Who is the manufacturer of Multitom Rax?

Siemens Medical Solutions filed the 510(k) submission for Multitom Rax (K221281).

What is the FDA product code for Multitom Rax?

OWB. It is classified under 21 CFR 892.1650 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Multitom Rax?

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

What are the predicate devices for Multitom Rax?

Multitom Rax With True2scale Body Scan Option (K212212).

Who can help prepare an FDA 510(k) submission like Multitom Rax?

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.

Multitom Rax

K221281 · Siemens Medical Solutions · OWB · Nov 17, 2022 · Radiology

Device Facts

Record ID	K221281
Device Name	Multitom Rax
Applicant	Siemens Medical Solutions
Product Code	OWB · Radiology
Decision Date	Nov 17, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1650
Device Class	Class 2
Attributes	Pediatric

Intended Use

Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes. The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m². Multitom Rax is not for mammography examinations.

Device Story

Multitom Rax is a stationary X-ray system for radiography and fluoroscopy; features floor-mounted table and ceiling-suspended X-ray tube/Solid State X-ray Imager (SSXI). System utilizes two telescopic arms to perform continuous scans. True2scale Body Scan uses slot-scanning acquisition for 2D skeletal alignment imaging. Real3D functionality performs circular cone-beam CT (CBCT) scans for 3D bone imaging. Operated by healthcare professionals in clinical settings. Output consists of 2D/3D images for diagnostic assessment of osseous structures, fractures, and bone angles. System includes error monitoring and visual/audible warnings. Benefits include comprehensive imaging modes and improved diagnostic quality for bone structures.

Clinical Evidence

Bench testing included high-contrast resolution (MTF), low-contrast detectability, CT number accuracy, uniformity, image noise, and slice sensitivity profile. Clinical evaluation involved a 3-month Customer Use Test and an image quality assessment of 21 anonymized clinical/phantom datasets (foot, ankle, knee, hip, lumbar spine, elbow, hand, head) by board-certified radiologists, confirming sufficient diagnostic quality for osseous assessment.

Technological Characteristics

Stationary X-ray system; SSXI with Cesium Iodide scintillator; 16-bit grayscale. High-frequency generator (65/80 kW); X-ray tube (820 KHU, 0.6/1.0 focal size). Two telescopic arms with 3 translational/2 rotational degrees of freedom. Connectivity: DICOM. Software: VF11. Standards: IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 62304, 62366, ISO 14971.

Indications for Use

Indicated for pediatric, adult, and bariatric patients requiring radiographic and fluoroscopic imaging, including gastrointestinal, cranial, skeletal, thoracic, lung, urogenital, emergency, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, and angiography. True2scale Body Scan indicated for 2D spine, lower limb, or full-body imaging for skeletal alignment assessment. Real3D indicated for 3D bone imaging of head, upper/lower extremities, and lumbar spine. Contraindications: Real3D not for torso imaging in patients with BMI > 30 kg/m²; not for mammography.

Regulatory Classification

Identification

An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Special Controls

*Classification.* Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Predicate Devices

Multitom Rax With True2scale Body Scan Option (K212212)

Reference Devices

LineUP (K180727)

Related Devices

K212212 — Multitom Rax with True2scale Body Scan Option · Siemens Medical Solutions · Feb 18, 2022
K152928 — Multitom Rax · Siemens Medical Solutions USA, Inc. · Nov 13, 2015
K183275 — DR 800 with Tomosynthesis · Agfa N.V. · Feb 1, 2019
K152244 — RADspeed Pro · Shimadzu Corporation · Jun 20, 2016
K203345 — MULTIX Impact · Siemens Medical Solutions USA, Inc. · Jan 7, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ November 17, 2022 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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. Siemens Medical Solutions % Denise Adams Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355 Re: K221281 Trade/Device Name: Multitom Rax Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA, JAK Dated: October 18, 2022 Received: October 19, 2022 Dear Denise Adams: 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 (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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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, Zhkke Laurel Burk, 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221281 Device Name Multitom Rax ### Indications for Use (Describe) Multitom Rax is a device intended to visualize anatomical structures by converting an X- ray pattern into a visible image. The system has medical applications ranging from gastrointestinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the genetrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes. The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m². Multitom Rax is not for mammography examinations. Type of Use (Select one or both, as applicable) | <div> ✖ Prescription Use (Part 21 CFR 801 Subpart D) </div> | |-----------------------------------------------------------------------------------------------------------------------| | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### 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}------------------------------------------------ Image /page/3/Picture/1 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 words is a graphic of orange dots arranged in a circular pattern. ## 510(k) Summary: Multitom Rax Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Date Prepared: November 16, 2022 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR § 807.92. #### 1. General Information: ## 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 91301 Forchheim, Germany Establishment Registration Number: 3004977335 #### 2. Contact Person: Denise Adams, RAC Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US adams.denise@siemens-healthineers.com ## Alternate Contact Person: Martin Rajchel Senior Regulatory Affairs Manager Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, US martin.rajchel @siemens-healthineers.com {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the word "Healthineers" is a graphic of orange dots. - 3. Device Name and Classification: Trade Name: Multitom Rax Classification Name: Image-intensified fluoroscopic x-ray system Classification Panel: Radiology Classification Regulation: 21 CFR §892.1650 Device Class: II Product Code: OWB Secondary Product Code: JAA, JAK #### 4. Legally Marketed Predicate Device: | Trade Name | Multitom Rax With True2scale Body Scan Option | |--------------------------------|-----------------------------------------------| | Company | Siemens Medical Solutions USA, Inc. | | 510(k) Number | K212212 | | Device Classi- ficationName | Interventional Fluoroscopic X-ray System | | Regulation Number | 892.1650 | | Review Panel | Radiology | | Product Code | OWB | | Secondary Product Code | JAA | | Device Class | 2 | #### 5. Legally Marketed Reference Device: | Trade Name | LineUP | |--------------------------------|----------------------------------| | Company | CurveBeam, LLC | | 510(k) Number | K180727 | | Device Classi- ficationName | Computed tomography X-ray System | | Regulation Number | 892.1750 | | Review Panel | Radiology | | Product Code | JAK | | Device Class | 2 | {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 words is a graphic of orange dots. #### 6. Device Description: Multitom Rax is a stationary X-ray system for radiography and fluoroscopy. Multitom Rax consists of a floor mounted patient table (option) and ceiling suspended X-ray tube, and a ceiling suspended Solid State X-ray Imager (SSXI). Together with an X-ray generator and a digital imaging system, Multitom Rax provides comprehensive image acquisition modes to support radiographic and fluoroscopic imaging procedures. With the True2scale Body Scan technology, Multitom Rax performs a continuous scan that moves along the patient's vertical axis with a highly collimated radiation beam along a line trajectory using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 2D representation of the scanned object. With the Real3D technology, Multitom Rax performs a continuous, circular scan around the patient using the system's two telescopic arms. The projections, which are acquired during the scanning process, form the basis for a reconstruction to obtain a 3D representation of the scanned object. #### 7. Indication for Use: Multitom Rax is a device intended to visualize anatomical structures by converting an X-ray pattern into a visible image. The system has medical applications ranging fromgastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications.lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients. The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes. The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m². Multitom Rax is not for mammography examinations. #### 8. Substantial Equivalence: The subject device is the same as the predicate device. The software was updated and new CBCT trajectories have been introduced. The Real3D (CBCT) functionality has been tested and does not raise any new concerns of safety and effectiveness. A comparison to a legally marketed CBCT device was done and supports substantial equivalence. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern. The device remains within the same classification regulation for the same technology as the predicate device with the addition of computed tomography. The system software design was completed in accordance with Siemens Quality Management System Design Controls. The scope of internationally recognized standards compliance remains the same. - Summary of Technological Characteristics of the Subject Device as Compared with 9. the Predicate Device: The software of the subject device was updated and new CBCT trajectories have been added. Comparison of the Subject Device (Multitom Rax) to the PredicateDevice (Multitom Rax With True2scale Body Scan Option) | Feature | Predicate device Multitom Rax With True2scale Body Scan Op- tion | Subject device Multitom Rax | Comment | |----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Regulation De- | Image-intensified fluoro- | Image-intensified fluoro- | Same | | scription | scopic X-ray system | scopic X-ray system | | | Regulation Number | 892.1650 | 892.1650 | Same | | Classification Product Code | OWB | OWB | Same | | Secondary Product Code | JAA | JAA, JAK | New product code for CBCT | | Indications for use | Multitom Rax is a device intended to visualize ana- tomical structures by con- verting an X-ray pattern into a visible image. The system has medical appli- cations ranging from gas- trointestinal examinationsto cranial, skeletal, thoracic and lung exposures as well asexaminations of the uro- genital tract. The unit may also be used in emergency applications, lymphogra- phy, endoscopy, myelog- raphy, venography, ar- thrography, interventional radiology, digital angi- ography, and digital sub- traction angiography (DSA). The system may be | Multitom Rax is a device intended to visualize ana- tomical structures by con- verting an X-ray pattern into a visible image. The system has medical applica- tions ranging from gastroin- testinal examinationsto cra- nial, skeletal, thoracic and lung exposures as well as examinations of the urogen- ital tract. The unit may also be used in emergency appli- cations, lymphography, en- doscopy, myelography, ve- nography, arthrography, in- terventional radiology, digi- tal angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and | Real3D added to Indications for Use | | | | | | | | used on pediatric, adult, and bariatric patients. The True2scale Body Scan functionality (i.e., slot- scanning-based acquisition and reconstruction tech- nique) of the Multitom Rax is intended to be used for the generation of a geomet- rically accurate (in scan- ning direction) 2-D repre- sentation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes. Multitom Rax is not for mammography examina- tions. | bariatric patients. The True2scale Body Scan functionality (i.e., slot- scanning-based acquisition and reconstruction tech- nique) of the Multitom Rax is intended to be used for the generation of a geomet- rically accurate (in scan- ning direction) 2-D repre- sentation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes. The Real3D functionality (i.e., cone-beam CT acqui- sition and reconstruction technique) of the Multitom Rax is intended to be used for 3D bone imaging of the head, the upper and lower extremities as well as the lumbar spine. Real3D is not intended for imaging of the torso of pa- tients with a Body Mass In- dex (BMI) exceeding 30 kg/m². Multitom Rax is not for mammography examina- tions. | | | Scan axis | Horizontal and Vertical | Horizontal and Vertical | Same | | Mechanical System design | Tube and detector both move on rails with three translational and two rota- tional degrees of freedom. They can move on defined paths (trajectories) around the patient to acquire the projections. | Tube and detector both move on rails with three transla- tional and two rotational de- grees of freedom. They can move on defined paths (tra- jectories) around the patient to acquire the projections. | Same | | | projections. | | | | High voltage generator | High frequency generator 65 or 80 kW | High frequency generator 65 or 80 kW | Same | | X-Ray Tube | Max anode heat capacity 820 KHU (Nominal) Focal size: 0.6 / 1.0 | Max anode heat capacity 820 KHU (Nominal) Focal size: 0.6 / 1.0 | Same | | Image detector | SSXI with Cesium Iodide scintillator | SSXI with Cesium Iodide scintillator | Same | | Gray scale | 16 bit | 16 bit | Same | | Patient Support Structure | Floor mounted patient ta- ble for supine examina- tions. Patient support de- vice for standing patient. | Floor mounted patient table for supine examinations. Patient support device for standing patient. | Same | | Cone-beam CT functionality | N/A | Trajectories for CBCT im- age acquisition allowing various Source-to- Imager and Source-to-Iso- center Distances parallel to axis of rotation. The X-ray beam is colli- mated to a rectangular shape matching the 43 cm x 43 cm flat panel detector (with a narrow unexposed margin). For the high-resolution mode, the beam size is lim- ited to 21 cm x 21 cm. Scans available for upper and lower extremities, head, and lumbar spine. Filtered backprojection- based reconstruction for CBCT, which accounts for the acquisition geometry. Metal Artifact Reduction for CBCT | Added support for CBCT func- tionality | | Feature | CurveBeam LineUp | Multitom Rax Real3D | Comment | | kVp | 100 - 120 | 60 - 130 | Better for Multitom Rax Real3D | | Voxel size | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel) | Better for Multitom Rax Real3D | | Slice spacing | 0.3 mm | 0.2 mm - 0.5 mm (depending on chosen reconstruction kernel | Better for Multitom Rax Real3D | | FOV (diameter, height) | Regular: 20 cm x 20 cm (d, h) Extended: 35 cm x 20 cm (d, h) | Real 3D Hi-Res: 15 cm x 15 cm (d, h) Real3D: 23 cm x 23 cm (d, h) | Extended FOV not available at Multitom Rax Regular FOV is bigger for Multitom Rax Real3D | | Scan time* | 23s or 26s | Real3D Hi-Res: 14s Real3D: 12s or 16s (depending on anatomy) | Better for Multitom Rax Real3D and Real3D Hi-Res *Scan time is defined as the duration in which the exposure alarm (buzzer) is ON and X-ray ON light is illuminated | | High-contrast resolution (10% MTF) | 12 lp/cm | Real 3D Hi-Res: up to 25 lp/cm (very sharp kernel) Real 3D: up to 15 lp/cm (sharp kernel) | Better for Multitom Rax Real3D | | Low-contrast detectability | n/a | 20 HU @ 4 mm (smooth kernel) 10 HU @ 8 mm (smooth kernel) | Not reported for CurveBeam LineUp. Also, the intended use of Real3D is high-contrast bone imaging, therefore the low-contrast detectability is not of as high importance as it would be for hemorrhage detection | | Slice Sensitivity Profile / z-axis point spread function | The LineUP has a fixed and rigid patient positioning platform that does not incorporate any table motion or indexing (no "table pitch"). The detector panel has a square shape, while the pixels on the panels are square shaped as well. The raw projections are acquired in a single 360° orbit, thus covering the entire Field of View (FOV) height in one rotation. This results in isotropic voxels in the reconstructed volume, hence the same spatial resolution in the z-axis as in the x-y plane. Due to this projection geometry, calculation of a separate z-axis point spread function should not be applicable. | $0.42 \text{ mm } \pm 0.1 \text{ mm}$ (Real3D) $0.31 \text{ mm } \pm 0.1 \text{ mm}$ (Real 3D Hi-Res) | Not reported for CurveBeam LineUp. Isotropic resolution for Multitom Rax Real3D. | | Image noise | n/a | Smooth: $20 \pm 15 \text{ HU}$ Medium: $60 \pm 40 \text{ HU}$ Sharp: $100 \pm 60 \text{ HU}$ Very sharp: $300 \pm 150 \text{ HU}$ | Not reported for CurveBeam LineUp. Also, as noise depends on both, radiation dose and the imaged object and the used post-processing (reconstruction kernel), a direct comparison of two devices is mostly not feasible. | | Uniformity (in-plane) | < 100 HU | < 150 HU | Better for CurveBeam LineUp Justification: Intended use of Real3D is high-contrast bone imaging, therefore the in-plane uniformity should at least allow to apply standard viewing windowing functions (typical bone windows are, for instance, 2000 HU / 300 HU (W/C) or 1500 HU/ 450HU (W/C)), which is fulfilled for the CBCT functionality | | | |…