Dental Image Plate Scanner, Model DFC-4T-SMART

K214091 · Hefei Dentafilm Medical Equipment Co., Ltd. · MUH · Mar 2, 2022 · Dental

Device Facts

• Record ID: K214091
• Device Name: Dental Image Plate Scanner, Model DFC-4T-SMART
• Applicant: Hefei Dentafilm Medical Equipment Co., Ltd.
• Product Code: MUH · Dental
• Decision Date: Mar 2, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.1800
• Device Class: Class 2

Intended Use

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

Device Story

Device scans intraoral phosphor imaging plates to digitize latent dental X-ray images. Operation: plate inserted into scanner; laser beam scans plate progressively; blue fluorescence excited proportional to image density; high-efficiency photoconductor collects light; photomultiplier tube converts light to electrical signal; A/D converter digitizes signal. Output: digital image for display, storage, or transmission. Used in hospitals/clinics by trained dental/medical staff. Software (DFC V1.0) manages patient data, examinations, and image processing. Benefits: enables digital review of dental X-rays.

Clinical Evidence

No clinical or animal studies were conducted. Substantial equivalence was demonstrated through non-clinical bench testing, including risk analysis (ISO 14971:2019), electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), laser safety (IEC 60825-1), and photobiological safety (IEC 62471).

Technological Characteristics

Components: laser, optical scanner, photomultiplier tube, amplifier, A/D converter. Imaging: 14-bit depth, 35μm pixel size, ≥12lp/mm resolution. Connectivity: USB 2.0, DICOM 3.0. Power: 100-240V AC adapter. Software: DFC V1.0 (Moderate level of concern).

Indications for Use

Indicated for scanning dental X-ray latent images from intraoral imaging plates to generate, browse, process, and review digital X-ray images in dental/medical clinical settings.

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.

Predicate Devices

• Digital Intraoral Imaging Plate System, Model F200, F210 (K192766)

Submission Summary (Full Text)

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March 2, 2022

Image /page/0/Picture/1 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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.

Hefei DentaFilm Medical Equipment Co., Ltd. % Ming Chang Qiu Management Representative No. 98 Tangkou Road, Economic and Technological Development Zone Hefei, Anhui 230601 CHINA

Re: K214091

Trade/Device Name: Dental Image Plate Scanner, Model DFC-4T-SMART Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: January 5, 2022 Received: January 5, 2022

Dear Ming Qiu:

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

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

Sincerely,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-ray Systems Team 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) K214091

Device Name

Dental Image Plate Scanner, Model DFC-4T-SMART

Indications for Use (Describe)

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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K214091

# Hefei DentaFilm Medical Equipment Co., Ltd

# Dental Image Plate Scanner, Model DFC-4T-SMART

Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: MUH Traditional 510(K) Submission Files

## SECTION 5

510(k) Summary or 510(k) Statement

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# 510(k) Summary

#### Submission Number: K214091

#### Submitter

Name: Hefei DentaFilm Medical Equipment Co., Ltd

Address: No. 98 Tangkou Road, Economic and Technological Development Zone,

230601 Hefei City, Anhui Province, People's Republic of China

Name of contact person: Ming Chang Qiu

Telephone: [phone]

Submission date: 2022-01-26

#### Device

Device trade name: Dental Image Plate Scanner, Model DFC-4T-SMART

Regulation Name: Extraoral Source X-ray System

Regulation class: 2

Regulation number: 21CFR 872.1800

Panel: Radiology

Product code: MUH

### Predicative device

Predicate Submission Number: K192766 Predicate Device Trade Name: Digital Intraoral Imaging Plate System, Model F200, F210 Regulation Name: Extraoral Source X-ray System Regulation number: 21CFR 872.1800 Panel: Radiology Product code: MUH

### Device description

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to scan and process image data contained in the intraoral imaging plate. Once the intraoral imaging

Traditional 510(K) Submission Files

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plate is inserted into the entrance of the scanner, the scanning program will be started to progressively scan the imaging plate, and move forward in the meantime to scan the imaging plate completely with the laser beam in a specified time. In the place where the laser is irradiated, blue fluorescence will be excited and the intensity of the fluorescence brightness is linearly related to the image data density at that point. The fluorescence will be collected by a high-efficiency photoconductor, which is positioned along the laser scanning line and then will be introduced into a photomultiplier tube, where it will be converted into a corresponding electrical signal. After the electrical signal is converted by A/D (analog/digital) converter in the electrical circuit, it can be used for digital image processing and then output to the image display, storage, or transmission communication system.

This Dental Image Plate Scanner, Model DFC-4T-SMART mainly consists of image plate scanner, power adapter, intraoral imaging plate and Dental image plate scanner control system software (Version: V1.0).

The image plate scanner is composed of lasers, optical scanners, photomultiplier tubes, amplifiers, A/D converters, image processing unit and output interfaces etc.

Dental image plate scanner control system software (DFC software) is mainly used to acquire and display the image data of the intraoral imaging plate as well as used for patient management, examination management, image storage, image printing etc. Dental image plate scanner control system software (Version: V1.0) is of Moderate level of concern.

### Indication for use

The Dental Image Plate Scanner, Model DFC-4T-SMART is intended to be used to scan dental X-ray latent images contained in the intraoral imaging plate and then generate, browse, process and review the intraoral dental digital X-ray image.

| Attribute | Subject device | Predicative device | Discussion/<br>Conclusion |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Dental Image Plate<br>Scanner, Model<br>DFC-4T-SMART | Digital Intraoral<br>Imaging Plate System,<br>Model F200, F210 | / |
| Manufacturer | Hefei DentaFilm | Fussen Technology Co., | / |
| DentaFilm<br>Section 5 510(k) Summary | | | |
| Attribute | Subject device | Predicative device | Discussion/<br>Conclusion |
| | Medical Equipment<br>Co., Ltd | Ltd. | |
| 510(k) number | K214091 | K192766 | / |
| Device<br>classification<br>name | Class II | Class II | Same |
| Classification<br>regulations | 21 CFR 872.1800 | 21 CFR 872.1800 | Same |
| Product code | MUH | MUH | Same |
| Product picture | Image: DentaFilm | Image: FUSSEN | / |
| Similarities | | | |
| Indication for<br>Use | The Dental Image<br>Plate Scanner is<br>intended to be used to<br>scan dental X-ray<br>latent images<br>contained in the<br>intraoral imaging plate<br>and then generate,<br>browse, process and<br>review the intraoral<br>dental digital X-ray<br>image. | Digital Intraoral Imaging<br>Plate System is indicated<br>for capturing, digitization<br>and processing of<br>intraoral x-ray images<br>stored in imaging plate<br>recording media. | Same<br>meaning |
| Intended user | The Dental Image<br>Plate Scanner is<br>expected to be used<br>only by professionally<br>qualified<br>dental/medical staffs.<br>Typical user is a dental<br>assistant with specific<br>training for using<br>dental diagnostic | It is intended for uses in<br>hospitals and clinics, and<br>shall be operated and used<br>by trained professionals<br>with physician's<br>guidance. | Same<br>meaning |
| DentaFilm | | | Section 5 510(k) Summary |
| Attribute | Subject device | Predicative device | Discussion/<br>Conclusion |
| Working<br>principle | The Dental Image<br>Plate Scanner is<br>intended to scan and<br>process image data<br>contained in the<br>intraoral imaging<br>plate. Once the<br>intraoral imaging plate<br>is inserted into the<br>entrance of the<br>scanner, the scanning<br>program will be started<br>to progressively scan<br>the imaging plate, and<br>move forward in the<br>meantime to scan the<br>imaging plate<br>completely with the<br>laser beam in a<br>specified time. In the<br>place where the laser is<br>irradiated, blue<br>fluorescence will be<br>excited and the<br>intensity of the<br>fluorescence<br>brightness is linearly<br>related to the image<br>data density at that<br>point. The<br>fluorescence will be<br>collected by a high-<br>efficiency<br>photoconductor, which<br>is positioned along the<br>laser scanning line and<br>then will be introduced<br>into a photomultiplier<br>tube, where it will be<br>converted into a<br>corresponding<br>electrical signal. After | The imaging plate<br>scanner functions as<br>interpreting the latent<br>image information stored<br>in the imaging plate, and<br>it consists of laser, optical<br>scanner, photomultiplier,<br>amplifier, A/D converter,<br>image processing unit,<br>output interface, etc.<br>After a phosphor imaging<br>plate is loaded into the<br>imaging plate scanner<br>inlet, start the scanning<br>program to scan the<br>imaging plate with latent<br>image information to be<br>interpreted row by row,<br>move forwards at the<br>same time, and it can be<br>completely scanned by<br>the laser beams once<br>within set time. Blue<br>florescence can be<br>excited from parts<br>radiated by the laser, and<br>the intensity of the<br>florescence brightness is<br>in linear relationship with<br>the density of the latent<br>image information at the<br>point. The florescence is<br>collected by efficient<br>photoconductor arranged<br>along laser scanning line,<br>is introduced into the<br>photomultiplier, and is<br>further converted into<br>corresponding electric<br>signals. After being<br>transmitted into circuit | Same<br>meaning |
| Attribute | Subject device | Predicative device | Discussion<br>Conclusion |
| Attribute | the electrical signal is<br>converted by A/D<br>(analog/digital)<br>converter in the<br>electrical circuit, it can<br>be used for digital<br>image processing and<br>then output to the<br>image display, storage,<br>or<br>transmission<br>communication<br>system. | A/D (analog/digital)<br>signal conversion, the<br>electric signals can be<br>used in digital image<br>processing, and can be<br>output to image display,<br>storage or transmission<br>communication system. | |
| Product<br>structure | The image plate<br>scanner is composed<br>of lasers, optical<br>scanners,<br>photomultiplier tubes,<br>amplifiers, A/D<br>converters, image<br>processing unit and<br>output interfaces etc. | The imaging plate<br>scanner consists of laser,<br>optical<br>scanner,<br>photomultiplier,<br>amplifier, A/D converter,<br>image processing unit,<br>output interface, etc. | Same |
| Software<br>function design | Dental image plate<br>scanner control system<br>software (DFC<br>software) is mainly<br>used to acquire and<br>display the image data<br>of the intraoral | Digital intraoral imaging<br>plate control system<br>software (CRFC) is<br>mainly used to read<br>images from oral imaging<br>plate and for patient and<br>examination management | Same |
| DentaFilm Section 5 510(k) Summary | | | |
| Attribute | Subject device | Predicative device | Discussion/<br>Conclusion |
| scanning<br>plate reuse. | | | |
| Transport/feed<br>mechanism of<br>imaging plate | Imaging plate tray | Imaging plate holding<br>groove | Same |
| Imaging plate | Intra Oral Dental<br>Phosphor Plates<br>Size 0: 22 x 35 mm<br>Size 1: 24 x 40 mm<br>Size 2: 31 x 41 mm<br>Size 3: 27 x 54 mm | Intra Oral Dental<br>Phosphor Plates<br>Size 0: 22 x 35 mm<br>Size 1: 24 x 40 mm<br>Size 2: 31 x 41 mm<br>Size 3: 27 x 54 mm | Same |
| Image data bit<br>depth | 14 bits/pixel | 14 bits/pixel | Same |
| Data<br>transmission<br>interface | USB 2.0 port | USB 2.0 port | Same |
| Communication | DICOM3.0…