HiRise (1040-230)

K241713 · Curvebeam, LLC · JAK · Jul 12, 2024 · Radiology

Device Facts

• Record ID: K241713
• Device Name: HiRise (1040-230)
• Applicant: Curvebeam, LLC
• Product Code: JAK · Radiology
• Decision Date: Jul 12, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs. The device is to be operated in a professional healthcare environment by qualified health care professionals only.

Device Story

HiRise is a Cone Beam Computed Tomography (CBCT) system for 3D volumetric imaging of extremities and pelvis. It utilizes a rotating gantry with an X-ray source and flat panel detector to acquire 360-degree projection sequences. The system includes a motorized gantry, patient positioners, and a non-weight bearing chair. Operated by trained professionals in hospitals or orthopedic clinics, the device captures images which are reconstructed and sent to DICOM-compliant viewing software. The system supports weight-bearing and non-weight-bearing scans. The updated version features a rotating anode X-ray tube and higher energy protocols (up to 20mA) to improve image contrast and reduce noise, particularly for hip imaging in larger patients. Healthcare providers use the reconstructed 3D volumes for diagnostic assessment of anatomical regions. The device benefits patients by providing high-quality diagnostic imaging for orthopedic conditions.

Clinical Evidence

No clinical trials were conducted. Evidence consists of bench testing and clinical image review. Performance was validated by a fellowship-trained MSK radiologist who confirmed that images produced by the updated higher energy protocols are clinically acceptable and of adequate diagnostic quality. Third-party testing verified compliance with IEC 60601-1, 60601-1-2, 60601-1-3, and 60601-2-44 standards.

Technological Characteristics

CBCT system; rotating anode X-ray tube (0.3mm/0.6mm focal spot); 100-120 kVP; 12-20 mA; amorphous silicon flat panel detector; 16-bit grayscale; DICOM connectivity. Materials: powder-coated aluminum, polyester vinyl, carbon fiber, nylon, polycarbonate. Software: virtualized Windows-based application. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-44, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for 3-D imaging of upper/lower extremities and pelvis in adult and pediatric patients weighing 40-450 lbs. Operated by qualified healthcare professionals in professional environments.

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

• HiRise (K203187)

Submission Summary (Full Text)

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July 12, 2024

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 & 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.

CurveBeam LLC % Ryan Conlon Director of Quality and Regulatory Affairs 2800 Bronze Drive Suite #110 Suite 110 HATFIELD, PA 19440

Re: K241713

Trade/Device Name: HiRise Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: June 11, 2024 Received: June 14, 2024

Dear Ryan Conlon:

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).

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerelv.

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

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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

| Submission Number (if known) | K241713 |
|------------------------------|---------|
| Device Name | HiRise |

Indications for Use (Describe)
The HiRise is intended to be used for 3-D imaging of the upper and the lower extremities and pelvis
of adult and pediatric patients weighing from 40 to 450 lbs.
The device is to be operated in a professional healthcare environment by qualified health care
professionals only.
Type of Use (Select one or both, as applicable)

| <label><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> |
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|

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# 510(k) Number: K241713 510(k) Summary

# Contents

| Table 5-1 Device Information | 2 |
|-------------------------------------------|----|
| Predicate Device: | 2 |
| High-level change description: | 2 |
| Device Description: | 3 |
| Device Characteristics and Performance | 3 |
| Key Device Components | 3 |
| Environment of Use | 3 |
| Patient Contacting Materials | 4 |
| Changes that resulted in a new 510(k) | 4 |
| Substantial equivalence comparison table: | 5 |
| Design Control Activities Summary: | 11 |
| Substantial Equivalence Discussion: | 12 |
| Safety and Effectiveness Information: | 12 |
| Conformity | 12 |
| FDA Guidance | 13 |
| Conclusion: | 13 |

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# Table 5-1 Device Information

| Manufacturer Name: | Curvebeam LLC |
|---------------------------------|--------------------------------------------|
| Manufacturer Address: | 2800 Bronze Drive, Suite 110, Hatfield, PA |
| Registration Number/FEI number: | 3009543051 |
| Contact Person: | Ryan Conlon |
| Submission Date | July 11, 2024 |
| Device Name: | HiRise |
| Classification: | Class II |
| Product code: | JAK |
| Regulation Number: | 21 CFR 892.1750 |
| Regulation Name: | Computed Tomography X-Ray System |
| Device Description: | The HiRise is a Computed Tomography X-ray |
| Intended Use: | The HiRise is intended to be used for 3-D |

## Predicate Device:

| Company | Device name | Product<br>Code | 510(k) | Regulation Number | Device<br>Classification |
|-------------------|-------------|-----------------|---------|-------------------|--------------------------|
| CurveBeam,<br>LLC | HiRise | JAK | K203187 | 892.1750 | Class II |

# High-level change description:

| Device Name: | HiRise |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | The HiRise is intended to be used for 3-D imaging of the upper and the lower<br>extremities and pelvis of adult and pediatric patients weighing from 40 to 450 lbs.<br>The device is to be operated in a professional healthcare environment by qualified<br>health care professionals only. |
| Device class: | Class II (21 CFR 892.1750) |
| Product code: | JAK |
| 510k Number/Type: | K203187 / Traditional 510k |
| Basic UDI-DI | 8631520003CBCTDevicesCL |
| Date of change: | TBA |
| Description of Change: | Changing the maximum mA output from 6.5mA to 20mA |
| Reason for Change: | The HiRise is indicated for imaging of upper and lower extremities. Current imaging<br>protocols for the HiRise have been deemed clinically acceptable, but the image |

CurveBeam, LLC – HiRise 510(k) Application

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| characteristics on certain patients, based on anatomy, could be improved for<br>enhanced contrast and lower noise. |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| When it comes to imaging the Hip, there is naturally a significantly higher volume of<br>adipose tissue for the X-Rays to penetrate. Therefore, a higher energy imaging<br>protocol is proposed to enhance the image characteristics of hip scans (especially for<br>larger patients, based on anatomy). |
| The HiRise is a versatile device, as prior to each scan the imaging protocol is selected<br>based on anatomy being scanned, purpose of the scan and size of patient. Due to<br>such complexities and variabilities the HiRise is also indicated to be operated by<br>trained professionals only. |

### Device Description:

#### Device Characteristics and Performance

The HiRise is a Cone Beam Computed Tomography Imaging Device that acquires 360-degree rotational projection sequences which are reconstructed into 3D volumetric images of the examined anatomical region. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry. The gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For non-weight bearing scans of the lower extremity, a patient positioner accessory allows the patient to sit into a position where he/she can comfortably place his/her anatomy into the imaging bore.

The gantry assembly is mounted on vertical actuators and can travel vertically to capture weight-bearing anatomy at various heights ranging from the feet to the pelvis regions. The HiRise provides total vertical travel of 37 inches to accommodate patients of various sizes. Images produced by the HiRise can be sent electronically to a DICOM complaint image viewing software.

#### Key Device Components

Embedded Controller Flat Panel Detector Gantry Assembly X-Ray Source X-Ray Power Supply Patient Platform and Positioners Patient non-weight bearing chair Operator Control Box External Server

#### Environment of Use

The HiRise is to be used in medical facilities including hospitals, and orthopedic clinics. The HiRise should be installed and operated according to state and federal regulations regarding radiationemitting products and the device room layout should be approved by a certified medical physicist prior to CurveBeam, LLC – HiRise 510(k) Application Page 3

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installation.

#### Patient Contacting Materials

The materials that could contact the patient are listed below.

- (1) Polyester patient platform lining
- (2) Vinyl Transporter cushion
- (3) Carbon fiber positioners
- (5) Powder coated Aluminum handlebars

### Changes that resulted in a new 510(k).

The proposed higher energy protocols (performance specifications) and the underlying component changes required to support the proposed protocols were evaluated. In summary, the conclusion is that this results in a performance change and there is an increased risk when it comes to patient radiation dose.

The most significant changes to the device include a redesign of the x-ray generator electronics. This includes the x-ray source (tube housing) and the x-ray power supply (high voltage power supply) along with the supporting cabling and safety electronics (isolation toroid and circuit breaker). All the above components exist in the current design but have been modified to support and enable higher energy imaging protocols to enhance the image characteristics of hip scans (especially for larger patients, based on anatomy).

The HiRise is a versatile device, as prior to each scan the imaging protocol is selected based on anatomy being scanned, purpose of the scan and size of patient. Due to such complexities and variabilities both the current and higher energy protocol versions of the HiRise are indicated to be operated by trained professionals only.

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# Substantial equivalence comparison table:

| SUBSTANTIAL EQUIVALENCE TABLE | | | |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature/<br>Component | HiRise V1 | HiRise V2 | Variance/Rationale |
| 510(k) number | K203187 | | |
| Product code | JAK | No changes | |
| Regulation<br>number | 21 CFR 892.1750 | No changes | |
| Indications for<br>use | The HiRise is intended to be used<br>for 3-D imaging of the upper and<br>the lower extremities and pelvis<br>of adult and pediatric patients<br>weighing from 40 to 450 lbs.<br>The device is to be operated in a<br>professional healthcare<br>environment by qualified health<br>care professionals only. | No changes | |
| Principal of<br>operation | Computed Tomography X-ray<br>System | No changes | |
| Scan axis | Horizontal and vertical | No changes | |
| Mechanical<br>Layout | A horizontal doughnut, with the<br>x-ray source and flat panel<br>detector mounted at each end of<br>a rotating gantry. The gantry<br>assembly lifts for scanning of the<br>lower extremities. Rotation of the<br>gantry to vertical imaging mode<br>allows for the positioning and<br>imaging of upper extremities. A<br>non-weight bearing chair allows<br>for non-weight bearing imaging of<br>the foot, ankle, and knee. | No changes | |
| Controller | Firmware Exposure Controller | No changes | |
| Tube | Stationary anode, glass envelope<br>x-ray tube.<br>Max KV: 130kV<br>Focal Spot: 0.5mm nominal<br>Target Angle: 15° degrees | Rotating Anode, glass<br>envelope x-ray tube.<br>Max KV: 130kV<br>Focal Spot: 0.3mm &<br>0.6mm nominal<br>Target Angle: 16°<br>degrees | The overall changes utilize a more robust<br>tube. Change of target angle and does<br>not impact the image sequence output<br>quality. Both the focal spot size and<br>target angle have been assessed in the<br>data sets sent to board-certified<br>radiologist and found to be of diagnostic<br>quality. |
| | | | |
| Tube Housing | Same except for shape of<br>aperture | Enlarged to account<br>for the rotating<br>anode tube | The updated Tube housing was designed<br>with the same principles as the previous<br>version but is designed for the updated<br>Imaging requirements.<br>While the tube housing has been made<br>larger, the collimation ensures that the<br>output is kept as low as possible and only<br>exposes the active imaging area of the<br>panel.<br>All electrical changes have been verified<br>by third party to meet IEC 60601-1<br>testing, including all particular and<br>collateral standards (specifically 60601-1-<br>2, 60601-1-3, and 60601-2-44). |
| High Voltage<br>Power Supply | High frequency generator | High frequency<br>generator updated to<br>allow for the<br>increased output<br>requirements | The updated High Voltage Power supply<br>utilizes the same design principles as the<br>previous version but is designed for the<br>updated Imaging requirements.<br>All electrical changes have been verified<br>by third party IEC 60601-1 testing,<br>including all particular and collateral<br>standards (specifically 60601-1-2, 60601-<br>1-3, and 60601-2-44). |
| Tube voltage | 100-130 kVP for CT scans | 100-120 kVP for CT<br>scans | Previous imaging protocols were limited<br>by the system requirements.<br>Bench testing determined optimal X-Ray<br>tube voltage (imaging characteristics) for<br>each anatomy and patient size.<br>Imaging characteristics have been<br>optimized for clinical diagnostic quality.<br>(especially for larger patients, based on<br>anatomy).<br>Labeling has been updated in alignment<br>with the new tube voltage range. |
| Tube current | 5.5 or 6.5 mA | 12 or 20 mA | Previous imaging protocols were limited<br>by the system requirements.<br>Bench testing determined optimal tube<br>current (imaging characteristics) for each<br>anatomy and patient size.<br>Imaging characteristics have been<br>optimized for clinical diagnostic quality. |
| Scan time | 26 sec for CT | 26 to 60 sec | (especially for larger patients, based on anatomy).<br>Labeling has been updated in alignment with the new tube current range.<br>Bench testing determined optimal imaging characteristics for each anatomy and patient size.<br>Based on device design, maintaining an appropriate duty cycle is critical.<br>Increases in mAs require longer scan times to maintain device duty cycle.<br>Labeling has been updated in alignment with the new scan times. |
| Max exposure time | 15 sec | 26 sec | Bench testing determined optimal imaging characteristics for each anatomy and patient size. Higher energy (exposure time) imaging protocol is proposed to enhance the image characteristics of hip scans (especially for larger patients, based on anatomy).<br>Labeling has been updated in alignment with the new max exposure times. |
| Image detector | Amorphous Silicon flat panel | No changes | |
| Reconstruction Algorithm | Filtered back projection with non-linear filtering for 3D Cone-Beam CT reconstruction | No changes | |
| Gray scale | 16 bit | No changes | |
| 3D Imaging Volume | Large FOV: 7.7" (19.5cm) height x 15.79" (40.1cm) diameter<br>Medium FOV: 7.7" (19.5cm) height x 9.9" (25.2cm) diameter | Large FOV: 7.67" (19.5cm) height x 16.53" (42.0 cm) diameter*<br>Medium FOV: 7.67" (19.5cm) height x 9.84" (25.0 cm) diameter*<br>*Reconstructed Imaged Volume | Slight changes to the imaging volume are based on the new Tube housing design (see Tube housing comparison).<br>The imaging volumes were reviewed by a board-certified radiologist and found to be of diagnostic quality.<br>Labeling has been updated in alignment with the new Imaging volumes. |
| | Typical resolution | LFOV: 0.3mm, MFOV: 0.25mm | Typical resolution defined by anatomy imaged |
| | | | |
| | | 0.25 mm, 0.3 mm, 0.5 mm | board-certified radiologist and found to be of diagnostic quality. |
| | | | Labeling has been updated in alignment with the changes in protocol resolution. Minor specific protocol changes from the predicate device and are covered under the intended use (lower extremity) of both the predicate and updated HiRise. Removal of humerus, forearm (radius/ulna) particular protocols were deemed not critical as imaging of these partial anatomy protocols has not been utilized in real-world use. The specific humerus and forearm protocols configurations have been removed in the updated HiRise. Labeling has been updated in alignment with body parts imaged. |
| Body part scanned | Upper and lower extremities, including the Humerus, Elbow, Forearm (radius/ulna), Hand, Wrist, Hip, Femur, Knee, Shin (lower leg or tib/fib) and Ankle, and Foot. | Upper and lower extremities, including the Elbow, Hand, Wrist, Pelvis, Hip, Femur, Knee, shin (lower leg or tib/fib), Ankle, and Foot. | |
| Size, inches h x d x w | 57"x58"x73" (145cm x 147cm x 185cm) | No changes | |
| Weight, lbs | Scanner 850 lbs (385.554 kg), Transporter 250 lb (113.398 kg) | Weight changed to 900lbs | Increased weight of tube housing plus Added counterweight. Both Devices were designed to be as small as possible and to be installed in a professional medical environment with minimal modifications. Labeling has been updated in alignment with the new scanner weight. |
| Power Requirements | 920VA | 4800 VA | The power consumption has increased from the predicate in alignment with the updated imaging characteristics. All electrical changes have been verified by third party 60601-1 testing, including all particular and collateral standards (specifically 60601-1-2, 60601-1-3, and 60601-2-44). Labing has been updated in alignment with the new power requirements. |
| Tissue Density Range | 0 to 2000 HU's (Hounsfield Units) | No changes | |
| Scatter Radiation Range | 0.0003 to 4.83mR | 0.2 to 12.9mR | When comparing the new scatter measurement numbers to the predicate, |
| | | | expected as higher energy imaging<br>protocols are proposed to enhance the<br>image characteristics of hip scans<br>(especially for larger patients, based on<br>anatomy).<br>The scatter radiation is in alignment with<br>the increased imaging protocols and has<br>not increased outside of the expected<br>amount.<br>Labeling has been updated in alignment<br>with the new scatter numbers. |
| Patient Support<br>Structure | Flat plastic platform and<br>handlebars for weight-bearing<br>imaging sequences, positioner<br>plate for knee, transporter<br>accessory for non-weight-bearing<br>imaging sequences | No changes | |
| Detector<br>Position | Source to Imager Distance Fixed<br>distance from detector to x-ray<br>beam center, parallel to axis of<br>rotation and orthogonal to x-ray<br>beam. | No changes | |
| X-Ray Beam<br>Position | Beam size matches the 40cm x<br>30cm flat panel (with a narrow<br>unexposed margin), there are two<br>vertical beam offsets from panel<br>center: beam offset below the<br>panel center for foot scans, and<br>beam offset above the panel<br>center for other extremity scans | Beam size matches<br>the 40cm x 30cm flat<br>panel (with a narrow<br>unexposed margin),<br>there are two<br>vertical beam offsets<br>from panel center:<br>Beam offset below<br>the panel center is<br>utilized for foot scans<br>or any protocols that<br>are continuous and<br>combine with the<br>foot. Beam offsets<br>above the panel<br>center for other<br>extremity scans | The slight change in the definition of<br>beam position was included in the<br>datasets sent to the board-certified<br>radiologist and found to be of diagnostic<br>quality. |
| Software<br>Capture Tool | Virtualized Windows environment<br>based application | No changes | There is new version of the software to<br>include the updated imaging protocols.<br>The application is still a virtualized<br>windows environment-based application. |
| Display | Computer with mouse and<br>keyboard | No changes | |
| Projection<br>Geometry | Beam collimated to a square<br>shape, Source to Imager Distance: | Beam collimated to a<br>square shape, Source<br>to Imager Distance: | Slight changes to the projection<br>geometry are based on the new Tube |
| | | | |
| | 767 mm, Source to Axis of<br>rotation Distance: 503 mm | 730.55 mm, Source<br>to Axis of rotation<br>Distance: 466.95 mm | housing design (see Tube housing<br>comparison).<br>Performance testing demonstrated that<br>new geometry does not harm image<br>quality.<br>The imaging volumes were reviewed by a<br>board-certified radiologist and found to<br>be of diagnostic quality. |
| Patient<br>Positioning<br>Guide | Foot: Circular markings on<br>platform<br>Knee/Hips: Accumeasure controls<br>height of the Gantry<br>Upper Extremity: Marks on upper<br>extremity platform insert | No changes | |
| Patient<br>Contacting<br>Material | Powder coated Aluminum<br>(Handlebar and Device cover),<br>Polyester Vinyl, Carbon fibers | Powder coated<br>Aluminum<br>(Handlebar and<br>Device cover),<br>Polyester Vinyl,<br>Carbon fibers,<br>Nylon (fastener for<br>hand platform &<br>Shielding curtain)<br>and Polycarbonate | Minor material changes, biocompatibility<br>assessed in alignment with 10993 and do<br>not impact the safety of the device.<br>The instructions for use regarding contact<br>with the machine on the predicate and<br>new version have not changed. The User<br>Manual on both devices recommends<br>avoiding direct contact with the scanner<br>using readily available materials. |
| Reconstruction<br>Method | Filtered back pro…