(262 days)
No
The summary describes a standard dental X-ray imaging system and its components, focusing on image acquisition and reconstruction techniques. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an imaging system designed for various dental radiographic examinations and 3D imaging, not for treating conditions.
Yes.
The "Intended Use / Indications for Use" section states that the device is "intended for dental radiographic examination of the teeth, jaw, and oral structures," and generates images for "diagnostic radiation exposure." The device collects data to be viewed, which aids in making a diagnosis.
No
The device description clearly outlines hardware components including an x-ray tube, detector, and c-arm, indicating it is a physical imaging system, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The RAYSCAN a-Expert 3D system is an extraoral x-ray imaging system. It uses x-rays to create images of the teeth, jaw, and oral structures directly on the patient's body.
- No Specimen Analysis: The description clearly states that the device projects an x-ray beam onto a detector and reconstructs images from this data. There is no mention of collecting or analyzing biological specimens.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.
The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
2D Image is obtained using the standard narrow beam technique.
Product codes
OAS
Device Description
RAYSCAN a-Expert 3D is a panoramic x-ray imaging system with cephalostat. It is an extraoral source x-ray system. The system's purpose is for 3D computed tomography scanning of hard tissues like bone and teeth. It functions by rotating a c-arm with an all-in-one x-ray tube and detector on each end. It attains a fault surface image of the whole body by recombining data from the same level scanned from different angles. It includes a panoramic image scanning function for imaging whole teeth and a cephalometric scanning option for obtaining cephalic images.
The system offers different models based on the detector type for CT, Pano, and Ceph:
- RAYSCAN α-3D: CT (model-C10900D) + PANO (model-C10500D)
- RAYSCAN α-SM3D: CT (model-C10900D) + PANO (model-C10500D) + Scan Ceph (model-XID-C24DS)
- RAYSCAN α-M3DL: CT (model-C10900D) + PANO (model-C10500D) + One shot ceph (model-PaxScan 4336X)
- RAYSCAN α-M3DS: CT (model-C10900D) + PANO (model-C10500D) + One shot ceph (model-PaxScan 2530C)
The device uses a cone-shaped x-ray beam projected onto a flat panel detector, and the examined volume image is reconstructed for 3D viewing. 2D images are obtained using a standard narrow beam technique.
The main components include: Ceph Apparatus, Vertical Carriage, Rotator, X-RAY Generator, X-ray tube, High Frequency Generator, Column, Touch monitor (panel), Detector (CT, Panoramic, Scan 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, Head rest, Automatic Collimator, Exposure switch, Emergency stop switch, and Console PC set.
Mentions image processing
Acquired resulting image is displayed on the monitor by the PC Software.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures, dento-maxillo-facial, TMJ, head areas
Indicated Patient Age Range
We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.
Intended User / Care Setting
Dentist. Care setting can be inferred to be a dental office or clinic.
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
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.
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-M3DL and M3DS on any protocols with random patient age, gender, and size.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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-M3DL and RAYSCAN α-M3DS 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 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-M3DL and M3DS 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2015
Ray Co., Ltd. % Mr. Andrew Paeng, Consultant 4747 Hoen Ave Santa Rosa. CA 95405
Re: K142247
Trade/Device Name: RAYSCAN a-Expert 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS 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.
1
Page 2 - Mr. Paeng
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K142247
Device Name
RAYSCAN a-Expert3D
Indications for Use (Describe)
RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.
The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.
2D Image is obtained using the standard narrow beam technique.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
5. 510(K) Summary
4
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.,Ltd |
| 332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, | |
| Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | Kyungha Seo |
| e-mail : Kyungha.seo@raymedical.co.kr |
Device Name
Trade/Proprietary Name: RAYSCAN α-Expert 3D Common Name: Dental panoramic/tomography and cephalometric x-ray system
Classification
Classification Name: Computed tomography x-ray system (21 CFR 892.1750) Class : II Product code : OAS Panel : Radiology
5
| Parameter | Predicated Device-1 | Predicated Device-2 |
|---|---|---|
| Device Name | RAYSCAN α-Expert3D | RAYSCAN α-Expert3D |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
| 510(K) Number | K122981 | |
| Traditional 510k | K131695 | |
| Special 510k | ||
| Classification name | Computed tomography x-ray | |
| system | Computed tomography x-ray | |
| system | ||
| Regulation number | 892.1750 | 892.1750 |
| Primary product code | OAS | OAS |
Predicate device
Description
System purpose RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth.
By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, fault surface image of whole body is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning option for attaining cephalic image are included.
Detector Options:
Specific models according to the detector type; CT, Pano and Ceph mounted in the RAYSCAN α- Expert 3D system are classified as shown below.
RAYSCAN α-3D: CT(model-C10900D)+PANO(model-C10500D) RAYSCAN α-SM3D: CT(model-C10900D)+PANO(model-C10500D)+ Scan Ceph(model-XID-C24DS) RAYSCAN α-M3DL: CT(model-C10900D)+PANO(model-C10500D)+ One shot ceph(model-PaxScan 4336X) RAYSCAN α-M3DS: CT(model-C10900D)+PANO(model-C10500D) + One shot ceph(model-PaxScan 2530C)
6
Non-clinical & clinical consideration report for all types of Detectors included in the RAYSCAN α- Expert3D 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-M3DL [One shot Ceph] is the PaxSca 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-M3DL [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
RAYSCAN α-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento-maxillo-facial 3D images.
The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.
"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.
7
Device functions
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 in 2D or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, 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-Multi3D in Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α
8
Expert3D[K131695, special] is SDX-4336CP (model name).
Whereas the One shot Ceph type mounted in the proposed RAYSCAN α-Expert 3D[K142247, Traditional] offers 2 models depending on the detector size.
In RAYSCAN α-M3DL, PaxScan 4336X(size: 42.4cm35.3cm) detector is mounted and in RAYSCAN α-M3DS, PaxScan 2530C(24.9cm30.2cm) detector is installed.
Meaning if One shot Ceph option is limited to RAYSCAN α-Multi3D in the predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K131695, special] then
The One shot Ceph option for the proposed device RAYSCAN α-Expert 3D[K142247, Traditional] offers 2 models RAYSCAN α-M3DL and RAYSCAN α-M3DS according to the detector size.
The detector installed in the Predicate device RAYSCAN α-Multi3D and Proposed devices RAYSCAN α-M3DL and RAYSCAN α-M3DS 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-Multi3D of the Predicate device and detectors PaxScan 4336X and PaxScan 2530C mounted in the Proposed device models RAYSCAN α-M3DL and RAYSCAN α-M3DS are shown in the following table.
The detector for 2 newly added models RAYSCAN α-M3DL(PaxScan 4336X) and RAYSCAN α-M3DS(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-M3DL(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[K122981, Traditional] and RAYSCAN α-Expert3D[K131695, special] of the Predicate device, basic(RAYSCAN α-3D) and scan type(RAYSCAN α-SM3D) are completely identical.
| Division | Proposed Device | Predicate Device #1 | Predicate Device #2 | |
|---|---|---|---|---|
| RAYSCAN α- | ||||
| Expert3D | RAYSCAN α-Expert3D | RAYSCAN α-Expert3D | ||
| K142247 | K122981 | K131695 | ||
| RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | ||
| Traditional | Traditional | Special | ||
| CT | ||||
| detector | Manufacturer | Same as predicate | ||
| device #1 | Hamamatsu | Same as predicate | ||
| device #1 | ||||
| Model | C10900D |
9
| Scintillator Material | CsI (Indirect type) | ||||
|---|---|---|---|---|---|
| Total pixel area | 124.8(W)x124.8(H)mm | ||||
| Total pixel | 624x624 | ||||
| Pixel size | 200um | ||||
| Limiting resolution | 2.5lp/mm | ||||
| Power supply/Main | 5VDC / 1250mA | ||||
| MTF | 60% at 1 LP/mm | ||||
| DQE | 0.23 at 1 LP/mm | ||||
| VOXEL | |||||
| (at Jaw protocol) | 280μm | ||||
| Manufacturer | Hamamatsu | ||||
| Model | Same as predicate | ||||
| device #1 | C10500D | ||||
| PANO | |||||
| detector | Scintillator Material | CsI (Indirect type) | |||
| Total pixel area | 6.0(W)x1512(H)mm | Same as predicate | |||
| device #1 | |||||
| Total pixel | 60x1512 | ||||
| Pixel size | 100um | ||||
| Limiting resolution | 5.0lp/mm | ||||
| Power supply/Main | 5VDC / 1100mA | ||||
| MTF | 70% at 1LP/mm | ||||
| DQE | 0.5 at 1LP/mm | ||||
| Manufacturer | N/A | ||||
| (No attached Scan | |||||
| Ceph) | i3System | ||||
| Model | XID-C24DS | ||||
| Scintillator Material | CdTe (Direct type) | ||||
| Ceph | |||||
| (Scan) | |||||
| detector | Total pixel area | Same as | |||
| predicate | |||||
| device #2 | 4.8(W)x240(H)mm | ||||
| Total pixel | 48x2400 | ||||
| Pixel size | 100um | ||||
| Limiting resolution | 5.0lp/mm | ||||
| Power supply/Main | 5VDC / 2A | ||||
| MTF | 75% at 1LP/mm | ||||
| DQE | 0.88 at 1LP/mm | ||||
| Ceph | |||||
| (One | |||||
| shot, | |||||
| Large | |||||
| Size) | |||||
| detector | Manufacturer | Varian | Samsung Mobile Display | ||
| Model | PaxScan 4336X | SDX-4336CP | |||
| Scintillator Material | GADOX (Indirect type) | CsI (Indirect type) | |||
| Total pixel area | 427(W)x356(H)mm | 43.2 x 36.0 cm | |||
| Total pixel | 3072x2560 | Same as predicate device #1 | 2880 x 2400 | ||
| Pixel size | 139um | 150 um | |||
| Limiting resolution | 3.6lp/mm | 3.3 lp/mm | |||
| Power supply/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 | ||||
| Model | PaxScan 2530C | ||||
| Ceph | |||||
| (One | |||||
| shot, | |||||
| Standard | |||||
| Size) | |||||
| detector | Scintillator Material | GADOX (Indirect type) | N/A | ||
| (No attached one shot CEPH.) | |||||
| Total pixel area | 302(W)x249(H)mm | ||||
| Total pixel | 2176x1792 | N/A | |||
| (No attached one shot СЕРН.) | |||||
| Pixel size | 139um | ||||
| Limiting resolution | 3.6lp/mm | ||||
| Power supply/Main | 100-240VAC, 47-63Hz | ||||
| MTF | 54% at 1LP/mm | ||||
| DQE | 0.2 at 1LP/mm |
10
Information for detector own 510(K) number or system in which it was cleared 510(K) number.
| Division | Model | Manufacturer | Own 510(k) number | System in which it was cleared
510(k) number. |
|----------|-------|--------------|-------------------|--------------------------------------------------|
| | | | | |
11
| CT | C10900D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D
2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K122981 |
|---------------|------------------|-----------|----|--------------------------------------------------------------------------------------------------|
| Pano | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D
2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K122981 |
| Scan Ceph | XID-C24DS | i3System | No | 1) System name: RAYSCAN α-Expert3D
2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K131695 |
| One shot Ceph | PaxScan
4336X | Varian | No | 1) System name: Multix Fusion
2) Manufacturer: Siemens
3) 510(K) Number: K121513 |
| One shot Ceph | PaxScan
2530C | Varian | No | 1) System name: Unknown
2) Manufacturer: Unknown
3) 510(K) Number: Unknown |
12
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-Expert3D | RAYSCAN α-Expert3D | RAYSCANα-Expert3D |
| 510(K) | |||
| Number | K142247 | ||
| Traditional 510k | K122981 | ||
| Traditional 510k | K131695 | ||
| Special 510k | |||
| Common | |||
| Name | Dental panoramic/tomography and | ||
| cephalometric x-ray system | Dental panoramic/tomography and | ||
| cephalometric x-ray system | Dental panoramic/tomography and | ||
| cephalometric x-ray system | |||
| Indications | |||
| for use | RAYSCAN α-Expert 3D panoramic x-ray | ||
| imaging system with cephalostat, is an | |||
| extraoral source x-ray system, which is | |||
| intended for dental radiographic examination of the | |||
| teeth, jaw, and oral structures, specifically for | |||
| panoramic examinations and implantology and for | |||
| TMJ studies and cephalometry, and it has the | |||
| capability, using the CBVT technique, to generate | |||
| dento-maxillo-facial 3D images. | |||
| The device uses cone shaped x-ray beam projected | |||
| on to a flat panel detector, and the examined volume | |||
| image is reconstructed to be viewed in 3D viewing | |||
| stations. | |||
| 2D Images are obtained using the | |||
| standard narrow beam technique. | RAYSCAN α-Expert 3D, panoramic x-ray imaging | ||
| system with cephalo Traditional 510k stat, is an | |||
| extraoral source x-ray system, which is intended for | |||
| dental radiographic examination of the teeth, jaw, | |||
| and oral | |||
| structures, specifically for panoramic examinations | |||
| and implantology and for TMJ studies and | |||
| cephalometry, and it has the capability, using the | |||
| CBVT technique, to generate dento-maxillo-facial 3D | |||
| images. | |||
| The device uses cone shaped x-ray beam projected | |||
| on to a flat panel detector, and the examined volume | |||
| image is reconstructed to be viewed in 3D viewing | |||
| stations.2D Images are obtained using the standard | |||
| narrow beam technique. | RAYSCAN α-Expert 3D panoramic x-ray | ||
| imaging system with cephalostat, is an | |||
| extraoral source x-ray system, which is | |||
| intended for dental radiographic examination of the | |||
| teeth, jaw, and oral structures, specifically for | |||
| panoramic examinations and implantology and for | |||
| TMJ studies and cephalometry, and it has the | |||
| capability, using the CBVT technique, to generate | |||
| dento-maxillo-facial 3D images. | |||
| The device uses cone shaped x-ray beam | |||
| projected on to a flat panel detector, and | |||
| the examined volume image is reconstructed to be | |||
| viewed in 3D viewing stations. | |||
| 2D Images are obtained using the | |||
| standard narrow beam technique. | |||
| Mode of | |||
| Operation | Continuous operation with | ||
| intermittent, stated permissible | |||
| loading | Continuous operation with | ||
| intermittent, stated permissible | |||
| loading | Continuous operation with | ||
| intermittent, stated permissible | |||
| loading | |||
| 3D | |||
| technology | CBCT Cone beam | ||
| Computed Tomography | CBCT Cone beam | ||
| Computed Tomography | CBCT Cone beam | ||
| Computed Tomography | |||
| Performance | |||
| Specification | 1) CBCT Computed tomography |
- Panoramic
- Cephalometric(optional)
- One shot type
- Scan type | 1) CBCT Computed tomography
- Panoramic
- Cephalometric(optional)
- One shot type | 1) CBCT Computed tomography
- Panoramic
- Cephalometric(optional)
- One shot type
- Scan type |
| Functional
Option | Base
RAYSCAN α-3D :
CT+PANO
Option(CEPH)
RAYSCAN α-SM3D:
CT + PANO + SCAN CEPH
RAYSCAN α-M3DS:
CT + PANO + One shot(9.8 X 11.9 inch)
RAYSCAN α-M3DL:
CT + PANO + One shot(16.8 X 14.0 inch) | Base
RAYSCAN α-3D :
CT+PANO
Option(CEPH)
RAYSCAN α-Multi 3D:
CT + PANO + One shot | Base
RAYSCAN α-3D :
CT+PANO
Option(CEPH)
RAYSCAN α-SM3D:
CT + PANO + SCAN
RAYSCAN α-Multi 3D:
CT + PANO + One shot |
13
14
| Standard | Standard | Standard | ||
|---|---|---|---|---|
| Implant | Implant | Implant | ||
| Surgical guide | Surgical guide | Surgical guide | ||
| CT | Endo | Endo | Endo | |
| Sinus | Sinus | Sinus | ||
| TMJ | TMJ | TMJ | ||
| Standard(Normal) | Normal(Adult) | Standard(Normal) | ||
| TMJ | Pedodontics(Children) | TMJ | ||
| PAN | Sinus | TMJ | Sinus | |
| Exam | O | Segmentation (Individual Tooth) | Sinus | Segmentation (Individual Tooth) |
| mode | Bitewing | Bitewing | ||
| Orthogonal | Orthogonal | |||
| Posterior/Anterior | PA,AP | Posterior/Anterior | ||
| Lateral | Lateral | Lateral | ||
| Ceph | SMV | SMV | SMV | |
| (Opti | Carpus | Carpus | Carpus | |
| onal) | Reverse Town's | Reverse Town's | Reverse Town's | |
| Waters | Waters | Waters | ||
| Lateral wide | Lateral wide | |||
| 1) Computed Tomography(CT) : | 1) Computed Tomography(CT) : | 1) Computed Tomography(CT) : | ||
| Detector | Flat panel X-ray sensor | Flat panel X-ray sensor | Flat panel X-ray sensor | |
| 2) Pano: | 2) Pano: | 2) Pano: | ||
| Flat panel X-ray sensor | Flat panel X-ray sensor | Flat panel X-ray sensor | ||
| Type | 3) Ceph(Option): | 3) Ceph(Option): | 3) Ceph(Option): | |
| - Scan type: CdTe Direct flat panel sensor | - One shot type: Flat panel X-ray sensor | - Scan type: CdTe Direct flat panel sensor | ||
| - One shot type: Amorphous Silicon | - One shot type: Flat panel X-ray sensor |
15
| Exposure
switch
| Type | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type |
|---|---|---|---|
| Main | |||
| Components | Ceph Apparatus | Ceph Apparatus | Ceph Apparatus |
| Vertical Carriage | Vertical Carriage | Vertical Carriage | |
| Rotator | Rotator | Rotator | |
| 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 |
- CT
- Panoramic
- Scan 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 | Detector - CT
- Panoramic
- One shot type Cephalometric | Detector
- CT
- Panoramic
- Scan type Cephalometric
- One shot type Cephalometric |
| | Chinrest | Chinrest | Chinrest |
16
| 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 | |||
| Collimator | CT exams | ||
| Panoramic exams | |||
| Cephalometric exams | CT exams | ||
| Panoramic exams | |||
| Cephalometric exams | CT exams | ||
| Panoramic exams | |||
| Cephalometric exams | |||
| Display Type | TFT LCD type(Normally black) | ||
| *1280x800 pixel | TFT LCD type(Normally black) | ||
| *1280x800 pixel | TFT LCD type(Normally black) | ||
| *1280x800 pixel | |||
| Class | Class I with type B applied parts | ||
| according to IEC 60601-1 | Class I with type B applied parts | ||
| according to IEC 60601-1 | Class I with type B applied parts | ||
| according to IEC 60601-1 | |||
| Focal size | 0:5 | 0:5 | 0:5 |
| Field of | |||
| View(CT) | 90x90mm | 90x90mm | 90x90mm |
| X-ray Voltage | 60~90kVp | 60~90kVp | 60~90kVp |
| X-ray Current | 4~17mA | 4~17mA | 4~17mA |
| Total | |||
| Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | 2.6 mm Al equivalent |
| Detector Pixel | |||
| size | Computed Tomography(CT): 200 μm | Computed Tomography(CT): 100 μm | Computed Tomography(CT): 100 μm |
| Pano: 100 μm | Pano: 100 μm | Pano: 100 μm | |
| Ceph[Scan type]: 100 μm | Ceph[Scan type]: 100 μm | Ceph[Scan type]: 100 μm | |
| Ceph[One shot type, installed in α-M3DS]: 139 μm | Ceph[One shot type]: 150 μm | Ceph[One shot type]: 150 μm | |
| Ceph[One shot type, installed in α-M3DL]: 139 μm | |||
| Magnification | CT : 1.39 | CT : 1.39 | CT : 1.39 |
| 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 | CT : below 14sec | CT : below 14sec | CT : below 14sec |
| Pano : below 14sec | Pano : below 14sec | Pano : below 14sec | |
| Ceph[Scan type] : below 18sec | Ceph[Scan type] : below 18sec | ||
| Ceph[One shot type, α-M3DS]: | Ceph[One shot type, α-Multi3D]: | Ceph[One shot type, α-Multi3D]: | |
| below 2sec | 0.3sec~3.0sec | 0.3sec~3.0sec | |
| Ceph[One shot type, α-M3DL]: | |||
| below 2sec | |||
| Format | |||
| compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible |
| Image | |||
| acquisition | Giga-Ethernet Network | Giga-Ethernet Network | Giga-Ethernet Network |
| Total Height | Max 2,296mm | Max 2,296mm | Max 2,296mm |
| Weight | 1) Computed Tomography(CT) + | ||
| Panoramic(PANO)=148kg(326lb) ± 10% | 1) Computed Tomography(CT) + | ||
| Panoramic(PANO)=148kg(326lb) ± 10% | 1) Computed Tomography(CT) + | ||
| Panoramic(PANO)=148kg(326lb) ± 10% | |||
| 2) Computed Tomography(CT) + Panoramic(PANO) + | |||
| Cephalostic (Scan type)= 164kg (362lb) ± 10% | 2) Computed Tomography(CT) + Panoramic(PANO) + | ||
| Cephalostic (One shot type)=165kg(364lb) ± 10% | 2) Computed Tomography(CT) + Panoramic(PANO) + | ||
| Cephalostic (Scan type)=164kg (362lb) ± 10% | |||
| 3) Computed Tomography(CT) + Panoramic(PANO) |
- Cephalostic (One shot type, installed in α-M3DS)=
166kg (366lb) ± 10% | | 3) Computed Tomography(CT) + Panoramic(PANO) - Cephalostic (One shot type)=165kg(364lb) ± 10% |
| | 4) Computed Tomography(CT) + Panoramic(PANO) - Cephalostic (One shot type, installed in α-M3DL)=
166kg (366lb) ± 10% | | |
| Type of
installation | Wall or floor mount | Wall or floor mount | Wall or floor mount |
17
18
19
| Patient
| position | Standing / Wheelchair | Standing / Wheelchair | Standing / Wheelchair | |
|---|---|---|---|---|
| Applicable | ||||
| Standards | IEC 60601-1 | |||
| IEC 60601-1-3 | ||||
| IEC 60601-2-28 | ||||
| IEC 60601-2-63 | ||||
| IEC 60601-1-2 | IEC 60601-1 | |||
| IEC 60601-1-1 | ||||
| IEC 60601-1-3 | ||||
| IEC 60601-2-7 | ||||
| IEC 60601-2-28 | ||||
| IEC 60601-2-32 | ||||
| IEC 60601-2-44 | ||||
| IEC 60601-1-2 | IEC 60601-1 | |||
| IEC 60601-1-1 | ||||
| IEC 60601-1-3 | ||||
| IEC 60601-2-7 | ||||
| IEC 60601-2-28 | ||||
| IEC 60601-2-32 | ||||
| IEC 60601-2-44 | ||||
| IEC 60601-1-2 | ||||
| Certificate | ||||
| Product | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) |
20
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-M3DL and RAYSCAN α-M3DS 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
Ray Co.,Ltd
21
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-M3DL and M3DS 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.
The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.
Conclusions
Based on a comparison of intended use, indications, constructions, construction materials, principal of Operation, features and technical data, the RAYSCAN α-Expert 3D system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device.