The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age The CT images can be obtained either with or without contrast.

OmniTom Elite with photon counting detectors (PCD) configuration has multi-energy CT functionality with spectral capability for material decomposition and virtual monoenergetic images (VMI). OmniTom Elite with PCD is supported for adult imaging of the head and neck.

Device Description

The subject OmniTom Elite Computed Tomography (CT) system provides the same functionality as the previous version of the device, OmniTom Elite (K223447). Both computed tomography systems are identical in terms of the high resolution, 16 row, 40 cm bore, and 30 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, collimator, control computer, communications link, power slip-ring, data acquisition system, reconstruction computer, power system, brushless DC servo drive system (disk rotation) and an internal drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system has the necessary safety features such as the emergency stop switch, x-ray indicators, interlocks, patient alignment laser and 110% x-ray timer. The gantry has omni-directional wheels that allow for robust diagonal, lateral, and rotational 360-degree movement and electrical drive system so the system can be moved easily to different locations.

The ability to upgrade the OmniTom Elite system with photon counting detector (PCD) remains the same. PCD provides the ability to capture CT data in multiple energy bands that can provide information on material composition of different tissues and contrast media. The multiple sets of CT data are acquired at the same time with configurable energy thresholds without any cross talk between images.

AI/ML Overview

The provided text describes the OmniTom Elite Computed Tomography (CT) system and its updates, focusing on the Photon Counting Detector (PCD) configuration. However, it does not contain specific numerical acceptance criteria for performance metrics or detailed results from a study that quantifies these criteria. The document states that the device successfully meets "all the image quality criteria that are used for testing" and that images were "confirmed diagnostic quality," but it doesn't provide the actual criteria or the numerical outcomes.

Therefore, many parts of the request cannot be fully answered with the given information.

Here's an attempt to answer based on the provided text, highlighting where information is missing:

Acceptance Criteria and Study Details for OmniTom Elite with PCD

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

The document does not explicitly state numerical acceptance criteria for image quality metrics. It broadly claims that the device "meets all the image quality criteria that are used for testing" and that images were of "diagnostic quality."

Metric / Feature	Acceptance Criteria (Not Explicitly Stated as Numerical Value)	Reported Device Performance (Not Explicitly Stated as Numerical Value)
Noise	Satisfactory for diagnostic quality	Successfully demonstrated comparable image quality to predicate
Slice Thickness	Satisfactory for diagnostic quality	Successfully demonstrated comparable image quality to predicate
Low Contrast Resolution	Satisfactory for diagnostic quality	Successfully demonstrated comparable image quality to predicate
High Contrast Resolution	Satisfactory for diagnostic quality	Successfully demonstrated comparable image quality to predicate
Radiation Metrics	Conformance with equipment performance standards & regulations	Successfully demonstrated comparable image quality to predicate
Modulation Transfer Function	Satisfactory for diagnostic quality	Successfully demonstrated comparable image quality to predicate
Diagnostic Quality of Images (Clinical)	Images confirmed to be of diagnostic quality by radiologists	Confirmed diagnostic quality of images

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: "Volunteers underwent CT scanning for a full head scan, the top of the skull, the midbrain, and through the sinuses." The number of volunteers is not specified.
Data Provenance: The study involved prospective scanning of volunteers. The country of origin is not specified.

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

Number of Experts: "independent board-certified practicing radiologists." The number of radiologists is not specified.
Qualifications of Experts: "board-certified practicing radiologists."

4. Adjudication method for the test set

The document does not specify an adjudication method (e.g., 2+1, 3+1). It only states that images were "reviewed by independent board-certified practicing radiologists."

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

MRMC Study Done: No. The study described is a clinical evaluation of the device's image quality, not an MRMC study comparing human reader performance with and without AI assistance. The device itself is a CT system, and while it introduces new image processing features (like MD Plus for bone removal, VNC, ultra-high resolution), it doesn't appear to be an AI-assisted diagnostic tool for humans, but rather an imaging system that produces images that radiologists interpret.
Effect Size: Not applicable as an MRMC comparative effectiveness study with AI assistance was not performed or described.

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

Yes, elements of standalone performance were evaluated.

Bench Testing: Software development and testing in accordance with IEC 62304 and FDA guidance for software functions, including risk management analysis and verification/validation testing, indicate standalone algorithm assessment for software functions.
Image Quality Evaluation: "Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests." This constitutes standalone testing of the imaging system's output characteristics without human interpretation.

7. The type of ground truth used

For Image Quality Evaluation: Physical phantom measurements were used to assess image quality metrics.
For Clinical Evaluation: The "ground truth" for diagnostic quality was established by the consensus or interpretation of "independent board-certified practicing radiologists." This is expert consensus on the diagnostic acceptability of the images. No mention of pathology or outcomes data as ground truth is made.

8. The sample size for the training set

The document does not provide information regarding a training set size or methodology, as the study described is an evaluation of the CT system's performance, not an AI algorithm that requires a distinct training phase. The MD Plus algorithm is mentioned, but its training details are not.

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

Not applicable/no information provided, as details about a training set for an AI algorithm are not given.

Summary

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June 10, 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 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.

NeuroLogica Corporation % Ninad Gujar Vice President 14 Electronics Avenue DANVERS, MA 01923

Re: K233767

Trade/Device Name: OmniTom Elite Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: JAK Dated: November 16, 2023 Received: May 6, 2024

Dear Ninad Gujar:

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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approvals in the device master record (21 CFR 820.181).

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

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,

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) K233767

Device Name OmniTom Elite

Indications for Use (Describe)

The OmniTom Elite computed tomography (CT) system is intended to be used for X-ray computed tomography applications for anatomy that can be imaged in the 40cm aperture, primarily the head and neck.

The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age The CT images can be obtained either with or without contrast.

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 "NeuroLogica" in a bold, sans-serif font. The "O" in "NeuroLogica" is replaced with a blue circle. Below the word "NeuroLogica" is the text "A Subsidiary of Samsung Electronics Co., Ltd" in a smaller font.

K233767 510(k) Summary

Date Prepared: May 4, 2024

Submitter

NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923

Establishment Registration

3004938766

Manufacturing Site

NeuroLogica Corp., a subsidiary of Samsung Electronics Co., Ltd 14 Electronics Avenue, Danvers, MA 01923

Official Correspondent & Contact Person

Dr. Ninad Gujar Vice President, Regulatory Affairs & Quality Assurance Telephone: 978-564-8632 E-mail: ngujar@neurologica.com

Device Name:

Trade Name:	OmniTom Elite
Device Model:	NL5000
Classification Name:	Computed Tomography X-ray System
Product Code:	JAK
Device Classification:	Class II (per 21 CFR § 892.1750)

Predicate Device:

510(k):	K223447
Trade Name:	OmniTom Elite
Device Model:	NL5000
Classification Name:	Computed Tomography X-ray System
Product Code:	JAK
Device Classification:	Class II (per 21 CFR § 892.1750)

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Device Description:

Indications for Use:

The OmniTom Elite computed tomography (CT) system is intended to be used for xray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and neck. The CT system is intended to be used for both pediatric and adult imaging and as such has preset dose settings based upon weight and age. The CT images can be obtained either with or without contrast.

Comparison of Technological Characteristics with the Predicate Device:

We modified the cleared OmniTom Elite (K223447) within our design controls to include technology improvements that include ultra-high resolution modes for PCD along with CT features based on material decomposition algorithm (MD Plus) for bone removal and virtual non contrast (VNC). Helical scanning capability was added along with increasing the field of view (FOV) and operating temperature.

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The indications for use between the subject device and the predicate device (K223447) only vary slightly, in that the subject device offers an additional resolution mode for the photon counting detector. The subject device still contains the same technology and basic functionality as the predicate device (K223447), and therefore, safety and efficacy are not of a concern. Please find both the subject and predicate indications for use below.

OmniTom Elite (Subject Device)	OmniTom Elite (Predicate – K223447)
The OmniTom Elite CT system is intendedto be used for x-ray computed tomographyapplications for anatomy that can be imagedin the 40cm aperture, primarily head andneck.	The OmniTom Elite computed tomography(CT) system is intended to be used for x-raycomputed tomography applications foranatomy that can be imaged in the 40cmaperture, primarily head and neck.
The CT system is intended to be used forboth pediatric and adult imaging and as suchhas preset dose settings based upon weightand age. The CT images can be obtainedeither with or without contrast.	The CT system is intended to be used forboth pediatric and adult imaging and as suchhas preset dose settings based upon weightand age. The CT images can be obtainedeither with or without contrast.
OmniTom Elite with photon countingdetectors (PCD) configuration has multi-energy CT functionality with spectralcapability for material decomposition andvirtual monoenergetic images (VMI).OmniTom Elite with PCD is supported foradult imaging of the head and neck.	OmniTom Elite with photon countingdetectors (PCD) configuration has multi-energy CT functionality with spectralcapability for material decomposition andvirtual monoenergetic images (VMI).OmniTom Elite with PCD is only supportedfor adult axial imaging for head and neck.

The optional upgrade of the photon counting detector (PCD) remains the same from a hardware standpoint with the exception of additional fans for temperature regulation. OmniTom Elite with the optional PCD kit for its intended use, is of comparable type in design, material, functionality, and technology and is substantially equivalent to the cleared predicate device - OmniTom Elite (K223447).

Similarities

트 Design: The OmniTom Elite is identical in design characteristics to its previous version and shares all of the control system designs and features of the cleared predicate device.

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트 Components: The OmniTom Elite uses similar components as the predicate device (OmniTom Elite) such as x-ray generator, collimator, slip ring and power system.
. Software: The OmniTom Elite, with the exclusion of PCD kit, uses the same software as the predicate (K223447). Refer to the differences listed below for software and hardware differences with PCD.

Differences

The following differences exist between the subject device (OmniTom Elite) and its previously cleared version, predicate device (K223447).

. The PCD configuration now includes the following:
- o Utilizing the current MD Plus algorithm, post reconstruction features of VNC and bone removal are added.
- Expanding scope of PCD scanning to the full 30 cm field of view о
- Helical scanning O
- Operating environment ambient temperature is now increased to O 27°C/80.6°F
- With the addition of ultra-high-resolution mode, detector coverage is the o following:
  - 16 x 0.707 mm for PCD (standard resolution) O
  - 26 X 0.424 mm for PCD (high resolution) o
  - 80 X 0.141 (ultra high resolution) o

For scanning with PCD configuration, scan voltage is 120 kV and scan current is selectable from 5 to 20 mA. Scanning of the head and neck using the PCD configuration is only applicable for adults.

General Safety and Effectiveness:

All components of the subject OmniTom Elite CT system that are subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR $1020.30 and §1020.33 are certified to meet those requirements. To minimize electrical, mechanical and radiation hazards, NeuroLogica adheres to recognized and established industry practices.

OmniTom Elite CT system is designed and manufactured to comply with the FDA Quality System Regulations (21 CFR part 820) and ISO 13485:2016 requirements. The device is in conformance with all applicable parts of the following FDA recognized consensus standards:

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NeurOLog Co., Ltd

FDARecognitionNumber	Standard	Description	Version
19-4	AAMI / ANSIES 60601-1	Medical Electrical Equipment --Part 1: General Requirements ForBasic Safety And EssentialPerformance	2012
19-8	IEC 60601-1-2	Medical electrical equipment -Part 1-2: General Requirementsfor Basic Safety and EssentialPerformance - Collateral Standard:Electromagnetic Compatibility.Requirements and Tests	2014
12-269	IEC 60601-1-3	Medical Electrical Equipment -Part 1-3: General RequirementsFor Basic Safety And EssentialPerformance - Collateral Standard:Radiation Protection In DiagnosticX-Ray Equipment	2013
5-89	IEC 60601-1-6	Medical Electrical Equipment -Part 1-6: General RequirementsFor Basic Safety And EssentialPerformance - Collateral Standard:Usability	2013
12-302	IEC 60601-2-44	Medical Electrical Equipment-Part 2-44: Particular Requirementsfor Basic Safety and EssentialPerformance of X-Ray Equipmentfor Computed Tomography	2016
12-273	IEC 60825-1	Safety Of Laser Products - Part 1:Equipment Classification, AndRequirements	2007
5-125	ISO 14971	Medical Devices - Application OfRisk Management To MedicalDevices	2019
FDARecognitionNumber	Standard	Description	Version
13-79	IEC 62304	Medical Device Software - Software Life Cycle Processes	2015
5-134	ISO 15223-1	Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements	2016
2-258	ISO 10993-1	Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process	2018
2-245	ISO 10993-5	Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	2009
2-174	10993-10	Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization	2010
12-325	NEMA XR 25	Computed Tomography Dose Check	2019
NR	NEMA XR 26	Access Controls for Computer Tomography: Identification, Interlocks, and Logs	2012
FDARecognitionNumber	Standard	Description	Version
12-330	NEMA XR 28	Supplemental Requirements forUser Information and SystemFunction Related to Dose in CT	2018
NR	NEMA XR 29	Standard Attributes on ComputedTomography (CT) EquipmentRelated to Dose Optimization andManagement	2013
12-349	NEMA PS 3.1 -3.20	Digital Imaging andCommunications in Medicine(DICOM) Set	2022
21 CFRsubchapter J\$ 1020.30	FDA	Performance Standards forIonizing Radiation EmittingProducts: Diagnostic x-raysystems and their majorcomponents	2023
21 CFRsubchapter J\$ 1020.33	FDA	Performance Standards forIonizing Radiation EmittingProducts: Computed tomography(CT) equipment	2023

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NeurOLo . . Ltd

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NeurOLoc

The OmniTom Elite was designed in accordance with the following FDA Guidance documents:

Content of Premarket Submissions for Device Software Functions, June 2023
Cybersecurity in Medical Devices: Quality System Considerations and Content of ■ Premarket Submissions, September 2023
Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] I Submissions, September 2023
. Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors, August 2023

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. Electronic Submission Template for Medical Device 510(k) Submissions, October 2023
. Medical Device Accessories – Describing Accessories and Classification Pathways, December 2017
. Computer Software Assurance for Production and Quality System Software, September 2022
. Guidance for Postmarket Management of Cybersecurity in Medical Devices, December 2016
. Off-The-Shelf Software Use in Medical Devices, August 2023
. Guidance for Deciding When to Submit a 510(k) for a Change to an Existing Device, October 2017
. Deciding When to Submit a 510(k) for a Software Change to an Existing Device, October 2017
. Guidance for Medical X-Ray Imaging Devices Conformance with IEC Standards, Mav 2019
. Information Disclosure by Manufacturers to Assemblers for Diagnostic X-ray Systems, September 2003
. Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI), July 2021
. Premarket Assessment of Pediatric Medical Devices, March 2014
. Pediatric Information for X-ray Imaging Device Premarket Notifications, November 2017
. The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)], July 28, 2014
. Guidance for Industry and FDA Staff: Use of Standards in Substantial Equivalence Determinations, March 12, 2000
Laser Products Conformance with IEC 60825-1 and IEC 60601-2-22; (Laser . Notice No. 50), June 2007
. Radiofrequency Wireless Technology in Medical Devices, August 2013

In addition to conformance to the above harmonized standards, OmniTom Elite quality assurance activities include the following:

. Risk analysis and mitigation
. Software verification and validation testing
. System verification and validation testing
Image quality tests
. Testing at unit level

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Performance Data:

The risk analysis, verification and validation activities and testing of product safety and EMC / EMI was completed successfully. The differences noted raise no new issues based on all testing performed and establish that specifications for the device have been met. Below a summary has been provided for the testing conducted.

Bench testing

The software contained in the proposed device has been developed & tested in accordance with IEC 62304, and the FDA guidance for Content of Premarket Submissions for Device Software Functions. Software is critical to the operation of the OmniTom Elite CT system and a malfunction or design flaw in the software could result in delay in delivery of appropriate medical care. As such, the risk management analysis identified potential hazards which were controlled and mitigated during development of OmniTom Elite. The verification/validation testing ensured substantial equivalence of OmniTom Elite.

Design verification and design validation testing was performed to confirm all design and user requirements were met. The proposed OmniTom Elite device demonstrated that the new features did not exhibit any negative effects on the requirements in place, as well as they did not exhibit any concerns.

Software verification and software validation testing was executed to confirm all software requirements were met. The proposed OmniTom Elite device was shown to meet all requirements and to not have any impact on imaging.

The OmniTom Elite with PCD underwent Electrical Safety and Electromagnetic Compatibility testing and proved to be in compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-44.

Image quality evaluation

Image quality metrics such as noise, slice thickness, low and high contrast resolution, radiation metrics, and modulation transfer function were measured utilizing phantom image quality tests in accordance with the equipment performance standards for diagnostic x-ray systems administered by the FDA. Imaging metrics successfully demonstrated that the proposed device with PCD has comparable image quality with its previous version, predicate device (K223447) and meets all the image quality criteria that are used for testing.

Clinical evaluation

Clinical study was conducted for evaluation of OmniTom Elite with PCD images. All study protocols were performed in accordance with the relevant regulations and the guidelines. Volunteers underwent CT scanning for a full head scan, the top of the skull, the midbrain, and through the sinuses. These images were reviewed by independent board-certified

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practicing radiologists and confirmed diagnostic quality of the images demonstrating the effectiveness of the subject device for clinical scanning.

The clinical scans indicate the ability of the PCD configuration of the OmniTom Elite device to generate diagnostically acceptable images, which are equivalent to those produced by predicate device. The subject device clinical benefits outweigh the risks and as such the device should be considered safe for its intended use and performs like other CT devices currently on the market. The clinical evaluation demonstrates performance of the OmniTom Elite system with PCD, when used under the conditions and for the purposes intended.

Conclusion

Both the proposed device (OmniTom Elite) with the optional PCD upgrade and the predicate device (K223447) are CT systems that are used for similar CT imaging purposes. The overall design of the CT system and basic functionality that it provides to the end user are the same. The differences in technological characteristics through the additional software features adding applications utilizing the multi-energy CT functionality for ultrahigh-resolution mode, helical scanning and full FOV do not raise additional questions and the system demonstrates substantial equivalence.

The results of the performance testing and conformance to the harmonized standards demonstrate that the subject device operates in accordance with specifications and meets user needs and intended use. The proposed OmniTom Elite CT system performs as well in its intended use as similar CT devices currently on the market.

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.