(267 days)
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray generator to get the image of interests. The unit has to be adjustable depending on height of a patient and PC system to reconstruct an image. Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, or Panorama only system depending on the needs. Digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance (Proposed Device Configuration: RAYSCAN α-OCL & α-OCS) | Predicate Device-1 Performance (RAYSCAN α-Expert [K122918]) | Predicate Device-2 Performance (RAYSCAN α-Expert [K131693]) |
|---|---|---|---|---|
| Detector Type (Ceph, One-shot, Large) | Indirect type (GADOX Scintillator) | GADOX (Indirect type) | N/A | CsI (Indirect type) |
| Total Pixel Area (Ceph, One-shot, Large) | 427(W)x356(H)mm | 427(W)x356(H)mm | Same as Predicate #1 | 43.2 x 36.0 cm |
| Total Pixel (Ceph, One-shot, Large) | 3072x2560 | 3072x2560 | N/A | 2880 x 2400 |
| Pixel Size (Ceph, One-shot, Large) | 139um | 139um | N/A | 150 um |
| Limiting Resolution (Ceph, One-shot, Large) | 3.6lp/mm | 3.6lp/mm | N/A | 3.3 lp/mm |
| MTF (Ceph, One-shot, Large) | 54% at 1LP/mm | 54% at 1LP/mm | N/A | 45% at 1LP/mm |
| DQE (Ceph, One-shot, Large) | 0.2 at 1LP/mm | 0.2 at 1LP/mm | N/A | 0.41 at 1LP/mm |
| Detector Type (Ceph, One-shot, Standard) | Indirect type (GADOX Scintillator) | GADOX (Indirect type) | N/A | N/A |
| Total Pixel Area (Ceph, One-shot, Standard) | 302(W)x249(H)mm | 302(W)x249(H)mm | N/A | N/A |
| Total Pixel (Ceph, One-shot, Standard) | 2176x1792 | 2176x1792 | N/A | N/A |
| Pixel Size (Ceph, One-shot, Standard) | 139um | 139um | N/A | N/A |
| Limiting Resolution (Ceph, One-shot, Standard) | 3.6lp/mm | 3.6lp/mm | N/A | N/A |
| MTF (Ceph, One-shot, Standard) | 54% at 1LP/mm | 54% at 1LP/mm | N/A | N/A |
| DQE (Ceph, One-shot, Standard) | 0.2 at 1LP/mm | 0.2 at 1LP/mm | N/A | N/A |
Note: The document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than explicit numerical acceptance criteria. The "Acceptance Criteria (Implicit)" column is derived from the performance of the predicate devices or the device's own reported values that are compared against. The primary claim of meeting criteria is that the "diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated as a number of patients or images. The document mentions "clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices where the predicate device is installed."
- Data Provenance: The images were gathered "on any protocols with random patient age, gender, and size." The location where images were collected is "the 2 offices where the predicate device is installed," which implies a clinical setting. The country of origin is not explicitly stated, but the manufacturer is based in Korea. The study appears to be prospective in the sense that images were collected from the new devices in a clinical setting to demonstrate performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two licensed practitioners/clinicians.
- Qualifications of Experts: The document states they were "licensed practitioners/clinicians." No further specific qualifications (e.g., years of experience, specialization like radiologist) are provided.
4. Adjudication Method for the Test Set
- Adjudication Method: The document states that the "two licensed practitioners/clinicians observed and verified that dental X ray system from RAYSCAN α" and, as licensed practitioners, their "diagnosis of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests." This suggests an expert consensus/agreement, but no formal adjudication method (like 2+1 or 3+1) is detailed. It implies a qualitative assessment of acceptability rather than a quantitative ground truth measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a formal MRMC comparative effectiveness study demonstrating human reader improvement with AI assistance (vs. without AI) was not explicitly conducted or described. The study focused on demonstrating substantial equivalence of the device's technical specifications and image quality.
6. Standalone (Algorithm Only) Performance Study
- No, a standalone (algorithm only without human-in-the-loop performance) study was not described. The evaluation involved "licensed practitioners/clinicians" observing and verifying the images.
7. Type of Ground Truth Used
- Ground Truth: The "ground truth" for the clinical evaluation was based on expert consensus/clinical diagnosis. The practitioners' "diagnosis of the images" was used to conclude that "the clinical diagnosis and structures are acceptable in the region of interests." There is no mention of pathology or outcomes data being used as ground truth.
8. Sample Size for the Training Set
- The document describes a 510(k) submission for an X-ray imaging device; it does not explicitly refer to an "AI algorithm" with a training set. The device is an image acquisition system. Therefore, the concept of a training set for an AI model is not applicable in this context. The focus is on the performance of the imaging hardware.
9. How the Ground Truth for the Training Set Was Established
- As mentioned above, the device is an X-ray imaging system, not an AI algorithm requiring a training set. Therefore, this question is not applicable to the provided document. The ground truth mentioned in the document pertains to the clinical assessment of the acquired images.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center – WO66-G609 Silver Spring, MD 20993-0002
April 22, 2015
Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405
Re: K142058
Trade/Device Name: RAYSCAN a-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: MUH Dated: March 20, 2015 Received: March 23, 2015
Dear Mr. Paeng:
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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142058
Device Name
RAYSCAN a-Expert
Indications for Use (Describe)
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
| 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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5. 510(K) Summary
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510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
Date:
| APPLICANT | RAY Co.,Ltd |
|---|---|
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,Korea |
| Manufacturer | RAY Co.,Ltd332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,Korea |
| TEL : +82-31-605-1000FAX : +82-2-6280-5534 | |
| Contact Person | Kyungha Seoe-mail : Kyungha.seo@raymedical.co.kr |
Device Name
Trade/Proprietary Name: RAYSCAN α–Expert Common Name: Dental panoramic and cephalometric X-ray system
Classification
Classification Name: Extraoral source x-ray system Regulatory Number: 21 CFR 872.1800 Product Code: MUH Device Class: II Review Panel: Radiology
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| Parameter | Predicated Device-1 | Predicated Device-2 |
|---|---|---|
| Device Name | RAYSCAN α-Expert | RAYSCAN α-Expert |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
| 510(K) Number | K122918Traditional 510k | K131693Special 510k |
| Classification name | Extraoral source x-ray system | Extraoral source x-ray system |
| Regulation number | 872.1800 | 872.1800 |
| Primary product code | MUH | MUH |
Predicate device
Description
RAYSCAN α-OC, SC, OCS, and OCL are designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam.
And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head.
RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.
Detector Options:
Specific models according to the detector type; Pano and Ceph mounted in the RAYSCAN α- Expert system are classified as shown below.
RAYSCAN α-P: PANO(model-C10500D) RAYSCAN α-SC: PANO(model-C10500D)+Scan Ceph(model-XID-C24DS) RAYSCAN α-ΟCL: PANO(model-C10500D)+One shot ceph(model-PaxScan 4336X) RAYSCAN α-ΟCS: PANO(model-C10500D)+One shot ceph(model-PaxScan 2530C)
Non-clinical & clinical consideration report for all types of Detectors included in the Ray Co.,Ltd Page 3 of 17
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RAYSCAN α- Expert system are prepared in compliance with 21CFR807.92(a)(7) of the FDA.
The Detector model mounted in our Dental X-ray system RAYSCAN α-OCL [One shot Ceph] is the PaxScan 4336X model. The Non-clinical report provided by Varian, manufacturer of the Detector, was submitted in place of the Non-clinical report regarding the Solid state Detectors required by FDA.
The Non-clinical report provided by the manufacturer Varian includes and describes the Non-Clinical Data for both models PaxScan 4336W and PaxScan 4336WX.
In particular the PaxScan 4336W model includes a wireless detector function however PaxScan 4336X, the detector mounted in our RAYSCAN α-OCL [One shot Ceph] system is a detector without the wireless function, therefore the data for wireless function is not attached.
SMARTDent software for processing and archiving is optional.
Indication for use
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.
Caution: Federal law restricts this device to sale by or on the order of a dentist.
Patient population
The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure.
There is no restriction for ethnic group, Gender, weight, health, or condition.
We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.
Device functions
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The purpose of this unit is diagnose clinical structures of a tooth and head areas mainly by using the characteristics of permeability from X-ray. The principle of functioning and formations are as following. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also, an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable depending on height of a patient and PC system to reconstruct an image
The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray generator to get the image of interests. The purpose of this mechanism is to provide the images as preferred to diagnose in a monitor.
Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, or Panorama only system depending on the needs. To provide the features as mentioned above, digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials.
Operating principle of the detector
X-ray data entered into the detector from an outside source is converted to visible ray by detector's Scintillator and The visible ray is transferred to CMOS ASIC and converted to an Electric signal to form an image signal.
Then the signal is changed to a Digital form and through the high speed LAN cable, the acquired image data is transmitted to the PC.
Acquired resulting image is displayed on the monitor by the PC Software.
Comparison of the detector
One shot ceph detector installed on the One shot ceph option RAYSCAN α-OC in Predicate devices RAYSCAN α-Expert[K122918, Traditional] and RAYSCAN α-Expert[K131693, special] is SDX-4336CP (model name).
Whereas the One shot Ceph type mounted in the proposed RAYSCAN α-Expert [K142058, Traditional] offers 2 models depending on the detector size.
In RAYSCAN α-OCL, PaxScan 4336X(size: 42.4cm*35.3cm) detector is mounted and in
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RAYSCAN α-OCS, PaxScan 2530C(24.9cm*30.2cm) detector is installed.
Meaning if One shot Ceph option is limited to RAYSCAN α-OC in the predicate devices RAYSCAN α–Expert [K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] then
The One shot Ceph option for the proposed device RAYSCAN α-Expert[K142058, Traditional] offers 2 models RAYSCAN α-OCL and RAYSCAN α-OCS according to the detector size.
The detector installed in the Predicate device RAYSCAN α-OC and Proposed devices RAYSCAN α-OCL and RAYSCAN α-OCS presents no differences in the technical principle and characteristics and only the manufacturer of the detector and part of the specification were changed.
Differences in the detector SDX-4336CP installed in RAYSCAN α-OC of the Predicate device and detectors PaxScan 4336X and PaxScan 2530C mounted in the Proposed device models RAYSCAN α-OCL and RAYSCAN α-OCS are shown in the following table.
The detector for 2 newly added models RAYSCAN α-OCL(PaxScan 4336X) and RAYSCAN α-OCS(PaxScan 2530C) share the same manufacturer as well as the same technical characteristics, only difference in the detector is its size. Detector in the RAYSCAN α-OCL(PaxScan 4336X) has the size 42.4 (V)cm x 35.3 (H) cm and size of the detector in RAYSCAN α-M3DS is 24.9(V)cm x 30.2(H)cm.
In addition, among the detector option of the RAYSCAN α-Expert3D included in RAYSCAN α-Expert 3D[K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] of the Predicate device, basic(RAYSCAN α-P) and scan type(RAYSCAN α-SC) are completely identical.
| Division | Proposed Device | Predicate Device#1 | Predicate Device#2 | |
|---|---|---|---|---|
| RAYSCAN α-Expert | RAYSCAN α-Expert | RAYSCAN α-Expert | ||
| K142058 | K122918 | K131693 | ||
| RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | ||
| Traditional | Traditional | Special | ||
| PANOdetector | Manufacturer | Hamamatsu | ||
| Model | C10500D | |||
| ScintillatorMaterial | Same as predicatedevice #1 | CsI (Indirect type) | Same as predicatedevice #1 | |
| Total pixel area | 6.0(W)x1512(H)mm | |||
| Total pixel | 60x1512 | |||
| Pixel size | 100um | |||
| Limiting resolution | 5.0lp/mm | |||
| Powersupply/Main | 5VDC / 1100mA | |||
| MTF | 70% at 1LP/mm | |||
| DQE | 0.5 at 1LP/mm | |||
| Manufacturer | N/A(No attached ScanCeph) | i3System | ||
| Model | XID-C24DS | |||
| ScintillatorMaterial | CdTe (Direct type) | |||
| Total pixel area | 4.8(W)x240(H)mm | |||
| Ceph(Scan)detector | Total pixel | Same as predicatedevice #2 | 48x2400 | |
| Pixel size | 100um | |||
| Limiting resolution | 5.0lp/mm | |||
| Powersupply/Main | 5VDC / 2A | |||
| MTF | 75% at 1LP/mm | |||
| DQE | 0.88 at 1LP/mm | |||
| Manufacturer | Varian | Samsung MobileDisplay | ||
| Model | PaxScan 4336X | SDX-4336CP | ||
| ScintillatorMaterial | GADOX (Indirecttype) | CsI (Indirect type) | ||
| Ceph(Oneshot,LargeSize)detector | Total pixel area | 427(W)x356(H)mm | Same as predicatedevice #1 | 43.2 x 36.0 cm |
| Total pixel | 3072x2560 | 2880 x 2400 | ||
| Pixel size | 139um | 150 um | ||
| Limiting resolution | 3.6lp/mm | 3.3 lp/mm | ||
| Powersupply/Main | 100-240VAC, 47-63Hz | 100-240VAC,50/60Hz | ||
| MTF | 54% at 1LP/mm | 45% at 1LP/mm | ||
| DQE | 0.2 at 1LP/mm | 0.41 at 1P/mm | ||
| Manufacturer | Varian | N/A(No attached one shotCEPH.) | N/A(No attached oneshot CEPH.) | |
| Model | PaxScan 2530C | |||
| ScintillatorMaterial | GADOX (Indirecttype) | |||
| Ceph(Oneshot,StandardSize)detector | Total pixel area | 302(W)x249(H)mm | ||
| Total pixel | 2176x1792 | |||
| Pixel size | 139um | |||
| Limiting resolution | 3.6lp/mm | |||
| Powersupply/Main | 100-240VAC, 47-63Hz | |||
| MTF | 54% at 1LP/mm | |||
| DQE | 0.2 at 1LP/mm |
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| Division | Model | Manufacturer | Own 510(K)number | System in which it was cleared510(k) number. |
|---|---|---|---|---|
| Pano | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K122981 |
| Scan Ceph | XID-C24DS | i3System | No | 1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K131695 |
| One shot Ceph | PaxScan4336X | Varian | No | 1) System name: Multix Fusion2) Manufacturer: Siemens3) 510(K) Number: K121513 |
| One shot Ceph | PaxScan2530C | Varian | No | 1) System name: Unknown2) Manufacturer: Unknown3) 510(K) Number: Unknown |
Information for detector own 510(K) number or system in which it was cleared 510(K) number.
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Statement of Substantial Equivalence
| Parameter | Proposed Device | Predicated Device | Predicated Device | |
|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | |
| Device name | RAYSCAN α-Expert | RAYSCAN α-Expert | RAYSCANα-Expert | |
| 510(K)Number | K142058Traditional 510k | K122918Traditional 510k | K131693Special 510k | |
| CommonName | Dental panoramic andcephalometric X-ray system | Dental panoramic andcephalometric X-ray system | Dental panoramic andcephalometric X-ray system | |
| Indicationsfor use | The RAYSCAN α- Expert Dental X-Ray System is anextraoral source dental panoramic and optionalcephalometric X-ray system intended to produce X-rays fordental radiographic examination anddiagnosis of diseases of the teeth, jaw, and oralstructures. | The RAYSCAN α- Expert Dental X-Ray System is anextraoral source dental panoramic and optionalcephalometric X-ray system intended to produce X-rays for dental radiographic examination anddiagnosis of diseases of the teeth, jaw, and oralstructures. | The RAYSCAN α- Expert Dental X-Ray System is anextraoral source dental panoramic and optionalcephalometric X-ray system intended to produce X-rays for dental radiographic examination anddiagnosis of diseases of the teeth, jaw, and oralstructures. | |
| Mode ofOperation | Continuous operation withintermittent, stated permissibleloading | Continuous operation withintermittent, stated permissibleloading | Continuous operation withintermittent, stated permissibleloading | |
| PerformanceSpecification | 1) Panoramic2) Cephalometric(optional)- One shot type- Scan type | 1) Panoramic2) Cephalometric(optional)- One shot type | 1) Panoramic2) Cephalometric(optional)- One shot type- Scan type | |
| FunctionalOption | BaseRAYSCAN α-P :PANOOption(CEPH)RAYSCAN α-SC:PANO + SCAN CEPHRAYSCAN α-OCS:PANO + One shot(9.8 X 11.9 inch)RAYSCAN α-OCL:PANO + One shot(16.8 X 14.0 inch) | BaseRAYSCAN α-P :PANOOption(CEPH)RAYSCAN α-OC:PANO + One shot | BaseRAYSCAN α-P :PANOOption(CEPH)RAYSCAN α-SC:PANO + SCAN CEPHRAYSCAN α-OC:PANO + One shot | |
| Exam | PANO | Standard(Normal)TMJSinusSegmentation (Individual Tooth)BitewingOrthogonal | Standard (Normal)TMJSinus | Standard(Normal)TMJSinusSegmentation (Individual Tooth)BitewingOrthogonal |
| mode | Ceph(Optional) | Posterior/AnteriorLateralSMVCarpusReverse Town'sWatersLateral wide | Posterior/AnteriorLateralSMVCarpusReverse Town'sWaters | Posterior/AnteriorLateralSMVCarpusReverse Town'sWatersLateral wide |
| 1) Pano: | 1) Pano: | 1) Pano: | ||
| Flat panel X-ray sensor | Flat panel X-ray sensor | Flat panel X-ray sensor | ||
| DetectorType | 2) Ceph(Option):- Scan type: CdTe Direct flat panel sensor- One shot type: Amorphous Silicon | 2) Ceph(Option):- One shot type: Flat panel X-ray sensor | 2) Ceph(Option):- Scan type: CdTe Direct flat panel sensor- One shot type: Flat panel X-ray sensor | |
| ExposureswitchType | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | |
| Ceph Apparatus | Ceph Apparatus | Ceph Apparatus | ||
| Vertical Carriage | Vertical Carriage | Vertical Carriage | ||
| Rotator | Rotator | Rotator | ||
| MainComponents | X-RAY Generator | X-RAY Generator | X-RAY Generator | |
| X-ray tube | X-ray tube | X-ray tube | ||
| High Frequency Generator | High Frequency Generator | High Frequency Generator | ||
| Column | Column | Column | ||
| Touch monitor (panel) | Touch monitor (panel) | Touch monitor (panel) | ||
| Detector | Detector | Detector | ||
| - Panoramic | - Panoramic | - Panoramic | ||
| - Scan type Cephalometric | - One shot type Cephalometric | - Scan type Cephalometric | ||
| - One shot type Cephalometric: | - One shot type Cephalometric | |||
| 24.9(V) x 30.2(H) cm | ||||
| One shot type Cephalometric: | ||||
| 42.4 (V) x 35.3 (H) cm | ||||
| Chinrest | Chinrest | Chinrest | ||
| Head rest | Head rest | Head rest | ||
| Automatic Collimator | Automatic Collimator | Automatic Collimator | ||
| Exposure switch | Exposure switch | Exposure switch | ||
| Emergency stop switch | Emergency stop switch | Emergency stop switch | ||
| Console PC set | Console PC set | Console PC set | ||
| Automatic | Panoramic exams | Panoramic exams | Panoramic exams | |
| Collimator | Cephalometric exams | Cephalometric exams | Cephalometric exams | |
| Display Type | TFT LCD type(Normally black) | TFT LCD type(Normally black) | TFT LCD type(Normally black) | |
| *1280x800 pixel | *1280x800 pixel | *1280x800 pixel | ||
| Class I with type B applied parts | Class I with type B applied parts | Class I with type B applied parts | ||
| Class | according to IEC 60601-1 | according to IEC 60601-1 | according to IEC 60601-1 | |
| Focal size | 0.5 | 0.5 | 0:5 | |
| Field ofView(CT) | 90x90mm | 90x90mm | 90x90mm | |
| X-ray Voltage | 60~90kVp | 60~90kVp | 60~90kVp | |
| X-ray Current | 4~17mA | 4~17mA | 4~17mA | |
| TotalFiltration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | 2.6 mm Al equivalent | |
| Detector Pixelsize | Pano: 100 μm | Pano: 100 μm | Pano: 100 μm | |
| Ceph[Scan type]: 100 μm | Ceph[One shot type]: 150 μm | Ceph[One shot type]: 150 μm | ||
| Ceph[One shot type, installed in α-M3DS]: 139 μm | ||||
| Ceph[One shot type, installed in α-M3DL]: 139 μm | ||||
| Magnification | Pano : 1.31 | Pano : 1.31 | Pano : 1.31 | |
| Ceph[Scan type] : 1.11 | Ceph[Scan type]: 1.11 | |||
| Ceph[One shot type, α-M3DS] : 1.12 | Ceph[One shot type, α-Multi3D]:: 1.13 | Ceph[One shot type, α-Multi3D]:: 1.13 | ||
| Ceph[One shot type, α-M3DL] : 1.13 | ||||
| Scan time | Pano : below 14sec | Pano : below 14sec | Pano : below 14sec | |
| Ceph[Scan type] : below 18secCeph[One shot type, α-M3DS]:below 2secCeph[One shot type, α-M3DL]:below 2sec | Ceph[One shot type, α-Multi3D]:0.3sec~3.0sec | Ceph[Scan type] : below 18secCeph[One shot type, α-Multi3D]:0.3sec~3.0sec | ||
| Formatcompatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| Imageacquisition | Giga-Ethernet Network | Giga-Ethernet Network | Giga-Ethernet Network | |
| Total Height | Max 2,296mm | Max 2,296mm | Max 2,296mm | |
| 1) Panoramic(PANO)=148kg(326lb) ± 10% | 1) Panoramic(PANO)=148kg(326lb) ± 10% | 1) Panoramic(PANO)=148kg(326lb) ± 10% | ||
| 2) Panoramic(PANO) + Cephalostic (Scan type) =164kg (362lb) ± 10% | 2) Panoramic(PANO) + Cephalostic (One shottype)=165kg(364lb) ± 10% | 2) Panoramic(PANO) + Cephalostic (Scantype)=164kg (362lb) ± 10% | ||
| Weight | 3) Panoramic(PANO) + Cephalostic (One shot type,installed in α-M3DS)= 166kg (366lb) ± 10%4) Panoramic(PANO) + Cephalostic (One shot type,installed in α-M3DL)= 166kg (366lb) ± 10% | 3) Panoramic(PANO) + Cephalostic (One shottype)=165kg(364lb) ± 10% | ||
| Type ofinstallation | Wall or floor mount | Wall or floor mount | Wall or floor mount | |
| Patientposition | Standing / Wheelchair | Standing / Wheelchair | Standing / Wheelchair |
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| ApplicableStandards | ||
|---|---|---|
| IEC 60601-1IEC 60601-1-3IEC 60601-2-28IEC 60601-2-63IEC 60601-1-2 | IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-2-44IEC 60601-1-2 | IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-2-44IEC 60601-1-2 |
| CertificateProduct | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) |
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Safety and Effectiveness Information
Electrical, mechanical and environmental safety testing according to standard of
IEC 60601-1: 2005 + CORR.1(2006) + CORR.2(2007), IEC 60601-1-3: 2008(Second Edition), IEC 60601-2-28: 2010(Second Edition) and IEC 60601-2-63: 2012(first Edition) were performed.
EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2007(Edition 3.0).
The software of RAYSCAN α-Expert3D has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the quidance document.
Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing – Bench"
Bench testing is 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 and IEC 61223-3-5.
All test results were satisfactory.
Non-clinical and test 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 Xray Imaging Devices".
All test results were satisfactory.
Both of the predicate device and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DOE (Detective Quantum Efficiency) were test and measured by IEC 62220-1.
RAYSCAN α-OCL and RAYSCAN α-OCS system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF) and Device Quantum Efficiency (DQE). Base on the Non-clinical test result, even though the new Csi detector differs in term of the pixel size and active area, the diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.
Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".
Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in
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addition to the laboratory performance data to show that the complete system works as intended.
For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RAYSCAN α.
The clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-OCL and OCS on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.
Conclusions
Based on a comparison of intended use, indications, constructions, construction materials, principal of Operation, features and technical data, the RAYSCAN α–Expert system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device.
§ 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.