LineUp

K180727 · Curvebeam, LLC · JAK · May 11, 2018 · Radiology

Device Facts

• Record ID: K180727
• Device Name: LineUp
• Applicant: Curvebeam, LLC
• Product Code: JAK · Radiology
• Decision Date: May 11, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Pediatric, 3rd-Party Reviewed

Intended Use

The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures. It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions. This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs *2D Imaging not intended for pediatric use

Device Story

LineUP is a Cone Beam Computed Tomography (CBCT) system for extremity imaging. Input: 360-degree rotational X-ray projection sequences. Transformation: Gantry assembly with X-ray source and CMOS flat panel detector acquires projections; software reconstructs 3D volumetric images using filtered back projection with non-linear filtering; also captures 2D plain X-ray projections. Output: 3D volumetric images and 2D X-ray images sent to DICOM-compliant viewing software. Used in hospitals, private practices, and orthopedic clinics by clinicians. Patient positioning: standing platform for feet/ankles; reclining transporter for hand/elbow/non-weight-bearing feet. Benefits: enables diagnostic assessment of fractures and joint spaces in extremities. Clinical decision-making: provides high-resolution anatomical visualization for orthopedic diagnosis and treatment planning.

Clinical Evidence

Bench testing only. Performance verified via image quality phantom scans evaluated by a medical physicist and clinical review of anatomic hand, foot, elbow, and knee phantom scans by a board-certified radiologist, confirming diagnostic quality. CMOS detector performance verified as equivalent or superior to predicate. Compliance with IEC 60601-2-54 for 2D X-ray performance and safety standards confirmed.

Technological Characteristics

CBCT system; CMOS flat panel detector; high-frequency generator; 100/120 kVp (CT), 60 kVp (2D); 0.3 mm voxel resolution. Materials: polyester, vinyl, carbon fiber, Lexan, powder-coated aluminum. Connectivity: DICOM-compliant. Reconstruction: Filtered back projection with non-linear filtering. Standards: AAMI ES60601-1, IEC 60601-1, IEC 60601-1-3, IEC 60601-2-44, IEC 60601-2-54, IEC 62304, NEMA PS 3.1-3.20.

Indications for Use

Indicated for 3D imaging and 2D plain X-ray of foot, knee, hand, and elbow regions in pediatric (3D only) and adult patients (50-400 lbs) to assess osseous and soft tissue structures, joint spaces, bone angles, and fractures.

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

• PedCat (K113548)

Reference Devices

• HF 718BD X-Ray System (K160857)

Submission Summary (Full Text)

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May 11, 2018

CurveBeam, LLC % Mr. Dave Yungvirt, CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place MILLBURN NJ 07041

Re: K180727

Trade/Device Name: LineUP Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 30, 2018 Received: May 1, 2018

Dear Mr. Yungvirt:

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. 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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K180727

Device Name LineUP

#### Indications for Use (Describe)

The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.

It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions.

This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs

*2D Imaging not intended for pediatric use

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 5 510(k) Summary - K180727

# Contents

| Table 5-1 Device Information |
|--------------------------------------------------------------------|
| Predicate Device: |
| Indications for Use: |
| Device Description: |
| Device Characteristics and Performance |
| Key Device Components |
| Environment of Use |
| Patient Contacting Materials |
| Table 5-3 pedCAT Substantial Equivalence Technical Characteristics |
| Substantial Equivalence Discussion: |
| 2D X-Ray Imaging |
| Safety and Effectiveness Information: |
| Conformity |
| FDA Guidance |
| Conclusion: |

# Table 5-1 Device Information

| 510 (k) Submitter/Owner | CurveBeam, LLC<br>175 Titus Ave, Suite 300<br>Warrington, PA 18976<br>Phone: [phone]<br>Fax: [phone] |
|-------------------------|----------------------------------------------------------------------------------------------------------------|
| Contact Person | Stuti Singh<br>Senior Project Engineer<br>267-483-8081<br>Email: [e-mail] |
| Date Prepared | April 26, 2018 |
| Trade Name | LineUP |
| Common Name | Computed tomography x-ray system |

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| Classification Name | Computed tomography x-ray system |
|-----------------------|----------------------------------|
| Product Code | JAK |
| 510(k) Type | Traditional |
| Regulation Number | 892.1750 |
| Device Classification | Class II |

This is the first 510(k) submission for this device. There were no prior submissions.

## Predicate Device:

Table 5-2 Predicate Device

| Company | Device name | Product<br>Code | 510(k) | Regulation Number | Device<br>Classification |
|-------------------|-------------|-----------------|---------|-------------------|--------------------------|
| CurveBeam,<br>LLC | PedCat | JAK | K113548 | 892.1750 | Class II |

## Indications for Use:

The LineUP is intended to be used for 3-D imaging of the foot, knee, hand, and elbow regions to visualize and assess the osseous and certain soft tissue structures, including joint spaces, bone angles and fractures.

It is also intended to capture 2-D images (standard plain x-ray projections) of the foot, knee, hand, and elbow regions.

This modality is anticipated to be applicable to pediatric* cases as well as adults, when appropriate diagnosis of a given condition is considered necessary. Patient parameters: 50 lbs to 400 lbs

*2D Imaging not intended for pediatric use

## Device Description:

#### Device Characteristics and Performance

The LineUP 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. It can also capture 2D plain X-Ray projections. The device uses a gantry assembly, which is comprised of an X- ray source, image detector, and a motorized gantry facilitates the acquisition of a full X-ray projection sequence by the acquisition software. For hand and elbow scans, a patient transporter accessory allows the patient to sit and then recline into a position where he/she can comfortably place his/her anatomy into the imaging bore. The transporter can also be configured to permit a seated non-weight bearing scan of the feet.

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 knee regions. The LineUP provides total vertical travel of 17 inches to accommodate patients of various sizes. Images produced by the LineUP can be sent electronically to a DICOM complaint image viewing software.

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#### Key Device Components

- Embedded Controller CMOS Flat Panel Detector Gantry Assembly X-Ray Source X-Ray Power Supply Patient Platform and Positioners Patient Transporter Operator Control Box External Server
#### Environment of Use

The LineUP is to be used in medical facilities including hospitals, private practices, and orthopedic clinics. The LineUP should be installed and operated according to state and federal regarding radiation-emitting products and the device room layout should be approved by a certified medical physicist prior to 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
- (4) Lexan panel shield
- (5) Powder coated Aluminum handlebars

| Feature or<br>Component | CurveBeam LineUP Computed<br>tomography x-ray system | CurveBeam pedCAT Computed<br>tomography x-ray system | Variance Explanation |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) number | JAK | K113548 | |
| Product code | JAK | JAK | |
| Regulation<br>number | 21 CFR 892.1750 | 21 CFR 892.1750 | |
| Indications for<br>Use | The LineUP is intended to be<br>used for 3-D imaging of the<br>foot, knee, hand, and elbow<br>regions to visualize and assess<br>the osseous and certain soft<br>tissue structures, including<br>joint spaces, bone angles and<br>fractures.<br>It is also intended to capture 2-<br>D images (standard plain x-ray<br>projections) of the foot, knee,<br>hand, and elbow regions. | The PedCAT is intended to be used<br>for 3-D imaging of the foot & ankle<br>region, to visualize and<br>assess the osseous and certain soft<br>tissue structures, including joint<br>spaces, bone angles and<br>fractures. This modality is<br>anticipated to be applicable to<br>pediatric* cases as well as adults*,<br>when appropriate diagnosis of a<br>given foot condition is considered<br>necessary. | Datasets of foot, knee, hand, and<br>elbow regions were reviewed by a<br>board-certified radiologist and found<br>to be of diagnostic quality. |
| | This modality is anticipated to<br>be applicable to pediatric*<br>cases as well as adults, when<br>appropriate diagnosis of a<br>given condition is considered<br>necessary. Patient parameters:<br>50 lbs to 400 lbs<br>*2D Imaging not intended for<br>pediatric use | * Patient parameters: Weight<br>range for pediatric patients: 50 lbs<br>to 99 lbs, adult patients: 100 lbs to<br>400 lbs; plus<br>Groin region at least 22" above the<br>floor | |
| Principle of<br>Operation | Cone Beam Computed<br>Tomography X-Ray<br>and<br>2D Standard Plain X-Ray<br>projections | Cone Beam Computed Tomography<br>X-Ray | For 2-D X-Rays, The LineUP was tested<br>to IEC 60601-2-54: Medical electrical<br>equipment - Part 2-54: Particular<br>requirements for the basic safety and<br>essential performance of X-ray<br>equipment for radiography and<br>radioscopy and was found to meet all<br>performance requirements.<br><br>A medical physicist did performance<br>and image quality tests on X-Ray<br>Images and found them to meet<br>industry standards.<br><br>A radiologist reviewed 2D images of<br>the foot, knee, hand and elbow and<br>found them to be of diagnostic<br>quality. |
| Scan axis | Horizontal | Horizontal | |
| Mechanical<br>Layout | A horizontal doughnut, with<br>the x-ray source and flat panel<br>detector mounted at each end<br>of a rotating gantry. Gantry<br>assembly lifts for scanning of<br>the knee. Reclining Transporter<br>allows for positioning of hand<br>or elbow in bore. | A horizontal doughnut, with the x-<br>ray source and flat panel detector<br>mounted at each end of a rotating<br>gantry. | Knee hand and elbow are new<br>indications but use same CBCT<br>concept as foot scan |
| Controller | Firmware Exposure Controller | Firmware Exposure Controller | |
| Tube | Same in both devices | Same in both devices | |
| Tube Housing | Same except for shape of<br>aperture | Same except for shape of aperture | New aperture allows for wider X-Ray<br>beam angle |
| High Voltage<br>Power Supply | High frequency generator | High frequency generator | |
| Tube voltage | 100 and 120 kVP for CT scans<br>60 kVp for 2D X-Rays | 100 and 120 kVP for CT scans | The LineUP was tested to IEC 60601-2-<br>54: Medical electrical equipment - Part<br>2-54: Particular requirements for the<br>basic safety and essential<br>performance of X-ray equipment for<br>radiography and radioscopy and was<br>found to meet all performance<br>requirements. |
| | | | Bench testing determined optimal 2D |
| | | | X-Ray tube voltage for each anatomy |
| | | | and patient size |
| Tube current | 5 mA | 5 mA | |
| Scan time | 21 sec for CT<br>0.15-1.3 sec for X-Ray | 17 and 56 sec for CT | CT: LineUP utilizes a single-orbit half<br>fan mode to capture a larger volume<br>instead of utilizing two full orbits with<br>the panel offset on either side like the<br>pedCAT. Image quality performance<br>was verified with Bench Testing. |
| | | | X-Ray: Bench testing determined<br>optimal exposure time for each<br>anatomy and patient size |
| Max exposure<br>time | 6 sec for CT<br>1.3 sec for 2D X-Ray | 9 sec | LineUP utilizes a single-orbit half fan<br>mode to capture a larger volume<br>instead of utilizing two full orbits with<br>the panel offset on either side like the<br>pedCAT. Image quality performance<br>was verified with Bench Testing. |
| Image detector | CMOS flat panel | Amorphous Silicon flat panel | Detector performance testing verified<br>image quality met requirements |
| Reconstruction<br>Algorithm | Filtered back projection with<br>non-linear filtering for 3D<br>Cone-Beam CT reconstruction | Feldkamp-Davis-Kress (FDK)<br>algorithm for 3D Cone-Beam CT<br>reconstruction | New reconstruction method's<br>performance has been evaluated in<br>bench testing and found to be<br>equivalent to predicate method |
| Gray scale | 14 bit | 14 bit | |
| 3D Imaging<br>Volume | 20cm (high) x 35 cm (diameter) | 20cm (high) x 35 cm (diameter) | |
| Typical<br>resolution | 0.3 mm voxel | 0.3 mm voxel | |
| Body part<br>scanned | Foot, knee, hand, elbow | Foot and ankle | Datasets of foot, knee, hand, and<br>elbow were reviewed by a radiologist<br>in Section 37 |
| Size, inches<br>h x d x w | 50"x63"x49" | 47"x59"x48" | |
| Weight, lbs | Scanner 750 lbs (340 kg),<br>Transporter 250 lb (113 kg) | Scanner 400 lbs | LineUP is larger and has more<br>components to accommodate<br>additional anatomy and has an<br>additional transporter device |
| Power<br>Requirements | 1150VA | 1150VA | |
| Tissue Density<br>Range | 0 to 2000 HU's (Hounsfield<br>Units) | 0 to 2000 HU's (Hounsfield Units) | |
| Scatter<br>Radiation<br>Range | .001 to .18 mR | .005 to .503 mR | |
| Patient Support<br>Structure | Flat plastic platform and<br>handlebars for weight-bearing<br>foot/ankle, positioner plate for<br>knee, transporter accessory for<br>hand, elbow and non-weight-<br>bearing foot | Flat plastic platform and<br>handlebars for weight-bearing<br>foot/ankle, seat for non-weight<br>bearing foot/ankle | New support structures permit<br>scanning of additional anatomical<br>regions. Support structures tested to<br>applicable safety standards. |

## JCAT Cubatantial Cauivolonao Toghniaal Ch

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| Detector<br>Position | | X-Ray Beam<br>Position | Software<br>Capture Tool | Display | Projection<br>Geometry | Patient<br>positioning<br>guide | Patient<br>Contacting<br>Materials |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detector<br>Position | Source to Imager Distance<br>Fixed distance from detector to<br>x-ray beam center, parallel to<br>axis of rotation and orthogonal<br>to x-ray beam. | X-Ray Beam<br>Position | Beam size matches the 31cm x<br>31cm flat panel (with a narrow<br>unexposed margin), there are<br>two vertical beam offsets from<br>panel center: beam offset<br>below the panel center for foot<br>scans, and beam offset above<br>the panel center for knee, hand<br>and elbow scans | Software<br>Capture Tool | Virtualized Windows<br>environment based application | Display | Computer with mouse and<br>keyboard |
| | | | Beam size matches the 30cm x<br>30cm flat panel detector (with a<br>narrow unexposed margin), the<br>beam center is vertically positioned<br>below the panel center (towards<br>the bottom of the FOV) where the<br>densest bones in the foot are<br>located. | | | | |
| | | | LineUP has a second offset to x-ray<br>beam center for knee, hand and<br>elbow scans | | | | |
| | | Software<br>Capture Tool | Virtualized Windows environment<br>based application | | | | |
| | | Display | Computer with mouse and<br>keyboard | | | | |
| | | Projection<br>Geometry | Beam collimated to a square<br>shape, Source to Imager Distance:<br>767 mm, Source to<br>Axis of rotation Distance: 528<br>mm | | Beam collimated to a square<br>shape, Source to Imager Distance:<br>734 mm,<br>Source to Axis of rotation Distance:<br>536mm | | Slightly different geometry<br>accommodates patients with wider<br>hips to receive a knee scan in the<br>LineUP. Performance testing<br>demonstrated that new geometry<br>does not harm image quality. |
| | | Patient<br>positioning<br>guide | Foot: Circular Markings on<br>Platform<br>Knees: Markings on Knee<br>Positioner<br>Hand and Elbow: Marks on<br>Hand and Elbow platform<br>insert | | Foot/ Ankle: Circular Markings on<br>Platform<br>Knees: N/A<br>Hand and Elbow: N/A | | LineUP includes additional positioning<br>guides for new anatomies |
| | | Patient<br>Contacting<br>Materials | (1) Polyester patient platform<br>lining (2) Vinyl Transporter<br>cushion (3) carbon fiber<br>positioners (4) Lexan panel<br>shield (5) Powder coated<br>Aluminum handlebars | | (1) the non-conducting Autoflex<br>EBG (Polyester) patient support (2)<br>the powder coated aluminum hand<br>rails | | The instructions for use regarding<br>contact with the machine on the<br>pedCAT and LineUP are similar. The<br>User Manual on both devices<br>recommends avoiding direct contact<br>with the scanner using readily<br>available materials. |

#### Substantial Equivalence Discussion:

The overall technology, key components and intended use of the LineUP Computed Tomography x-ray system and the predicate device are substantially similar, with certain inconsequential differences described henceforth.

Both the LineUP and pedCAT devices image extremities of similar bone density ranges and utilize a similar gantry to capture the desired anatomy. They are both able to scan feet in a bilateral position. The LineUP has an added capability to elevate the gantry and scan the knees, as well as a transporter accessory to assist in scanning the hand and elbow. The additional support structures on the LineUP have been tested to applicable safety standards. Images of the additional anatomy have been reviewed by a radiologist and

CurveBeam, LLC - LineUP 510(k) Application

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have been found to be of adequate diagnostic quality.

To establish equivalency in performance, an image quality phantom was scanned in the LineUP and evaluated by a medical physicist. Anatomic hand, foot, elbow, and knee phantom scans were also reviewed by a radiologist and found to be of diagnostic quality.

The LineUP uses the same X-Ray tubehead and a similar power supply as the PedCat. The LineUP utilizes a CMOS flat panel image detector while the PedCat uses an amorphous silicon flat panel detector to capture projection images. Performance testing demonstrated that the image quality of the CMOS detector is statistically equivalent or superior to that of the predicate.

The combination of performance testing by a medical physicist, safety and functional testing by a certified third-party testing body, and clinical review of images by a radiologist indicate that LineUP is safe and effective when used as labeled.

#### 2D X-Ray Imaging

Since the predicate device does not capture 2D Plain X-Ray projections, a reference device was used to evaluate the technical performance characteristics of this feature. Information about the reference device is presented in Table 5-4.

| Company | Device name | Product Code | 510(k) | Regulation Number | Device Classification |
|-------------------------|-----------------------|--------------|---------|-------------------|-----------------------|
| X-Cel X-Ray Corporation | HF 718BD X-Ray System | KPR | K160857 | 892.1680 | Class II |

#### Table 5-4 Reference Device

2D X-Ray performance bench testing was done and the LineUP was found to perform to industry standards. A board certified radiologist reviewed X-Ray images of the foot, knee, hand, and elbow regions and found them to be of diagnostic quality. The LineUP was also tested to IEC 60601-2-54: Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy and was found to meet all safety and performance requirements.

The described tests and features establish that the LineUP produces diagnostic quality 2D X-Rays in a safe and effective manner, similar to the currently marketed X-Cel X-Ray Corporation HF 718BD X-Ray System.

#### Safety and Effectiveness Information:

The LineUP Computed Tomography X-ray system is a Class II medical device.

The LineUP Computed Tomography X-ray system complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices.

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## Conformity

The LineUP device has been tested to the following standards to ensure safety, effectiveness, and compliance with industry norms:

AAMI ES60601-1:2005+C1; A2 IEC 60601-1:2005, 3rd Edition+C1; C2; A1 IEC 60601-1-3, Edition 2.1, 04/2013 IEC 60601-1-6, Edition 3.1, 10/2013 IEC 62366, Edition 1.1, 01/2014 IEC 62304:2006 Ed.1 +A1 IEC 60601-2-44, Edition 3.1, 09/2012 IEC 60601-2-54:2009Ed.1+C1; C2; A1 IEC 60601-1-2, Edition 4, 02/2014 IEC 61223-3-5, first edition, 08/2004 NEMA PS 3.1-3.20, 2016

### FDA Guidance

The following FDA Guidance Documents were referenced to the extent they were applicable in the preparation of this 510(k) Submission

- . Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography
- Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices
- Guidance for the Submission Of Premarket Notifications for Medical Image Management Devices
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
- Applying Human Factors and Usability Engineering to Medical Devices
- Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices
- Content of Premarket Submissions for Management of Cybersecurity in Medical Devices
- Guidance for Industry, FDA Reviewers and Compliance on Off-The-Shelf Software Use in Medical Devices
- . Pediatric Information for X-ray Imaging Device Premarket Notifications

# Conclusion:

CurveBeam, LLC has demonstrated through its comparison of characteristics with the predicate device and comparison of performance data with the predicate device that the LineUP Computed Tomography X-ray System is substantially equivalent to the predicate device.