Who is the manufacturer of SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option?

Arineta , Ltd. filed the 510(k) submission for SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option (K241200).

What is the FDA product code for SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option?

JAK. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option?

510(k) clearance (submission type: Traditional).

What are the predicate devices for SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option?

SpotLight/ SpotLight Duo (with DLIR option) (K230370).

Who can help prepare an FDA 510(k) submission like SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option

K241200 · Arineta , Ltd. · JAK · Jan 13, 2025 · Radiology

Device Facts

Record ID	K241200
Device Name	SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option
Applicant	Arineta , Ltd.
Product Code	JAK · Radiology
Decision Date	Jan 13, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended Use

The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications. The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. 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. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

Device Story

SpotLight/SpotLight Duo is a CT scanner acquiring X-ray transmission data via dual X-ray tubes and fast scintillator detector arrays. System performs computer reconstruction of cross-sectional images of cardiovascular and thoracic anatomies. Operated by clinicians in clinical settings. New Low Dose Lung Cancer Screening (LD LCS) option provides specific scan protocols compliant with AAPM dose requirements for medium/large patients. Device transforms projection data into trans-axial/reformatted images; output used by physicians for diagnosis and therapy planning. LD LCS option excludes use of DLIR and ASIR-CV algorithms. Benefits include optimized image quality for lung cancer screening while minimizing radiation dose.

Clinical Evidence

Clinical image quality assessment performed by two U.S. board-certified radiologists on 14 cases (medium and large patients). All cases evaluated as diagnostic for intended use. Readers identified various pathologies, including 2mm nodules, confirming capability for LD LCS findings.

Technological Characteristics

Dual-source CT system; 2x Varex MCS 2093 X-ray tubes; fast scintillator array (CdWO4/GOS) with photodiode array; 1D antiscatter collimator; direct drive DC motor; 60cm bore; 227kg max patient weight. Reconstruction via multicore PC/GPU using modified FDK cone beam algorithm. Connectivity includes console, image reconstruction, and embedded software. Power: 380-480V 3-phase.

Indications for Use

Indicated for x-ray CT imaging of cardiovascular and thoracic anatomies in patients of all ages (DLR limited to >2 years). Low Dose CT Lung Cancer Screening option indicated for medium and large patients per established governmental or professional society protocols (e.g., ACR, AAPM).

Regulatory Classification

Identification

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

Predicate Devices

SpotLight/ SpotLight Duo (with DLIR option) (K230370)

Reference Devices

GE Revolution CT

Related Devices

K250650 — SpotLight / SpotLight Duo with Low Dose Lung Cancer Screening Option · Arineta , Ltd. · Apr 15, 2025
K190505 — Low Dose Lung Screening Option · Canon Medical Systems Corporation · Jun 5, 2019
K213465 — CardioGraphe · Arineta , Ltd. · Dec 2, 2022
K180901 — Low Dose CT Lung Cancer Screening Option · Hitachi Healthcare Americas · May 16, 2018
K153444 — Philips Multislice CT System with Low Dose CT Lung Cancer · Philips Medical Systems (Cleveland), Inc. · Apr 8, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below. January 13, 2025 Arineta Ltd. % Tanya Shalem VP QA&RA 15 Halamish St. Caesarea, 3088900 ISRAEL Re: K241200 Trade/Device Name: SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: April 30, 2024 Received: December 13, 2024 Dear Tanya Shalem: 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. {1}------------------------------------------------ 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 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. 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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K241200 #### Device Name SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option #### Indications for Use (Describe) The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLR is limited for patient use of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. 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. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. 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." {4}------------------------------------------------ ### 510(k) Summary (K241200) ### Arineta's SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option ### I. SUBMITTER Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel Phone: +972-4-6374000 Contact Person: Tanya Shalem, VP of QA&RA, E-mail: tanya.shalem@arineta.com 510k Number: K241200 Date Prepared: January 13, 2025 ### II. DEVICE Name of Device: SpotLight/ SpotLight Duo with Low Dose Lung Cancer Screening Option Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK ## III. PREDICATE DEVICE Predicate Device Name: SpotLight/ SpotLight Duo (with DLIR option) Manufacturer: Arineta Ltd. 510(k) Number: K230370 Common Name: System, X-ray, Tomography, Computed Classification Name: Computed tomography x-ray system Regulation Number: 892.1750 Product Code(s): JAK {5}------------------------------------------------ ## IV. DEVICE DESCRIPTION The Low Dose Lung Cancer Screening (LD LCS) option is an indication being added to the existing Arineta scanners for SpotLight and SpotLight Duo, previously cleared by the FDA (K230370, K213465). There are not any functional, performance, feature, or design changes required for the CT systems to which the option is applied. This option includes scan protocols with CTDI that comply with AAPM's requirements for Low Dose Lung Cancer Screening. No Hardware modifications and minor Software modifications (for compatibility with the Low-Dose Lung Cancer Screening protocols) are required for the subject device, which includes the following LD LCS protocol characteristics: • Lung Cancer Screening protocols for medium and large patients according to AAPM's definitions. · Lung Cancer Screening protocols option will be activated by service or production personnel (no need for additional installation, option activation only). ## V. INTENDED USE The SpotLight Computed Tomography X-ray system is intended for head, body, cardiac and vascular X-ray computed tomography applications. ## VI. INDICATIONS FOR USE The SpotLight / SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of transaxial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) - resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) {6}------------------------------------------------ and subsequent literature, for further information. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. ## VII. INDICATIONS FOR USE COMPARISON The proposed devices do not constitute a new intended use. There is a minor change in the indication for use - the addition of the LD LCS Option, references to ACR and AAPM guidelines, and specific DLIR and ASIR-CV limitations for that option. ### VIII. TECHNOLOGICAL COMPARISON The technological characteristics of the SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening (LD LCS) option and the predicate currently marketed SpotLight/ SpotLight Duo are substantially the same, with no functional, performance, feature, or design changes, except for the added LD LCS scan protocols. The proposed LD LCS option has substantially the same reconstruction technology compared to the predicate currently marketed device. The DLIR and ASIR-CV algorithms are not compatible with the Low Dose Lung Cancer Screening option, as reflected in the Indications for Use. There is no new technology related to these LCS protocols or their operation. There are no significant differences that may raise new issues of safety or effectiveness. The proposed LD LCS scan protocols have low dose characteristics for medium and large patients and comply with the relevant AAPM CTDI dose values. These parameters were chosen to optimize image quality while minimizing the dose. The determination of substantial equivalence of the proposed new LD LCS protocols to the cleared predicate device was further evaluated on the bench testing. The new LDCT LCS protocols for Arineta systems were tested and validated by using traditional Image Quality (IQ) metrics on standard phantoms, and compared to the IQ results of the cleared predicate standard dose device. The results indicate maintaining the proposed device's LD LCS protocols for all IQ metrics, including accuracy, uniformity, resolution, contrast scale, and NPS frequencies. Testing was also performed using a semi-anthropomorphic clinical simulation lung phantom where the CNR and nodule sizing comparisons were performed for Arineta systems using their new LDCT LCS protocols. The results showed that the nodules' level of conspicuity and accurate sizing were maintained for the proposed device LDCT LCS protocols. Therefore, it indicated that the proposed devices LD LCS protocols and predicate devices were substantially equivalent. A table comparing the key features of the subject and predicate device is provided below. {7}------------------------------------------------ | | Proposed devices – Low Dose CT Lung Cancer Screening (LD LCS) Option for Qualified Arineta Systems | Primary Predicate devices – The Cleared Arineta's SpotLight / SpotLight Duo (K230370) CT X-ray System (with DLIR option) | Discussion | |----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | | | | | Indications for use | The SpotLight / SpotLight Duo is intended to produce cross- sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for x-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field-of-view. The Low Dose CT Lung Cancer Screening Option for SpotLight / SpotLight Duo is indicated for using low dose CT for lung cancer screening. The screening must be conducted with the established program criteria and protocols (for medium and large patients) that have been approved and published by a governmental body or a professional medical society. Information from professional societies related to lung cancer screening can be found but is not limited to: American College of Radiology® (ACR) – resources and technical specification; accreditation American Association of Physicists in Medicine (AAPM) - Lung Cancer Screening Protocols; radiation management. 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. The DLIR and ASIR-CV options are not compatible with the Low Dose Lung Cancer Screening option. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. | The SpotLight / SpotLight Duo (with DLIR option) is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission projection data taken at different angles. The system has the capability to image cardiovascular and thoracic anatomies, including the heart, in a single rotation. The system may acquire data using Axial, Cine, and Cardiac scan techniques from patients of all ages (DLIR is limited for patient use above the age of 2 years). These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories. This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes. The system is indicated for X-ray Computed Tomography imaging of cardiovascular and thoracic anatomies that fit in the scan field of view. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures. | The indications for use are similar, with the same indications for the entire device, except for minor differences; the indications for use for the proposed SpotLight/SpotLight Duo devices include Low Dose Lung Cancer Screening Option with additional references to ACR and AAPM guidelines, and specific DLIR and ASIR-CV limitation for that option. LCS indication for use does not constitute a new intended use for the CT. | | | Proposed devices - Low Dose CT Lung Cancer Screening (LD LCS) Option for Qualified Arineta Systems | Primary Predicate devices - The Cleared Arineta's SpotLight / SpotLight Duo (K230370) CT X-ray System (with DLIR option) | Discussion | | Technological Characteristics | | | | | Detector technology and geometry | Fast scintillator array coupled to photodiode array. | Fast scintillator array coupled to photodiode array. | Same | | | 33 (WFOV) or 23 (EFOV) configurable high resolution (HR) modules comprising 192 detector rows X pitch 0.5mm (Z direction, measured at scanner center). | 33 (WFOV) or 23 (EFOV) configurable high resolution (HR) modules comprising 192 detector rows X pitch 0.5mm (Z direction, measured at scanner center). | | | | 10 (WFOV) or 20 (EFOV) configurable low resolution (LR). EFOV includes 10 modules on each wing while WFOV includes 10 modules on one wing. comprising 48 detector rows X pitch 2.0mm | 10 (WFOV)-20 (EFOV) configurable low resolution (LR). EFOV includes 10 modules on each wing while WFOV includes 10 modules on one wing. comprising 48 detector rows X pitch 2.0mm | | | | Analog to digital conversion per channel on the detection module. | Analog to digital conversion per channel on the detection module. | | | | 1D antiscatter collimator. | 1D antiscatter collimator. | | | Data transmission from rotor | Contactless transmission (capacitive coupling). Rate up to 6.25 GBit/sec | Contactless transmission (capacitive coupling). Rate up to 6.25 GBit/sec | Same | | Power and control transmission to rotor | Brush contact slipring | Brush contact slipring | Same | | Rotation drive | Direct drive DC motor | Direct drive DC motor | Same | | X Ray source | 2 x MCS 2093 X ray tubes by Varex Imaging Corp. | 2 x MCS 2093 X ray tubes by Varex Imaging Corp. | Same | | | Single ended grounded rotating anode | Single ended grounded rotating anode | | | | Anode angle 13 degrees | Anode angle 13 degrees | | | | 1.0 MHU anode heat capacity…