(64 days)
Not Found
No
The description focuses on the hardware and basic digital image processing steps (A/D conversion, image processing unit) without mentioning any advanced algorithms or learning processes typically associated with AI/ML. The software description is limited to image acquisition, display, and management functions.
No
Explanation: The device is intended to scan and process dental X-ray images, not to treat or cure a disease or condition. Its function is diagnostic imaging.
Yes
The device is intended to "scan dental X-ray latent images" and "generate, browse, process and review the intraoral dental digital X-ray image." The processed images are used by "professionally qualified dental/medical staffs" for diagnostic purposes.
No
The device description explicitly states that the device "mainly consists of image plate scanner, power adapter, intraoral imaging plate and Dental image plate scanner control system software". It also details the hardware components of the image plate scanner (lasers, optical scanners, photomultiplier tubes, etc.). While software is a component, it is not the sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Dental Image Plate Scanner, Model DFC-4T-SMART, scans dental X-ray latent images from intraoral imaging plates. It processes and displays these images.
- Lack of Specimen Analysis: The device does not analyze biological specimens from the human body. It processes images derived from X-rays, which are a form of medical imaging, not in vitro diagnostics.
The device is clearly a medical imaging device used in dentistry.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
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 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
intraoral dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The Dental Image Plate Scanner is expected to be used only by professionally qualified dental/medical staffs. Typical user is a dental assistant with specific training for using dental diagnostic. It is intended for uses in hospitals and clinics, and shall be operated and used by trained professionals with physician's guidance.
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)
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2019.
- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
- IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems
- Software development: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Cybersecurity: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Image Quality: ≥12lp/mm
Pixel Size: 35μm
MTF: ≥41% at 3 lp/mm
DQE: More than 9% at 3 lp/mm
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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
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,
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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
4
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: +86-551-63528008
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
5
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/
Conclusion |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product name | Dental Image Plate
Scanner, Model
DFC-4T-SMART | Digital Intraoral
Imaging Plate System,
Model F200, F210 | / |
| Manufacturer | Hefei DentaFilm | Fussen Technology Co., | / |
| DentaFilm
Section 5 510(k) Summary | | | |
| Attribute | Subject device | Predicative device | Discussion/
Conclusion |
| | Medical Equipment
Co., Ltd | Ltd. | |
| 510(k) number | K214091 | K192766 | / |
| Device
classification
name | Class II | Class II | Same |
| Classification
regulations | 21 CFR 872.1800 | 21 CFR 872.1800 | Same |
| Product code | MUH | MUH | Same |
| Product picture | Image: DentaFilm | Image: FUSSEN | / |
| Similarities | | | |
| Indication for
Use | The Dental Image
Plate Scanner 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. | Digital Intraoral Imaging
Plate System is indicated
for capturing, digitization
and processing of
intraoral x-ray images
stored in imaging plate
recording media. | Same
meaning |
| Intended user | The Dental Image
Plate Scanner is
expected to be used
only by professionally
qualified
dental/medical staffs.
Typical user is a dental
assistant with specific
training for using
dental diagnostic | It is intended for uses in
hospitals and clinics, and
shall be operated and used
by trained professionals
with physician's
guidance. | Same
meaning |
| DentaFilm | | | Section 5 510(k) Summary |
| Attribute | Subject device | Predicative device | Discussion/
Conclusion |
| Working
principle | The Dental Image
Plate Scanner is
intended to scan and
process image data
contained in the
intraoral imaging
plate. Once the
intraoral imaging 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 imaging plate
scanner functions as
interpreting the latent
image information stored
in the imaging plate, and
it consists of laser, optical
scanner, photomultiplier,
amplifier, A/D converter,
image processing unit,
output interface, etc.
After a phosphor imaging
plate is loaded into the
imaging plate scanner
inlet, start the scanning
program to scan the
imaging plate with latent
image information to be
interpreted row by row,
move forwards at the
same time, and it can be
completely scanned by
the laser beams once
within set time. Blue
florescence can be
excited from parts
radiated by the laser, and
the intensity of the
florescence brightness is
in linear relationship with
the density of the latent
image information at the
point. The florescence is
collected by efficient
photoconductor arranged
along laser scanning line,
is introduced into the
photomultiplier, and is
further converted into
corresponding electric
signals. After being
transmitted into circuit | Same
meaning |
| Attribute | Subject device | Predicative device | Discussion
Conclusion |
| Attribute | 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. | A/D (analog/digital)
signal conversion, the
electric signals can be
used in digital image
processing, and can be
output to image display,
storage or transmission
communication system. | |
| Product
structure | The image plate
scanner is composed
of lasers, optical
scanners,
photomultiplier tubes,
amplifiers, A/D
converters, image
processing unit and
output interfaces etc. | The imaging plate
scanner consists of laser,
optical
scanner,
photomultiplier,
amplifier, A/D converter,
image processing unit,
output interface, etc. | Same |
| Software
function design | Dental image plate
scanner control system
software (DFC
software) is mainly
used to acquire and
display the image data
of the intraoral | Digital intraoral imaging
plate control system
software (CRFC) is
mainly used to read
images from oral imaging
plate and for patient and
examination management | Same |
| DentaFilm Section 5 510(k) Summary | | | |
| Attribute | Subject device | Predicative device | Discussion/
Conclusion |
| scanning
plate reuse. | | | |
| Transport/feed
mechanism of
imaging plate | Imaging plate tray | Imaging plate holding
groove | Same |
| Imaging plate | Intra Oral Dental
Phosphor Plates
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm
Size 3: 27 x 54 mm | Intra Oral Dental
Phosphor Plates
Size 0: 22 x 35 mm
Size 1: 24 x 40 mm
Size 2: 31 x 41 mm
Size 3: 27 x 54 mm | Same |
| Image data bit
depth | 14 bits/pixel | 14 bits/pixel | Same |
| Data
transmission
interface | USB 2.0 port | USB 2.0 port | Same |
| Communication | DICOM3.0 | DICOM3.0 | Same |
| Patient
Contamination
prevention | In order to ensure
hygiene, the imaging
plate must be packed
in an imaging plate
protective bag during
exposure procedure. | Use a barrier envelope to
pack an imaging plate in
order to ensure sanitation. | Same
meaning |
| Differences | | | |
| Product size and
weight | size (H×W×D):
296×170×196mm;
Wight: ≤7kg | size (H×W×D):
260×167×325mm
Weight: 5.2kg | differences on
product size and
weight will
not affect the
performance
and safety of
the scanner
totally. |
| Imaging
scanning | Laser/Photomultiplier
Tube | Laser/Photomultiplier
Tube | Same |
| Image Quality | ≥12lp/mm | 12lp/mm | Same |
| Pixel Size | 35μm | 35μm | Same |
| MTF | ≥41% at 3 lp/mm | not publicly available | The scanner
is only used
to transfer the
recorded
image in the |
| DentaFilm | Section 5 510(k) Summary | | |
| Attribute | Subject device | Predicative device | Discussion/
Conclusion |
| DQE | More than 9% at 3 lp/mm | not publicly available | image plate, and will not adversely affect the image quality as demonstrated by the solid-state device testing. The scanner is only used to transfer the recorded image in the image plate, and will not adversely affect the image quality as demonstrated by the solid-state device testing. |
| Imaging
Software | DFC Software V1.0 | CRFC V2.0.2 | software is evaluated and validated according to the FDA Guidance. Such difference will not affect the performance and safety of the device. |
| External power
source | Power adapter:
input 100-240 V AC, 50/60Hz,1.4-0.7A
Output: 15V | Power adapter:
Input 100-240V ~ 47-63Hz 1.62-0.72A
Output: DC15V 4.2A | slight difference on power adapter will |
| Attribute | Subject device | Predicative device | Discussion/
Conclusion |
| | 4.0A;60W MAX. | max. 63W | not affect the
effectiveness
and safety of
the device. |
Comparison of technological characteristics with the predicate device
Traditional 510(K) Submission Files
6
7
8
and image storage and
the recorded image plate
is scanned using a laser.
printing.
6
imaging plate as well |
as used for patient
storage, image printing
the recorded image
plate is scanned using
image
management, examination management,
etc.
scan
Image
design
DentaFilm
Same
Same
erasing
Section 5 510(k) Summary
ﮐﮯ ﺑ
9
10
11
Section 5 510/k) Summa
The subjective device and predicative device have the same intended use. The subject and predicative device have similar technological characteristics as evidenced by the table above. The differences in technological characteristics do not raise different questions of safety or effectiveness. Detailed information on difference discussion and conclusion refer to section 12 Substantial equivalence discussion.
Summary of non-clinical testing (Performance testing-bench)
The following performance data were provided to verify that the subject device met all design specifications and provided support of the substantial equivalence determination.
- Risk Analysis developed in accordance with ISO 14971:2019. .
- IEC 60601-1:2005+A1:2012 Medical electrical equipment Part 1: General . requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General ● requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances – Requirements and tests
- . IEC 60825-1:2014 Safety of laser products - Part 1: Equipment classification and requirements
- IEC 62471: 2006 Photobiological safety of lamps and lamp systems ●
- Software development: Guidance for the Content of Premarket Submissions ● for Software Contained in Medical Devices.
- Cybersecurity: Content of Premarket Submissions for Management of ● Cybersecurity in Medical Devices.
Summary of clinical testing
No animal study and clinical studies are available for our device. Clinical testing was not required to demonstrate the substantial equivalence of the subject device to its predicate device.
12
Conclusions
The differences between the subjective device and its predicate device do not introduce a new intended use and do not raise new issues of safety and effectiveness. Verification and Validation testing demonstrated that no adverse effects have been introduced by these differences and that the device performs as intended. From the results of nonclinical testing described, it can be concluded that the subject device is substantially equivalent to the legally marketed predicate device.