(113 days)
Not Found
No
The summary describes standard digital imaging and 3D reconstruction techniques (CBVT) performed by a computer, but there is no mention of AI, ML, or any related concepts like deep learning, neural networks, or algorithms that learn from data. The image processing described is typical for digital radiography and CBVT reconstruction.
No.
This device is an imaging system designed for diagnostic purposes, specifically for dental radiographic examination. It does not provide any therapeutic intervention.
Yes
The device is an imaging system (X-ray) used for diagnostic examinations of dental and oral structures. It generates 2D and 3D images for various studies like panoramic, implantology, TMJ, and cephalometry, all of which are diagnostic procedures.
No
The device description clearly states it is an "extra-oral source Xray system" and a "panoramic x-ray system utilizing digital imaging," which are hardware components. While it includes software for image processing and reconstruction, it is not solely 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 provide information about a person's health.
- Device Function: The I-MAX Touch 3D is an X-ray imaging system. It uses X-rays to create images of the teeth, jaw, and oral structures. It does not perform tests on biological samples.
- Intended Use: The intended use is for dental radiographic examination and image generation, not for analyzing biological samples.
Therefore, the I-MAX Touch 3D falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source X-ray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dento-maxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector and the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.
Product codes (comma separated list FDA assigned to the subject device)
OAS
Device Description
The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It can be equipped with a cephalostat. The device can be equipped with accessories to fulfill different diagnostic needs. The images are acquired by a flat panel detector and are displayed on a monitor; image processing, manipulation, archiving, communication and 3D reconstruction (starting from cross-sectional images taken using CBVT (Cone Beam Volumetric Tomography) technique) are performed using a computer.
Mentions image processing
image processing, manipulation, archiving, communication and 3D reconstruction
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray, Cone Beam Volumetric Tomography (CBVT)
Anatomical Site
teeth, jaw, and oral structures, dento-maxillofacial
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists, radiologists and other legally qualified health care professionals
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 software development for this device follows documented processes for software design, verification and validation testing. Final device validation and risk assessment has been conducted to identify potential design hazards that could cause an error or injury based on the use of this device. Appropriate steps have been taken to control all identified risks. The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety and its derivatives.
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.
Villa Sistemi Medicali Rotograph EVO 3D (K111152)
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
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510(k) Summary
JUN 1 4 2013
1
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
:
| Submitter: | OWANDY.
Le Coruscant, 2 rue des Vieilles Vignes
77183 CROISSY-BEAUBOURG
FRANCE
Registration # 9615832 |
|------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Olivier Maurier
Phone: 0033-164-111818 |
| Designated Agent: | Claude BERTHOIN
Denterprise International, IncRF America, Inc.
110 W. Granada Blvd., Suite 207
Ormond Beach, FL 32176
Phone: 800-323-2690 Ext 304
Fax: 386-672-4402 |
| Date Prepared: | February 3, 2012 |
| Trade Name:
Common Name:
Classification Name:
Classification Regulation:
Panel:
Class:
Product Code: | I-MAX Touch 3D
Computed Tomography X-Ray System
X-Ray, Tomography, Computed, Dental
21 CFR 892.1750
Dental
II
OAS |
| Predicate Devices: | Villa Sistemi Medicali Rotograph EVO 3D (K111152) |
| Product Description: | The I-MAX Touch 3D is a panoramic x-ray system utilizing digital imaging. It
can be equipped with a cephalostat. The device can be equipped with
accessories to fulfill different diagnostic needs. The images are acquired by a
flat panel detector and are displayed on a monitor; image processing,
manipulation, archiving, communication and 3D reconstruction (starting from
cross-sectional images taken using CBVT (Cone Beam Volumetric
Tomography) technique) are performed using a computer. |
| Indications for Use: | The I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is
an extra-oral source X-ray system which is intended for dental radiographic
examination of the teeth, jaw, and oral structures, specifically for panoramic
examinations and implantology and for TMJ studies and cephalometry. It also
has the capability, using the CBVT technique, to generate dento-maxillofacial |
・
.
1
K130443
Page 2 of 2
3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector and the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals.
Rationale for Substantial
Equivalence:
Information:
The I-MAX Touch 3D has the same indication for use as the predicate device. It is identical to the predicate device except for the design of some of its external plastic covers and for the control panel. It shares the same technological characteristics as the predicate device. The minor technological and design differences do not raise any new questions regarding safety or effectiveness of the device; both devices are used in the same identical way.
Safety and Effectiveness
The device labeling contains operating instructions for safe and effective use of the I-MAX Touch 3D. The software development for this device follows documented processes for software design, verification and validation testing. Final device validation and risk assessment has been conducted to identify potential design hazards that could cause an error or injury based on the use of this device. Appropriate steps have been taken to control all identified risks. The device has been tested for compliance to IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety and its derivatives.
Conclusion: The I-MAX Touch 3D performs the same identical functions in the same environment as the predicate device. It uses the same technology as the predicate device, based on well-known technology. It is as safe and effective as the predicate device. We believe it does not introduce any new potential safety risks and is substantially equivalent and identical to the predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three overlapping shapes, resembling birds in flight or abstract human figures, creating a sense of movement and unity.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G Silver Spring, MD 20993-0002
June 14, 2013
Owandy % Mr. Claude Berthoin 110 E. Granada Blvd. Suite 207 ORMOND BEACH, FL 32176
Re: K130443
Trade/Device Name: I-MAX Touch 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: March 26, 2013 Received: March 27, 2013
Dear Mr. Berthoin:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical
3
Page 2 - Mr. Berthoin
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding 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 Division of Small 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/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
Smif)
for
Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
I-MAX Touch 3D
Indications for Use:
I-MAX Touch 3D, panoramic X-ray imaging system with cephalostat, is an extra-oral source Xray system which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry. It also has the capability, using the CBVT technique, to generate dentomaxillofacial 3D images. The device uses a cone shaped X-ray beam projected on a flat panel detector; the examined volume image is reconstructed to be viewed on 3D viewing stations. 2D Images are obtained using the standard narrow beam technique. The device is to be operated and used by dentists, radiologists and other legally qualified health care professionals
Prescription Use > (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE-DO-NOT-WRITE-BELOW-THIS-LINE-CONTINUE.ON ANOTHER.PAGE IF NEEDED).
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR)
Smmp)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K130443 510(k)
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