(56 days)
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No
The summary describes a digital sensor for acquiring images and does not mention any AI or ML capabilities for image processing, analysis, or interpretation.
No.
The device is described as a digital sensor for acquiring dental intra-oral radiology images, which is diagnostic in nature, not therapeutic.
No
The device is described as a "USB-driven digital sensor which is intended to acquire dental intra-oral radiology images." Its function is image acquisition, which is a step in imaging, but the provided text does not indicate that the device itself performs diagnosis or provides diagnostic information. It captures images to be interpreted by a healthcare professional.
No
The device description explicitly states it is a "USB-driven digital sensor," which is a hardware component used for image acquisition.
Based on the provided information, the QuickRayPRO is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- QuickRayPRO's function: The QuickRayPRO is described as a digital sensor intended to acquire dental intra-oral radiology images. This involves capturing images of structures within the mouth using X-rays.
- No mention of specimen analysis: The description focuses on image acquisition and does not mention the analysis of any biological specimens.
Therefore, the QuickRayPRO falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals , who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
Product codes
MUH
Device Description
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
dental intra-oral radiology
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 22, 2023
Denterprise International Inc. % Mr. Lee W. Strong Quality Systems Manager 510K FDA Inc. 156 E Granada Blvd. ORMOND BEACH FL 32176
Re: K231202
Trade/Device Name: QuickRayPRO Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: April 27, 2023 Received: April 27, 2023
Dear Mr. Lee W. Strong:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231202
Device Name QuickRayPRO
Indications for Use (Describe)
QuickRayPRO is a USB-driven digital sensor which is intended to acquire dental intra-oral radiology images. The QuickRayPRO shall be operated by healthcare professionals , who are educated and competent to perform the acquisition of dental intra-oral radiographs. The QuickRayPRO can be used either in combination with special positioning devices to facilitate positioning and alignment with the x-ray beam or it may also be positioned by hand with the assistance of a patient.
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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