(189 days)
No
The summary describes a standard dental X-ray imaging device and its operational principles, focusing on hardware and basic image reconstruction software. There is no mention of AI, ML, or any related concepts in the device description, performance studies, or key metrics.
No
The device is used for diagnostic imaging (radiographic examination) and does not directly treat or alleviate a medical condition.
Yes
The device description states, "This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination." Additionally, its intended use is for "radiographic examination" of teeth and temporomandibular joints, with images used for "display and analysis" to view "anatomical structure...for the diagnosis purposes."
No
The device description clearly states it is a dental X-ray imaging device that includes hardware components like an X-ray generator, detector, and rotating arm. While software is used for image reconstruction, the device itself is a physical piece of equipment.
No, this device 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, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Description: The description clearly states that this device is a "dental X-ray imaging device" that obtains images by "rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector." This is an in vivo imaging process, meaning it takes images of the body directly, not from a specimen taken from the body.
- Intended Use: The intended use is for "dental radiographic examination of the teeth and temporomandibular joints," which is also an in vivo application.
Therefore, based on the provided information, the DENTIOIII series is a medical imaging device, specifically a dental X-ray system, and not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
Product codes
MUH
Device Description
This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.
-
The DENTIOIII Series are classified as shown below.
▪ DENTIOIII: PANORAMA Mode
▪ DENTIOIII-S: PANORAMA Mode + CEPHALO Mode (SCAN) -
Description of the image detectors used.
-
Model: DENTIOIII
- Contents: Scanning (Pano)
- Detector model: Xineos-1501, ARGUS-PAN (DM-20-05K10-00-R)
- Manufacturer: Teledyne DALSA, Teledyne DALSA
- Detector type: Scanning detector (CMOS), Scanning detector (CCD)
- Resolution (pixels): 1536 x 68, 5580 x 256
- Pixel size (um): 99.0, 27.0
- MTF: 65% at 1LP/mm, 70% at 1LP/mm
- DQE: 57% at 1LP/mm, 50% at 0LP/mm
- Active area (mm): 152.0 x 7.0 mm, 151.0 x 6.9 mm
- A/D Conversion: 14 bits, 16 bits
- FDA 510(k) Number: Not known, Not known
-
Model: DENTIOIII-S
- Contents: Scanning (Pano /Ceph)
- Detector model: Xineos-2301, ARGUS - CEPH (DM-20-08K10-00-R)
- Manufacturer: Teledyne DALSA, Teledyne DALSA
- Detector type: Scanning detector (CMOS), Scanning detector (CMOS)
- Resolution (pixels): 2305 x 68, 8160 x 256
- Pixel size (um): 99.0, 27.0
- MTF: 65% at 1LP/mm, 70% at 1LP/mm
- DQE: 57% at 1LP/mm, 50% at 0LP/mm
- Active area (mm): 228.0 x 7.0 mm, 221.0 x 6.9 mm
- A/D Conversion: 14 bits, 16 bits
- FDA 510(k) Number: Not known, Not known*
-
Note: Information for detector own 510(K) number or system in which it was cleared 510(k) number.
- Contents: CEPHALO detector
- Model: ARGUS - CEPH (DM-20-08K10-00-R)
- Own 510(K) number: No
- System in which it was cleared 510(k) number: 1) System name: DENTRIα series (DENTRIα, DENTRI-Ca, DENTRI-Sa) 2) Manufacturer: HDX WILL CORP. 3) 510(K) Number: K160140
The DENTIOIII series communicates with the Workstation by transmitting data using Ethernet cable and RS232 Cable.
- Laser
The laser is used for patient positioning and is class 1. This technical characteristic is as follows:
-
Model: LM-6501RS (Option1)
- Optical output: 1 mW or less
- Wavelength: 655 nm ± 5 nm
- Line type: Accurate Straight
- Form of beam output: Gaussian
-
Model: P9-655-5L (Option2)
- Optical output: 1 mW or less
- Wavelength: 655 nm ± 6 nm
- Line type: Accurate Straight
- Form of beam output: Gaussian
Mentions image processing
Yes, "reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes."
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-Ray
Anatomical Site
Teeth, temporomandibular joints, jaw, oral structures, ENT and dentomaxillofacial areas
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental practitioners and/or radiologists
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)
Non-Clinical Test Summary
The DENTIOIII series complies with international standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
-
- Electrical Safety, Electromagnetic Compatibility and Performance:
The DENTIOIII series comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
- Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007
- Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3:2008/AMD1:2013
- Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63:2012
- Acceptance Tests Imaging Performance of Dental X-Ray requirements of IEC 61223-3-4:2000
- Electrical Safety, Electromagnetic Compatibility and Performance:
Bench testing was used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance. Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory. The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review.
-
- Software Validation
The DENTIOIII series use original software. The DENTIOIII series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."
- Software Validation
-
- Biocompatibility
A biocompatibility study is not necessary.
- Biocompatibility
-
- SSXI Report
Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". Both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 6220-1. Base on the Non-clinical test results, even though the used detector differs in term of the pixel size and active area, the diagnostic image quality of the detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
- SSXI Report
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
Image /page/0/Picture/0 description: The image contains 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.
November 21, 2018
HDX WILL CORP. Lee Myoung-Joon General Manager #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro Osong-eup, Heungdeok-gu CHEONGJU-SI CHUNGCHEONGBUK-DO 28161 REPUBLIC OF KOREA
Re: K181297
Trade/Device Name: DENTIOIII series (DENTIOIII, DENTIOIII-S) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: September 21, 2018 Received: September 25, 2018
Dear Lee Myoung-Joon:
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.
1
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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Hole 2. Mils
for Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181297
Device Name DENTIOIII series (DENTIOIII, DENTIOIII-S)
Indications for Use (Describe)
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalome. It is to be used only by dental practitioners and/or radiologists
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
K181297 Page 1/8
510(k) Summary
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
Sept. 21. 2018
2. Submitter's Information [21 CFR 807.92(a)(1)]
| - Name of Manufacturer: | HDX WILL CORP. |
|---|---|
| - Address: | #105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, |
| Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do | |
| 28161, Korea | |
| - Contact Name: | Myoung-Joon Lee / General Manager |
| - Telephone No.: | +82-43-710-7318 |
| - Fax No.: | +82-43-710-7312 |
| - Email Address: | mjlee@iwillmed.com |
| - Registration No.: | 3013511605 |
3. Trade Name, Regulation Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name | DENTIOIII series (DENTIOIII, DENTIOIII-S) |
|---|---|
| Regulation Number | 21 CFR 872.1800 |
| Regulation Name | Extraoral source x-ray system |
| Regulation Class | II |
| Product Code | MUH |
| Product Code Name | System, X-Ray, Extraoral Source, Digital |
4
K181297 Page 2/8
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)[
The identified predicate devices within this submission are shown as follow;
Predicate device #1 - 510(k) Number: K142058 - Applicant: RAY Co., Ltd. - Regulation Name: Extraoral source x-ray system - Product Code: MUH - Device Class: Class II - Device Name: RAYSCAN α-Expert
Predicate device #2
| - 510(k) Number: | K992385 |
|---|---|
| - Applicant: | INSTRUMENTARIUM CORP. |
| - Regulation Name: | Extraoral source x-ray system |
| - Product Code: | MUH |
| - Device Class: | Class II |
| - Device Name: | Orthopantomograph® OP100 D |
Predicate device #3
| - 510(k) Number: | K160140 |
|---|---|
| - Applicant: | HDX WILL CORP. |
| - Regulation Name: | Computed tomography x-ray system |
| - Product Code: | OAS |
| - Device Class: | Class II |
| - Device Name: | DENTRIα series (DENTRIα, DENTRI-Cα, DENTRI-Sα) |
There are no significant differences between the DENTIOIII, DENTIOIII, DENTIOIII-S) and the predicate device that would adversely affect the use of the product.
5. Description of the Device [21 CFR 807.92(a)(4)]
This equipment is a dental X-ray imaging device used for diagnostic purposes in dental examination. The operating principle of this device is obtaining the panoramic images by rotating the arm to get the recombination data, having the X-ray generator and detector rotate around the patient to irradiate the X-ray, and measuring the penetrated X-ray using the detector. When the X-ray irradiates the teeth area for instance, a large amount of X-ray is attenuated because objects such as bones are highly dense. By contrast, the X-ray permeates more through small molecules with low density such as skin or tissue measuring the X-ray is reconstructed by the software for display and analysis, the anatomical structure can be viewed for the diagnosis purposes. In addition, the Cephalo arm uses the scanning method.
- The DENTIOIII Series are classified as shown below.
▪ DENTIOIII: PANORAMA Mode
▪ DENTIOIII-S: PANORAMA Mode + CEPHALO Mode (SCAN)
- Description of the image detectors used.
5
K181297 Page 3/8
| Model | DENTIOIII | DENTIOIII-S | ||
|---|---|---|---|---|
| Contents | Scanning (Pano) | Scanning (Pano /Ceph) | ||
| Detector model | Xineos-1501 | ARGUS-PAN | ||
| (DM-20-05K10-00-R) | Xineos-2301 | ARGUS - CEPH | ||
| (DM-20-08K10-00-R) | ||||
| Manufacturer | Teledyne DALSA | Teledyne DALSA | Teledyne DALSA | Teledyne DALSA |
| Detector type | Scanning detector | |||
| (CMOS) | Scanning detector | |||
| (CCD) | Scanning detector | |||
| (CMOS) | Scanning detector | |||
| (CMOS) | ||||
| Resolution (pixels) | 1536 x 68 | 5580 x 256 | 2305 x 68 | 8160 x 256 |
| Pixel size (um) | 99.0 | 27.0 | 99.0 | 27.0 |
| MTF | 65% at 1LP/mm | 70% at 1LP/mm | 65% at 1LP/mm | 70% at 1LP/mm |
| DQE | 57% at 1LP/mm | 50% at 0LP/mm | 57% at 1LP/mm | 50% at 0LP/mm |
| Active area (mm) | 152.0 x 7.0 mm | 151.0 x 6.9 mm | 228.0 x 7.0 mm | 221.0 x 6.9 mm |
| A/D Conversion | 14 bits | 16 bits | 14 bits | 16 bits |
| FDA 510(k) | ||||
| Number | Not known | Not known | Not known | Not known* |
- Note. Information for detector own 510(K) number or system in which it was cleared 510(k) number.
| Contents | Model | Own 510(K)
number | System in which it was cleared 510(k) number. |
|---------------------|------------------------------------|----------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| CEPHALO
detector | ARGUS - CEPH
(DM-20-08K10-00-R) | No | 1) System name: DENTRIα series (DENTRIα,
DENTRI-Ca, DENTRI-Sa)
2) Manufacturer: HDX WILL CORP.
3) 510(K) Number: K160140 |
The DENTIOIII series communicates with the Workstation by transmitting data using Ethernet cable and RS232 Cable.
3) Laser
The laser is used for patient positioning and is class 1. This technical characteristic is as follows:
| LM-6501RS (Option1) | P9-655-5L (Option2) | |
|---|---|---|
| Optical output | 1 mW or less | 1 mW or less |
| Wavelength | 655 nm ± 5 nm | 655 nm ± 6 nm |
| Line type | Accurate Straight | Accurate Straight |
| Form of beam output | Gaussian | Gaussian |
6. Indications for Use [21 CFR 807.92(a)(5)]
The DENTIOIII series is intended for dental radiographic examination of the teeth and temporomandibular joints, specifically for panoramic and cephalometric examinations. It is to be used only by dental practitioners and/or radiologists
6
W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
K181297 Page 4/8
7. Determination of Substantial Equivalence
The DENTION series is substantially equivated predicate devices with respect of the companison of technical features. The subject device was fund to be equivalent to predicate devices with regarding to dechnical characteristics. The table below presents comparisons for each origations of technological characteristics of the device compared to the predicate devices. [21 CFR 807.92(a)(6)]
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
|---|---|---|---|---|
| K Number | K181297 | K142058 | K992385 | K160140 |
| Model | DENTIOIII series | |||
| · DENTIOIII | ||||
| · DENTIOIII-S | RAYSCAN α- Expert | |||
| · RAYSCAN α -P | ||||
| · RAYSCAN α -SC | ||||
| · RAYSCAN α -OCL | ||||
| · RAYSCAN α -OCS | Orthopantomograph® OP100 D | DENTRIα series | ||
| · DENTRIα | ||||
| · DENTRI-Cα | ||||
| · DENTRI-Sα | ||||
| Manufacturer | HDX WILL CORP. | RAY Co., Ltd. | INSTRUMENTARIUM CORP. | HDX WILL CORP. |
| Indications for Use | The DENTIOIII series is intended | |||
| for dental radiographic examination | ||||
| of the teeth and temporomandibular | ||||
| joints, specifically for panoramic | ||||
| and cephalometric examinations. It | ||||
| is to be used only by dental | ||||
| practitioners and/or radiologists | The RAYSCAN α - Expert Dental | |||
| X-Ray System is an extraoral | ||||
| source dental panoramic and | ||||
| optional cephalometric X-ray | ||||
| system intended to produce X-rays | ||||
| for dental radiographic examination | ||||
| and diagnosis of diseases of the | ||||
| teeth, jaw, and oral structures. | Orthopantomograph® OP100 D is | |||
| intended to be used for producing | ||||
| diagnostic X-ray radiograph of | ||||
| dentition, TM-joints and other oral | ||||
| structures. | The DENTRIα series is a Computed | |||
| Tomography X-Ray imaging device | ||||
| specialized in diagnosing general | ||||
| dental treatments and orthodontic | ||||
| purpose using Panoramic and | ||||
| Cephalometric images respectively. | ||||
| In addition, DENTRIα series is | ||||
| used in the field of Otolaryngology | ||||
| by capturing 360 degree rotation | ||||
| sequence of the head and neck | ||||
| areas, including the ENT and | ||||
| dentomaxillofacial areas for a | ||||
| dental treatment in adult and | ||||
| pediatric dentistry, and obtains x- | ||||
| ray images from different angles | ||||
| and calculate though computer- | ||||
| processed to produce 3D x-ray | ||||
| tomographic images. The | ||||
| Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | |
| DENTRIα series is used by physicians, dentists, and x-ray technologists. | ||||
| Operation Mode | 1) Panorama |
-
Cephalo
• Scan type | 1) Panorama -
Cephalo
• One shot type
• Scan type | 1) Panorama -
Cephalo (Option) | 1) CT
-
Panorama
-
Cephalo
• One shot type
• Scan type |
| X-ray tube assembly | | | | |
| X-ray tube | D-054S | Not known | D-051S | OPX/105 (C.E.I. X-ray tube) |
| Focal spot size | 0.5 mm | 0.5 mm | 0.5 mm | 0.5 mm |
| Target angle | Target angle 5° | Target angle 5° | Target angle 5° | Target angle 5° |
| Total filtration of X-ray tube assembly | > 2.8 mmAl | 2.6 mm Al equivalent | > 2.5 mmAl | > 2.5 mmAl |
| Anode material | Tungsten | Tungsten | Tungsten | Tungsten |
| range of X-ray tube voltage settings | 60 - 90 kV | 60 - 90 kV | 57 - 85 kV | 1) CT: 60 - 110 kV -
Panorama: 60 - 90 kV
-
Cephalo
• Scan type:60 - 90 kV
• One shot type: 60 - 110 kV |
| range of X-ray tube current settings | 4 - 10 mA | 4 - 10mA | 2 - 16 mA | 4 - 10mA |
| range of irradiation time settings | 1) Panorama
Max 14.2 s -
Cephalo
• Scan type:
Max 8.2 s (Normal) / 4.2 s (Fast) | 1) Panorama:
below 14sec -
Cephalo
• Scan type: below 18sec
• One shot type: below 2sec | 1) Panorama
Max 17.6 s -
Cephalo
8 - 20 s | 1) CT(Normal):
8 s or 24 s -
Panorama:
Max 14.2 s -
Cephalo
• Scan type: 8.2 s and less
• One shot type:
0.5, 1, 1.5, 2 s |
| Detector type | 1) Panorama
• Flat panel (CCD or CMOS) | 1) Panorama
• Flat panel | 1) Panorama
• Flat panel (CCD) | 1) CT: Flat panel -
Panorama: Flat panel |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 |
| | 2) Cephalo
· Scan type:
Flat panel (CCD or CMOS) | 2) Cephalo
· Scan type:
CdTe Direct flat panel sensor
· One shot type: Amorphous
Silicon | 2) Cephalo
· Scan type:
Flat panel (CCD) | 3) Cephalo
· Scan type: CCD
· One shot type: Flat panel |
| Pixel size | 1) Panorama: 99 µm -
Cephalo:
99 µm | 1) Panorama: 100 µm -
Cephalo
· Scan type: 100 µm
· One shot type: 139 µm | 1) Panorama: 96 x 96 µm -
Cephalo
· Scan type: 96 x 96 µm | 1) CT: 100.1 or 127 µm -
Panorama: 100.1 or 127 µm
-
Cephalo
· Scan type: 27 µm
· One shot type: 129 µm |
| Active area (mm) | 1) Pano
· 152.0 x 7.0 mm or
151.0 x 6.9mm -
Pano/Ceph
· Scan type:
228.0 x 7.0 mm or
221.0 x 6.9 mm | 1) Panorama:
· 151.2 x 6.0 mm -
Cephalo
· Scan type:
240.0 x 4.8 mm
· One shot type:
427.0 x 356.0 mm or
302.0 x 249.0 mm | 1) Panorama:
· 138.0 x 138.0 mm/ 1440 pixels -
Cephalo
· 190.0 x 190.0 mm / 1980 pixels | 1) CT:
· 131 x 131 mm or
· 130 x 130 mm -
Panorama:
· 6 x 131 mm or
· 3.94 x 128.78 mm -
Cephalo
· Scan type: 6.9 x 221 mm
· One shot type:
193 x 259 mm |
| MTF | 1) Panorama:
· 70 % at 1LP/mm or
65% at 1LP/mm -
Cephalo
· Scan type:
70 % at 1LP/mm or
65% at 1LP/mm | 1) Panorama:
· 70 % at 1LP/mm -
Cephalo
· Scan type:
75 % at 1LP/mm
· One shot type:
54 % at 1LP/mm | Not known | 1) CT: 57% or 55% at 1LP/mm -
Panorama:
· 57% or 55% at 1LP/mm -
Cephalo
· Scan type:
70% at 1LP/mm
· One shot type:
83.3% at 2 LP/mm |
| DQE | 1) Panorama:
· 57% at 1LP/mm or
· 50% at 0LP/mm | 1) Panorama:
· 50 % at 1LP/mm -
Cephalo | Not known | 1) CT:
· 70% at 0 LP/mm or |
| | Proposed Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 |
| | 2) Cephalo
• Scan type:
57% at 1LP/mm or
50% at 0LP/mm | • Scan type:
88 % at 1LP/mm
• One shot type:
20 % at 1LP/mm | | • 58% at 1 LP/mm -
Panorama:
• 58% at 1 LP/mm or
• 70% at 0 LP/mm -
Cephalo
• Scan type:
50% at 0 LP/mm
• One shot type:
38.5% at 0 LP/mm |
| Geometry | | | | |
| Source Image Distance
(SID) | 1) Panorama: 535mm -
Cephalo
• 1735 mm (Single detector type)
• 1729mm (Dual detector type) | Not known | 1) Panorama:
19.2 inches / 487 mm -
Cephalo
68.7 inches / 1745 mm | 1) CT: 600 mm -
Panorama: 560 mm
-
Cephalo:
• Scan type:1783 mm
• One shot type: 1790 mm |
| Format
compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
[Table of Comparison of Proposed Device to Predicate Device]
7
W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
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8
W HDXWILL
#105, 106, 201, 202, 203, 204, 38, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do, 28161, Korea, Tel: +82-43-710-7318/ Fax: +82-43-710-7312
K181297 Page 6/8
9
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Justification to Support Substantial Equivalence
Although the clectors wed differ with predicate including image proposed device is enough to perform each mode with respect to the finctional aspects. The clinical data shows that the DENTIOII series is effective . Clinical inages were provided as further on addition to the combet system works as intended. As licenses or clinical daggoses of the images, it might be proved that the region of interests. Therefore, these technological differences of detectors used do not raise different questions of safety and effectiveness to diagnosis.
10
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Non-Clinical Test Summary
The DENTIOIII series complies with international standards for electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
-
- Electrical Safety, Electromagnetic Compatibility and Performance:
The DENTIOIII series comply with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Electrical Safety, Electromagnetic Compatibility and Performance:
-
· Electrical Basic Safety and Essential Performance requirements in accordance with IEC 60601-1:2005/AMD1:2012
-
· Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2:2007
-
· Radiation Protection In Diagnostic X-Ray Equipment requirements of IEC 60601-1-3:2008/AMD1:2013
-
" Dental Extra-Oral X-Ray Equipment requirements of IEC 60601-2-63:2012
-
· Acceptance Tests Imaging Performance of Dental X-Ray requirements of IEC 61223-3-4:2000
Bench testing was used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance. Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4. All test results were satisfactory. The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31 and the records are available for review.
-
- Software Validation
The DENTIOIII series use original software. The DENTIOIII series contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA guidance: "The content of premarket submissions for software contained in medical devices, on May 11, 2005."
- Software Validation
-
- Biocompatibility
A biocompatibility study is not necessary.
- Biocompatibility
4) SSXI Report
Non-clinical performance was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". Both of the predicate devices and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 6220-1. Base on the Non-clinical test results, even though the used detector differs in term of the pixel size and active area, the diagnostic image quality of the detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
8. Conclusion [21 CFR 807.92(b)(3)]
Based on the comparison of intended use, technological characteristics and performance specifications, the DENTIOIII series is safe and effective and substantially equivalent to the predicate devices.