BODYTOM NL 4000

K102677 · Neurologica Corporation · JAK · Mar 24, 2011 · Radiology

Device Facts

• Record ID: K102677
• Device Name: BODYTOM NL 4000
• Applicant: Neurologica Corporation
• Product Code: JAK · Radiology
• Decision Date: Mar 24, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The NL4000 BodyTom is intended to be used for x-ray Computed Tomography applications for anatomy that can be imaged in the 85cm aperture.

Device Story

BodyTom (NL4000) is a mobile, high-resolution, multi-row, 85cm bore x-ray computed tomography (CT) system. Input: x-ray attenuation data collected via rotating gantry containing solid-state x-ray generator and detector array. Transformation: system uses reconstruction computer to process raw data into tomographic images. Output: 2D, multi-planar reconstruction (MPR), and 3D images displayed on workstation and archived via DICOM/PACS. Used in clinical settings (radiology, ICU, ED, surgical, interventional) by qualified healthcare professionals. Features motorized transport wheels and battery-powered operation (LiPO batteries) for mobility. Includes radiation safeguards (dose reporting, lockout, 110% timer) and quality assurance software. Benefits include portable diagnostic imaging capability for patients requiring CT scans outside traditional radiology suites.

Clinical Evidence

Bench testing only. No clinical data provided. System verified against recognized safety standards (UL60601-1, IEC 60601-1, EN 60601-1, IEC 60601-2-44). Battery system validated using 50kW passive load simulation under severe duty cycles.

Technological Characteristics

85cm bore, 60cm FOV, 32-slice CT. Solid-state CdWO4 detectors, rotating anode x-ray tube (42kW). Battery-powered (LiPO, 540VDC). Motorized transport. Connectivity: Wireless data transfer, DICOM 3.0/PACS. Safety: Emergency stop, laser alignment, radiation safeguards (dose display, lockout). Standards: 21 CFR 1020.30/33, UL60601-1, IEC 60601-1 series.

Indications for Use

Indicated for x-ray computed tomography imaging of any anatomy fitting within the 85cm aperture. Intended for prescription use.

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

• NeuroLogica Corporation, NL3000 CereTom™ CT (K051765)
• Hitachi Medical Systems America, Inc. ECLOS16™ (K071806)
• NeuroLogica Corporation, inSPira HD™ (K090811)

Submission Summary (Full Text)

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K102677 Page 1 of 13

Image /page/0/Picture/1 description: The image shows a logo with the word "NeuroLogica" written in a bold, sans-serif font. The "O" in "Logica" is stylized as a circle with a dot in the center. Behind the text is a stylized drawing of a brain, with an elliptical shape encircling it. The overall design appears to be a logo for a company or organization related to neurology or logic.

MAR 2 4 2011

## 510(k) SUMMARY For NeuroLogica Corporation NL4000 BodyTom™ Computed Tomography System

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

| (1) Submitter: | NeuroLogica Corporation 14 Electronics Avenue Danvers, MA, 01923 |
|----------------|--------------------------------------------------------------------|
|----------------|--------------------------------------------------------------------|

## Establishment Registration number: FDA #3004938766

Contact person: Mr. Donald D. Fickett Vice President of Regulatory Affairs and Quality Systems Telephone [phone] FAX [phone] e-mail: [e-mail]

Date this summary was prepared: September 9, 2010

#### (2) Device Name:

Proprietary or Trade Name: BodyTom

Device Model: NL4000

Classification Name: Computed Tomography X-ray System

Product code: 90JAK

Device classification: Class II

Regulation number: 21 CFR 892.1750

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Image /page/1/Picture/1 description: The image shows a logo for "NeuroLogica". The logo features a stylized drawing of a brain with an orbit around it. The word "NeuroLogica" is written in a simple font below the brain drawing. The "O" in "Logica" is stylized as a circle with a dot in the center.

### (3) Predicate device:

The legally marketed device to which substantial equivalence is being claimed is as follows:

- NeuroLogica Corporation, NL3000 CereTom™ CT per Pre-Market . Notification Submission K051765
- Hitachi Medical Systems America, Inc. ELCOS16™ per Pre-Market . Notification Submission K071806
- NeuroLogica Corporation, inSPira HD™ per Pre-Market Notification � Submission K090811

#### (4) Device Description:

The NL4000 BodyTom is essentially a larger bore version of our predicate NL3000 CereTom CT system. It is a high resolution, multi row, 85 cm bore, 60cm field of view, x-ray computed tomography system. The lightweight translating gantry consists of a rotating disk with a solid state x-ray generator, solid state 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 stepper drive system (translation). The power system consists of batteries which provide system power while unplugged from the charging outlet. The system software is based upon the CereTom software, however, does not contain application specific software for contrast imaging. In addition, the system has the necessary safety features such as emergency stop switch, x-ray indicators, interlocks, patient alignment laser, and 110 percent x-ray timer. The gantry has retractable rotating caster wheels and electrical drive system so the system can be moved easily to different locations.

#### (5) Intended Use:

The NL4000 BodyTom is intended to be used for non-contrast x-ray computed tomography applications for anatomy that can be imaged in the 85cm aperture.

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Image /page/2/Picture/1 description: The image shows a logo for a company called "NeuroLogica". The logo features a stylized drawing of a brain with a ring around it, suggesting a planet. The text "NeuroLogica" is written in a simple, sans-serif font, with the "O" in "Logica" replaced by a circle with a dot in the center, resembling an eye or a target.

### (6) Comparison of Technological Characteristics with the predicate device:

NeuroLogica Corporation's NL4000 Computed Tomography System, for its intended use, is of comparable type in design, material, functionality, technology and is substantially equivalent to the following cleared predicate dey, ces: NeuroLogica Corporation NL3000 CereTom™ (K051765), Hitachi ELCOS16TM (K071806) and NeuroLogica Corporation inSPira HD™ (K090811) includine

- Material: The BodyTom uses similar material to the above listed o scanners such as solid state detectors, x-ray generator, slip ring, data acquisition ICs, rotational bearing, and motion control systems,
- Design: The BodyTom is similar in general design principle to the o above listed scanners except it does not contain application specific software for contrast imaging.

## 7) General Safety and Effectiveness Concerns:

All components of the NL4000 BodyTom system subject to Federal Diagnostic Equipment Performance Standard and applicable regulations of 21 CFR Part 1020.30 and 1020.33 are certified to meet those requirements.

An initial report as per 21CFR Part 1002.10 will be filed with the Center for Device and Radiological Health (CDRH).

To minimize electrical, mechanical and radiation hazards, Neurologica adheres to recognized and established industry practices. The NL4000 BodyTom system is designed to meet UL60601-1, IEC 60601-1 and EN 60601-1 Medical Electrical Equipment - Part 1: General Requirements for Safety, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60101-2-28, and IEC 60101-2-32 and IEC 60601-2-44.

Relating to concerns per unnecessary radiation exposure, the BodyTom, like the CereTom, has software safeguards such as: security scanner ID/password log-in, dose display/reporting, lockout to prevent excessive dose, protocol protection, and quality assurance.

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# Substantial Equivalence Comparison

The NeuroLogica NL4000 BodyTom™ Computed tomography system has similarities/differences to the NeuroLogica NL 3000 CereTom® Computed Tomography system (K051765) as follows:

Similarities

- 1. Diagnostic imaging for Computed Tomography applications
- 2. Same Detector fabrication
- 3. Same Detector measurement electronics
- 4. Same mechanism to translate system
- 5. Similar caster wheels for transport
- 6. Same Laser alignment
- 7. Similar workstation
- 8. Computers and algorithms to compute tomographic images
- 9. Applications: Scout, Axial, Helical, Dynamic, contrast enhanced
- 10. Display(DICOM 3.0) and connectivity(PACS) capability
- 11. Emergency Stop switch
- 12. Slipring to transmit electrical power to rotating disk
- 13. Mobility via transport wheels
- 14. Battery system
- 15. Wireless transfer of Image Data
- 16. 2D, MPR, 3D Viewing & archiving
- 17. Quality assurance phantom and test software
- 18. Radiation Safeguards Hardware (110% timer, warning light, etc)
- 19. Radiation Safeguards Software (login, excessive dose lockout, dose reporting,etc)
- 20. Same Wireless communication with Workstation
- 21. Same Manufacturing Quality System
- 22. Same Design Control System
- 23. Same Software Development methodology
- 24. Same Validation and Verification methods

## Differences:

- Size of Bore/Field of View ( CereTom = 32/25 cm, BodyTom = 85/60 cm) 1.
- Applicable software modifications to accommodate larger Bore 2.
- Motorized transport system on BodyTom 3.
- 4. X-ray tube type (Rotating Anode(BodyTom) vs. fixed Anode (CereTom))
- ഗ് Type of Batteries (SLA vs. LiPO)

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The NeuroLogica NL4000 BodyTom™ Computed tomography system has similarities/differences to the Hitachi ECLOS16 Computed Tomography system (K071806) as follows:

K102677 Page 5 of 13

### Similarities

- 1. Diagnostic imaging for Computed Tomography applications
- 2. Similar Multi slice Detector fabrication
- 3. Similar Detector measurement electronics
- 4. Laser alignment
- 5. Similar workstation with Windows Operating System
- 6. Computers and algorithms to compute tomographic images
- 7. Applications: Scout, Axial, Helical, Dynamic, contrast enhanced
- Display(DICOM 3.0) and connectivity(PACS) capability 8.
- 9. Emergency Stop switch
- 10. Slip ring to transmit electrical power to rotating disk
- 11. 2D, MPR, 3D Viewing & archiving
- 12. Quality assurance phantom and test software
- 13. Radiation Safeguards Hardware (110% timer, warning light, etc)
- 14. Rotating Anode X-ray Tube
- 15. Exactly the same X-ray Power (42 kilowatt)
- 16. Whole Body sized bore {BodyTom = 85, ECLOS = 70cm}

### Differences:

- 1. Motorized transport system on BodyTom
- ECLOS has a moving patient table, BodyTom has translate mechanism to move on floor 2.
- BodyTom is battery Powered 3.
- 4. Caster Wheels for mobility on BodyTom, ECLOS is fixed mount
- 5. Number of Slices (ECLOS = 16, BodyTom = 32)
- 6. BodyTom uses wireless link to communicate with workstation

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The NeuroLogica NL4000 BodyTom™ Computed tomography system has K102677 Page 6 of 13 similarities/differences to the NeuroLogica NL1000 inSPira® SPECT system (K090811) as follows:

## Similarities

- 1. Same mechanism to translate system
- Similar caster wheels for transport 2.
- 3. Same Laser alignment
- 4. Similar workstation
- 5. Display(DICOM 3.0) and connectivity(PACS) capability
- 6. Emergency Stop switch
- 7. Slipring to transmit electrical power to rotating disk
- 8. Mobility via transport wheels
- 9. Battery system
- 10. Wireless transfer of Image Data
- 11. 2D, MPR, 3D Viewing & archiving
- 12. Same Manufacturing Quality System
- 13. Same Design Control System
- 14. Same Software Development methodology
- 15. Same Validation and Verification methods

## Differences:

- 1. InSPira is a SPECT system, BodyTom is a CT system
- 2. Motorized transport system on BodyTom
- 3. Type of Batteries (SLA vs. LiPO)

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| Company | NeuroLogica | NeuroLogica | Hitachi | NeuroLogica |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Model/Name | NL4000 BodyTom | NL 3000 CereTom | ECLOS16 | NL1000 inSPira |
| Predicate/Submission | Submission | Predicate | Predicate | Predicate |
| 510(k) number | | K051765 | K071806 | K090811 |
| Type of System | Computed<br>tomography | Computed<br>tomography | Computed<br>tomography | Single Photon<br>Emission CT |
| Aperture (cm) | 85 | 32 | 70 | 29 |
| Image Field of View (cm) | 60 | 25 | 50 | 20 |
| Detector material | Solid State CdWO4 | Solid State CdWO4 | Solid State Ceramic | Nal, PMT |
| Detector configuration | 32 x 1.25mm | 8 x 1.25mm | 16 x 1.25 | 3 x 24 |
| MTF at 0% (lp/cm) | 17 | 17 | 17 | N/A |
| Xray Tube type | Rotating Anode | Fixed Anode | Rotating Anode | N/A |
| Heat storage (MHU) | 3.5 and 5.0 | 0.3 | 5 | N/A |
| Cooling | Oil | Air | Oil | N/A |
| Xray fan angle (deg) | 54 | 62 | Unknown | N/A |
| Max X-ray Power (kW) | 42 | 1.2 | 42 | N/A |
| otate Speed (seconds) | 1,2 | 1,2,4,6 | 0.8 | 1,2 |
| Jantry weight, kg | 1200 | 400 | 1320 | 850 |
| Wireless | Yes | Yes | No | Yes |
| Mobile | Yes (Motorized) | Yes (manual) | No | Yes (manual) |
| Battery system | Yes (LiPO) | Yes (SLA) | No | Yes (SLA) |
| Wheels | Wheels (6 inch) | Wheels (3 inch) | No | Wheels (4 inch) |
| Input voltage | 1 phase 110-<br>240Volt | 1 phase 110-<br>240Volt | 208VAC, 3- phase | 1phase 110-<br>240Volt |
| Input power max | 3.6kw | 1.5kw | 75kVA | 1.5kw |
| PACS / DICOM 3.0 | Yes | Yes | Yes | Yes |
| 2D scout | Yes | Yes | Yes | NA |
| bolus tracking | Yes | Yes | Yes | NA |
| Dynamic scan | Yes | Yes | Yes | NA |
| Axial/Helical | Both | Both | Both | NA |
| MPR | Yes | Yes | Yes | NA |
| 3D Viewing | Yes | Yes | Yes | NA |
| Patient Table | Not Required<br>(optional) | Not Required<br>(optional) | Yes | Not Required<br>(optional) |
| Scan motion | Scanner Moves | Scanner Moves | NA | Scanner Moves |
| Company | NeuroLogica | NeuroLogica | Hitachi | NeuroLogica |
| odel/Name | NL4000 BodyTom | NL 3000 CereTom | ECLOS16 | NL1000 inSPira |
| Predicate/Submission | Submission | Predicate | Predicate | Predicate |
| 510(k) number | | K051765 | K071806 | K090811 |
| Radiation Safeguards | | | | |
| Hardware | | | | |
| - X-ray warning light | Yes | Yes | Yes | NA |
| -110% X-ray timer | Yes | Yes | Yes | NA |
| -E-Stop | Yes | Yes | Yes | Yes |
| - Internal lead shield | Yes | Yes | No | NA |
| -external Lead curtains | Yes | Yes | No | NA |
| -Operator x-ray on switch | Yes | Yes | Yes | NA |
| -Quality Test Phantom | Yes | Yes | Yes | NA |
| | | | | |
| Radiation Safeguards | | | | |
| Software | | | | |
| - login ID/password | Yes | Yes | Unknown | Yes |
| -Administrator privileges | Yes | Yes | Unknown | Yes |
| -Dose display | Yes | Yes | Unknown | NA |
| - Dose report/audit | Yes | Yes | Unknown | NA |
| -Protocol override | Yes | Yes | Unknown | NA |
| protection | | | | |
| - Protocols by age/weight | Yes | Yes | Unknown | NA |
| -cessive dose lockout | Yes | Yes | Unknown | NA |
| -QA test report | Yes | Yes | Unknown | NA |
| | | | | |
| Quality Test Phantom | Included | Included | Included | Included |
| Biocompatibility | N/A | N/A | N/A | N/A |
| EM emissions | ETL testing | ETL testing | ETL testing | ETL testing |
| Sterility | N/A | N/A | N/A | N/A |
| Chemical Safety | N/A | N/A | N/A | N/A |
| Thermal Safety | ETL testing | ETL testing | ETL testing | ETL testing |
| IEC EN 60601 Electrical | ETL testing | ETL testing | ETL testing | ETL testing |
| Safety Testing | | | | |
| IEC EN 60601 | ETL testing | ETL testing | ETL testing | ETL testing |
| Mechanical Safety |…