BodyTom Elite (NL4000)
Device Facts
| Record ID | K253450 |
|---|---|
| Device Name | BodyTom Elite (NL4000) |
| Applicant | NeuroLogica Corp., a Samsung Company |
| Product Code | JAK · Radiology |
| Decision Date | Jul 28, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1750 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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. BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
Device Story
BodyTom Elite is a mobile, multi-row, 85cm bore CT system; features translating gantry with rotating disk, solid-state x-ray generator, Gd2O2S detector array, and collimator. System includes power slip-ring, data acquisition, and reconstruction computer. Operates via battery or AC power; includes motorized wheels for transport. Used in clinical settings for pediatric and adult imaging; supports low-dose lung cancer screening. Clinicians operate system to obtain CT images (with/without contrast) for diagnostic evaluation. Output consists of reconstructed CT images used for clinical decision-making. System includes safety features: emergency stop, x-ray indicators, interlocks, and patient alignment lasers.
Clinical Evidence
Bench testing only. Verification and validation testing confirmed design and user requirements were met. Image quality metrics (noise, slice thickness, low/high contrast resolution, MTF) were measured using phantoms and compared to the predicate device, demonstrating comparable performance. Electrical safety and EMC testing confirmed compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-44.
Technological Characteristics
Mobile CT system; 85cm bore; 60cm FOV. Components: Gd2O2S detector array, solid-state x-ray generator, brushless DC servo drive. Power: Battery/AC. Connectivity: DICOM (NEMA PS 3.1-3.20). Software: Linux-based reconstruction OS. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-2-44, IEC 62304, ISO 14971, NEMA XR 25/26/28/29. Sterilization: N/A.
Indications for Use
Indicated for pediatric and adult patients requiring x-ray computed tomography imaging of anatomy within an 85cm aperture, including low dose lung cancer screening. Contraindications: None stated.
Regulatory Classification
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.
Predicate Devices
- BodyTom Elite (K170238)
Reference Devices
- BodyTom 64 (K250928)
Submission Summary (Full Text)
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**U.S. FOOD & DRUG**
ADMINISTRATION
July 28, 2026
NeuroLogica Corp., a Samsung Company
% Ninad Gujar
Vice President
14 Electronics Ave.
DANVERS, MA 01923
Re: K253450
Trade/Device Name: BodyTom Elite (NL4000)
Regulation Number: 21 CFR 892.1750
Regulation Name: Computed Tomography X-Ray System
Regulatory Class: Class II
Product Code: JAK
Dated: June 29, 2026
Received: June 30, 2026
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.
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
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K253450 - Ninad Gujar
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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).
Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3).
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 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-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
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K253450 - Ninad Gujar
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assistance/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,
Lu Jiang, Ph.D.
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
# **Indications for Use**
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K253450
Device Name
BodyTom Elite (NL4000)
Indications for Use (Describe)
The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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.
BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
*Please refer to clinical literature, including the results of the National Lung Screening
Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
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)
**CONTINUE ON A SEPARATE PAGE IF NEEDED.**
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**\*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:
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FORM FDA 3881 (8/23)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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NeuroLogica
A SAMSUNG COMPANY
# 510(k) Summary
Date Prepared: October 2, 2025
K253450
## Submitter
NeuroLogica Corp., a Samsung Company
14 Electronics Ave., Danvers, MA 01923
## Establishment Registration
3004938766
## Manufacturing Site
NeuroLogica Corp., a Samsung Company
14 Electronics Ave., Danvers, MA 01923
## Official Correspondent & Contact Person
Ninad Gujar, Vice President
Regulatory Affairs & Quality Assurance
Telephone: 978-564-8632
E-mail: ngujar@neurologica.com
## Device
| Trade Name: | BodyTom Elite (NL4000) |
| --- | --- |
| Device Model: | NL4000 |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
## Predicate Device
| Trade Name: | BodyTom Elite (K170238) |
| --- | --- |
| Classification Name: | Computed Tomography X-ray System |
| Product Code: | JAK |
| Device Classification: | Class II (per 21 CFR § 892.1750) |
## Reference Device
| Trade Name: | BodyTom 64 (K250928) |
| --- | --- |
| 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
BodyTom Elite computed tomography (CT) system provides the same functionality as the previous version of the device BodyTom Elite (K170238). Both CT systems are identical in terms of the high resolution, multi row, 85 cm bore, and 60 cm field of view. The lightweight translating gantry consists of a rotating disk with a solid-state x-ray generator, Gd2O2S detector array, 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 retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.
# Intended Use / Indications for Use
The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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.
BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies.
*Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
# Comparison of Technological Characteristics with the Predicate Device
The BodyTom Elite, for its intended use, is of comparable type in design, material, functionality, and technology and is substantially equivalent to the cleared predicate device – BodyTom Elite (K170238).
We modified the cleared BodyTom Elite (K170238) within our design controls to include technology improvements, specifically the change of the reconstruction computer operating system to Linux.
The indications for use between the subject device and the predicate device (K170238) are identical. The subject device still contains the same technology and basic functionality as the predicate device (K170238), and therefore, safety and efficacy are not of a concern. Please find both the subject and predicate device indications for use below.
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| BodyTom Elite (Subject Device) | BodyTom Elite (Predicate – K170238) |
| --- | --- |
| The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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. The BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies. | The BodyTom Elite system is intended to be used for x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture. 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. The BodyTom Elite system can be used for low dose lung cancer screening. The screening must be performed in compliance with the approved and established protocols as defined by professional medical societies. |
The change is a software update, and the CT system remains the same from a hardware standpoint.
## Similarities
- Design: The BodyTom 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.
- Components: The BodyTom Elite uses the same components as the predicate device such as x-ray generator, collimator, slip ring and power system.
## Differences
The following differences exist between the subject device (BodyTom Elite) and its previously cleared version, predicate device (K170238).
- The software revision has undergone few updates since the BodyTom Elite (K170238) was cleared. The updates were implemented to enhance the user experience and improve clinical workflow while using the CT system by adding features based on feedback from our current customers.
- Subject device, reconstruction computer operating system has been updated to Linux.
The internal verification and validation activities and external testing of product safety and EMC / EMI was completed successfully. The differences noted above raise no new issues of safety or effectiveness based on all testing performed. Below a summary has been provided for the testing conducted.
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# **General Safety and Effectiveness Concerns:**
All components of the subject BodyTom Elite 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.
BodyTom Elite CT system is designed and manufactured to comply with the FDA Quality System Regulations and ISO 13485:2016 requirements. The device is in conformance with all applicable parts of the following FDA recognized consensus standards:
| FDA Recognition Number | Standard | Description | Version |
| --- | --- | --- | --- |
| 19-46 | AAMI / ANSI ES 60601-1 | Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance | 2012 |
| 19-36 | IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility. Requirements and Tests | 2014 |
| 12-336 | IEC 60601-1-3 | Medical Electrical Equipment - Part 1-3: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Radiation Protection In Diagnostic X-Ray Equipment | 2013 |
| 5-132 | IEC 60601-1-6 | Medical Electrical Equipment - Part 1-6: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Usability | 2013 |
| 12-302 | IEC 60601-2-44 | Medical Electrical Equipment- Part 2-44: Particular Requirements for Basic Safety and Essential Performance of X-Ray Equipment for Computed Tomography | 2016 |
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| FDA Recognition Number | Standard | Description | Version |
| --- | --- | --- | --- |
| 12-273 | IEC 60825-1 | Safety Of Laser Products - Part 1: Equipment Classification, And Requirements | 2007 |
| 5-125 | ISO 14971 | Medical Devices - Application Of Risk Management To Medical Devices | 2019 |
| 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 |
| 2-296 | 10993-10 | Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | 2010 |
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| FDA Recognition Number | Standard | Description | Version |
| --- | --- | --- | --- |
| 12-325 | NEMA XR 25 | Computed Tomography Dose Check | 2019 |
| NR | NEMA XR 26 | Access Controls for Computer Tomography: Identification, Interlocks, and Logs | 2012 |
| 12-330 | NEMA XR 28 | Supplemental Requirements for User Information and System Function Related to Dose in CT | 2018 |
| NR | NEMA XR 29 | Standard Attributes on Computed Tomography (CT) Equipment Related to Dose Optimization and Management | 2013 |
| 12-352 | NEMA PS 3.1 - 3.20 | Digital Imaging and Communications in Medicine (DICOM) Set | 2023 |
| 21 CFR subchapter J § 1020.30 | FDA | Performance Standards for Ionizing Radiation Emitting Products: Diagnostic x-ray systems and their major components | 2025 |
| 21 CFR subchapter J § 1020.33 | FDA | Performance Standards for Ionizing Radiation Emitting Products: Computed tomography (CT) equipment | 2025 |
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The BodyTom 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)] Submissions, September 2023
- Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors, August 2023
- 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, May 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
- Applying Human Factors and Usability Engineering to Medical Devices, February 3, 2016
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In addition to conformance to the above harmonized standards, BodyTom 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
**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 BodyTom 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 BodyTom Elite. The verification/validation testing ensured substantial equivalence of BodyTom Elite.
Design verification and design validation testing was performed to confirm all design and user requirements were met. The proposed BodyTom 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 BodyTom Elite device was shown to meet all requirements and to not have any impact on imaging.
The BodyTom Elite 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 has comparable
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image quality with its previous version, predicate device (K170238) and meets all the image quality criteria that are used for testing.
## Conclusion
Both the proposed device (BodyTom Elite) and the predicate device, prior version of BodyTom Elite (K170238) are CT systems that are used for pediatric and adult imaging (similar intended use). 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 do not raise different questions of safety and effectiveness.
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 BodyTom Elite CT system performs as well in its intended use as similar devices currently on the market.
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