syngo.CT Extended Functionality is intended to provide advanced visualization tools to prepare and process medical images for diagnostic purpose. The software package is designed to support technicians and physicians in qualitative and quantitative measurements and in the analysis of clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners, and possibly other medical imaging modalities (e.g. MR scanners).

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.

Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

Device Description

syngo.CT Extended Functionality is a software bundle that offers tools to support special clinical evaluations. The "tools" are represented by the so-called Extensions. syngo.CT Extended Functionality can be used to create advanced visualizations and measurements on clinical data that was acquired and reconstructed by Computed Tomography (CT) scanners or other medical imaging modalities (e.g. MR scanners) by using the Extensions.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the syngo.CT Extended Functionality device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance Study

The provided document describes the syngo.CT Extended Functionality as a software bundle offering tools for advanced visualization and measurements on medical images. It serves as an extension of a previously cleared predicate device, syngo.CT Clinical Extensions (K173625). The focus of the 510(k) submission is to demonstrate substantial equivalence to the predicate device, primarily through verification and validation of software functionality, especially the new Interactive Spectral Imaging (ISI) feature and modifications to existing extensions.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a quantitative table with specific target values (e.g., accuracy > X%, sensitivity > Y%). Instead, the acceptance criteria are implicitly defined by the successful completion of various software verification and validation activities, performance standards, and the demonstration that the device "performs as intended" and is "comparable to the predicate devices in terms of technological characteristics and safety and effectiveness."

Implicit Acceptance Criteria and Demonstrated Performance:

Acceptance Criterion (Implicit)	Reported Device Performance/Validation
Functional Performance (General)	All conducted testing was found acceptable to support the claim of substantial equivalence. The device "performs as intended."
Functional Performance (New/Modified Features)	- Interactive Spectral Imaging (ISI): A "phantom-based validation" and "Detailed Description and Bench Tests" were conducted to show the feature "operates as intended." - Vascular/Vessel Extension: "This modification is a usability improvement." (Implies successful verification of the improved functionality). - Oncology Extension: "Modified to support MR data for Diameter WHO." (Implies successful verification of MR data processing). - Multiphase Support for Merged 4D Series: "Usability improvement: The grouping logic has been extended to include cardiac gated datasets." (Implies successful verification of the extended grouping logic).
Compliance with Safety and Performance Standards	The device fulfills requirements of: - Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20 (Recognition Number 12-300) - Medical Device Software – Software Life Cycle Processes; 62304:2006 (1st Edition) (Recognition Number 13-32) - Medical devices – Application of risk management to medical devices; 14971 Second Edition 2007-03-01 (Recognition Number 5-40) - Medical devices - Part 1: Application of usability engineering to medical devices IEC 62366-1:2015 (Recognition Number 5-114)
Software Quality and Risk Management	- "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 included as part of this submission." - "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." - "The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device."
Equivalence to Predicate Device	The device is deemed "as safe, as effective, and with performance substantially equivalent to the commercially available predicate devices." Test results show the subject device is "comparable to the predicate devices in terms of technological characteristics and safety and effectiveness."

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

Sample Size: The document explicitly mentions that for the Interactive Spectral Imaging (ISI) functionality, a "phantom-based validation" was conducted. However, no specific number of images, patient cases, or phantom instances are provided. For other features, it refers to "non-clinical tests" and "bench tests" but does not give sample sizes.
Data Provenance:
- The "phantom-based validation" suggests synthetic or controlled data.
- No specific country of origin for any human patient data is mentioned, nor whether it was retrospective or prospective. Given that this is a software update for an existing imaging workstation, it's highly probable that internal test data, possibly from various sources (pre-existing clinical de-identified data or synthetic data), was used for verification.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for any aspect of the testing. The testing described appears to be primarily focused on technical performance and functional verification rather than diagnostic accuracy studies involving human expert reads. The phrase "Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis" implies that the software provides tools for diagnosis, not a diagnosis itself, which aligns with the focus on technical verification.

4. Adjudication Method for the Test Set

No information is provided regarding an adjudication method. This is consistent with the likely focus on technical functional testing (e.g., verifying image transformations, measurements within software, and compliance with standards) rather than clinical accuracy studies requiring human reader agreement.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or performed. The submission focuses on demonstrating substantial equivalence through technical and functional verification and compliance with standards, rather than a clinical trial assessing human reader performance with and without AI assistance. The device is described as providing "advanced visualization tools" to "support technicians and physicians," not necessarily an AI-driven diagnostic aid that would directly influence human reader accuracy in the way a CAD (Computer-Aided Detection) system might.

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

The document describes "performance tests" and "phantom-based validation" for the Interactive Spectral Imaging (ISI) functionality and "non-clinical tests and a phantom-based bench test" for other features. These types of tests are inherently standalone performance evaluations of the software's functionality, without a human in the loop for the performance assessment itself (though a human would operate the software). The focus is on whether the software performs its intended function accurately (e.g., correct image generation, measurement calculations).

7. The Type of Ground Truth Used for the Test Set

The ground truth for the testing appears to be primarily technical specifications, phantom measurements, and expected output values based on the software's design and engineering requirements. For the "phantom-based validation" of ISI, the ground truth would likely be the known material properties or quantitative measurements of the phantom. For other functional tests, it would be the expected software output when processing specific input data according to defined algorithms. No mention of expert consensus, pathology, or outcomes data as ground truth is made for the described testing.

8. The Sample Size for the Training Set

The document is a 510(k) summary for a software update and extension of an existing product, and the testing described is primarily for verification and validation, implicitly for a mature software product built upon established technology. It does not mention or provide information about a "training set" for AI/ML algorithms. The device's description as "advanced visualization tools" and "measurements" suggests traditional image processing and analysis algorithms, not necessarily deep learning or AI that would require large, labeled training datasets. The "Interactive Spectral Imaging" feature is described as allowing the user to display representations of Dual Energy data, which often relies on pre-defined material decomposition algorithms rather than trained models.

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

Since no "training set" for AI/ML is mentioned, the method for establishing its ground truth is not applicable here. The ground truth for the verification and validation of this device (as per point 7 above) would be based on technical specifications and known physical properties, not a labeled training dataset derived from human expert annotations.

Summary

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Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 20, 2019

Siemens Medical Solutions USA, Inc. % Alaine Medio Regulatory Affairs Specialist 810 Innovation Drive KNOXVILLE TN 37932

Re: K192402

Trade/Device Name: syngo.CT Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: August 29, 2019 Received: September 3, 2019

Dear Alaine Medio:

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,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192402

Device Name syngo.CT Extended Functionality

Indications for Use (Describe)

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.

Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

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)

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510(K) SUMMARY FOR SYNGO.CT EXTENDED FUNCTIONALITY

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

Date Prepared: September 18, 2019

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.

I. Submitter

Importer/Distributor

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

Establishment Registration Number 2240869

Manufacturing Site Siemens Healthcare GmbH Siemensstr. 1 D-91301 Forchheim, Germany

Establishment Registration Number 3004977335

Contact Person

Alaine Medio Regulatory Affairs Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive Knoxville, TN 37932 Phone: (865)206-0337 Fax: (865) 218-3019 Email: alaine-medio(@siemens-healthineers.com

Alternate Contact :

Tabitha Estes

II. Device Name and Classification

Product Name:	syngo.CT Extended Functionality
Classification Name:	Computed Tomography X-ray System
Classification Panel:	Radiology
CFR Section:	21 CFR §892.1750
Device Class:	Class II
Product Code:	JAK

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III. Predicate Device

Primary Predicate Device:

Trade Name:	syngo.CT Clinical Extensions
510(k) Number:	K173625
Clearance Date:	03/08/2018
Classification Name:	System, X-Ray, Tomography, Computed
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	There are currently no recalls for this device

Secondary Predicate Device:

Trade Name:	syngo.CT Dual Energy
510(k) Number:	K150757
Clearance Date:	08/11/2015
Classification Name:	System, Image Processing, Radiological
Classification Panel:	Radiology
CFR Section:	21 CFR § 892.1750
Device Class:	Class II
Product Code:	JAK
Recall Information:	There are currently no recalls for this device

IV. Device Description

No	Extension	No	Extension
1	Interactive Spectral Imaging (new)	5	Neuro DSA (unmodified)
2	Vascular/Vessel Extension (modified)	6	ROI HU Threshold (unmodified)
3	Oncology Extension (modified)	7	Dual Energy (unmodified)
4	Osteo (unmodified)	8	Endoscopic View (unmodified)

syngo.CT Extended Functionality is an extension of the previously cleared primary predicate device post-processing application software syngo.CT Clinical Extensions (K173625) and includes the following modifications in comparison to the primary predicate device:

Support of Interactive Spectral Imaging a.
Vascular Extension modification: b.
- i. 2D Filter Type Support
- ii. Multiphase Support in Vessel Layout
Oncology Extension modification: C.
- i. Support of MR Data
General: Multiphase support for merged 4D series d.

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V. Indications for Use

An interface shall enable the connection between the syngo.CT Extended Functionality software package and the interconnected CT Scanner system.

Result images created with the syngo.CT Extended Functionality software package can be used to assist trained technicians or physicians in diagnosis.

VI. Comparison of Technological Characteristics with the Predicate Device

The indications for use for the syngo.CT Extended Functionality are identical to the predications for Use (see Table 2). The only difference is the renaming of the feature from syngo.CT Clinical Extensions to syngo.CT Extended Functionality. The intended use of this product is identical to the predicates.

Subject Device	Predicate Device (K173625)	Comparison Result
syngo.CT Extended Functionality	syngo.CT Clinical Extensions	Identical with the exceptionof the name of the product.
syngo.CT Extended Functionality isintended to provide advanced visualizationtools to prepare and process medicalimages for diagnostic purpose. Thesoftware package is designed to supporttechnicians and physicians in qualitativeand quantitative measurements and in theanalysis of clinical data that was acquiredand reconstructed by ComputedTomography (CT) scanners, and possiblyother medical imaging modalities (e.g. MRscanners).An interface shall enable the connectionbetween the syngo.CT ExtendedFunctionality software package and theinterconnected CT Scanner system.Result images created with the syngo.CTExtended Functionality software packagecan be used to assist trained technicians orphysicians in diagnosis.	syngo.CT Clinical Extensions is intendedto provide advanced visualization tools toprepare and process medical images fordiagnostic purpose. The software packageis designed to support technicians andphysicians in qualitative and quantitativemeasurements and in the analysis ofclinical data that was acquired andreconstructed by Computed Tomography(CT) scanners, and possibly other medicalimaging modalities (e.g. MR scanners).An interface shall enable the connectionbetween the syngo.CT ClinicalExtensions software package and theinterconnected CT Scanner system.Result images created with the syngo.CT.Clinical Extensions software package canbe used to assist trained technicians orphysicians in diagnosis.

Table 2: Indications for Use / Intended Use Comparison

As with the primary predicate device, the subject device is a bundle software package consisting of previously cleared software applications (unmodified and modified) that provide advanced visualization and measurement tools.

Software version SOMARIS/8 VB40 supports additional post-processing application features for MR datasets, dual energy images, and endoscopic visualization tools. At a high-level, the subject and predicate devices are based on the following same or similar technological characteristics as listed in Table 3 below:

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		Table 3: Technological Characteristic Comparison
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Feature	Subject Device	Predicate Deviceand Supported Functionality	Comparison Result
	yngo.CT Extended Functionality
SoftwareVersion	SOMARIS/8 VB40	Primary Predicate Device:K173625, clearance date 03/08/2018SOMARIS/8 VB30	Modified tosupport additionalfunctionality
	1. Interactive Spectral Imaging
InteractiveSpectralImaging	The Interactive Spectral Imagingfunctionality allows the user to displaydifferent representations of DualEnergy data with an interactive imagetext.	Secondary Predicate DeviceK150757, clearance date 08/11/2015The user can change the visualizationof Dual Energy data generated fromLow and High data to different DualEnergy types.	This feature isnew in the subjectdevice, but thefundamentaltechnology hasbeen cleared withthe secondarypredicate device.
	2. Vascular/Vessel Extension
Vascular/VesselExtension	The Vascular Tool provides tools andlayouts for vascular assessment.Additionally, the subject deviceVascular Tool provides a 2D FilterType Support and Multiphase Supportin Vessel Layout.	Primary Predicate Device:K173625, clearance date 03/08/2018The Vascular Tool provides tools andlayouts for vascular assessment andCT data.	This modificationis a usabilityimprovement.
	3. Oncology Extension
OncologyExtension	The oncology Tool offers tools forlocalization and evaluation of nodules.Additionally, the subject device nowprovides MR Support for DiameterWHO.	Primary Predicate Device:K173625, clearance date 03/08/2018The oncology extension offers toolsfor localization and evaluation ofnodules.	Modified tosupport MR datafor DiameterWHO.
	4. Osteo Extension
OsteoExtension	The Osteo extension is used for theevaluation of Bone Mineral Density(BMD) values (mg CA-HA/ml) of thelumbar spine based on Osteo CT scans.	Primary Predicate Device:K173625, clearance date 03/08/2018The Osteo extension is used for theevaluation of Bone Mineral Density(BMD) values (mg CA-HA/ml) of thelumbar spine based on Osteo CTscans.	Same – There areno modifications.
	5. Neuro DSA Extension
Neuro DSAExtension	Bone removal tool from a CTangiography dataset.	Primary Predicate Device:K173625, clearance date 03/08/2018Bone removal tool from a CTangiography dataset.	Same – There areno modifications.
	6. Dual Energy ROI
DualEnergy ROI	Evaluation of low/high kV images fromdual energy data.	Primary Predicate Device:K173625, clearance date 03/08/2018Evaluation of low/high kV imagesfrom dual energy data.	Same – There areno modifications.
7. Endoscopic View
EndoscopicView Tool	Fly through tubular structures whichare either filled by low-intensity (e.g.air-filled) or high-intensity (e.g. blood-filled) material.	Primary Predicate Device:K173625, clearance date 03/08/2018Fly through tubular structures whichare either filled by low-intensity (e.g.air-filled) or high-intensity (e.g.blood-filled) material.	Same – There areno modifications.

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Feature	Subject Devicesyngo.CT Extended Functionality	Predicate Deviceand Supported Functionality	ComparisonResult
8. ROI HU Threshold
ROI HUThreshold	Evaluation of HU value distributionswithin a user defined region of interest.	Primary Predicate Device:K173625, clearance date 03/08/2018Evaluation of HU value distributionswithin a user defined region ofinterest	Same – There areno modifications.
General, Extension-independent Functionality
Pre-generatedresults	Support of pre-generated results and theability to edit pre-generated results	Primary Predicate Device:K173625, clearance date 03/08/2018Support of pre-generated results andthe ability to edit pre-generatedresults	Same – There areno modifications.

Multiphasesupport formerged 4Dseries	Grouping of multiphase seriesgenerated by respiratory gated,perfusion and cardiac datasets.	Primary Predicate Device:K173625, clearance date 03/08/2018Grouping of multiphase seriesgenerated by respiratory gated andperfusion datasets.	Usabilityimprovement: Thegrouping logic hasbeen extended toinclude cardiacgated datasets.

Any differences in technological characteristics do not raise different questions of safety and effectiveness. Testing and validation is completed. Test results show that the subject device, syngo.CT Extended Functionality are comparable to the predicate devices in terms of technological characteristics and safety and effectiveness and therefore are substantially equivalent to the predicate devices.

VII. Performance Data

Software Verification and Validation Testing

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 included as part of this submission.

Non-Clinical / Clinical Testing Summary

syngo.CT Dual Energy is designed to fulfill the requirements of the following safety and performance standards:

RecognitionNumber	ProductArea	Title of Standard	PublicationDate	StandardsDevelopmentOrganization
12-300	Radiology	Digital Imaging and Communications inMedicine (DICOM) Set; PS 3.1 – 3.20	06/27/2016	NEMA
13-32	Software	Medical Device Software –Software LifeCycle Processes; 62304:2006 (1st Edition)	08/20/2012	AAMI, ANSI,IEC
5-40	Software/Informatics	Medical devices – Application of riskmanagement to medical devices; 14971Second Edition 2007-03-01	08/20/2012	ISO
5-114	General I(QS/RM)	Medical devices - Part 1: Application ofusability engineering to medical devicesIEC 62366-1:2015	12/23/2016	IEC

Performance tests were conducted to test the Interactive Spectral Imaging (ISI) functionality of the syngo.CT Extended Functionality post-processing application. A phantom-based validation "Detailed Description and Bench

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Tests for the Plugin "Interactive Spectral Imaging"" has been conducted to show that the feature ISI operates as intended.

Non-clinical tests and a phantom-based bench test have been conducted to establish the proficiency of the features of the subject device. The results of these tests demonstrate that the subject device performs as intended. The result of all conducted testing was found acceptable to support the claim of substantial equivalence.

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.

VIII. Conclusions

syngo.CT Extended Functionality has the same indication for use as the primary predicate device. The technological characteristics such as image visualization, operating platform, and image measurement are the same as the predicate devices. For the subject device, syngo.CT Extended Functionality, Siemens used the same testing with the same workflows as used to clear the primary predicate device. Siemens considers syngo.CT Extended Functionality to be as safe, as effective, and with performance substantially equivalent to the commercially available 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.