(72 days)
Not Found
No
The description focuses on standard image reconstruction techniques from rotational X-ray data and does not mention any AI or ML algorithms for image processing, analysis, or interpretation.
No
The device is described as an "X-ray imaging device" that constructs a three-dimensional model for diagnostic purposes, not for treating any condition.
No
The MiniCAT™ is an X-ray imaging device that constructs a three-dimensional model to produce two-dimensional views for viewing. While it aids in providing images, there is no mention of it making a diagnosis.
No
The device description explicitly states that the MiniCAT™ is a dedicated X-ray imaging device with hardware components including a motorized scanning arm, X-ray source, and image detector, in addition to the software.
Based on the provided information, the MiniCAT™ is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- MiniCAT™ Function: The MiniCAT™ is an X-ray imaging device that directly images the human body (head and neck area) to create 3D models. It does not analyze samples taken from the body.
The description clearly states it's an "X-ray imaging device" that "acquires a 360° rotational X-ray sequence" of the "head and neck area". This is a form of in vivo imaging, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are 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.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The MiniCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational Xray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The MiniCAT™ can measure distances and thickness on two dimensional images. Images produced by the MiniCAT™ can be printed or exported on magnetic and optical media.
The building blocks of the MiniCAT™ are a motorized scanning arm carrying an X-ray source and image detector, and a computer running the MiniCAT™ 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
head and neck, maxillofacial complex, temporal bone, sinuses
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
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.(b)
Classification. Class II.
0
OCT = 2 2003
510(K) SUMMARY 5.
5.1. Identification of Submitter
f
Predrag Sukovic, Ph.D. President Xoran Technologies, Inc 309 N. First Street Ann Arbor, MI 48103
5.2. Identification of Product
| Name | MiniCAT™ |
|---|---|
| Manufacturer: | Xoran Technologies, Inc |
| 309 N. First Street | |
| Ann Arbor, MI 48103 | |
| Distributor | Xoran Technologies, Inc |
| 309 N. First Street | |
| Ann Arbor, MI 48103 |
5.3. Marketed Devices
The MiniCAT™ is substantially equivalent to the devices listed below:
| Device | NewTom QR-DVT 900 |
|---|---|
| Manufacturer | NIM s.r.l. |
| Via Silverstrini, 20 | |
| 37135 Verona | |
| Italy | |
| 510(k) Number | K003787 |
| Device | Advantage 3-D XR |
| Manufacturer | General Electric Medical Systems |
| 283, rue de la Miniere | |
| 78533 Buc Cedex | |
| France | |
| 510(k) Number | K945375 |
| Device | 3D Accu-I-tomo XYZ Slice View Tomograph |
| Manufacturer | J. Morita Manufacturing Corporation |
| 680 Higashihama Minami-cho, Fushimi-ku | |
| Japan | |
| 510(k) Number | K030450 |
1
5.4. Device Description
The MiniCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational Xray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The MiniCAT™ can measure distances and thickness on two dimensional images. Images produced by the MiniCAT™ can be printed or exported on magnetic and optical media.
The building blocks of the MiniCAT™ are a motorized scanning arm carrying an X-ray source and image detector, and a computer running the MiniCAT™ 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.
5.5. Intended Use
The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are 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.
5.6. Comparison with the Predicate Devices
The MiniCAT™ reconstructs a three dimensional model from X-ray images similar to the model obtained using the predicate devices. It displays either two-dimensional crosssections or three dimensional views and allows the user to take measurements on the reconstructed images.
5.7. Conclusion
The MiniCAT™ acquires an X-ray rotational sequence and provides three-dimensional information on the analyzed volume. The 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 MiniCAT™ 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with its wings spread and head facing to the right.
OCT - 2 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Predrag Sukovic, Ph.D. President Xoran Technologies, Inc. 309 N. First Street ANN ARBOR MI 48103
Re: K032243 Trade/Device Name: MiniCATTM Regulation Number: 21 CFR §892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: July 15, 2003 Received: July 29, 2003
Dear Dr. Sukovic:
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 (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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1. STATEMENT OF INDICATIONS FOR USE
The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are 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
Daniel A. Wynn
f Reproductive, Abdominal, levices