MINICAT

K113421 · Xoran Technologies, Inc. · JAK · Jul 11, 2012 · Radiology

Device Facts

• Record ID: K113421
• Device Name: MINICAT
• Applicant: Xoran Technologies, Inc.
• Product Code: JAK · Radiology
• Decision Date: Jul 11, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

Device Story

MiniCAT is a dedicated CT scanner for head and neck imaging. It acquires a 360-degree rotational X-ray sequence; software reconstructs these images into a 3D model. Used in clinical settings for maxillofacial, temporal bone, sinus, and neuro-angiography imaging. Operated by trained personnel. Software manages patient database, scan acquisition, reconstruction, viewing, report generation, and hardware control (X-ray source, scanning arm, detector). Modified software includes a forced 10-minute scan delay, Windows shell operation, daily calibration check, and DICOM UID compliance. Output allows clinicians to visualize 3D anatomy for diagnostic decision-making.

Clinical Evidence

Bench testing only. Verification and validation testing performed on software modifications confirmed the system functions as intended.

Technological Characteristics

Dedicated CT X-ray system. Hardware: X-ray source, scanning arm (motor), detector. Software: Windows-based, manages acquisition, reconstruction, and viewing. Connectivity: DICOM compliant. Features: forced 10-minute scan delay, daily calibration date checking.

Indications for Use

Indicated for imaging of the maxillofacial complex, temporal bone, sinuses, and neuro-angiography in patients requiring head and neck CT scans. Prescription use only.

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)

Submission Summary (Full Text)

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K113421

#### 510(k) SUMMARY

### Xoran Technologies, Inc.'s MiniCAT

JUL 1 1 2012

Sponsor/Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Xoran Technologies, Inc. 5210 S. State Road Ann Arbor, MI, 48108

[phone] Phone: Facsimile:

. Ms. Martha J. Rumford Contact Person: Regulatory Affairs Manager

Name of Device: Xoran MiniCAT™ CT Scanner

Common or Usual Name: Computed Tomography X-Ray System

Classification Name: Computed Tomography X-Ray System

Predicate Devices

Xoran Technologies, Inc., MiniCAT™ (K032243)

#### Purpose of the Special 510(k) notice

The MiniCAT is a modification to the cleared MiniCAT. This Special 510(k) Notice - Corrective Action Being Effected is to address certain reported software failures in the MiniCAT device. No injuries resulted from the reported failures.

#### Intended Use

The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

#### Technological Characteristics

The MiniCAT is a dedicated X-ray imaging device that acquires a 360-degree rotation x-ray sequence of images. The MiniCAT consists of both software and hardware components. The software is used for image acquisition, processing, and viewing and consists of the following main functional units patient database, study (scan) acquisition, study reconstruction, study view, report generation, and file saving. The software also controls the hardware components of the device. The major hardware components include the X-ray source, scanning arm (motor), and detector.

The MiniCAT software has been modified as follows:

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- A forced 10-minute delay has been added between scans to prevent the user from scanning . during the "dwell" time.
- The software has been modified to run as a Windows shell. .
- . The software includes a daily calibration date checking function that displays a warning message to the user prior to scanning, if the calibration has not yet been performed that day.
- The DICOM image unique identifiers (UIDs) have been brought into compliance with the . DICOM standard.

#### Performance Data

Verification and Validation testing were performed to support this software modification. The Xoran MiniCAT computed tomography x-ray system met all requirements and functions as intended. Thus, the modified MiniCAT is safe and effective for its intended use.

#### Substantial Equivalence

MiniCAT has the same intended use and similar indications, principles of operation, and technological characteristics as the predicate MiniCAT. The minor differences in the device software do not raise any new questions of safety or effectiveness. Software verification and validation testing demonstrates that the modified MiniCAT functions as intended and is as safe and effective as the predicate MiniCAT for its intended use. Thus, the MiniCAT is substantially equivalent.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle symbol.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

JUL 1 1 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Ms. Martha J. Rumford Regulatory Affairs Manager Xoran Technologies, Inc. 5210 S. State Road ANN ARBOR MI 48108

Re: K113421

Trade/Device Name: MiniCAT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: June 12, 2012 Received: June 13, 2012

Dear Ms. Rumford:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for associated in the May 28, 1976, the enactment date of the Medical Device Amendments, or to conimered prior to 114) 20, 1977, is accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic (110. (110.) that to neview subject to the general controls provisions of the Act. The r va may, alores, manns of the Act include requirements for annual registration, listing of general vonlive provisions of ractice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device is bluestified (600 acorregulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 I loase be advisou that I Drist issue of the your device complies with other requirements of the Act that I Dri has made a acterimistics as administered by other Federal agencies. You must or any I catal statutes and regaraments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device related ad reless chality systems (QS) regulation (21 CFR Part 820). This letter requirences as be form marketing your device as described in your Section 510(k) premarket whil anow you to begal mainen.ing your antial equivalence of your device to a legally marketed nonicate 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 Parts 801 and If you desire specific ad not 10. Join Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Theose 1100, processions regarding the reporting the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Four international Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

510(k) Number (if known):_

Device Name: MiniCAT

Indications for Use:

The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

Prescription Use X (Per 21 C.F.R. 801.109)

## AND/OR

Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Radiological Devices
Lwin Dovice Evaluation and Safety

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K. K113421

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