XCAT; XCAT FOR NEURO

K061834 · Xoran Technologies, Inc. · JAK · Aug 7, 2006 · Radiology

Device Facts

• Record ID: K061834
• Device Name: XCAT; XCAT FOR NEURO
• Applicant: Xoran Technologies, Inc.
• Product Code: JAK · Radiology
• Decision Date: Aug 7, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The xCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).

Device Story

xCAT is a dedicated X-ray CT imaging system. It utilizes a motorized scanning arm with an X-ray source and detector to acquire a 360° rotational sequence of the target anatomy. The system software reconstructs these 2D projections into a 3D volume matrix. The device provides 2D cross-sectional views and 3D visualizations on a computer monitor. Users can perform distance and thickness measurements on the reconstructed images. Data can be exported via Ethernet, optical media, or memory stick. The device is intended for clinical use to assist healthcare providers in diagnostic imaging. By providing high-resolution 3D anatomical information, it supports clinical decision-making and diagnosis for various orthopedic and cranial applications.

Clinical Evidence

No clinical data provided; bench testing and software validation were used to demonstrate substantial equivalence.

Technological Characteristics

Motorized scanning arm with X-ray source and detector; computer-based image reconstruction; Ethernet, optical media, and memory stick connectivity; 360° rotational acquisition; 2D/3D image display and measurement capabilities.

Indications for Use

Indicated for x-ray computed tomography imaging of anatomy fitting within the imaging gantry, specifically head, neck, wrist, ankle, hand, and foot.

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

• MiniCAT™ (K032243)
• NL 3000 CereTom (K051765)

Submission Summary (Full Text)

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### 510(K) SUMMARY

#### 1.14. Identification of Submitter

Jim Bertolina, Ph.D. VP, New Product Development Xoran Technologies, Inc 309 N. First Street Ann Arbor, MI 48103 [e-mail] 310.525.0701 (phone)

#### Identification of Product 1.15.

| Name | xCAT™ |
|---------------|-----------------------------------------------------------------------|
| Manufacturer: | Xoran Technologies, Inc<br>309 N. First Street<br>Ann Arbor, MI 48103 |
| Distributor | Xoran Technologies, Inc<br>309 N. First Street<br>Ann Arbor, MI 48103 |

#### Marketed Devices 1.16.

The xCAT™ is substantially equivalent to the devices listed below:

| Device | MiniCAT™ |
|---------------|------------------------------------------------------------------|
| Manufacturer | Xoran Technologies<br>309 N. First Avenue<br>Ann Arbor, MI 48103 |
| 510(k) Number | K032243 |
| Device | NL 3000 CereTom |
| Manufacturer | Neurologica<br>14 Electronics Ave.<br>Danvers, MA 01923 |
| 510(k) Number | K051765 |

AUG - 7 2006

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# 1.17. Device Description

The xCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The xCAT™ can measure distances and thickness on two dimensional images. Images produced by the xCAT™ can be exported via Ethernet or onto optical media or a memory stick.

The building blocks of the xCAT'th are a motorized scanning arm carrying an Xray source and image detector, and a computer running the xCAT™ software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.

### 1.18. Intended Use

The xCAT is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into the imaging gantry (such as the head, neck, wrist, ankle, hand, and foot).

### 1.19. Comparison with the Predicate Devices

The xCAT™ reconstructs a three dimensional model from X-ray images similar to those obtained using the predicate devices. It displays either two-dimensional cross-sections or three dimensional views and allows the user to take measurements on the reconstructed images. The xCAT™ is substantially equivalent in design, material, functionality, and technology to the predicate devices (Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243).

# 1.20. Conclusion

The xCAT™ by Xoran Technologies acquires an X-ray rotational sequence and provides three-dimensional information on the analyzed volume. It is intended to be used for x-ray computed tomography imaging of anatomy that safely fits into its imaging gantry (such as the head, neck, wrist, ankle, hand, and foot), and is substantially equivalent in design, material, functionality, and technology to Neurologica's NL 3000 CereTom, ref: K051765, and Xoran Technologies Inc. MiniCATTM ref: K032243.

Potential hazards (e.g., electrical, mechanical, thermal, radiation, incorrect measurements, and misdiagnosis) are controlled by a risk management system including: Hazard Analysis and Software Development and Validation Process.

The xCAT™ is an X-ray imaging system that complies with the requirements of 21 CFR 807.87(h) and does not pose any new safety risks or effectiveness issues.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG - 7 2006

Jim Bertolina, Ph.D. VP. New Product Development Xoran Technologies, Inc. 309 N. First Street ANN ARBOR MI 48103

Re: K061834

Trade/Device Name: Xoran xCatTM Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 28, 2006 Received: June 29, 2006

Dear Dr. Bertolina:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

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Protecting and Promoting Public Health

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Page 2 -

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 that I Drederal statutes and regulations administered by other Federal agencies. You must or uny 1 other all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI K I at 6075, lacemig (21 CFR Part 820); and if applicable, the electronic form in the quality byevelles (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and my Jurie FDA finding of substantial equivalence of your device to a legally premated predicated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (210) 11 from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone]

or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy Brogdon
Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K061834

Device Name: Xoran XCAT

Indications For Use:

The XCAT is intended to be used for x-ray computed tomography imaging of anatomy The XCAT is intended to be used for x fay sompact as the head, neck, wrist, ankle, hand and foot).

Prescription Use (Part 21 CFR 801 Subpart D) ANDIOR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David Ch. Lypon

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number