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

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called "LineUP," a Computed Tomography X-ray system. Here's a breakdown of the acceptance criteria and supporting study details:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantified, pass/fail manner. Instead, it describes performance in terms of diagnostic quality and equivalence to predicate/reference devices.

Feature / Criterion (Implicit)	Reported Device Performance (LineUP)
3D Imaging Diagnostic Quality (Foot, Knee, Hand, Elbow)	Datasets of foot, knee, hand, and elbow regions were reviewed by a board-certified radiologist and found to be of diagnostic quality. Anatomic hand, foot, elbow, and knee phantom scans were also reviewed by a radiologist and found to be of diagnostic quality. Performance testing by a medical physicist with an image quality phantom also confirmed diagnostic quality.
2D Imaging Diagnostic Quality (Foot, Knee, Hand, Elbow)	The LineUP was tested to IEC 60601-2-54 and met all performance requirements. A medical physicist did performance and image quality tests on X-Ray Images and found them to meet industry standards. A radiologist reviewed 2D images of the foot, knee, hand and elbow and found them to be of diagnostic quality.
Equivalence of Image Quality (vs. PedCAT for CT)	Performance testing demonstrated that the image quality of the CMOS detector (LineUP) is statistically equivalent or superior to that of the amorphous silicon flat panel detector of the predicate device (PedCAT). New reconstruction method's performance has been evaluated in bench testing and found to be equivalent to predicate method. Performance testing by a medical physicist with an image quality phantom confirmed equivalence.
2D Imaging Performance (vs. X-Cel X-Ray System for 2D)	Bench testing was done and the LineUP was found to perform to industry standards. The LineUP was also tested to IEC 60601-2-54 and was found to meet all safety and performance requirements.
Safety and Effectiveness	Complies with applicable FDA and international standards pertaining to electrical, mechanical, software, EMC, and radiation safety of medical devices (AAMI ES60601-1, IEC 60601-1-3, IEC 60601-1-6, IEC 62366, IEC 62304, IEC 60601-2-44, IEC 60601-2-54, IEC 60601-1-2, IEC 61223-3-5, NEMA PS 3.1-3.20).
Patient Parameter Range	50 lbs to 400 lbs (same as predicate for adult weight range, with extension down to 50 lbs for pediatric cases in 3D).
Support Structures Safety	New support structures (for knee, hand, elbow) tested to applicable safety standards.
Geometric Differences (Source to Imager/Axis Distance)	Performance testing demonstrated that new geometry does not harm image quality.

2. Sample Sizes used for the test set and data provenance:

Sample Size for Test Set: The document does not provide specific numerical sample sizes for the "datasets of foot, knee, hand, and elbow regions" or "anatomic hand, foot, elbow, and knee phantom scans" that were reviewed by radiologists. It refers to these as "datasets" and "anatomic phantom scans" without quantification. For 2D X-ray images, it states "X-Ray images of the foot, knee, hand, and elbow regions" were reviewed, again without a specific number.
Data Provenance: Not explicitly stated. The context implies that the data would be internal to CurveBeam's testing, likely from phantom studies and potentially some clinical volunteers for the specific anatomies scanned. It does not mention country of origin or whether it's retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Multiple instances refer to "a board-certified radiologist" (singular) reviewing images for diagnostic quality. It also mentions "a medical physicist" for technical image quality assessments.
Qualifications of Experts: For clinical image review, the expert is identified as "a board-certified radiologist." For technical performance, the expert is "a medical physicist." No specific years of experience are provided.

4. Adjudication method for the test set:

The document describes a sole expert review (a single board-certified radiologist and a single medical physicist). There is no mention of an adjudication process (such as 2+1, 3+1) because only one expert appears to have been involved in each specific type of review.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not conducted or described. The LineUP device is an imaging system, not an AI-assisted diagnostic tool for interpretation. The study focused on assessing the diagnostic quality of images produced by the device itself and its equivalence to predicate devices, not on comparing human reader performance with or without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, the performance evaluations described are essentially "standalone" in the context of the device itself.
- For 3D CT imaging, the device's image quality was assessed by a medical physicist using phantoms and by a radiologist reviewing datasets and anatomical phantom scans for diagnostic quality.
- For 2D X-ray imaging, technical performance was bench-tested against industry standards and reviewed by a medical physicist and a radiologist.
- The focus is on the device's ability to produce diagnostic-quality images, not on its ability to interpret those images or interact with a human reader's workflow.

7. The type of ground truth used:

The ground truth for image quality and diagnostic utility appears to be primarily expert consensus/opinion by a board-certified radiologist for clinical aspects and a medical physicist for technical aspects.
For technical performance (e.g., meeting IEC standards, detector performance, reconstruction algorithm performance), the ground truth is established through bench testing against established industry standards and internal performance requirements.

8. The sample size for the training set:

The document does not provide information regarding a specific "training set" or its sample size. This is typical for a 510(k) submission for an imaging device, which primarily demonstrates image quality and safety, rather than an AI/ML algorithm that requires training data.

9. How the ground truth for the training set was established:

Since no specific training set is mentioned in the document, there is no information on how ground truth for such a set was established.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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

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, LLC175 Titus Ave, Suite 300Warrington, PA 18976Phone: 267-483-8081Fax: 267-483-8086
Contact Person	Stuti SinghSenior Project Engineer267-483-8081Email: Stuti.singh@curvebeam.com
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	ProductCode	510(k)	Regulation Number	DeviceClassification
CurveBeam,LLC	PedCat	JAK	K113548	892.1750	Class II

Indications for Use:

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 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 orComponent	CurveBeam LineUP Computedtomography x-ray system	CurveBeam pedCAT Computedtomography x-ray system	Variance Explanation
510(k) number	JAK	K113548
Product code	JAK	JAK
Regulationnumber	21 CFR 892.1750	21 CFR 892.1750
Indications forUse	The LineUP is intended to beused for 3-D imaging of thefoot, knee, hand, and elbowregions to visualize and assessthe osseous and certain softtissue structures, includingjoint spaces, bone angles andfractures.It is also intended to capture 2-D images (standard plain x-rayprojections) of the foot, knee,hand, and elbow regions.	The PedCAT is intended to be usedfor 3-D imaging of the foot & ankleregion, to visualize andassess the osseous and certain softtissue structures, including jointspaces, bone angles andfractures. This modality isanticipated to be applicable topediatric* cases as well as adults*,when appropriate diagnosis of agiven foot condition is considerednecessary.	Datasets of foot, knee, hand, andelbow regions were reviewed by aboard-certified radiologist and foundto be of diagnostic quality.
	This modality is anticipated tobe applicable to pediatriccases as well as adults, whenappropriate diagnosis of agiven condition is considerednecessary. Patient parameters:50 lbs to 400 lbs2D Imaging not intended forpediatric use	* Patient parameters: Weightrange for pediatric patients: 50 lbsto 99 lbs, adult patients: 100 lbs to400 lbs; plusGroin region at least 22" above thefloor
Principle ofOperation	Cone Beam ComputedTomography X-Rayand2D Standard Plain X-Rayprojections	Cone Beam Computed TomographyX-Ray	For 2-D X-Rays, The LineUP was testedto IEC 60601-2-54: Medical electricalequipment - Part 2-54: Particularrequirements for the basic safety andessential performance of X-rayequipment for radiography andradioscopy and was found to meet allperformance requirements.A medical physicist did performanceand image quality tests on X-RayImages and found them to meetindustry standards.A radiologist reviewed 2D images ofthe foot, knee, hand and elbow andfound them to be of diagnosticquality.
Scan axis	Horizontal	Horizontal
MechanicalLayout	A horizontal doughnut, withthe x-ray source and flat paneldetector mounted at each endof a rotating gantry. Gantryassembly lifts for scanning ofthe knee. Reclining Transporterallows for positioning of handor elbow in bore.	A horizontal doughnut, with the x-ray source and flat panel detectormounted at each end of a rotatinggantry.	Knee hand and elbow are newindications but use same CBCTconcept 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 ofaperture	Same except for shape of aperture	New aperture allows for wider X-Raybeam angle
High VoltagePower Supply	High frequency generator	High frequency generator
Tube voltage	100 and 120 kVP for CT scans60 kVp for 2D X-Rays	100 and 120 kVP for CT scans	The LineUP was tested to IEC 60601-2-54: Medical electrical equipment - Part2-54: Particular requirements for thebasic safety and essentialperformance of X-ray equipment forradiography and radioscopy and wasfound to meet all performancerequirements.
			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 CT0.15-1.3 sec for X-Ray	17 and 56 sec for CT	CT: LineUP utilizes a single-orbit halffan mode to capture a larger volumeinstead of utilizing two full orbits withthe panel offset on either side like thepedCAT. Image quality performancewas verified with Bench Testing.
			X-Ray: Bench testing determinedoptimal exposure time for eachanatomy and patient size
Max exposuretime	6 sec for CT1.3 sec for 2D X-Ray	9 sec	LineUP utilizes a single-orbit half fanmode to capture a larger volumeinstead of utilizing two full orbits withthe panel offset on either side like thepedCAT. Image quality performancewas verified with Bench Testing.
Image detector	CMOS flat panel	Amorphous Silicon flat panel	Detector performance testing verifiedimage quality met requirements
ReconstructionAlgorithm	Filtered back projection withnon-linear filtering for 3DCone-Beam CT reconstruction	Feldkamp-Davis-Kress (FDK)algorithm for 3D Cone-Beam CTreconstruction	New reconstruction method'sperformance has been evaluated inbench testing and found to beequivalent to predicate method
Gray scale	14 bit	14 bit
3D ImagingVolume	20cm (high) x 35 cm (diameter)	20cm (high) x 35 cm (diameter)
Typicalresolution	0.3 mm voxel	0.3 mm voxel
Body partscanned	Foot, knee, hand, elbow	Foot and ankle	Datasets of foot, knee, hand, andelbow were reviewed by a radiologistin Section 37
Size, inchesh x d x w	50"x63"x49"	47"x59"x48"
Weight, lbs	Scanner 750 lbs (340 kg),Transporter 250 lb (113 kg)	Scanner 400 lbs	LineUP is larger and has morecomponents to accommodateadditional anatomy and has anadditional transporter device
PowerRequirements	1150VA	1150VA
Tissue DensityRange	0 to 2000 HU's (HounsfieldUnits)	0 to 2000 HU's (Hounsfield Units)
ScatterRadiationRange	.001 to .18 mR	.005 to .503 mR
Patient SupportStructure	Flat plastic platform andhandlebars for weight-bearingfoot/ankle, positioner plate forknee, transporter accessory forhand, elbow and non-weight-bearing foot	Flat plastic platform andhandlebars for weight-bearingfoot/ankle, seat for non-weightbearing foot/ankle	New support structures permitscanning of additional anatomicalregions. Support structures tested toapplicable safety standards.

JCAT Cubatantial Cauivolonao Toghniaal Ch

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DetectorPosition		X-Ray BeamPosition	SoftwareCapture Tool	Display	ProjectionGeometry	Patientpositioningguide	PatientContactingMaterials
DetectorPosition	Source to Imager DistanceFixed distance from detector tox-ray beam center, parallel toaxis of rotation and orthogonalto x-ray beam.	X-Ray BeamPosition	Beam size matches the 31cm x31cm flat panel (with a narrowunexposed margin), there aretwo vertical beam offsets frompanel center: beam offsetbelow the panel center for footscans, and beam offset abovethe panel center for knee, handand elbow scans	SoftwareCapture Tool	Virtualized Windowsenvironment based application	Display	Computer with mouse andkeyboard
			Beam size matches the 30cm x30cm flat panel detector (with anarrow unexposed margin), thebeam center is vertically positionedbelow the panel center (towardsthe bottom of the FOV) where thedensest bones in the foot arelocated.
			LineUP has a second offset to x-raybeam center for knee, hand andelbow scans
		SoftwareCapture Tool	Virtualized Windows environmentbased application
		Display	Computer with mouse andkeyboard
		ProjectionGeometry	Beam collimated to a squareshape, Source to Imager Distance:767 mm, Source toAxis of rotation Distance: 528mm		Beam collimated to a squareshape, Source to Imager Distance:734 mm,Source to Axis of rotation Distance:536mm		Slightly different geometryaccommodates patients with widerhips to receive a knee scan in theLineUP. Performance testingdemonstrated that new geometrydoes not harm image quality.
		Patientpositioningguide	Foot: Circular Markings onPlatformKnees: Markings on KneePositionerHand and Elbow: Marks onHand and Elbow platforminsert		Foot/ Ankle: Circular Markings onPlatformKnees: N/AHand and Elbow: N/A		LineUP includes additional positioningguides for new anatomies
		PatientContactingMaterials	(1) Polyester patient platformlining (2) Vinyl Transportercushion (3) carbon fiberpositioners (4) Lexan panelshield (5) Powder coatedAluminum handlebars		(1) the non-conducting AutoflexEBG (Polyester) patient support (2)the powder coated aluminum handrails		The instructions for use regardingcontact with the machine on thepedCAT and LineUP are similar. TheUser Manual on both devicesrecommends avoiding direct contactwith the scanner using readilyavailable 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.

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.