(56 days)
Not Found
No
The description focuses on standard 3D reconstruction from X-ray data and does not mention AI or ML algorithms for image processing or analysis.
No
The device is an imaging system designed to acquire and reconstruct 3D images for diagnostic purposes, not to provide therapy or treatment.
Yes
The device is described as an X-Ray imaging device that constructs a three-dimensional model to provide 3D information of high contrast objects, intended for use by medical professionals to image various anatomical sites within the maxillofacial complex. This information helps in diagnosis, even if not explicitly stated as "diagnostic" use in the text, providing essential data for clinical assessment and decision-making.
No
The device description explicitly states it is a dedicated X-Ray imaging device comprised of hardware components like an X-ray source, image detector, and motorized gantry, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The i-CAT Scanner is an imaging device that uses X-rays to create 3D models of anatomical structures within the body. It does not perform tests on biological samples.
- Intended Use: The intended use clearly states it's for obtaining 3D information of high contrast objects within the maxillofacial complex for diagnostic and planning purposes. This is consistent with medical imaging, not in vitro testing.
Therefore, the i-CAT Scanner falls under the category of a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Product codes (comma separated list FDA assigned to the subject device)
MUH
Device Description
The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.
The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry 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 workstation monitor for viewing.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
TM Joint, mandible, maxilla, sinuses, maxillofacial complex
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist, oral surgeon, or other physician
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)
The i-CAT Scanner 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 or misdiagnosis) are controlled by the design development, verification and validation process which includes a risk management system.
The i-CAT Scanner complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues.
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
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.
0
JUL - 3 2006
510 (k) Summary
Submitters Information
Name:
Address:
Phone Number:
Fax Number:
Person To Contact:
Date Of Summary:
Trade Name Of The Device:
Common Or Usual Name:
Classification Name:
Imaging Sciences International Inc.
1910 North Penn Road Hatfield PA, 19440
215-997-5666
215-997-5665
David W. Cowan Vice President of Engineering, Quality Assurance and Government Compliance
May 05, 2006
i-CAT Scanner
Extraoral Source X-ray System
Extraoral Source X-ray System
1
Substantial Equivalence Claim: The Imaging Sciences International Inc. i-CAT Scanner is substantially equivalent to the devices listed below:
| Device: | NewTom QR - DVT 9000 |
|---|---|
| Manufacturer: | NIM s.r.1. |
| Via Silverstrini, 20 | |
| 37135 Verona | |
| Italy | |
| 510 (k) Number: | K003787 |
| 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 |
Description Of The Device: The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.
The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry 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 workstation monitor for viewing.
Intended Use Of The Device: The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Comparison with Predicate Devices: The i-CAT Scanner reconstructs a three dimensional model from X-ray images similar to the model obtained using the predicate devices. It displays either two-dimensional cross-sections or three dimensional views and allows the user to take measurements on reconstructed images.
Conclusions: The i-CAT Scanner 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 or misdiagnosis) are controlled by the design development, verification and validation process which includes a risk management system.
2
The i-CAT Scanner complies with the requirements of 21 CFR 807.87 and does not
pose any new safety risks or effectiveness issues.
:
3
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUL - 3 2006
Mr. David W. Cowan Vice President of Engineering, Quality Assurance and Government Compliance Imaging Sciences International, Inc. 1910 North Penn Road HATFIELD PA 19440
Re: K061284
Trade/Device Name: i-CAT Scanner Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: May 5, 2006 Received: May 9, 2006
Dear Mr. Cowan:
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 croomerse 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 Nossmatic 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 offecting 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.
Image /page/3/Picture/9 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo. The word "Centennial" is below the letters "FDA". There are three stars below the word "Centennial".
oting Public S
4
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 sectronic product radiation control provisions (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) premarket notification. The FDA finding of substantial equivalence of your device to a legal|y marketed predicate device results in a classification for your device and thus, permitts 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 the Act from the Division of Small Manufacturers, International and Consumer Assistence at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
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
5
Indications for Use
510(k) Number (if known): _ K061284
Device Name: i-CAT Scanner
Indications For Use: The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
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)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
K061284