(55 days)
Not Found
Not Found
No
The provided 510(k) summary does not mention AI, ML, deep learning, or any related terms in the "Mentions AI, DNN, or ML" section or elsewhere in the document. The description focuses on the imaging modalities and anatomical sites without indicating any advanced processing beyond standard digital radiography.
No
The device is an X-ray system intended for diagnostic imaging and examination, not for treating or curing a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended to "carry out diagnostic examination" and for "diagnostic support."
No
The device is described as a "digital panoramic, cephalometric and tomographic extra-oral X-ray system," which inherently includes hardware components for generating X-rays and capturing images.
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 description clearly states that this device is an extra-oral X-ray system that produces images (panoramic, cephalometric, and tomographic) of anatomical structures within the body. It does not perform tests on samples taken from the body.
The device is an imaging device used for diagnostic purposes, but it falls under the category of medical devices that produce images of the internal structures of the body, not IVDs.
N/A
Intended Use / Indications for Use
hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:
(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH):
(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
Product codes
OAS, MUH
Device Description
hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
X-ray
Anatomical Site
maxillofacial region, teeth, dental arches, oral cavity, jaws, parts of the skull, carpus, head, ear, nose, throat (ENT), dento-maxillofacial complex, mandible, maxilla, temporomandibular-articular joint (TMI), human skull, neck, cervical spine.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physicians, dentists, x-ray technologists and other legally qualified 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)
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
§ 892.1750 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
CEFLA S.C. % Ms. Elena Arcangeli Regulatory Affairs Via Selice Provinciale 23/A Imola, Bo 40026 ITALY
April 24, 2019
Re: K190496
Trade/Device Name: hyperion X9 pro, NewTom GiANO HR, X-RADiUS TRiO PLUS Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS, MUH Dated: February 15, 2019 Received: February 28, 2019
Dear Ms. Arcangeli:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing
1
safety reporting (21 CFR 4. Subpart B) for combination products (see
https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara
For
Thalia T. Mills, 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) K190496
Device Name
hyperion X9 pro , NewTom Giano HR, X-RADiUS TRiO PLUS
Indications for Use (Describe)
hyperion X9 pro, NewTom Giano HR, X-RADiUS TRiO PLUS is a digital panoramic, cephalometric and tomographic extra-oral X-ray system, intended to:
(1) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental arches and other structures in the oral cavity;
(II) produce radiographs of jaws, parts of the skull and carpus for the purpose of cephalometric examination, when equipped with tele-radiographic arm (CEPH):
(III) the production of tomographic images of the head, including the ear, nose and throat (ENT), of the dento-maxillofacial complex, teeth, mandible and maxilla, temporomandibular-articular joint (TMI), other areas of the human skull and neck with sections of the cervical spine for use in diagnostic support, if equipped with the CBCT option.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Remediation Use (Part 213, SER 301 Subject Site) |
|---|
| On-Site Containment Use (213 SER 301 Subject Site) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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