(110 days)
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Not Found
No
The document describes standard image processing and management features without mentioning AI, ML, or related concepts.
No
The device is described as dental imaging software for diagnostic purposes, used to process and display images for a dentist to diagnose dental health. It does not provide treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the software enables a dentist "to diagnose the dental health of a patient."
Yes
The device description explicitly states that CADI is a "dental imaging software" and describes its functions as controlling the capture, display, treatment, analysis, and saving of digital images. It lists various software modules. There is no mention of any accompanying hardware components that are part of the device itself. While it interacts with hardware (x-ray units, cameras, scanners), the device being submitted for 510(k) appears to be solely the software.
Based on the provided information, CADI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
- CADI's Function: CADI processes and analyzes images of the dental and maxillo-facial area, which are acquired directly from the patient using various imaging modalities (X-ray, cameras, scanned film). It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "dental imaging software for general dental and maxillo-facial diagnostic" and "to enable a dentist to diagnose the dental health of a patient" based on these images.
Therefore, CADI falls under the category of medical imaging software, not an IVD.
N/A
Intended Use / Indications for Use
CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient.
CADI is a modular software, meaning that it offers dentistry professionals the choice to activate specific modules, depending on the type of image sources they use. These modules are as follows:
Digital x-ray module: This module features a 16-bit x-ray viewer and imaging tools used to enhance the image quality of x-rays taken by sensors or phosphor plate systems.
Intraoral Camera Module: CADI automatically enhances images captured by intraoral cameras and sorts them by tooth number.
Digital Camera Module:
This module allows importing digital camera images, and sorts them in order in a patient file. Printouts are automatically sorted in AAO order, or any custom order. This module also crops and prints images.
Cosmetic and Whitening Module:
CADI simulates whitening results in minutes to help build an in-office program for patients. It also provides cosmetic makeover simulations using a library of natural smile images.
Natural Smiles Library: Smiles library that sorts images in a logical order, including images for a range of ethnic backgrounds.
Orthocephalometric Tracing (DFO) Module:
CADI DFO uses point location tools and a tutor window to help achieve cephalometric tracings. It includes most current and popular tracing analysis, and allows the user to create his/her own analysis.
CADI is a prescription use only product, intended to be used by dental professionals only.
Product codes
LLZ
Device Description
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Mentions image processing
Yes
Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray units, intraoral or extraoral dental camera, digital cameras, images acquired by digitizing film with a scanner
Anatomical Site
Dental, maxillo-facial
Indicated Patient Age Range
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Intended User / Care Setting
Dental professionals
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows a logo for the Department of Health. The logo features a stylized human figure with three wavy lines representing the body and head. The words "DEPARTMENT OF HEALTH" are arranged vertically along the left side of the logo, with the letters oriented to follow the curve of the logo.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
NOV 2 0 2006
Mr. Stephane Arsenault Official Correspondent Synca Marketing, Inc. 337 Marion Street Le Gardeur, Quebec, J5Z 4W8 CANADA
Re: K062237
Trade/Device Name: CADI Version 4 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 25, 2006 Received: October 26, 2006
Dear Mr. Arsenault:
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 cnactment 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.
Image /page/0/Picture/10 description: The image is a circular seal or logo. The text "1906 - 2006" is at the top of the seal. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are four stars at the bottom of the seal.
ag and Promoting Public 9
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I that FDA has made a determination that your device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must of any I cacial statutes and registerients, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI N Far 6077, adomig (21 CFR Part Paulation (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (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) This icael with anow you're ough times of substantial equivalence of your device to a legally premarket notification: "The Presults 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 If you desire specific advise to your and 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 (21 CF F r at 60 : 31). " v of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.litml.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Section 4 Indications for Use Statement
CADI is a dental imaging software for general dental and maxillo-facial diagnostic. It controls capture, display, treatment, analysis and saving of digital images from x-ray units, intraoral or extraoral dental camera, digital cameras, and images acquired by digitizing film with a scanner, in order to enable a dentist to diagnose the dental health of a patient.
CADI is a modular software, meaning that it offers dentistry professionals the choice to activate specific modules, depending on the type of image sources they use. These modules are as follows:
Digital x-ray module: This module features a 16-bit x-ray viewer and imaging tools used to enhance the image quality of x-rays taken by sensors or phosphor plate systems.
Intraoral Camera Module: CADI automatically enhances images captured by intraoral cameras and sorts them by tooth number.
Digital Camera Module:
This module allows importing digital camera images, and sorts them in order in a patient file. Printouts are automatically sorted in AAO order, or any custom order. This module also crops and prints images.
Cosmetic and Whitening Module:
CADI simulates whitening results in minutes to help build an in-office program for patients. It also provides cosmetic makeover simulations using a library of natural smile images.
Natural Smiles Library: Smiles library that sorts images in a logical order, including images for a range of ethnic backgrounds.
Orthocephalometric Tracing (DFO) Module:
CADI DFO uses point location tools and a tutor window to help achieve cephalometric tracings. It includes most current and popular tracing analysis, and allows the user to create his/her own analysis.
CADI is a prescription use only product, intended to be used by dental professionals only.
Stephane Arsenault
October 25, 2006
Prescription Use
(Per 21 CFR 801.109)
(Division Sign-Off)
Division of Reproductius
Division of Reproductive, Abdon and Radiological Devi 510(k) Number
Image /page/2/Picture/19 description: The image shows the word "SYNCA" in all capital letters. To the right of the word is a circular graphic with a solid black circle on top of a target-like design. The target design consists of three concentric circles, with the innermost circle being white and the other two being black.
337 Marion Street. Le Gardeur, QC, Canada, J5Z 4W8 1-800-667-9622 Fax : 1-800-554-1021 email : synca@synca.com