CAS-One IR is a user controlled, stereotactic accessory intended to assist in planning, navigation and manual advancement of one or more instruments, as well as in verification of instrument position and performance during Computed Tomography (CT) guided procedures.

In planning, the desired needle configuration and performance is defined relative to the target anatomy.

In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.

In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.

CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

Device Description

The system consists of the following main components:

. A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer.
. Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle.
CAS-One IR software: The software provides the step-by-step workflow assistance for needle ● navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.

AI/ML Overview

Let's break down the information regarding the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for CAS-One IR (K232022).

First, it's important to note that this 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device (CAS-One IR, K152473). Therefore, the "study" described is a non-clinical performance testing and algorithm validation study, specifically addressing the differences and new features of the updated device. It is not an MRMC comparative effectiveness study or a typical standalone performance study with clinical endpoints.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document explicitly mentions acceptance criteria for the segmentation algorithms.

Acceptance Criteria (Mean DICE Coefficient)	Reported Device Performance
Liver: 0.9	Passed
Tumor: 0.8	Passed
Effective Treatment Volume: 0.8	Passed
Kidney: 0.85	Passed
Lung: 0.9	Passed
Mean Centerline DICE (Liver-Vessels): 0.6	Passed

For instrument detection algorithms, the performance is generally described as "reliability was gauged by analyzing the ground truth positions and the positions identified by the algorithm," and "These validation efforts provide a robust foundation for asserting the accuracy and effectiveness of the algorithms." Specific quantitative performance metrics for instrument detection are not provided in this summary, but it states they were assessed against ground truth.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size for the test set used for algorithm validation. It also doesn't provide information about the data provenance (e.g., country of origin, retrospective or prospective nature). It only mentions "ground truth data annotated by personnel considered expert in the domain."

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)

The document states that the ground truth data was "annotated by personnel considered expert in the domain." It does not specify the number of experts or their specific qualifications (e.g., years of experience, specific medical specialty like radiologist).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

The document does not specify any adjudication method for establishing the ground truth for the test set. It simply states "annotated by personnel considered expert in the domain."

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The document explicitly states: "Clinical testing was not required to demonstrate the safety and effectiveness of the device." The studies performed were non-clinical performance and algorithm validation.

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

Yes, a standalone algorithm validation was performed. The "Algorithm validation" section describes testing the segmentation algorithms (comparing mean DICE coefficient with state-of-the-art algorithms) and instrument detection algorithms (gauging reliability by comparing algorithm-identified positions with ground truth). These are evaluations of the algorithm's performance in isolation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth used for algorithm validation was expert annotation/segmentation. The document states, "Test protocols were systematically executed to assess the performance of the algorithmic validation procedures involved comparisons with ground truth data annotated by personnel considered expert in the domain." This implies the ground truth for segmentation and instrument positions was established by human experts.

8. The sample size for the training set

The document does not provide the sample size for the training set. It focuses on the validation of the algorithms rather than their development or training data.

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

The document does not provide information on how the ground truth for the training set was established. Given the focus on substantial equivalence and non-clinical testing, this level of detail about training data is typically not required in a 510(k) summary if the primary claim relies on equivalence and validation of specific new features.

Summary

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March 13, 2024

Image /page/0/Picture/1 description: The image shows 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Cascination AG % Andreas Meschberger Senior Regulatory & Clinical Affairs Manager Steigerhubelstrasse 3 BERN. 3008 SWITZERLAND

Re: K232022

Trade/Device Name: CAS-One IR Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: February 14, 2024 Received: February 14, 2024

Dear Andreas Meschberger:

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Smita Kakar

for

Lu Jiang Assistant Director DHT8B: Division of Radiologic 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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Indications for Use

510(k) Number (if known) K232022

Device Name CAS-One IR

Indications for Use (Describe)

In planning, the desired needle configuration and performance is defined relative to the target anatomy.

In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.

In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.

CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

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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Image /page/3/Picture/0 description: The image shows the word "CASCINATION" in green font. To the right of the word is a red square with a white cross in the center. The cross is a symbol of Switzerland.

Steigerhubelstrasse 3 CH-3008 Bern Switzerland

510(K) SUMMARY

K232022

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR §807.92.

I. SUBMITTER

Manufacturer:	CASCINATION AG
	Steigerhubelstrasse 3
	CH-3008 Bern
	Switzerland
	Tel: +41 31 306 26 26
Contact Person:	Andreas Meschberger
	Senior Regulatory & Clinical Affairs Manager
Date Prepared:	March 08, 2024

II. SUBJECT DEVICE

Device Name:	CAS-One IR
Classification Name:	Computed tomography x-ray system
Regulation:	892.1750
Common Name:	System, X-Ray, Tomography, Computed
Regulatory Class:	Class II
Product Code:	JAK

The Subject Device is an updated version of the Predicate Device.

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III. PREDICATE DEVICE

Primary Predicate Device
Company:	CASCINATION AG, Steigerhubelstrasse 3, CH-3008 Bern, Switzerland
Device name:	CAS-One IR
510(k) number:	K152473
Classification Name:	Computed tomography x-ray system
Regulation:	892.1750
Common Name:	System, X-Ray, Tomography, Computed
Regulatory Class:	Class II
Product Code:	JAK

IV. INDICATIONS FOR USE

In planning, the desired needle configuration and performance is defined relative to the target anatomy.

In navigation, the instrument position is displayed relative to the patient and guidance for needle alignment is provided while respiratory levels are monitored.

In verification, the achieved instrument configuration and performance are displayed relative to the previously defined plan through an overlay of the pre- and post- treatment image data.

CAS-One IR is indicated for use with rigid straight instruments such as needles and probes used in CT guided interventional procedures performed by physicians trained for CT procedures.

CAS-One IR is intended to be used for patients older than 18 years and eligible for CT-guided percutaneous interventions.

V. DEVICE DESCRIPTION

The system consists of the following main components:

. A mobile navigation platform: this platform can be moved in and out of radiology rooms and is positioned next to the patient in front of the CT scanner. The platform includes two touch screens, a camera, and a computer.
. Instruments: The instrument set comprises a guide arm, aiming device and a navigational pointer that are connected to each other and assist the user in aligning and positioning a needle trajectory relative to the patient. After positioning the aiming device using the guide arm, the

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aiming device is aligned with respect to the desired entry point (translational alignment) and rotationally oriented to the desired insertion angle.

CAS-One IR software: The software provides the step-by-step workflow assistance for needle ● navigation. It provides a means for users to precisely plan a single or multiple needle trajectories, navigate a needle to this exact position and validate the inserted needle's position to the planned position.

VI. SUBSTANTIAL EQUIVALENCE

The following characteristics were compared between the subject device and the predicate device in order to demonstrate substantial equivalence:

Item	Subject Device(CAS-One IR)	Predicate Device(CAS-One IR) K152473	Conclusion
RegulationNumber	Regulation Number: 21 CFR892.1750Product Code: JAK	Regulation Number: 21 CFR892.1750Product Code: JAK	⇒ SameBoth the subject andpredicate devices havethe same product codeand regulation number
Item	Subject Device(CAS-One IR)	Predicate Device(CAS-One IR) K152473	Conclusion
Indications ForUse Statement	CAS-One IR is a user controlled,stereotactic accessory intendedto assist in planning, navigationand manual advancement ofone or more instruments, as wellas in verification of instrumentposition and performance duringComputed Tomography (CT)guided procedures.In planning, the desired needleconfiguration and performanceis defined relative to the targetanatomy.In navigation, the instrumentposition is displayed relative tothe patient and guidance forneedle alignment is providedwhile respiratory levels aremonitored.In verification, the achievedinstrument configuration andperformance are displayedrelative to the previously definedplan through an overlay of thepre- and post- treatment imagedata.CAS-One IR is indicated for usewith rigid straight instrumentssuch as needles and probesused in CT guided interventionalprocedures performed byphysicians trained for CTprocedures.CAS-One IR is intended to beused for patients older than 18years and eligible for CT-guidedpercutaneous interventions.	CAS-One IR is a user controlled,stereotactic accessory intendedto assist in planning, navigationand manual advancement ofone or more instruments, as wellas in verification of instrumentposition and performance duringComputed Tomography (CT)guided procedures.In planning, the desired needleconfiguration and performanceis defined relative to the targetanatomy.In navigation, the instrumentposition is displayed relative tothe patient and guidance forneedle alignment is providedwhile respiratory levels aremonitored.In verification, the achievedinstrument configuration andperformance are displayedrelative to the previously definedplan through an overlay of thepre- and post- treatment imagedata.CAS-One IR is indicated for usewith rigid straight instrumentssuch as needles and probesused in CT guided interventionalprocedures performed byphysicians trained for CTprocedures.	⇒ Same, but morespecificBoth the subject andpredicate devices havethe same generalindications for usestatement and thesubject device has anadditional specificityregarding the targetpopulation
User	physicians trained forinterventional CT procedures	physicians trained forinterventional CT procedures	⇒ SameBoth the subject andpredicate devices havethe same user
Item	Subject Device(CAS-One IR)	Predicate Device(CAS-One IR) K152473	Conclusion
		System
System	Consists of:• Platform• Pointer, Aiming device, Guide Arm• CAS-One IR software	Consists of:• Platform• Pointer, Aiming device, Guide Arm• CAS-One IR software	⇒ SameThere was no changein the system concept
Compatibility	The system is compatiblewith needle-shaped devicesused in percutaneousinterventional proceduresthat have the followingphysical properties:• Cylindrical, straight shape• Design that allows theplacement of instruments inthe Guide	The system is compatiblewith needle-shaped devicesused in percutaneousinterventional proceduresthat have the followingphysical properties:• Cylindrical, straight shape• Design that allows theplacement of instruments inthe Guide	⇒ SameThere was no changein the systemcompatibility
		Hardware
NavigationPlatform	Same: Camera, Rack,Screen Arms, Camera ArmsUpdated: Touch screens,Graphic Cards, Mother boardand Power Supplier	Same: Camera, Rack,Screen Arms, Camera ArmsPredicate: Touch screens,Graphic Cards, Mother boardand Power Supplier	⇒ SameThe updatedcomponents have thesame technicalprinciples and justrepresent an updatedtechnical state. Theparts are covered bythe Electrical Safetyand EMC Testing, andSystem Validation
Pointer (AimingInsert andMarker Shield),Aiming Device,Guide Arm.	Surgical Stainless Steel1.4301 & 1.4305Slight mechanical designimprovements.	Surgical Stainless Steel1.4301	⇒ SameBoth devices use asurgical stainless steelof a slightly differenttype. Minor mechanicaldesign improvements.
PatientFixation	Vacuum cushion on top ofcarbon baseplate.	Vacuum cushion on top ofcarbon baseplate.	⇒ Same
Energy Source	110-230V, 50-60Hz, singlephase	110-230V, 50-60Hz, singlephase	⇒ Same
Item	Subject Device(CAS-One IR)	Predicate Device(CAS-One IR) K152473	Conclusion
Software
OperatingSystem	Windows 10	Windows 7	⇒ SameBoth devices run onMicrosoft Windows,installed on theplatform. Programminglanguage and softwarearchitecture remain thesame. Full SoftwareV&V has beenexecuted and passed
Image datasets	DICOM file format:• CT or MRI image modality	DICOM file format:• CT image modality	⇒ SameThe subject deviceallows to import MRIimages, but they mustalso comply to theDICOM standard
DataManagement	Function to import imagedatasets.	Function to import imagedatasets.	⇒ Same
DICOM Viewer	Function to view, pan, zoom,adjust brightness andinsensitivity, and carry outmeasurements in image dataand to overlay image data	Function to view, pan, zoom,adjust brightness andinsensitivity, and carry outmeasurements in image dataand to overlay image data
Module Plan	Trajectory PlanningSingle / Multiple needlesDisplay of manufacturerablation parametersPoint-based image fusion CTto CT or MR.Segmentation of organs (livertissue, portal vein, hepaticvein, liver lesions, kidneytissue, lung tissue, and lungairway)	Trajectory PlanningSingle / Multiple needlesDisplay of manufacturerablation parametersPoint-based image fusion CTto CT	⇒ DifferentTechnologicalcharacteristic"Segmentation oforgans and lesions"which does not raiseany concern aboutsafety andeffectiveness.The Point-basedregistration MRI to CTimages of the subjectdevice is similar to thePoint-basedregistration CT to CTimages of thepredicate device anddoes not represent atechnologicaldifference
Item	Subject Device(CAS-One IR)	Predicate Device(CAS-One IR) K152473	Conclusion
Navigation	Module Name "Place"	Module Name "Navigation"	⇒ Same
	Supports Instrument Guide	Supports Instrument Guideand Freehand	The module wasrenamed but thefunctionality remainsthe same
			The optional support offreehand navigationhas been discontinuedin the subject device
Verify (ControlScan)	Verify (Control Scan)Instrument Detection	Verify (Control Scan)	⇒ DifferentTechnologicalcharacteristic"Instrument Detection"which does not raiseany concern aboutsafety andeffectiveness.
Verification	Module "Assess"Manual review of planningand validation images (togglevisibility)AblaSure® AblationAssessment (for liver lesions)	Module "Assess"Manual review of planningand validation images (togglevisibility)	⇒ DifferentTechnologicalcharacteristic"AblaSure® AblationAssessment" whichdoes not raise anyconcern about safetyand effectiveness.
Performance Testing
PerformanceTesting	Software design verificationand validation anddocumentation (the softwarefor this device wasconsidered a "moderate"level of concern.)	Software design verificationand validation anddocumentation (the softwarefor this device wasconsidered a "moderate"level of concern.)	⇒ SameThe performancetesting for the subjectdevice are the same,additional tests werecarried out for thesegmentationalgorithms, whiletesting forbiocompatibility andsterilization were notrequired to the similardesign and materialsto the predicate device
	Formal Internal TestingStandards	Formal Internal TestingStandards
	Electrical Safety according toANSI AAMI ES60601-1	Electrical Safety according toANSI AAMI ES60601-1
	ElectromagneticCompatibility according toIEC 60601-1-2	ElectromagneticCompatibility according toIEC 60601-1-2
	Testing of SegmentationAlgorithms according tointernal Testing Standards	Biocompatibility andSterilization

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Substantial Equivalence Discussion

Both the Subject Device and the Predicate Device have the same Intended Use. The Subject Device is an updated version of the Predicate Device. The differences between the Subject and Predicate Device are: Incremental improvements to the hardware (updated mainboard, GPU, and touchscreens on the platform; mechanical improvements to the pointer, aiming device, and quide arm), and Software Changes (update Operating System, increments, addition of segmentation functions for tumor and ablation area)

The subject device introduces seven new software functions which are considered to have the same technological characteristics as the predicate device because similar software functions are included in the predicate device.

The subject device has three different technological characteristics compared to the predicate device: Segmentation of organs and liver lesions, Instrument Detection, AblaSure® Ablation Assessment (for liver lesions). All three different technological characteristics are related to Software Functions.

Software Validation has been carried out for all functions. Specific Non-Clinical Performance Testing has been carried out for the segmentation algorithms. The instructions for use include warnings for the limitations of the segmentation algorithms.

It has been demonstrated that the technological differences do not adversely affect the safety and effectiveness of the subject device. No questions for safety and effectiveness were raised. Therefore, we can conclude that no technological differences, that may adversely affect the safety and effectiveness, have been identified between the subject and predicate device.

Conclusion - Substantial Equivalence Discussion:

The subject device is substantially equivalent to the predicate device with regard to intended use, safety, and effectiveness. This conclusion is based upon a comparison of intended use, technological characteristics, and non-clinical performance testing.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Biocompatibility Testing

Not Applicable. The subject device has similar material properties, and it was evaluated there is no effect to the biocompatibility properties of the subject device.

Electrical safety and electromagnetic compatibility (EMC)

The subject device was tested for electrical safety (ANSI AAMI ES60601-1) and electromagnetic compatibility (ANSI AAMI IEC 60601-1-2).

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Mechanical and Acoustic Testing

Not Applicable to the subject device.

Software Verification and Validation Testing

Software verification and validation testing were provided to demonstrate safety and effectiveness of the subject device. Software validation and documentation was prepared according to the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005).

This includes a hazard analysis, and the potential hazards have been classified as a moderate level of concern similar to the predicate device.

Algorithm validation

Test protocols were systematically executed to assess the performance of the algorithmic validation procedures involved comparisons with ground truth data annotated by personnel considered expert in the domain.

The segmentation algorithms of organs, hepatic veins, and lesions were validated by comparing the mean DICE coefficient with state-of-the-art algorithms. Defined acceptance criteria for mean DICE (Liver: 0.9, Tumor: 0.8, Effective Treatment Volume: 0.8, Kidney: 0.85, Lung: 0.9) and mean centerline DICE (Liver-Vessels: 0.6) were passed.

For instrument detection algorithms, the reliability was gauged by analysing the pround truth positions and the positions identified by the algorithm.

These validation efforts provide a robust foundation for asserting the accuracy and effectiveness of the algorithms in the context of their application in medical settings.

Animal Study

Animal performance testing was not required to demonstrate safety and effectiveness of the device.

Clinical Studies

Clinical testing was not required to demonstrate the safety and effectiveness of the device. This conclusion is based upon a comparison of intended use, technological characteristics, and non-clinical performance data (Software Verification and Validation Testing, and Internal Test Standards).

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VIII. CONCLUSIONS

The subject device is substantially equivalent to the predicate device with regard to device performance. This conclusion is based upon a comparison of the intended use, technological characteristics, and benchtop testing.

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.