical devices (FDA recognition number: 5-129).
ISO 14971:2019: Medical devices - Application of risk management to medical devices (FDA recognition number: 5-125).
ISO 10993-1:2018: Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (FDA recognition number: 2-258)

Device Specific Guidance Document:

Guidance for Industry and FDA Staff – Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 11, 2005).
Guidance for Industry and FDA Staff – Content of Premarket Submissions for Device Software Functions (issued June 14, 2023).
Pediatric Information for X-ray Imaging Device Premarket Notifications – Guidance for Industry and Food and Drug Administration Staff (November 28, 2017)
Guidance for Industry and FDA Staff – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions (issued September 27, 2023)
Guidance for Industry and FDA Staff – Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (issued September 6, 2017)

Design verification planning and testing were conducted at the system level. The system is tested against the System Requirements Specifications (SRS). System verification activities demonstrate the system meets the established system design input requirements.

The traceability between the requirements, the hazard mitigations, and the test protocols are described in the traceability matrix.

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Design Validation tests the user needs and intended use that are documented in the top-level User Requirement Specification (PRS). The validation testing covered new features, clinical validation, and serviceability validation. All the validation tests as per validation plan were performed and acceptance criteria met for each of the requirements.

Non-clinical design validation testing demonstrates that the proposed Spectral CT system can be used as defined in its clinical workflow and intended use.

All these tests were used to support substantial equivalence of the subject device and demonstrate that the proposed Spectral CT system:

Complies with the aforementioned international and FDA-recognized consensus standards and/or FDA guidance document, and;
Meets the acceptance criteria and is adequate for its intended use.

Summary of Clinical Performance Data

Therefore, the proposed Spectral CT system is substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020), in terms of safety and effectiveness.

Substantial equivalence to the currently marketed primary predicate device Spectral CT system (K203020) and the cleared secondary predicate device Spectral CT 7500 RT system (K240844) were demonstrated through the following attributes:

Indication for use
Technological characteristics
Non-clinical performance testing
Clinical Image Evaluation
Safety and effectiveness

To support the evaluation of the new features, the submission includes:

Phantom-based image quality (IQ) testing, assessing parameters such as noise, resolution, and artifacts
A representative clinical image assessment
Comparison of performance data against internal performance requirements

This data supports the safety, effectiveness, and substantial equivalence of the subject device.

Substantial Equivalence Conclusion

The proposed Spectral CT system is substantially equivalent to the currently marketed primary predicate device, Spectral CT system (K203020) and currently cleared secondary predicate device Spectral CT 7500 RT system (K240844), in terms of indications for use, technological characteristics and principles of operation. The minor technological differences between the proposed Spectral CT system and currently marketed primary predicate device, Spectral CT system (K203020), raise no new issues of safety or effectiveness. Non-clinical performance data demonstrate that the proposed Spectral CT system performs as expected and in a manner that is substantially equivalent to its predicate device. Thus, the proposed Spectral CT system is substantially equivalent.

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.