NAEOTOM Alpha

K233657 · Siemens Medical Solutions USA, Inc. · JAK · Mar 28, 2024 · Radiology

Device Facts

Record IDK233657
Device NameNAEOTOM Alpha
ApplicantSiemens Medical Solutions USA, Inc.
Product CodeJAK · Radiology
Decision DateMar 28, 2024
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 892.1750
Device ClassClass 2

Intended Use

This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Story

Dual-source CT scanner; utilizes photon-counting detector technology (QuantaMax) to generate cross-sectional images. Inputs: X-ray transmission data. Processing: SOMARIS/10 syngo CT VB10 software platform performs image reconstruction, data management, and scan control. Outputs: DICOM-format CT images. Used in professional healthcare facilities by physicians, radiologists, or technologists. Features include FAST 3D camera for patient positioning, myNeedle Guide for interventional procedures, and spectral imaging capabilities. Output aids clinicians in diagnosis, treatment planning, and interventional guidance. Benefits include high-resolution imaging, reduced artifacts via ZeeFree (Cardiac Stack Artefact Correction), and optimized workflow through automated detection and positioning tools.

Clinical Evidence

Bench testing only. No clinical data. Performance verified via phantom studies (ACR, Gammex) evaluating noise, homogeneity, high-contrast resolution, slice thickness, CNR, and HU accuracy. Accuracy of automated needle detection algorithm demonstrated in 90.76% of cases. Spectral imaging accuracy validated against reference values and predicate device.

Technological Characteristics

Dual-source CT scanner; photon-counting detector (QuantaMax); VECTRON X-ray tubes; 82 cm gantry bore. Connectivity: DICOM, networked. Software: SOMARIS/10 syngo CT VB10 (Windows-based). Energy: 70-150 kV. Sterilization: N/A (non-invasive). Standards: IEC 60601-1, IEC 60601-2-44, NEMA XR 25/28.

Indications for Use

Indicated for generation and processing of cross-sectional patient images via computer reconstruction of x-ray transmission data. Used by trained staff for diagnosis, treatment, and diagnostic/therapeutic interventions. Includes low-dose lung cancer screening for high-risk populations as defined by professional medical societies.

Regulatory Classification

Identification

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

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 28, 2024 Siemens Medical Solutions USA, Inc. % Tabitha Estes Regulatory Affairs Proffecional 810 Innovation Drive KNOXVILLE, TN 37932 Re: K233657 Trade/Device Name: NAEOTOM Alpha Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 22, 2024 Received: February 23, 2024 Dear Tabitha Estes: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). {1}------------------------------------------------ Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health {2}------------------------------------------------ ### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K233657 Device Name NAEOTOM Alpha Indications for Use (Describe) This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### 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." {3}------------------------------------------------ K233657 Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the text is a graphic of orange dots arranged in a circular pattern. # 510(k) Summary for # NAEOTOM Alpha CT Scanner System ## with software version SOMARIS/10 syngo CT VB10 Date Prepared: March 22, 2024 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92. ### l. Submitter Siemens Medical Solutions USA, Inc. 810 Innovation Drive Knoxville, TN 37932 Establishment Registration Number: 1034973 Importer/Distributor Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869 Location of Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 -OR- Rittigfeld 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335 Note: Descriptions in this submission use the short company name Siemens. Brand name on all products is Siemens Healthineers. Submitter Contact Person: Tabitha Estes Regulatory Affairs Siemens Medical Solutions USA, Inc. (865) 804-4553 (work cell) tabitha.estes@Siemens-healthineers.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are several orange dots arranged in a circular pattern. ### II. Device Name and Classification | Product Name: | NAEOTOM Alpha | |-----------------------|----------------------------------| | Trade Name: | NAEOTOM Alpha | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | ### III. Predicate Device | Primary Predicate Device: | | |-----------------------------|------------------------------------------------------------------------------------| | Trade Name: | NAEOTOM Alpha, Scan&GO | | 510(k) Number: | K220814 | | Clearance Date: | July 12, 2022 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | All predicate device recalls have been considered in the subject<br>device design. | | Secondary Predicate Device: | | | Trade Name: | SOMATOM Force | | 510(k) Number: | K230421 | | Clearance Date: | June 16, 2023 | | Classification Name: | Computed Tomography X-ray System | | Classification Panel: | Radiology | | Regulation Number: | 21 CFR §892.1750 | | Device Class: | Class II | | Product Code: | JAK | | Recall Information: | All predicate device recalls have been considered in the subject<br>device design. | Note: K230421 was a bundle submission with various Siemens CT Scanner Systems, including the dual source CT scanner systems SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash and the single source CT scanner CT systems SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" are a series of orange dots arranged in a circular pattern. ### IV. Device Description Siemens intends to market a new software version, SOMARIS/10 syngo CT VB10, for the Dual Source CT system NAEOTOM Alpha based on the SOMARIS/10 platform. The subject device NAEOTOM Alpha with software version SOMARIS/10 syngo CT VB10 is a Computed Tomography X-ray system which features two continuously rotating tube-detector systems, denominated as A- and B-systems respectively (dual source CT scanner system). The detectors' function is based on photon-counting technology. The NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 produces CT images in DICOM format, which can be used by trained staff for postprocessing applications commercially distributed by Siemens and other vendors as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. The computer system delivered with the CT scanner is able to run optional post-processing applications. Only trained and qualified users, certified in accordance with country-specific regulations, are authorized to operate the system. For example, physicians, radiologists, or technologists. The user must have the necessary U.S. qualifications in order to diagnose or treat the patient with the use of the images delivered by the system. The platform software for the NAEOTOM Alpha is syngo CT VB10 (SOMARIS/10 syngo CT VB10). It is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation. The software platform provides plugin software interfaces that allow for the use of specific commercially available post-processing software algorithms in an unmodified form from the cleared stand-alone post-processing version. Software version syngo CT VB10 (SOMARIS/10 syngo CT VB10) is a modified software version of the primary predicate device, syngo CT VA50 (SOMARIS/10 syngo CT VA50) cleared in K220814. Software version SOMARIS/10 syngo CT VB10 will be offered ex-factory and as optional upgrade for the existing NAEOTOM Alpha systems. The subject device NAEOTOM Alpha will support previously cleared software and hardware features in addition to the applicable modifications as described within this submission. The intended use and the indications for use remain unchanged compared to the predicate devices. ### V. Indications for Use This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Siemens Healthineers logo. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. ### VI. Indications for Use Comparison #### Subject Device Indications for Use: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### Primary Predicate Device Indications for Use: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations*. * As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### Secondary Device Indications for Use: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by trained staff as an aid in diagnosis, treatment and radiation therapy planning as well as for diagnostic and therapeutic interventions. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information. #### Comparison: 1. The subject device Indications for Use is the exact same as the primary predicate's Indications for Use (K220814), however it is slightly different than the secondary predicate's Indications for Use. 2. Compared to the secondary predicate device, the subject device does not contain the phrase "radiation therapy planning" in the sentence "The images delivered by the system can be used by a trained staff as an aid in diagnosis and treatment as well as for diagnostic and therapeutic interventions." because NAEOTOM Alpha does not support radiation therapy planning. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the word "Healthineers" is a graphic of orange dots arranged in a circular pattern. None of the intended uses include computed tomography as the principal means of guidance in invasive procedures (involving the introduction of a device, such as a needle or a catheter into the body of the patient). The NAEOTOM Alpha is not the principal means of guidance, because the CT System does not guide the invasive procedures, the needle orientation and the needle advance, and handling is always done under the physicians control. ### VII. Comparison of Technological Characteristics with the Predicate Device Supported by the subject device, SOMARIS/10 syngo CT VB10 software version is a further development of the SOMARIS/10 syngo CT VA50 software version which is cleared in K220814. The NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 software version provides the same technological characteristics in terms of materials, energy source, and control mechanisms when compared to the predicate devices. The software features of NAEOTOM Alpha have been modified or improved in comparison to the predicate devices to support enhanced device functionality compared to the predicate devices. The new syngo CT VB10 software reuses all unmodified software features of the legacy software syngo CT VA50 cleared in K220814. Additionally, no features present in the predicate device are descoped. Software version SOMARIS/10 syngo CT VB10 is designed to reuse hardware independent extended functionalities and GO technologies provided by Siemens cleared software applications. The intended use and fundamental scientific technology for the NAEOTOM Alpha remain unchanged from the predicate devices. At a high level, the subject and predicate devices are based on the same subset of technological elements: - . Scanner Principle – Whole body X-Ray Computed Tomography Scanner - System Acquisition Continuously rotating tube detector system ● - Iterative Reconstruction – Support of various iterative reconstruction principles - Workplaces – Support of workplaces that include reconstruction and image evaluation software - Patient table - Patient table foot switch for movement - Tin filtration technology - Vectron X-ray Tube - Power Generator - Scan&GO - Mobile workflow (Tablet) ● - Optional injector arm - Optional support of CT guided intervention workflow (myNeedle Guide) - Optional support of FAST 3D Camera operation for fast patient positioning workflow - Scanner display and control functionality - Remote Scan Control - Long scan range {8}------------------------------------------------ Image /page/8/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a cluster of orange dots. The subject device NAEOTOM Alpha with SOMARIS/10 syngo CT VB10 will support the modifications/further developments in comparison to the predicate devices as listed in the tables under subsections 1) Modified Hardware and 2) Modified Software below. The configuration table and comparison table use the following terms to describe various technological characteristics in comparison to the primary and secondary predicate devices information: | Term | Definition | |----------|----------------------------------------------------------------------------------------------------------------------------------| | New | The feature is newly supported for Siemens CT Scanners and the subject device | | Modified | This feature is a modified form of a feature cleared within the predicate devices | | Enabled | This feature is currently supported by other cleared Siemens CT systems or<br>cleared Siemens stand-alone software applications. | #### 1) Modified Hardware Table 2: Overview of hardware modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VB10 compared to the predicate/secondary devices. | | Hardware properties | NAEOTOM Alpha<br>SOMARIS/10 syngo CT VB10<br>(subject device) | |----|-----------------------------|---------------------------------------------------------------| | 1. | Tin Filtration | modified | | 2. | FAST 3D Camera | modified | | 3. | Multi-Purpose Table (Vitus) | modified | #### 2) Modified Software (syngo CT VB10) Table 3: Overview of software modifications of NAEOTOM Alpha supported by software version SOMARIS/10 syngo CT VB10 compared to the predicate/secondary devices. | | Software properties | NAEOTOM Alpha<br>SOMARIS/10 syngo CT VB10<br>(subject device) | |----|-----------------------------------------------------|---------------------------------------------------------------| | 1. | ZeeFree | new | | 2. | FAST Integrated Workflow | modified | | 3. | myNeedle Guide (with MyNeedle Detection) | modified | | 4. | myExam Companion – myExam Cockpit/myExam<br>Compass | modified | | 5. | Recon&GO | modified | {9}------------------------------------------------ Image /page/9/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern. | | Software properties | NAEOTOM Alpha<br>SOMARIS/10 syngo CT VB10<br>(subject device) | |-----|---------------------------------|---------------------------------------------------------------| | 6. | CT View&GO | modified | | 7. | Scan&GO | enabled | | 8. | Quantum Spectral Imaging | modified | | 9. | Quantum HD Cardiac | modified | | 10. | HD FoV | enabled | | 11. | Multi-Threshold Acquisition | modified | | 12. | myExam Satellite (Remote Recon) | modified | A tabular summary of the comparable hardware and software properties between the subject device NAEOTOM Alpha with software version syngo CT VB10 and primary/secondary predicate device are listed in Table 4 and Table 5 below (modifications are in gray shaded sections). | Table 4: Technical hardware characteristics for the subject device NAEOTOM Alpha (software version SOMARIS/10 syngo CT | | |------------------------------------------------------------------------------------------------------------------------|--| | VB10) compared to the predicate devices. | | | Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device | |------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VB10 | NAEOTOM Alpha<br>SOMARIS/10 syngo CT<br>VA50<br>(K220814) | SOMATOM Force<br>SOMARIS/7 syngo CT VB30<br>(K230421) | | Scanner | whole body X-ray<br>computed<br>tomography scanner | whole body X-ray<br>computed<br>tomography scanner | whole body X-ray<br>computed tomography<br>scanner | | System<br>configuration | Dual Source | Dual Source | Dual Source | | Environment of<br>Use | Professional<br>Healthcare Facility | Professional<br>Healthcare Facility | Professional Healthcare<br>Facility | | Generator<br>max. power (kW) | 2x 120 | 2x 120 | 2x 120 | | Detector<br>technology | QuantaMax | QuantaMax | UFC<br>(Ultra Fast Ceramic) | | Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device | | | NAEOTOM Alpha | NAEOTOM Alpha | SOMATOM Force | | | SOMARIS/10 syngo CT<br>VB10 | SOMARIS/10 syngo CT<br>VA50<br>(K220814) | SOMARIS/7 syngo CT VB30<br>(K230421) | | | Direct Conversion<br>with "Quantum<br>Technology" | Direct Conversion<br>with "Quantum<br>Technology" | | | Detector<br>volume coverage<br>(mm) | 2x 57.6 | 2x 57.6 | 2x 57.6 | | Detector<br>physical rows | 2x 288 | 2x 288 | 2x 96 | | Detector<br>slice width (mm) | 0.2 | 0.2 | 0.6<br>(optional: 0.4, 0.5) | | Detector | 2752 (A system) | 2752 (A system) | 920 (A system) | | DAS channel no. | 1984 (B system) | 1984 (B system) | 640 (B system) | | Tube<br>technology | VECTRON | VECTRON | VECTRON | | Tube<br>kV steps | 70, 90, 100, 120, 140,<br>150<br>(150 kV only available<br>on the smaller tube-<br>detector system (B<br>system) and only in<br>combination with the<br>additional Sn filter, 0.7<br>mm) | 70, 90, 100, 120, 140 | 70, 80, 90, 100, 110, 120,<br>130, 140, 150 | | Tube<br>max. current<br>(mA) | 2x 1300 | 2x 1300 | 2x 1300 | | Tube | 0.4 x 0.5/8° | 0.4 x 0.5/8° | 0.4 x 0.5/8° | | tube focus (mm) | 0.6 x 0.7/8° | 0.6 x 0.7/8° | 0.6 x 0.7/8° | | | 0.8 x 1.1/8° | 0.8 x 1.1/8° | 0.8 x 1.1/8° | | Hardware<br>property | Subject device | Primary predicate<br>device | Secondary predicate<br>device | | | NAEOTOM Alpha | NAEOTOM Alpha | SOMATOM Force | | | SOMARIS/10 syngo CT<br>VB10 | SOMARIS/10 syngo CT<br>VA50<br>(K220814) | SOMARIS/7 syngo CT VB30<br>(K230421) | | | (for both tubes) | (for both tubes) | (for both tubes) | | Tube<br>heat capacity | higher than 30 MHU | higher than 30 MHU…
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%