(336 days)
Not Found
No
The summary describes a standard panoramic X-ray system with various imaging modes and automatic parameter selection based on pre-defined combinations. There is no mention of AI, ML, or any algorithms that learn from data to improve performance or make decisions. The image manipulation mentioned is likely standard post-processing, not AI-driven analysis.
No
The device is an X-ray unit used for imaging teeth, jaw, and oral structures, which is a diagnostic function, not a therapeutic one.
No
This device is an X-ray unit that produces images of teeth, jaw, and oral structures. It is used by healthcare professionals for radiography, to aid in diagnosis. It does not perform the diagnosis itself.
No
The device is described as a "complete panoramic X-ray system" and includes hardware components such as a CCD sensor and the X-ray unit itself. While it includes software for image manipulation and archiving, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "radiograph teeth, jaw and oral structures." This describes an imaging device used for diagnostic purposes, but it does not involve testing samples taken from the body (in vitro).
- Device Description: The description details an X-ray system that acquires images using a CCD sensor. This is consistent with an imaging device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, calibrators, controls, or any other components typically associated with in vitro diagnostics.
- Input Modality: The input modality is X-ray, which is an imaging technique, not an in vitro diagnostic method.
In summary, the device is an extra-oral dental panoramic X-ray unit, which is a medical imaging device used for diagnosis, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
Product codes
MUH
Device Description
Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs:
- -Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
- -Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
- -TMJ (closed/open mouth) exams in lateral projection.
XP (Extended Projection Package) optional function allows to carry out the following additional exams:
- -Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
- -Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
- Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
- -Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
- Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
- -Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.
The images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type. Here below a list of the main characteristics of the digital sensor:
- -Detector type: FFT-CCD area image sensor
- Sensible area (HxL) PAN Sensor: 146x6 mm
- -Pixel dimension: 48 um (96 um in 2X2 binning mode)
- -Number of pixels: 3072x128
- -Spatial resolution: 4 lp/mm
- -Sensor cover attenuation equivalent:
§ 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.
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Image /page/0/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" around the perimeter. Inside the circle is an abstract symbol that resembles three human profiles connected by flowing lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 6, 2017
VILLA SISTEMI MEDICALI S.P.A. PAOLO SANTIN QA MANAGER VIA DELLE AZALEE 3 BUCCINASCO I-20090 IT
Re: K162190
Trade/Device Name: Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-max (under Trade Mark Owandy Radiology) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: June 5, 2017 Received: June 8, 2017
Dear Mr. Santin:
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 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162190
Device Name
Rotograph Prime (under Trade Mark Villa Sistemi Medicali), I-MAX (under Trade Mark Owandy Radiology)
Indications for Use (Describe)
Rotograph Prime and I-MAX are extra-oral dental panoramic X-ray units to radiograph teeth, jaw and oral structures.
The devices are operated and used by dentists, radiologists and other legally qualified health care professionals.
They can be used with both pediatric and adult patients.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Villa. The logo consists of a blue square with a white letter "N" inside. Below the square is the word "VILLA" in white, block letters. The letter "N" is stylized with a sharp, angular design.
510(k) Summary - rev. 1
This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Villa Sistemi Medicali S.p.A.
via delle Azalee 3
20090 Buccinasco (MI)
ITALY
Phone: +39 02 488591
Registration # 8021091 | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Contact Person: | Paolo Casagrande Santin
QA Manager
Phone: +39 02 48859 239
Fax: +39 02 48859 303
Email: p.casagrande@villasm.com | |
| Designated Agent: | Ernesto Filizzola
Villa Radiology Systems
91 Willenbrock Rd. B-1
Oxford, CT, 06478
ph 203 2628836
e-mail ernesto@villaus.com | |
| Date Prepared: | June 27, 2017 | |
| Device Name: | Rotograph Prime (under trade mark Villa Sistemi Medicali)
I-MAX (under Trade mark Owandy Radiology as Private Labeler) | |
| Device Type: | System, x-ray, extraoral source, digital | |
| Regulation Number: | 21 CFR 872.1800 | |
| Regulation Name: | Extraoral Source X-Ray System | |
| Regulatory Class: | Class II | |
| Product Code: | MUH | |
| Predicate Device: | The Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is compared
with the following predicate device: | |
| | Villa Sistemi Medicali Rotograph EVO D (K090749)
- Regulation Number: 21 CFR 872.1800
- Regulation Name: Extraoral Source X-Ray System
- Regulatory Class: Class II
- Product Code: MUH | |
4
Image /page/4/Picture/0 description: The image is a logo with a blue square background. Inside the square is a white stylized letter "N" that is tilted slightly to the right. Below the square is a white rectangle with the word "VILLA" in a bold sans-serif font.
Product Description: Rotograph Prime (and I-MAX under trade mark Owandy Radiology) is a complete panoramic X-ray system. The basic version performs:
- -Panoramic adult or child exams, with 3 sizes and 3 tvpes of biting for a total of 18 combinations with automatic parameter selection; with manual selection, it is possible to select a high voltage between 60kV and 70kV, in 2kV steps and anodic current from 2 mA to 7.1 mA in the R20 scale steps.
- -Sinus mode to take exams of the paranasal sinuses with front projection (postero/anterior);
- -TMJ (closed/open mouth) exams in lateral projection.
XP (Extended Projection Package) optional function allows to carry out the following additional exams:
- -Right or left half-panoramic, to be used when the patient is known to have a problem only on one side of the arch, in order to reduce radiation;
- -Low dose Panoramic, which reduces the dose radiated by excluding the TMJ's ascending rami from the radiograph;
- Frontal dentition, for a radiograph of the front part (roughly from canine to canine); -
- -Ortho Rad Panoramic which reduces teeth overlap, thereby improving the diagnosis of interproximal decay:
- Bitewing left or right for lateral dentition (generally from eighth to fourth) with a trajectory that reduces teeth overlap;
- -Bilateral Bitewing (left and right), which sequentially performs both bitewings, showing them on the same image.
The images are acquired by a CCD sensor and are displayed on a monitor, and image manipulation, archiving and communication are performed via a computer (not included in the device). In particular, Rotograph Prime is equipped with a PAN sensor: it is suitable for Panoramic-type imaging, all Panoramic, i.e. all images with about 14cm-high field; all Panoramic. TMJ, and Sinus images belong to this type. Here below a list of the main characteristics of the digital sensor:
146x6 mm
3072x128
- -Detector type:
FFT-CCD area image sensor
48 um (96 um in 2X2 binning mode)
- Sensible area (HxL) PAN Sensor: -
- -Pixel dimension:
- -Number of pixels:
- -Spatial resolution:
- 4 lp/mm
- -Sensor cover attenuation equivalent: