Digital Intraoral Imaging Plate System

K192766 · Fsusen Technology Co., Ltd. · MUH · Dec 5, 2019 · Dental

Device Facts

• Record ID: K192766
• Device Name: Digital Intraoral Imaging Plate System
• Applicant: Fsusen Technology Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Dec 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Indications for Use

Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media. And it is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.

Device Story

Digital Intraoral Imaging Plate System (Models F200, F210) captures, digitizes, and processes intraoral x-ray images. The system utilizes imaging plate recording media to store x-ray data, which is then processed by the device to produce digital images. Used in hospitals and clinics, the system is operated by trained professionals under physician guidance. The resulting digital output assists clinicians in diagnostic imaging workflows.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Digital intraoral x-ray imaging system; utilizes imaging plate recording media for data capture; processes and digitizes x-ray signals for clinical display.

Indications for Use

Indicated for capturing, digitizing, and processing intraoral x-ray images in hospital and clinical settings; for use by trained professionals under physician guidance.

Regulatory Classification

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.

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 5, 2019

Fussen Technology Co., Ltd. % Miss Elsa Li Regulation Engineer 1F, 3# Building, Tongfuyu Industrial Zone, Taoyuan Street, Nanshan District Shenzhen, Guangdong 518055 CHINA

Re: K192766

Trade/Device Name: Digital Intraoral Imaging Plate System, Model F200, F210 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: September 25, 2019 Received: September 30, 2019

Dear Miss Li:

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); labeling (21 CFR Part

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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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K192766

Device Name

Digital Intraoral Imaging Plate System, model F200, F210

Indications for Use (Describe)

Digital Intraoral Imaging Plate System is indicated for capturing, digitization and processing of intraoral x-ray images stored in imaging plate recording media.

And it is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.

| Type of Use (Select one or both, as applicable) | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;"><b></b></span> | | |
| <table border="0"><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" height="15" src="checked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) </td></tr><tr><td><div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" height="15" src="unchecked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) </td></tr></table> | <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" height="15" src="checked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" height="15" src="unchecked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) |
| <div style="display:inline-block; vertical-align:middle;"> <img alt="Checked" height="15" src="checked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Prescription Use (Part 21 CFR 801 Subpart D) | | |
| <div style="display:inline-block; vertical-align:middle;"> <img alt="Unchecked" height="15" src="unchecked_checkbox.png" style="vertical-align:middle;" width="15"/> </div> Over-The-Counter Use (21 CFR 801 Subpart C) | | |

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