The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial, Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

The system is indicated for X-ray Computed Tomography imaging of organs that fit in the scan field of view, including cardiac and vascular CT imaging. The device output is useful for diagnosis of disease or abnormality and for planning of therapy procedures.

Device Description

The SpotLight Duo is a multi-slice (192 detector rows), dual tube CT scanner consisting of a gantry, patient table, operator console, power distribution unit (PDU) and interconnecting cables. The system includes image acquisition hardware, image acquisition and reconstruction software for operator interface and image handling. As in other CT scanned subject is irradiated by X rays and a detector array measures attenuation data of X rays that have been attenuated by the subject from multiple view angles. This is achieved by rotation source and the detector about the subject while acquiring the attenuation data. A computer is used to reconstruct cross sectional images of the subject from the attenuation data.

AI/ML Overview

The provided text describes the regulatory clearance of a medical device, the "SpotLight Duo," and its substantial equivalence to predicate devices based on non-clinical performance testing. However, it does not include detailed acceptance criteria or the specific results of a study designed to prove the device meets these criteria in the format requested.

Here's a breakdown of the missing information and what can be inferred:

1. A table of acceptance criteria and the reported device performance: This information is not explicitly provided in a table format with specific quantitative criteria and corresponding performance metrics. The document mentions "performance specifications are met" but does not detail what these specifications are.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): No information about sample size or data provenance is provided. The testing described is non-clinical performance testing using phantoms, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, as the testing described is non-clinical performance testing using phantoms. No human expert review for establishing ground truth is mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, as the testing described is non-clinical performance testing using phantoms.

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: An MRMC comparative effectiveness study was not done. The device is a CT scanner, not an AI-assisted diagnostic tool.

6. If a standalone (i.e., algorithm-only without human-in-the-loop performance) was done: The document describes non-clinical performance testing of the CT scanner hardware and software. It's essentially a standalone performance evaluation of the imaging system itself, independent of human interpretation for the purpose of demonstrating technical specifications.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical performance testing, the ground truth would be established by the known physical properties and configurations of the phantoms used, as well as established metrology and physics principles for evaluating CT image quality and dose.

8. The sample size for the training set: Not applicable. The device is a CT scanner, and the "training set" concept is typically associated with machine learning or AI models, which is not the primary focus of this submission. The software adaptations mentioned are for supporting new detector configurations, reconstruction at larger FOV, and scan modes based on engineering modifications, not machine learning model training.

9. How the ground truth for the training set was established: Not applicable for the reasons stated above.

In summary, the provided text describes a 510(k) premarket notification for a Computed Tomography X-ray System (SpotLight Duo). The "study" proving it meets acceptance criteria refers to a series of non-clinical performance tests using phantoms to demonstrate that the device's technical specifications - regarding image quality (spatial resolution, low contrast detectability, noise, uniformity, CT number accuracy) and dose performance - are met, and that it complies with relevant electrical safety and radiation protection standards.

The document does not contain information about clinical studies with human participants, expert review of images, or AI-specific performance metrics. It focuses on the physical and technical performance of the imaging device itself.

Summary

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

December 2, 2022

Arineta Ltd. % Tanya Shalem Director QA&RA 15 Halamish Street Caesarea. 3088900 ISRAEL

Re: K213465

Trade/Device Name: SpotLight Duo Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: November 4, 2022 Received: November 4, 2022

Dear Tanya Shalem:

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

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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 medical devices and radiation-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,

2022.12.02
10:54:01
-05'00'
Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known) K213465

Device Name SpotLight Duo

Indications for Use (Describe)

The SpotLight Duo is intended to produce cross-sectional images of the body by computer reconstruction of X-ray transmission projection data taken at different angles. The system has the capability to image whole organs, including the heart, in a single rotation. The system may acquire data using Axial. Cine and Cardiac scan techniques from patients of all ages. These images may be obtained either with or without contrast. This device may include signal analysis and display equipment, patient and equipment supports, components and accessories.

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

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

図 Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY Arineta's SpotLight Duo

Submitter

Arineta Ltd. 15 Halamish Street Caesarea 3088900 Israel Tel: +972-4-6374000 Fax: +972-4-6277006

Contact Person: Tanya Shalem, VP of QA&RA

Date Prepared: August 12, 2022

Name of Device: SpotLight Duo

Common or Usual Name: Computed Tomography X-ray System

Regulation Medical Specialty: Radiology

Regulation Number: 892.1750

Regulatory Class: Class II

Product Code: JAK

Predicate Devices

Device Name	Manufacturer	510(k) Number
SpotLight CT	Arineta Ltd.	K161066
Revolution CT	GE Healthcare LLC	K133705

Device Description

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The primary predicate, SpotLight CT (K161066), reconstructs high resolution images up to Field of View (FOV) 250mm. Scout images used for patient positioning and scan planning are reconstructed and displayed at a wide FOV larger than 250mm.

The primary changes in the modified SpotLight Duo device include two optional configurations:

1. Wide FOV reconstructs high resolution images up to 450mm FOV. 10 HR detector modules replace LR detector modules (as in the primary predicate) on one wing of the detector. Therefore, there are 33 HR modules instead of 23 HR modules. Although the HR part of the detector is asymmetric, the device is capable of imaging the entire FOV of 450mm at high resolution when acquiring data for 360° of rotation. The data from the LR wing is still used to avoid truncation artifacts.
1. Extended FOV reconstructs high resolution images up to 250mm FOV and 250-450mm low resolution FOV with no change to the detector.
. Both configurations include software adaptation to 450mm FOV. The software is modified to support data acquisition with the modified detector, reconstruction at larger FOV, scan modes and protocols according to confiquration.
. There is an additional minor adaptation to collimator to support wide FOV collimation (250mm/450mm).

Intended Use

The SpotLight Duo is intended to be used for body, cardiac and vascular X-ray Computed Tomography applications.

Indications for Use

This device may include data and image processing to produce images in a variety of trans-axial and reformatted planes.

Technological Characteristics

The system generates images through computed reconstruction of data acquired at different view angles of the rotating gantry, while irradiating the scanned subject by two alternating X-ray sources. The gantry rotates at up to 0.24 seconds per rotation and can acquire up to 560 overlapping 0.5mm slices of image data in a single axial scan with a maximum total coverage of 140mm in the z direction. While the basic scanner (SpotLight CT) covers a field of view (FOV) of 450mm, the radiation outside

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250mm (or 160mm) FOV is attenuated, providing diagnostic image quality up to 250mm FOV. With the Extended and Wide Field of View configurations, the system is adapted to provide standard resolution (STD) or high resolution (HR) diagnostic images at FOV 450mm. The system can be operated in axial (partial or full scan), cine, cardiac and ECG gated modes.

The SpotLight Duo features two MCS-2093 X-ray tubes to provide two X-ray sources displaced in the z axis (parallel to rotation axis). The sources are alternating using electrostatic grid control, such that the scanned subject is irradiated alternatively by two overlapping cone X-ray beams while the gantry rotates, and attenuation data is acquired by a single array detector. Image reconstruction is accomplished by a Stereo CT reconstruction algorithm based on common algorithms used in single source scanners that are modified to combine the data acquired from the two sources.

A table comparing the key features of the subject and predicate devices is provided below.

	Proposed device - SpotLightDuo	Primary predicate - SpotLightCT (K161066)	Secondary predicate -Revolution CT (K133705)	Discussion
Detectortechnologyandgeometry	Fast scintillator array coupled tophotodiode array.33 (WFOV) or 23 (EFOV)configurable high resolution (HR)modules comprising 192 detectorrows X pitch 0.5mm (Z direction,measured at scanner center).10(WFOV) or 20 (EFOV)configurable low resolution (LR).EFOV includes 10 modules oneach wing while WFOV includes10 modules on one wing.comprising 48 detector rows Xpitch 2.0mmAnalog to digital conversion perchannel on the detection module.1D antiscatter collimator.	Fast scintillator array coupled tophotodiode array.23 high resolution (HR) modulescomprising 192 detector rows Xpitch 0.5mm (Z direction,measured at scanner center).20 low resolution (LR) modules(10 on each wing) comprising 48detector rows X pitch 2.0mmAnalog to digital conversion perchannel on the detection module.1D antiscatter collimator.	Fast scintillator (garnet) arraycoupled to photodiode array.256 detector rows X pitch0.625mm (Z direction,measured at scanner center).Analog to digital conversion perchannel on the detectionmodule.2D antiscatter collimator.All detectors are from the sametype (full FOV).	Sametechnology andsub-assemblies asthe primarypredicate. Theproposeddevice addsoptionalconfigurationswith wider fieldof view (FOV)than theprimarypredicate, asavailable in thesecondarypredicate.
Datatransmissionfrom rotor	Contactless transmission(capacitive coupling). Rate up to6.25 GBit/sec	Contactless transmission(capacitive coupling). Rate up to6.25 GBit/sec	Contactless transmission(capacitive coupling). Rate up to40 GBit/sec	Same
Power andcontroltransmissionto rotor	Contact less transmission	Brush contact slipring	Contact less transmission	Same assecondarypredicate
Rotationdrive	Direct drive DC motor	DC motor and belt	Direct drive DC motor	Same assecondarypredicate
X Raysource	2 x MCS 2093 X ray tubes byVarex Imaging Corp.	2 x MCS 2093 X ray tubes byVarex Imaging Corp.	Perfomex HDwX ray tube byGEHC	Same asprimarypredicate
	Proposed device - SpotLightDuo	Primary predicate - SpotLightCT (K161066)	Secondary predicate –Revolution CT (K133705)	Discussion
	Single ended grounded rotatinganode	Single ended grounded rotatinganode	Single ended grounded rotatinganode
	Anode angle 13 degrees	Anode angle 13 degrees	Anode angle 10.5 degrees
	1.0 MHU anode heat capacity	1.0 MHU anode heat capacity	5.5 MHU anode heat capacity
	Grid controlled focal spotmodulation in X direction	Grid controlled focal spotmodulation in X direction	Grid controlled focal spotmodulation in X direction
	Small and large focal spots	Small and large focal spots	Small, large and extra-largefocal spots
	Max kVp: 140 kV	Max kVp: 140 kV	Max kVp: 140 kV
	Max power: 72 KW	Max power: 72 KW	Max power: 103 KW
Patient table	Motorized vertical and horizontalmotion	Motorized vertical and horizontalmotion	Motorized vertical andhorizontal motion	Same
	Optional lateral motion	Optional lateral motion	Optional lateral motion.
	Cantilever carbon fiber patientcradle.	Cantilever carbon fiber patientcradle.	Cantilever carbon fiber patientcradle.
Imagereconstruction hardware	Multicore PC and GPU	Multicore PC and GPU	Multicore PC and GPU	Same
Imagereconstruction algorithm	Modified FDK cone beamalgorithm adapted for dual tubesgeometry.	Modified FDK cone beamalgorithm adapted for dual tubesgeometry.	GE proprietary VHD cone beamalgorithm.	Samealgorithm asprimarypredicate.
	Adaptive filter to reducedirectional noise in low level rawdata (MBAF)	Adaptive filter to reducedirectional noise in low level rawdata (MBAF)	Iterative reconstructionalgorithm (ASIR-V).	The primarypredicatereconstructshigh resolutionimages up toFOV250mm.
	Iterative reconstruction algorithm(ASIR-CV)	Iterative reconstruction algorithm(ASIR-CV)
	For WFOV configuration,adapted to reconstruct highresolution images according todetector configuration, lowerresolution images outside FOVcovered by high resolutiondetectors.	Adapted to reconstruct highresolution images up toFOV250mm, lower resolutionimages outside FOV250mm		The proposeddevicereconstructshigh resolutionimagesaccording tooptionalconfiguration,
	For extended FOV configuration,adapted to reconstruct highresolution images up toFOV250mm, lower resolutionimages outside FOV250mm.			up toFOV450mm,as thesecondarypredicate.
	Proposed device - SpotLight Duo	Primary predicate - SpotLight CT (K161066)	Secondary predicate - Revolution CT (K133705)	Discussion
Construction Materials	Metal parts (mostly steel and aluminum)Lead and tungsten for X-ray shieldingPCB, electronic components and electronic cables componentsTable top made of carbon fiber reinforced resinCovers made pf molded polymers and reinforced resinsOil in X-ray tubes cooling systemsDetector scintillators made of CdWO4 and Gadolinium Oxysulfide (GOS) used in other legally marketed CT scanners	Metal parts (mostly steel and aluminum)Lead and tungsten for X-ray shieldingPCB, electronic components and electronic cables componentsTable top made of carbon fiber reinforced resinCovers made pf molded polymers and reinforced resinsOil in X-ray tubes cooling systemsDetector scintillators made of CdWO4 and Gadolinium Oxysulfide (GOS) used in other legally marketed CT scanners	Metal parts (mostly steel and aluminum)Lead and tungsten for X-ray shieldingPCB, electronic components and electronic cables componentsTable top made of carbon fiber reinforced resinCovers made pf molded polymers and reinforced resinsOil in X-ray tube and detector cooling systemsDetector scintillators made of GE proprietary garnet scintillator	Same
Energy sources	Wall supply 380 to 480 V 3 phaseMax power demand 115 kVAMax X ray power (total for two tubes) 72kWLaser alignment lights: gantry bore external lasers. <0.1mW per laser beamThree lead ECG trigger module, powered by medical grade power supply through the system PDU	Wall supply 380 to 480 V 3 phaseMax power demand 115 kVAMax X ray power (total for two tubes) 72kWLaser alignment lights: gantry bore external lasers. <0.1mW per laser beamThree lead ECG trigger module, powered by medical grade power supply through the system PDU	Wall supply 380 to 480 V 3 phaseMax power demand 150 kVAMax X ray power 103kWLaser alignment lights: gantry bore internal and external lasers. <0.1mW per laser beamFour lead ECG trigger module	Same
Software	The SpotLight is provided with software in three domains:Console softwareImage reconstruction softwareEmbedded softwareThe software is modified to support data acquisition with the modified detector, reconstruction at larger FOV, scan modes and protocols according to configuration.	The SpotLight is provided with software in three domains:Console softwareImage reconstruction softwareEmbedded software	The Revolution CT is provided with software serving same functionalities as the proposed device and complying with same standards.	Substantially the same
	Proposed device – SpotLightDuo	Primary predicate – SpotLightCT (K161066)	Secondary predicate –Revolution CT (K133705)	Discussion
MaxRotationspeed	250 RPM (0.24 sec per rotation)	250 RPM (0.24 sec per rotation)	214 RPM (0.28 sec per rotation)Gantry supports 300 RPM (0.2sec per rotation)	Thedifferences inperformance ofthe proposeddevice andprimarypredicate areoptional higherimageresolution atFOV largerthan 250mm inlieu ofFOV160mmcollimation.
Min scantime	0.16 sec (partial), 0.24 sec (fullscan) – FOV up to 250mm0.24 sec (full scan) – HR imagingat FOV above 250mm forasymmetric detector	0.16 sec (partial), 0.24 sec (fullscan)	0.28 sec (full scan)
Max axialcoverage ina single axialscan	140mm (280 slices x 0.5mmpitch)	140mm (280 slices x 0.5mmpitch)	160mm (256 slices x 0.625mmpitch)	than 250mm inlieu ofFOV160mmcollimation.
Field of View(FOV)	High resolution images atconfigurable FOV between250mm and 450mmLower resolution in the FOVbetween HR coverage and450mm	250mm or 160mm at highresolutionOptional, up to 450mm withlower resolution outside FOV250mm	Up to 500mm	The proposeddevice and thesecondarypredicate offera larger HRFOV.
Max spatialresolution	17.5 lp/cm cutoff at center10.0 lp/cm cutoff at radius above125mm (outside FOV 250mm)covered by HR detectors7.0 Ip/cm cutoff at radius above125mm (outside FOV 250mm)covered by LR detectors	17.5 lp/cm cutoff at center7.0 lp/cm cutoff at radius above125mm (outside FOV 250mm)	21.4 lp/cm (cutoff)
Bore size	60 cm	60 cm	80 cm	Same asprimarypredicate
Max Patientweight	227 Kg (500 lbs)	227 Kg (500 lbs)	227 Kg (500 lbs)	Same asprimarypredicate
Add on partsandaccessories	Built in trigger ECG (IvyBiomedical CTM300 K083854)Operator console table and/orchairIntegrated Injector (BayerConnect.CT K182273, K173773)Various table accessoriesBar code readerUSB data storage device	Built in trigger ECG (IvyBiomedical CTM300 K083854)Operator console table and/orchairIntegrated Injector (BayerConnect.CT K182273, K173773)Various table accessoriesBar code reader	Operator console tableEnhanced Injector Class IVNG2000 Table slickersBar code readerUninterruptible Power Supply	Same asprimarypredicate
Proposed device – SpotLightDuo	Primary predicate – SpotLightCT (K161066)	Secondary predicate –Revolution CT (K133705)	Discussion
Console Uninterruptible PowerSupply	Console Uninterruptible PowerSupply
Partial System UninterruptiblePower Supply	Partial System UninterruptiblePower Supply
A1 Disconnect panel	A1 Disconnect panel
20cm Water phantom	20cm Water phantom
QA phantom	QA phantom
Seismic kit	Seismic kit
Mobile kit	Mobile kit

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Testing of the modifications to the primary predicate, SpotLight CT (K161066), as well as the SpotLight Duo as a whole included:

Testing on unit level
Integration testing
. Performance testing
. Safety testing

Non-Clinical Performance Testing

The electromagnetic compatibility of the SpotLight Duo was tested and was found to be in compliance with the requirements of the following standards:

. IEC 60601-1:2005+AMD1:2012 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for . basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and test
IEC 60601-1-3:2008+AMD1:2013 Medical electrical equipment Part 1-3: General ● requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
IEC 60601-2-44:2009/AMD1:2012 Medical electrical equipment Part 2-44: Particular ● requirements for the basic safety and essential performance of X-ray equipment for computed tomography

SpotLight Duo was tested and is in compliance with AAMI/ES 60601-1, IEC 60601-1 Ed. 3 and its associated collateral standards and particular standards, 21CFR Subchapter J and NEMA XR-25, XR-28 and XR-29.

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The device was developed under a rigorous quality system and has successfully completed design control activities, including risk management, verification and validation.

The performance evaluation used a variety of test methods, phantoms and scan conditions. Various mathematical, physics and statistical analyses were performed to demonstrate that performance specifications are met. The tests evaluated image quality and dose performance. Image quality evaluation included evaluation of artifacts, spatial resolution, low contrast detectability, noise, and uniformity and CT number accuracy.

Conclusions

Based on the extensive testing as described above, the SpotLight Duo is as safe and effective as the SpotLight CT. The SpotLight Duo has the same intended uses and similar indications, technological characteristics, energy type and principles of operation as its predicate devices. The technological differences between the SpotLight Duo and its predicate devices raise no new issues of safety or effectiveness. Thus, the SpotLight Duo is substantially equivalent.

Based on the conformance to standards, as well as the bench testing provided, Arineta Ltd. believes that the SpotLight Duo is substantially equivalent to the predicate devices, SpotLight CT (K161066) and Revolution CT (K133705).

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.