(196 days)
None
No
The description focuses on the hardware and basic image processing steps (scanning, digitalization, display, storage, erasure). There is no mention of AI/ML algorithms for image analysis, interpretation, or enhancement beyond standard digital processing. The performance studies also do not mention any AI/ML-specific validation.
No.
The device is an image scanner used to digitize dental X-ray images from imaging plates for display and storage. It does not provide any direct therapeutic benefit to the patient.
No.
This device is an image scanner that processes digital images exposed on IP Imaging Plates, essentially digitizing X-ray films. It does not analyze or interpret these images to provide a medical diagnosis; its function is solely to produce the image for a clinician to then interpret.
No
The device description clearly outlines hardware components such as a laser, oscillating mirror, optical sensor (PMT), LED-PCB, and plate inserts, which are integral to the device's function of scanning and processing images from IP Imaging plates. While it includes software for image processing and control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The described device is a digital image scanner that reads X-ray images captured on imaging plates placed in the patient's mouth. It processes these images for display and storage.
- No Specimen Analysis: The device does not analyze any biological specimens taken from the patient. It processes images generated by an external energy source (X-rays) interacting with the patient's anatomy.
Therefore, the device's function falls under the category of medical imaging equipment, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Digital image scanner of dental is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
Product codes
MUH
Device Description
Digital image scanner of dental is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on the screen and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size S0, S1, S2 and S3. The intraoral plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with 630-645 nm laser. The laser beam is moved across the surface of the plate by an oscillating mirror. The laser beam stimulates the top coating of the plates, which consists of X-rays sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier tube/ PMT) and transferred into an electrical output signal. This signal is digitalized and is the data for the digital X-ray image. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the screen, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-rays
Anatomical Site
Dental
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operated and used by trained professionals with physician's guidance in Hospitals and clinics.
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
The safety and effectiveness of the Digital image scanner of dental were established and the substantial equivalence determination was supported by a series of performance testing, including Electrical safety and electromagnetic compatibility (EMC), Software Verification Testing, image reading and checking testing.
Key Metrics
Not Found
Predicate Device(s)
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.
0
December 20, 2023
Jiangsu Dynamic Medical Technology Co., Ltd. % Doris Dong General Manager Shanghai CV Technology Co., Ltd. Room 602, No. 19 Dongbao Road, Songjiang Area SHANGHAI, SHANGHAI 201613 CHINA
Re: K231660
Trade/Device Name: Digital image scanner of dental Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: November 20, 2023 Received: November 24, 2023
Dear Doris Dong:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K231660
Device Name Digital image scanner of dental
Indications for Use (Describe)
Digital image scanner of dental is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.
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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3
510(k) Summary [As required by 21 CFR 807.92]
1. Submission Information
| 510(k) Number: | K231660 |
|---|---|
| Date: | December 08, 2023 |
| Type of 510(k) Submission: | Traditional 510(k) |
| Basis for 510(k) Submission: | New device |
| Owner: | JIANGSU DYNAMIC MEDICAL TECHNOLOGY CO., LTD. |
| No.108 Xingpu Road, Lujia Town, Kunshan, Suzhou, Jiangsu, China | |
| 215331 | |
| Tel: 86-512-82627666 | |
| Email: technic2@dynamicgroup.cn | |
| Contact: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 602, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 | |
| China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description
| Proprietary Name: | Digital image scanner of dental |
|---|---|
| Model: | DDT-100, DDT-100C, DDT-200, DDT-200C |
| Common Name: | Extraoral source x-ray system |
| Classification Name: | Extraoral source x-ray system |
| Regulation Number: | 21 CFR 872.1800 |
| Product Code: | MUH |
| Device Class: | 2 |
| Review Panel: | Radiology |
| Device Description: | Digital image scanner of dental is a dental device that scans IP |
maging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on the screen and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size S0, S1, S2 and S3. The intraoral plates are put into the mouth of the patient, exposed to X-rays and then are read out with the device. The read-out-process is carried out with 630-645 nm laser. The laser beam is moved across the surface of the plate by an oscillating mirror. The laser beam stimulates the top coating of the plates, which consists of X-rays sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier tube/ PMT) and transferred into an electrical output signal. This signal is digitalized and is the data for the digital X-ray image. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate
4
| insert into the device. He then exposes the plate and then puts the plate | |
|---|---|
| directly into the insert by pushing it out of the light protection envelope. | |
| The user closes the light protection over and starts the read-out process. | |
| After the read out process the picture is transmitted to the screen, the | |
| picture can be viewed, and the IP is erased and ready to use for the next | |
| acquisition. | |
| Indications for use: | Digital image scanner of dental is intended to be used for scanning and |
| processing digital images exposed on IP Imaging Plate in dental | |
| applications. |
3. Predicate Device Information
| Predicate 510(k) Number: | K212080 |
|---|---|
| Marketing clearance date: | 27/09/2021 |
| Product name: | i-Scan Imaging Plate Scanner |
| Manufacturer: | Guilin Woodpecker Medical Instrument Co., Ltd. |
| Parameters | New Device | Predicate Device | Comparison |
|---|---|---|---|
| 510(k) number | K231660 | K212080 | -- |
| Submitter | JIANGSU DYNAMIC | ||
| MEDICAL TECHNOLOGY | |||
| CO.,LTD. | Guilin Woodpecker Medical | ||
| Instrument Co., Ltd. | -- | ||
| Device name | Digital image scanner of dental | i-Scan Imaging Plate Scanner | -- |
| Model | DDT-100,DDT-100C,DDT-200, | ||
| DDT-200C | i-Scan | -- | |
| Regulation number | 21 CFR 872.1800 | 21 CFR 872.1800 | Same |
| Device class | II | II | Same |
| Product code | MUH | MUH | Same |
| Classification name | Extraoral source x-ray system | Extraoral source x-ray system | Same |
| Indications for use | Digital image scanner of dental | ||
| is intended to be used for | |||
| scanning and processing digital | |||
| images exposed on IP Imaging | |||
| Plate in dental applications. | i-Scan Imaging Plate Scanner is | ||
| intended to be used for scanning | |||
| and processing digital images | |||
| exposed on IP Imaging Plate in | |||
| dental applications. | Same | ||
| Prescription Use | Yes | Yes | Same |
| Site of Use | Hospitals and clinics | Hospitals and clinics | Same |
| Intended user | Operated and used by trained | ||
| professionals with physician's | |||
| guidance | Operated and used by trained | ||
| professionals with physician's | |||
| guidance | Same | ||
| Sterile | Non-Sterile | Non-Sterile | Same |
| Product Dimension | |||
| (HWD) | DDT-100,DDT-100C:365262 | ||
| 287mm | |||
| DDT-200,DDT-200C:320170 | |||
| 384mm | 138245.5290.2mm | Similar | |
| Note 1 | |||
| Product Weight | DDT-100,DDT-100C:9.3kg | ||
| DDT-200.DDT-200C:9.3kg | 4.5kg | ||
| Mechanical design | The exposed and unwrapped plates are scanned using a laser with a certain wavelength of 630-645 nm. The scan pattern is line by line | The exposed and unwrapped plates are scanned using a laser with a certain wavelength of 651-665 nm. The scan pattern is line by line. | Similar Note 2 |
| Electrical design | Light with a wavelength of approximately 380 nm is from the plate in proportion to the number of captured x-ray photons. This light is collected and formed into an image that may be viewed on a video display and stored for later recovery in a computer memory. | Light with a wavelength of approximately 380 nm is from the plate in proportion to the number of captured x-ray photons. This light is collected and formed into an image that may be viewed on a video display and stored for later recovery in a computer memory. | Same |
| Viewing the image | The touch screen only shows a preview which serves to provide an initial impression of the final x-ray image. For the purposes of diagnosis, the x-ray image must be viewed on a diagnostic monitor. The scanned images are displayed on an internal LCD or an external monitor using a computer and user software including image storage, retrieval and manipulation. | The touch screen only shows a preview which serves to provide an initial impression of the final x-ray image. For the purposes of diagnosis, the x-ray image must be viewed on a diagnostic monitor. The scanned images are displayed on an internal LCD or an external monitor using a computer and user software including image storage, retrieval and manipulation. | Same |
| Image scanning | Laser/Photomultiplier Tube | Laser/Photomultiplier Tube | Same |
| Erasing the residual image following scanning for plate reuse | The residual image is erased in the scanner by an inline erasing function. | The residual image is erased in the scanner by an inline erasing function. | Same |
| Transport/feed mechanism of imaging plate | The Plate realizes transmission movement through a conveyor belt, and the movement of the laser and the IP image board provides two orthogonal scanning directions. | The Plate realizes transmission movement through a conveyor belt, and the movement of the laser and the IP image board provides two orthogonal scanning directions. | Same |
| Imaging plate size | S0:22×35 mm | ||
| S1:24×40 mm | |||
| S2:31×41 mm | |||
| S3:27×54 mm | Size 0: 22×35 mm | ||
| Size 1: 24×40 mm | |||
| Size 2: 31×41 mm | |||
| Size 3: 27×54 mm | Same | ||
| Image data bit depth | 16 bits | 16 bits | Same |
| Contact body site | The device does not directly contact with human body or organ. | The device does not directly contact with human body or organ. | Same |
| Patient Contamination | Single patient use barrier | Single patient use barrier | Same |
| prevention | envelope encloses the imaging plate while in the patient's mouth. | envelope encloses the imaging plate while in the patient's mouth. | |
| Electronic User | |||
| Manual | User manual is provided in printed form to the user. | User manual is provided in printed form to the user. | Same |
| Image Quality | Theoretical resolutions: 17 LP/mm | Theoretical resolutions: 10 or 33 LP/mm | Similar |
| Note 3 | |||
| RFID | No | No | Same |
| MTF | More than 45% at 3 lp/mm | More than 45% at 3 lp/mm | Same |
| DQE | More than 21.0% at 3 lp/mm | More than 21.0% at 3 lp/mm | Same |
| Software/Firmware/M | |||
| icroprocessor | |||
| Control? | Digital Image Scanner Of Dental | Air-dental-woodpecker | Similar |
| Note 4 | |||
| External power source | 100 to 240VAC, 50/60 Hz | 100 to 240VAC, 50/60 Hz | Same |
| Compliance standards | ANSI AAMI ES60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 61223-3-4 | |||
| IEC 60825-1 | ANSI AAMI ES60601-1 | ||
| IEC 60601-1-2 | |||
| IEC 62220-1 | |||
| IEC 61223-3-4 | |||
| IEC 60825-1 | |||
| IEC 61010-1 | Similar | ||
| Note 5 | |||
| Picture | Image: DDT-100, DDT-100C, DDT-200, DDT-200C | Image: Scanner | Similar |
| Note 1 | |||
| Labeling | Meet FDA's requirement | Meet FDA's requirement | Same |
4. Comparison to predicate device
5
6
Differences between New device and Predicate Device:
Note 1:
The weight, dimensions and appearance of the proposed device differ slightly from the predicate device,depending on the design and sales requirements of these differences are insignificant in terms of safety or effectiveness.
Note 2:
The operating principle of scanning the image plates with a laser of approximately the same wavelength,both the proposal device and the predicate device scans the plates with a line-by-line pattern. The scans collect the same data and process this for visual imaging. They support the same indications for use; the differences in the mechanical design does not raise issues of safety and effectiveness.
Note 3:
The subject device displays theoretical resolutions of 17-Line Pairs per mm, whereas the predicate shows theoretical resolutions of 10- or 33-Line Pairs per mm. And the image resolution of the proposed device is between the image resolution of the predicate device. The differences do not affect the operating principle and the Image Quality distinctness is such that it does not affect the effectiveness of the device. Note 4:
7
The software is not the same between the subject device and the predicate, but both the subject and predicate have followed the FDA Guidance for the Content of Premarket for Submissions for Software Contained in Medical Devices.
Note 5:
According to the latest requirements, IEC 6220-1 is not applicable to digital X-ray imaging equipment for dental radiography. IEC 61010-1 is the test for laboratory equipment, we have done the test for ANSI AAMI ES60601-1, the standard is more stringent than IEC 61010-1.Other tests are the same as the predicate equipment, so it does not cause safety problems.
5. Summary of Non-clinical Testing
The safety and effectiveness of the Digital image scanner of dental were established and the substantial equivalence determination was supported by a series of performance testing, including Electrical safety and electromagnetic compatibility (EMC), Software Verification Testing, image reading and checking testing.
Electrical safety and electromagnetic compatibility (EMC)
General Requirements For Basic Safety And Essential Performance:This product has passed the IEC 60601-1 test and does not raise questions about safety effectiveness.
General Requirements For Basic Safety And Essential Performance -- Collateral Standard: Electromagnetic Disturbances -- Requirements And Tests:This product has passed the IEC 60601-1-2 test and does not raise questions about safety effectiveness.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate devices. The test results demonstrated that the proposed device complies with the following standards:
-
ANSI AAMI ES60601-1: 2005/(R)2012 And A1:2012, C1:2009(R)2012 And A2:2010/(R)2012 (Consolidated Text) Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance (IEC 60601-1:2005, MOD);
-
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;
Performance Testing
Acceptance tests - Imaging performance of dental X-ray:Imaging standard requirements were met for X-ray equipment.
Safety of laser products:Laser products have passed safety test.
-
IEC 61223-3-4 First edition 2000-03, Evaluation and routine testing in medical imaging departments -Part 3-4: Acceptance tests - Imaging performance of dental X-ray;
-
IEC 60825-1 Edition 2.0 2007-03, Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)].
Software Verification and Validation Testing
Software testing and V&V:As a result of unit level test, integration review and system level test, we hereby certify that all the functions those support system specification are proper. We confirm that software verification and validation test is properly accomplished.
8
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Image Reading and Checking Testing
Regarding image reading and checking testing, we performed image plates test and image accuracy and fidelity test respectively. Image plate test contains imaging area, degree of attenuation, uniformity, image contrast, bit depth and spatial resolution or MTF test, etc..Image accuracy and fidelity test contains accuracy test, uniformity, image contrast,spatial resolution or MTF test,and image fidelity test. The accuracy of image reading and checking results was verified by above testing.
6. Animal Study
Animal testing was not required for this submission.
7. Clinical Testing
Clinical testing was not required for this submission.
8. Substantial Equivalent (SE) Conclusion
Based upon comparison to the predicate devices, the proposed device is Substantial Equivalent (SE) to the predicate devices.