The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

Device Description

syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data of the myocardium following the injection of contrast media. By providing information about myocardial blood flow and myocardial blood volume, syngo.CT Myocardial Perfusion allows the evaluation of potential perfusion disturbances in the myocardium due to coronary artery disease. This might aid in the assessment of the hemodynamic relevance of coronary stenosis

syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:

Myocardial blood flow (MBF) image .
Myocardial blood volume (MBV) image ●
Flow Extraction Product (FE) image ●
Perfused Capillary Blood Volume (PCBV) image ●
Extravascular Extracellular Volume (EEV) image
Time to Peak (TTP) image ●
Time to Start (TTS) image ●
Tissue Transit Time (TTT) image ●
Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image

AI/ML Overview

This premarket notification (K150713) for syngo.CT Myocardial Perfusion states that it is a post-processing image analysis software that offers quantitative analysis of dynamic CT data of the myocardium following contrast media injection. It calculates myocardial blood flow (MBF), myocardial blood volume (MBV), and other hemodynamic parameters to evaluate perfusion disturbances caused by coronary artery disease.

The device is considered substantially equivalent to the predicate device, syngo® Volume Perfusion CT Body (K092013). The modifications made to the predicate include:

Separation of the Myocardial Perfusion algorithm into a stand-alone software application.
Migration to the syngo.via client-server software platform.
Updated Graphical User Interface (GUI).
Additional option to store image results as Enhanced CT.
Parallel display of several time attenuation curves (TAC).
A modified Indication for Use specific to Myocardial Perfusion.

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "the test results show that all of the software specifications have met the acceptance criteria." However, it does not provide a quantitative table of specific acceptance criteria values and corresponding device performance metrics. Instead, it relies on general statements about verification and validation testing.

Acceptance Criteria Category	Reported Device Performance
Software Specifications Conformance	"The test results show that all of the software specifications have met the acceptance criteria."
Verification and Validation Testing	"Nonclinical tests were conducted for syngo.CT Myocardial Perfusion during product development. The modifications described in this premarket notification are supported with verification and validation testing. Results of this verification and validation testing were found acceptable to support the claim of substantial equivalence.""Integration and functional tests were conducted... The test results show that all of the software specifications have met the acceptance criteria."
Supportive Articles/Clinical Utility	"Supportive articles that demonstrate the usability of syngo.CT Myocardial Perfusion were provided to support device performance and functionality." (No specific metrics or studies are detailed in the provided text for these articles.)
General Safety and Effectiveness	"The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.""Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing."
Substantial Equivalence (Non-clinical)	"The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that syngo.CT Myocardial Perfusion performs as intended. The non-clinical test data demonstrates that syngo.CT Myocardial Perfusion device performance is comparable to the predicate device that is currently marketed for the same intended use."
DICOM Conformance	Claims conformance to PS 3.1 – 3.18 (03/16/2012)
Software Life Cycle Processes	Claims conformance to IEC 62304 First edition 2006-05
Risk Management	Claims conformance to ISO 14971 Second Edition 2007-03-01
Usability	Claims conformance to IEC 60601-1-6 Edition 3.0 2010-01
Programmable Electrical Medical Systems	Claims conformance to IEC 60601-1-4:2000, Consol. Ed. 1.1
Cybersecurity	"Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient."

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "verification and validation testing" and "integration and functional tests." However, it does not specify the sample size (number of cases or images) used for these test sets. It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective nature of the data). It only mentions that the device uses scans from Siemens SOMATOM Definition Flash and SOMATOM Force scanners and was tested with both normal perfusion data (non-shuttle mode) and shuttle mode data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not provide information on the number of experts used to establish ground truth for any test set or their specific qualifications. The regulatory submission primarily focuses on the technical verification and validation of the software itself rather than clinical validation with expert-derived ground truth.

4. Adjudication Method for the Test Set:

No information regarding an adjudication method (such as 2+1 or 3+1) is provided in the document for any test set. The submission focuses on software testing against its specifications.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:

The document does not mention any Multi-Reader Multi-Case (MRMC) comparative effectiveness study or any effect size for human readers improving with or without AI assistance. This type of clinical study is not detailed in this 510(k) submission, which primarily focuses on substantial equivalence based on technical and performance characteristics comparison to a predicate device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document states, "syngo.CT Myocardial Perfusion is post-processing image analysis software that offers the quantitative analysis of dynamic CT data..." and "As syngo.CT Myocardial Perfusion is a post processing application only..." This suggests that the core functionality of generating perfusion maps and parameters is performed by the algorithm in a standalone manner. The "performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion," which would generally refer to testing the algorithm's output against expected results or specifications. However, specific details of a standalone performance study with quantitative metrics are not provided beyond the general statement of "verification and validation testing."

7. The Type of Ground Truth Used:

The document does not explicitly describe the type of ground truth used for any performance evaluation. Given the nature of a 510(k) for post-processing software, the "ground truth" for the verification and validation (V&V) testing would typically refer to:

Known input-output relationships: Testing if the software accurately calculates parameters based on defined algorithms and synthetic or well-characterized real data where the expected output is known.
Comparison to predicate device results: Ensuring the new software produces comparable results to the legally marketed predicate device for similar input data.
Scientific literature/published models: Conformance to established scientific models for perfusion calculation.

No mention of expert consensus, pathology, or outcomes data being used as ground truth is present in the provided text.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. As a post-processing software application, syngo.CT Myocardial Perfusion is described as utilizing deconvolution and Tofts' models for parameter calculation. This implies that the software is based on established mathematical models and algorithms, rather than a machine learning model that would require a distinct "training set" in the conventional sense. The development likely involved algorithmic optimization and software engineering rather than deep learning model training.

9. How the Ground Truth for the Training Set Was Established:

Since the document does not indicate the use of a "training set" for a machine learning model, it also does not describe how ground truth for such a set was established. The software's underlying algorithms (deconvolution, Tofts' model) are likely validated through theoretical correctness and empirical testing against known physical models or data with pre-calculated expected outputs.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the left side of the image. To the right of the text is a symbol consisting of three stylized human profiles facing to the right, with flowing lines extending from the heads.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 2, 2015

Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65 1-A MALVERN PA 19355

Re: K150713

Trade/Device Name: syngo.CT Myocardial Perfusion Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: September 18, 2015 Received: September 29, 2015

Dear Ms. Mangum:

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

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael 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

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The background is plain white, which makes the text stand out. The word is presented in all capital letters.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150713

Device Name syngo.CT Myocardial Perfusion

Indications for Use (Describe)

The Siemens syngo. CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.

The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

*An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (1/14)

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The text is a light blue color, and the letters are evenly spaced. The logo is simple and modern, with a clean design. The image is likely a logo for the Siemens company.

510(K) SUMMARY FOR syngo.CT Myocardial Perfusion

Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355

Date Prepared: September 18, 2015

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

1. General Information lmporter/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355 Establishment Registration Number: 2240869
  Manufacturing Facility: Siemens AG Medical Solutions Siemens Str. 1 D-91301 Forchheim, Germany Establishment Registration Number: 3004977335

2. Contact Person:

Kimberly Mangum Requlatory Affairs Specialist Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, Mail Code 65 1-A Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com

3. Device Name and Classification

Product Name:	syngo.CT Myocardial Perfusion
Propriety Trade Name:	syngo.CT Myocardial Perfusion
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	90JAK

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color. There is a black line underneath the word.

বা	Legally Marketed Predicate Device
	Trade Name:	syngo® Volume Perfusion CT Body
	510(k)#:	K092013
	Clearance Date:	July 17, 2009
	Classification Name:	Computed Tomography X-ray System
	Classification Panel:	Radiology
	Classification Regulation: 21 CFR § 892.1750
	Device Class:
	Product Code:	90JAK
	Recall Information:	This predicate device has not been thesubject of any design related recalls

5. Device Description:

syngo.CT Myocardial Perfusion provides a fast simultaneous multi-slice calculation of the following perfusion parameter images:

Myocardial blood flow (MBF) image .
Myocardial blood volume (MBV) image ●
Flow Extraction Product (FE) image ●
Perfused Capillary Blood Volume (PCBV) image ●
Extravascular Extracellular Volume (EEV) image
Time to Peak (TTP) image ●
Time to Start (TTS) image ●
Tissue Transit Time (TTT) image ●
Myocardial Blood Flow Corrected (MBFC) image; this parameter . map is a copy of the Myocardial blood flow (MBF) image

The following modifications have been made to the previously cleared predicate device syngo® Volume Perfusion CT Body (K092013, clearance date July 17, 2009):

New software version SOMARIS/8 VB10 which supports the 1. following features:
- Separation of the Myocardial Perfusion algorithm from Volume a. Perfusion CT Body into a stand-alone SW application called "syngo.CT Myocardial Perfusion"

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image features the word "SIEMENS" in a bold, sans-serif font. The color of the text is a light blue or teal. The word is horizontally oriented and appears to be a logo or brand name.

Migration of the Myocardial Perfusion application to the syngo.via ﻗ client server Software platform (cleared in K123375)
Updated Graphical User Interface C.
Result Storage Additional option to store image results as d. Enhanced CT
TAC Display Parallel display of several time attenuation curves e. (TAC)
1. A modified Indication for Use which is specific to Myocardial Perfusion.

6. Indications for Use

The Siemens syngo.CT Myocardial Perfusion software package has been designed to evaluate perfusion of the myocardium.

The software can calculate blood flow, blood volume, and other hemodynamic parameters from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.

It supports evaluation of regions of interest and the visual inspection of time attenuation curves.

1. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
  syngo.CT Myocardial Perfusion software package has the same intended use and operating principle as the predicate syngo® Volume Perfusion-CT Body (K092013, clearance date 06/17/2009). syngo.CT Myocardial Perfusion is a post-processing application operating on the syngo.via platform in a single or multi user environment.

syngo.CT Myocardial Perfusion does not have significant changes in technological characteristics when compared to the predicate device. The Indications for Use and fundamental scientific technology are similar. The subject device and the predicate device are the same in regards to:

Application and Acquisition ●
Motion Correction ●
CT Scanning Mode ●
Time Point Removal ●
4D Noise Reduction ●
Organ Segmentation ●
Arterial Input Function Definition ●
Vessel Definition ●
Region of Interest and Volume of Interest ●
Archiving/Storage
Communication DISOM compatible. ●

{6}------------------------------------------------

The myocardial and body perfusion algorithms use a deconvolution algorithm to estimate the perfusion parameters. The algorithms differ in the parametric convolution kernel. Body perfusion uses an adiabatic approximation to the tissue homogeneity model. The parameter map calculation in myocardial perfusion is based on the Tofts' model. According to the different scanning modes, the registration is different. A global registration is used in body perfusion. This global registration for myocardial perfusion is applied after a preceding rigid registration that aligns the stitching slices. The same algorithms and registrations were used in the predicate device syngo® Volume Body Perfusion CT Body (K092013, clearance date July 17, 2009).

The following table shows the differences in technological characteristics between the subject device and the predicate device.

Technological Characteristics of the Subject Device as Compared to the Predicate Device
Feature	Subject Devicesyngo.CT MyocardialPerfusion	Predicate Devicesyngo® VolumePerfusion CT Body(K092013)	Comparison
ResultStorage	Storage of all resultimages in thedatabase as DICOMCT grayscale, colorRGB, Enhanced CT	Storage of all resultimages in thedatabase as DICOMCT grayscale, colorRGB	The subject device has theadditional option of savingimages as Enhanced CT.Verification and Validationtesting supports thismodification.
TACDisplay	Parallel display ofseveral timeattenuation curves	Display of a singletime attenuationcurve	The subject device can displaymultiple Time AttenuationCurves, instead of only one.Verification and Validationtesting supports thismodification.
UserInterface	syngo.via based GUI	syngo® based GUI	The user interface has beenadapted to the current syngo.viaframework. Changes arecosmetic in nature. Verificationand Validation testing supportsthis modification.
OperatingSoftwarePlatform	syngo.via: WindowsXP, Windows Vista orWindows 7 systems.Multiuser HW/SWarchitecture withclient/server support	syngo®:Windows XPProfessional orequivalentSingle-user HW/SWarchitecture	syngo.via is a client/server multi-user framework and is furtherdevelopment of syngo®. It runson updated Windows systems,and can support multiple users.Verification and Validationtesting supports thismodification.

Subject and Predicate Device Compared Technological Characteristics

{7}------------------------------------------------

SIEMENS

As the predicate device, syngo.CT Myocardial Perfusion uses scans of Siemens SOMATOM Definition Flash and Siemens SOMATOM Force scanners. These scanners are fast enough to acquire data of the left ventricle in the end systolic phase without motion. As the images are acquired in a single heart phase without motion. ECG gating is used to trigger the scans.

The detectors of these two scanners are not wide enough to scan the complete left ventricle in one scan, dedicated shuttle mode scans are used instead. These scans acquire the heart in two alternating slabs, scanning the upper and lower part of the heart. In between the scans the patient is moved. The scan protocols are described in Attachment 5 and 6 in more detail.

Currently two Siemens scanners (namely SOMATOM Definition Flash K082220, clearance date 10/10/08 the SOAMTOM Definition Flash and SOMATOM Force K133589, clearance date 04/17/2014), can provide data for CT Myocardial Perfusion. In the future scanners that are fast enough might be able to support scanning with a normal perfusion scan without shuttle because they are wide enough to scan the entire heart.

As syngo.CT Myocardial Perfusion is a post processing application only, it can use both types of data. normal perfusion data (non-shuttle mode) as well as shuttle mode data. The application was tested with both types, emulating the normal perfusion data by only using one of the slabs.

8. Nonclinical Testing:

Nonclinical tests were conducted for syngo.CT Myocardial Perfusion during product development. The modifications described in this premarket notification are supported with verification and validation testing. Results of this verification and validation testing were found acceptable to support the claim of substantial equivalence.

Siemens claims conformance to the following five safety and performance standards for syngo.CT Myocardial Perfusion.

Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
Digital Imaging and Communicationsin Medicine (DICOM) Set	PS 3.1 – 3.18	03/16/2012	NEMA
Medical device software – Softwarelife cycle processes	62304 Firstedition 2006-05	08/20/2012	IEC
Medical devices – Application of riskmanagement to medical devices	14971 SecondEdition 2007-03-01	08/20/2012	ISO

{8}------------------------------------------------

Title of Standard	ReferenceNumber andDate	PublicationDate	StandardsDevelopmentOrganization
Medical electrical equipment -- Part1-6: General requirements for basicsafety and essential performance --Collateral Standard: Usability	60601-1-6Edition 3.0 2010-01	1/30/2014	IEC
Medical electrical equipment - Part1-4: General requirements for safety-- Collateral standard:Programmable electrical medicalsystems, edition 1.1	60601-1-4:2000,Consol. Ed. 1.1	09/08/2009	IEC

Verification and Validation

This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Integration and functional tests were conducted for syngo.CT Myocardial Perfusion during product development.

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission. The test results show that all of the software specifications have met the acceptance criteria.

Siemens conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. It is the hospital's responsibility to comply with IEC 8001-1-2010.

Summarv

Performance tests were conducted to test the functionality of the subject device, syngo.CT Myocardial Perfusion. Supportive articles that demonstrate the usability of syngo.CT Myocardial Perfusion were provided to support device performance and functionality. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.

9. General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical,

{9}------------------------------------------------

SIEMENS

mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

10. Conclusion as to Substantial Equivalence

The predicate device was cleared based on non-clinical supportive information. The subject device non-clinical data supports the safety of the software with verification and validation testing. Verification and validation testing demonstrates that syngo.CT Myocardial Perfusion performs as intended. The non-clinical test data demonstrates that syngo.CT Myocardial Perfusion device performance is comparable to the predicate device that is currently marketed for the same intended use.

In summary, Siemens is of the opinion that the syngo.CT Myocardial Perfusion does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

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.