(103 days)
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No
The document describes a standard digital radiography sensor and does not mention any AI or ML capabilities for image processing, analysis, or diagnosis.
No
The device is described as an imaging system used for diagnosis, not for treating any specific condition or disease.
Yes
The "Intended Use / Indications for Use" section states that the device displays an x-ray image on the computer screen "that ultimately diagnose general dental complications or abnormalities." This indicates its role in diagnosis.
No
The device description explicitly states it is a "digital radiography sensor" which is a hardware component that captures X-rays.
Based on the provided information, the Tio-h Digital Radiography Sensor is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- Tio-h Function: The Tio-h Digital Radiography Sensor is an imaging system that captures X-rays of the inside of the mouth (intra-oral). It works by receiving X-rays from an external generator and converting them into digital images displayed on a computer screen.
- No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly interacts with the patient's body using X-rays to create an image.
Therefore, the Tio-h Digital Radiography Sensor falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.
Product codes
MUH
Device Description
The Tio-h Digital Radiography Sensor is a digital radiography imaging system.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
x-ray
Anatomical Site
intra-oral (dental)
Indicated Patient Age Range
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Intended User / Care Setting
qualified dental and healthcare 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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing right. The profiles are stacked on top of each other, with the top profile being the most prominent.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2016
Denttio, Inc. % Mr. Young Han President 3235 N. San Fernando Road, Bldg. 7B LOS ANGELES CA 90065
Re: K153144
Trade/Device Name: Tio-h Digital Radiography Sensor Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: January 20, 2016 Received: January 22, 2016
Dear Mr. Han:
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 Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K153144
Device Name Tio-h Digital Radiography Sensor
Indications for Use (Describe)
The Tio-h Digital Radiography Sensor is a digital radiography imaging system and intended to be used by a qualified dental and healthcare professionals in order to perform basic dental intra-oral x-ray imaging procedures. The digital radiography sensor captures the X-rays produced by an external X-ray generator. It transmits the image data to the computer and displays the x-ray image on the computer screen that ultimately diagnose general dental complications or abnormalities.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CER 801 Subpart D) | Over-The-Counter Use (21 CER 801 Subpart C) |
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