MINICAT

{0}------------------------------------------------ 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 (734) 418-5156 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: {1}------------------------------------------------ - 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. #### IIDC - 031044000002 - 3325758 v1 {2}------------------------------------------------ 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 {3}------------------------------------------------ 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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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 {4}------------------------------------------------ ## 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 \\DC - 031044/000002 - 3325758 v1