(116 days)
CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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.
RCT700 is 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, CBCT images of dental maxillofacial 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 cephalometric image are included.
Here's an analysis of the acceptance criteria and study details for the RCT700 device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly list specific quantitative "acceptance criteria" in a table format with pass/fail thresholds. Instead, it compares the performance of the proposed device (RCT700) to its predicate devices (RAYSCAN α-Expert3D) based on established imaging quality metrics. The ultimate acceptance criterion communicated is "similar or better than the predicate device."
| Metric / Parameter | Acceptance Criteria (Implicit) | Reported Device Performance (RCT700) |
|---|---|---|
| Imaging Quality - CT | ||
| Pixel Size (SiX 650HD-E) | Similar to predicate (C10900D: 200um) | SiX 650HD-E: 150um (Smaller, indicating potentially higher resolution) |
| Limiting Resolution | Similar or better than predicate (C10900D: 2.5lp/mm) | SiX 650HD-E: 3.3lp/mm (Better) |
| MTF (650HD-E at 1LP/mm) | Similar or better than predicate (C10900D: 58%) | SiX 650HD-E: 60% (Better) |
| DQE (650HD-E at 1LP/mm) | Similar or better than predicate (C10900D: 0.22) | SiX 650HD-E: 0.45 (Better) |
| VOXEL | Similar to predicate (C10900D: 0.28mm) | 0.07~0.4mm (Range encompasses predicate, with smaller minimum, indicating potentially higher resolution) |
| Imaging Quality - PANO | ||
| MTF (XID-C15DP) | Similar to C10500D | XID-C15DP: 75% at 1LP/mm (Similar to C10500D's 70% at 1LP/mm, though the comparison specifically states "similar characteristics") |
| DQE (XID-C15DP) | Similar to C10500D | XID-C15DP: 0.88 at 1LP/mm (Better than C10500D's 0.5 at 1LP/mm, though the comparison specifically states "similar characteristics") |
| NPS (XID-C15DP) | Similar to C10500D | Demonstrated similar characteristics |
| Overall | Image quality equal or better than predicate | "the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant in efficiency and safety." |
| Safety | Compliance with relevant IEC and FDA standards | Electrical, mechanical, environmental, and EMC safety testing conducted according to IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-63, IEC 60601-1-2. Complies with FDA standards 21 CFR 1020.30, 1020.31, 1020.33. All test results satisfactory. |
| Software Validation | Compliance with FDA guidance | Validated according to "Guidance for the Content and Premarket Submissions for Software Contained in Medical Devices." |
| Clinical Efficacy | Clinical diagnosis and structures are acceptable | Clinical images collected from the new detector deemed acceptable by licensed practitioners/clinicians. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative sample size (e.g., number of patients, number of images) for the clinical test set. It mentions "clinical imaging samples are collected from the new detector on propose device at the 2 offices" and "These images were gathered from the new detector installed with RCT700 on any protocols with random patient age, gender, and size." This suggests a qualitative, observational approach rather than a statistically powered clinical trial.
- Data Provenance: The document doesn't explicitly state the country of origin for the clinical data. It mentions the manufacturer is in Korea, but the location of the 2 offices where clinical images were collected is not specified. The data is prospective, as it states "clinical imaging samples are collected from the new detector on propose device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "two licensed practitioners/clinicians observed and verified" the images.
- Qualifications: "licensed practitioners/clinicians." Their specific specialties (e.g., dentist, radiologist) and years of experience are not mentioned.
4. Adjudication Method for the Test Set
The document states, "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." This indicates that the "ground truth" or verification was established through expert review of the images, effectively serving as an expert consensus. There is no mention of a formal adjudication method like 2+1 or 3+1. It appears to be an agreement by the two practitioners.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an imaging system (CT, panoramic, cephalometric X-ray), not an AI-powered diagnostic aide designed to improve human reader performance with AI assistance. The performance comparison is between the new imaging hardware/system and older predicate imaging hardware/system, not between human readers with and without AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone performance evaluation was done, but it's for the imaging system's technical image quality (hardware and image reconstruction algorithm), not an AI algorithm for autonomous diagnosis. The bench testing and non-clinical considerations evaluated the inherent imaging capabilities of the device/sensor alone across various technical metrics (MTF, DQE, NPS, pixel size, limiting resolution). This is described as proving "the complete system works as intended" and ensuring "diagnostic image quality of the new sensor is equal or better than those of the predicate device."
7. The Type of Ground Truth Used
- For Technical Performance (Bench Testing/Non-Clinical): Established technical benchmarks and measurements against the predicate device using standardized phantom images and physical characterization methods (e.g., image quality phantoms, test patterns). This is a form of objective technical measurement against established metrics.
- For Clinical Efficacy: Expert consensus ("licensed practitioners/clinicians observed and verified that dental X ray system from RCT700" and their diagnoses determined "the clinical diagnosis and structures are acceptable"). There is no mention of pathology or outcomes data as ground truth.
8. The Sample Size for the Training Set
The document does not describe a "training set" in the context of machine learning or AI. The RCT700 is a medical imaging device (hardware and associated reconstruction software), not an AI diagnostic algorithm that requires a separate training dataset.
9. How the Ground Truth for the Training Set Was Established
As no training set is described for an AI algorithm, this question is not applicable. The device's performance is established through technical benchmarks and clinical observation/verification.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, composed of three intertwined figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the caduceus in a circular fashion. The seal is presented in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 20, 2016
RAY Co., Ltd. c/o Jeff Rongero, Staff Engineer UL LLC 12 LABORATORY DRIVE RESEARCH TRIANGLE PARK, NC 27709
Re: K160525
Trade/Device Name: RCT700 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed Tomography X-Ray System Regulatory Class: Class II Product Code: OAS Dated: May 6, 2016 Received: May 10, 2016
Dear Jeff Rongero:
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 devicerelated 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}------------------------------------------------
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 Ochs
Robert 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) K160525
Device Name RCT700
Indications for Use (Describe)
CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ 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 Drug 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."
{3}------------------------------------------------
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: | December 30, 2015 |
|---|---|
| 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 | Changhwan Leee-mail : ch0406.lee@raymedical.co.kr |
Device Name
Trade/Proprietary Name: RCT700 Common Name: Dental panoramic/tomography and cephalometric x-ray system
Classification
Classification Name: Computed tomography x-ray system (21 CFR 892.1750) Class : Il Product code : OAS Panel : Radiology
Predicate device
| Parameter | Predicated Device-1 | Predicated Device-2 |
|---|---|---|
| Device Name | RAYSCAN α-Expert3D | RAYSCAN α-Expert3D |
| Manufacturer | RAY Co., Ltd | RAY Co., Ltd |
{4}------------------------------------------------
| 510(K) Number | |||
|---|---|---|---|
| K122981Traditional 510k | K142247Traditional 510k | ||
| Classification name | Computed tomography x-raysystem | Computed tomography x-raysystem | |
| Regulation number | 892.1750 | 892.1750 | |
| Primary product code | OAS | OAS |
Description
System purpose RCT700 is 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, CBCT images of dental maxillofacial 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 cephalometric image are included. RCT700 options combination are as shown in the table below.
Indication for use
CBCT, panoramic x-ray imaging system with cephalostat, is an extra oral 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 dental maxillofacial 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.
{5}------------------------------------------------
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 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 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.
Detector Options
RCT700 detector, depending on the modality, consists of SIX 650HD-E (Manufacturer: THALES) in case of the CT and one of three detectors in case of PANO, C10500D-43 (Manufacturer: Hamamatsu), XID-C15DP (Manufacturer: i3System) or SIX 650HD-E (Manufacturer: THALES).
Ceph is categorized by Scan Ceph or One shot Ceph according to the imaging methodology and the detector implemented in RCT700 Scan ceph is the XID-C24DS (Manufacturer: i3system) model whereas the detector used in the One shot Ceph is PaxScan 4336X (Manufacturer: Varian medical systems) and PaxScan 2530C (Manufacturer: Varian medical systems).
In particular, the detector used in SIX 650HD-E may also be used as a detector for PANO. Meaning the SIX 650HD-E detector is capable of being used as an independent detector in CT or the PANO modality or in CT and PANO Modality simultaneously.
{6}------------------------------------------------
| Device Designation | |
|---|---|
| Division | Description |
| CT + Pano | CT(SIX 650HD-E) + Pano(C10500D-43) |
| CT + Pano | CT(SIX 650HD-E) + Pano(XID-C15DP) |
| CT + Pano + Scan Ceph | CT(SIX 650HD-E) + Pano(C10500D-43) + Scan Ceph(XID-C24DS) |
| CT + Pano + Scan Ceph | CT(SIX 650HD-E) + Pano(XID-C15DP) + Scan Ceph(XID-C24DS) |
| CT + Pano + One shot Ceph(L) | CT(SIX 650HD-E) + Pano(C10500D-43) + One shot Ceph(PaxScan 4336X) |
| CT + Pano + One shot Ceph(L) | CT(SIX 650HD-E) + Pano(XID-C15DP) + One shot Ceph(PaxScan 4336X) |
| CT + Pano + One shot Ceph(S) | CT(SIX 650HD-E) + Pano(C10500D-43) + One shot Ceph(PaxScan 2530C) |
| CT + Pano + One shot Ceph(S) | CT(SIX 650HD-E) + Pano(XID-C15DP) + One shot Ceph(PaxScan 2530C) |
| CT | CT(SIX 650HD-E) |
| CT + Scan Ceph | CT(SIX 650HD-E) + Scan Ceph(XID-C24DS) |
| CT + One shot Ceph(L) | CT(SIX 650HD-E) + One shot Ceph(PaxScan 4336X) |
| CT + One shot Ceph(S) | CT(SIX 650HD-E) + One shot Ceph(PaxScan 2530C) |
| CT,Pano | CT,Pano(SIX 650HD-E) |
| CT,Pano + Scan Ceph | CT,Pano(SIX 650HD-E) + Scan Ceph(XID-C24DS) |
| CT,Pano + One shot Ceph(L) | CT,Pano(SIX 650HD-E) + One shot Ceph(PaxScan 4336X) |
| CT,Pano + One shot Ceph(S) | CT,Pano(SIX 650HD-E) + One shot Ceph(PaxScan 2530C) |
| Remark | |
| *Pano: C10500D-43(Hamamatsu) | |
| *Pano: XID-C15DP(i3System) | |
| *CT: SIX 650HD-E(THALES) | |
| *Scan Ceph: XID-C24DS(i3system) | |
| *One shot Ceph(S): PaxScan 2530C(Varian medical systems) | |
| *One shot Ceph(L): PaxScan 4336X(Varian medical systems) |
RCT700 options combinations are as shown in the table below.
Comparison with predicate device
Similarities:
The proposed device has the same intended for use and technical characteristic as the predicate device. A comparative analysis indicates that the following categories are similar: the mode of operation, 3D technology, performance specification, main features [such as X-ray tube, High voltage generator, CT detector, PANO detector and CEPH (Scan type, one-shot type) detector], Collimator operation type (Auto),
{7}------------------------------------------------
Class I with type B applied parts according to IEC 60601-1, focal size, DICOM 3.0 format compatible, network method, type of installation, and applicable standards. (See Table 1 for compares the characteristics between the predicate device)
Differences:
In case of RCT700, detector implemented in the device varies according to its modality; CT, PANO, Ceph and the corresponding detectors are described below.
In case of CT, Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K142247, Traditional] included the C10900D model, however the Proposed device RCT700 includes the SIX 650HD-E model detector.
In case of PANO, Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K142247, Traditional] uses the C10500D model whereas the Proposed device RCT700 is capable of incorporating one of 3 types of detector models; C10500D, SIX 650HD-E or XID-C15DP.
Cephalometry is classified into Scan type or the One shot type depending on the imaging method and in case of the Scan type, Predicate device included the XID-C24DS detector which is an equivalent model to that of RAYSCAN α-Expert3D[K142247, Traditional].
In the One shot type, Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] included the SDX-4336CP model detector whereas RAYSCAN α-Expert3D[K142247, Traditional] and the Proposed device is capable of handling both the PaxScan 4336X and PaxScan 2530C detector models.
These 2 types of detectors are identical in technical characteristics, method and manufacturer and the only mentionable difference is that PaxScan 4336X detector is 42.4 (V) cm x 35.3 (H) cm in size and PaxScan 2530C detector is 24.9(V)cm x 30.2(H)cm.
Hereafter, the PaxScan 4336X mounted in the proposed device RCT700 One shot type will be referred to as Large size and PaxScan 2530C detector as the standard size.
Following is the comparison table listing the type of modality detectors mounted in Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K142247, Traditional] and the optional detector types mounted in the proposed device RCT700.
| Division | Proposed Device | Predicate Device #1 | Predicate Device #2 | ||
|---|---|---|---|---|---|
| RCT700 | RAYSCAN α-Expert3D | RAYSCAN α-Expert3D | |||
| K160525,Traditional | K122981,Traditional | K142247,Traditional | |||
| CT | Manufacturer | Thales | Hamamatsu | ||
| Model | SiX 650HD-E | C10900D | Same as predicatedevice #1 | ||
| ScintillatorMaterial | CsI (Indirect type) | CsI (Indirect type) | |||
| Total pixel area | 144.0(W)x117.9(H)mm | 124.8(W)x124.8(H)mm | |||
| Total pixel | 960x786 | 624x624 | |||
| Pixel size | 150um | 200um | |||
| Limitingresolution | 3.3lp/mm | 2.5lp/mm | |||
| Powersupply/Main | 5VDC / 7.5W | 5VDC / 1250mA | |||
| MTF | 60% at 1LP/mm | 58% at 1LP/mm | |||
| DQE | 0.45 at 1LP/mm | 0.22 at 1LP/mm | |||
| VOXEL | 0.07~0.4mm | 0.28mm | |||
| Manufacturer | Hamamatsu | ||||
| Model | C10500D | ||||
| ScintillatorMaterial | CsI (Indirect type) | ||||
| Total pixel area | 6.0(W)x1512(H)mm | ||||
| PANO-1 | Total pixel | Same as predicatedevice #1 | 60x1512 | Same as predicatedevice #1 | |
| Pixel size | 100um | ||||
| Limitingresolution | 5.0lp/mm | ||||
| Powersupply/Main | 5VDC / 1100mA | ||||
| MTF | 70% at 1LP/mm | ||||
| DQE | 0.5 at 1LP/mm | ||||
| Manufacturer | Thales | ||||
| Model | SiX 650HD-E | ||||
| ScintillatorMaterial | CsI (Indirect type) | ||||
| Total pixel area | 144.0(W)x117.9(H)mm | ||||
| PANO-2 | Total pixel | N/A | N/A | ||
| Pixel size | N/A | ||||
| Limitingresolution | 3.3lp/mm | ||||
| Powersupply/Main | 5VDC / 7.5W | ||||
| MTF | 60% at 1LP/mm | ||||
| DQE | 0.45 at 1LP/mm | ||||
| PANO-3 | Manufacturer | i3System | |||
| Model | XID-C15DP | ||||
| ScintillatorMaterial | CdTe(Direct type) | N/A | N/A | ||
| Total pixel area | 4.8(W)x150(H)mm | ||||
| Total pixel | 48x1500 | ||||
| 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(scantype) | Manufacturer | N/A | i3System | ||
| Model | XID-C24DS | ||||
| ScintillatorMaterial | CdTe (Direct type) | ||||
| Total pixel area | 4.8(W)x240(H)mm | ||||
| Total pixel | Same as predicatedevice #2 | 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 | ||||
| Manufacturer | Samsung Mobile Display | Varian | |||
| Model | SDX-4336CP | PaxScan 4336X | |||
| ScintillatorMaterial | SDX-4336CP | GADOX (Indirect type) | |||
| Ceph(Oneshot )-1,LargeSize | Total pixel area | Same as predicatedevice #2 | 43.2 x 36.0 cm | 427(W)x356(H)mm | |
| Total pixel | 2880 x 2400 | 3072x2560 | |||
| Pixel size | 150 um | 139um | |||
| Limitingresolution | 3.3 lp/mm | 3.6lp/mm | |||
| Power supply/Main | 100-240VAC, 50/60Hz | 100-240VAC, 47-63Hz | |||
| MTF | 45% at 1LP/mm | 54% at 1LP/mm | |||
| DQE | 0.41 at 1P/mm | 0.2 at 1LP/mm | |||
| Manufacturer | N/A | Varian | |||
| Model | Same as predicatedevice #2 | PaxScan 2530C | |||
| Ceph(Oneshot)-2,StandardSize | ScintillatorMaterial | GADOX (Indirect type) | |||
| Total pixel area | |||||
| Total pixel | |||||
| Pixel size | 139um | ||||
| Limitingresolution | 3.6lp/mm |
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Powersupply/Main | 100-240VAC, 47-63Hz | |
|---|---|---|
| MTF | 54% at 1LP/mm | |
| DQE | 0.2 at 1LP/mm |
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 cleared510(k) number. |
|---|---|---|---|---|
| CT | SiX 650HD-E | Thales | No | 1) System name: Unknown2) Manufacturer: Unknown3) 510(K) Number: Unknown |
| Pano-1 | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K122981 |
| Pano-2 | SiX 650HD-E | Thales | No | 1) System name: Unknown2) Manufacturer: Unknown3) 510(K) Number: Unknown |
| Pano-3 | XID-C15DP | i3System | No | 1) System name: PAPAYA plus2) Manufacturer: Genoray3) 510(K) Number: K130419 |
| 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: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K142247 |
| One shot Ceph | PaxScan2530C | Varian | No | 1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K142247 |
{11}------------------------------------------------
Statement of Substantial Equivalence
| Parameter | Proposed Device | Predicated Device | Predicated Device | Ceph(Optional) | Posterior/AnteriorLateralSMVCarpusReverse Town'sWatersLateral wide | PA,APLateralSMVCarpusReverse Town'sWaters | Posterior/AnteriorLateralSMVCarpusReverse Town'sWatersLateral wide | Touch monitor (panel) | Touch monitor (panel) | Touch monitor (panel) | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | DetectorType | CT | SIX 650HD-E | C10900D | C10900D | Detector | Detector- CTSIX 650HD-E- PANOC10500DSIX 650HD-EXID-C15DP- CephXID-C24DS(Scan)PaxScan 4336X(One shot, Large Size)PaxScan 2530C(One shot, StandardSize) | Detector- CTC10900D- PANOC10500D- CephSDX-4336CP (One shot) | Detector- CTC10900D- PANOC10500D- CephXID-C24DS(Scan)PaxScan 4336X(One shot, Large Size)PaxScan 2530C(One shot, StandardSize) | |
| Device name | RCT700 | RAYSCAN α-Expert3D | RAYSCANα-Expert3D | PANO | C10500D | C10500D | C10500D | Chinrest | Chinrest | Chinrest | Chinrest | ||
| 510(K) Number | K160525(Traditional 510K) | K122981(Traditional 510K) | K142247(Traditional 510K) | SIX 650HD-E | Head rest | Head rest | Head rest | Head rest | |||||
| CommonName | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | Dental panoramic/tomography andcephalometric x-ray system | XID-C15DP | Automatic Collimator | Automatic Collimator | Automatic Collimator | Automatic Collimator | |||||
| Indicationsfor use | RCT700, panoramic x-ray imagingsystem with cephalostat, is an extraoralsource x-ray system, which is intendedfor dental radiographic examination ofthe teeth, jaw, and oral structures,specifically for panoramic examinationsand implantology and for TMJ studiesand cephalometry, and it has thecapability, using the CBVT technique, togenerate dento-maxillo-facial 3Dimages.The device uses cone shaped x-raybeam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique. | RAYSCAN α-Expert 3D, panoramic x-ray imaging system with cephalostat, isan extraoral source x-ray system, whichis intended for dental radiographicexamination of the teeth, jaw, and oralstructures, specifically for panoramicexaminations and implantology and forTMJ studies and cephalometry, and ithas the capability, using the CBVTtechnique, to generate dento-maxillo-facial 3D images.The device uses cone shaped x-raybeam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique. | RAYSCAN α-Expert 3D panoramic x-ray imaging system with cephalostat, isan extraoral source x-ray system, whichis intended for dental radiographicexamination of the teeth, jaw, and oralstructures, specifically for panoramicexaminations and implantology and forTMJ studies and cephalometry, and ithas the capability, using the CBVTtechnique, to generate dento-maxillo-facial 3D images.The device uses cone shaped x-raybeam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique. | Ceph (Scan) | XID-C24DS | XID-C24DS | Exposure switch | Exposure switch | Exposure switch | Exposure switch | |||
| Mode ofOperation | Continuous operation withintermittent, stated permissibleloading | Continuous operation withintermittent, stated permissibleloading | Continuous operation withintermittent, stated permissibleloading | Ceph (One shot) | PaxScan 4336X | SDX-4336CP | PaxScan 4336X | Emergency stop switch | Emergency stop switch | Emergency stop switch | Emergency stop switch | ||
| 3D technology | CBCT Cone beamComputed Tomography | CBCT Cone beamComputed Tomography | CBCT Cone beamComputed Tomography | PaxScan 2530C | PaxScan 2530C | Console PC set | Console PC set | Console PC set | Console PC set | ||||
| PerformanceSpecification | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- One shot type | 1) CBCT Computed tomography2) Panoramic3) Cephalometric(optional)- One shot type- Scan type | Exposure switchType | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | AutomaticCollimator | CT examsPanoramic examsCephalometric exams | CT examsPanoramic examsCephalometric exams | CT examsPanoramic examsCephalometric exams | ||
| FunctionalOption | Refer to Device Designation table indescription section of 510K summary. | BaseRAYSCAN α-3D :CT+PANOOption(CEPH)RAYSCAN α-Multi 3D:CT + PANO + One shot | BaseRAYSCAN α-3D :CT+PANOOption(CEPH)RAYSCAN α-SM3D:CT + PANO + SCAN CEPHRAYSCAN α-M3DS:CT + PANO + One shot(9.8 X 11.9inch)RAYSCAN α-M3DL:CT + PANO + One shot(16.8 X 14.0inch) | MainComponents | Ceph Apparatus | Ceph Apparatus | Ceph Apparatus | Display Type | TFT LCD type(Normally black)*1280x800 pixel | TFT LCD type(Normally black)*1280x800 pixel | TFT LCD type(Normally black)*1280x800 pixel | ||
| ExamMode | CT | Jaw(Standard)Jaw-FastSurgical guideFacialTeethEndodonticsTMJSinusAirway | StandardSurgical guideImplant surgeryEndo treatmentTMJSinus | Jaw(Standard)Surgical guideImplant surgeryEndo treatmentTMJSinus | Vertical Carriage | Vertical Carriage | Vertical Carriage | Class | Class I with type B applied partsaccording to IEC 60601-1 | Class I with type B applied partsaccording to IEC 60601-1 | Class I with type B applied partsaccording to IEC 60601-1 | ||
| PANO | Standard(Normal)TMJSinusSegmentation (Individual Tooth)BitewingOrthogonal | Normal(Adult)Pedodontics(Children)TMJSinus | Standard(Normal)TMJSinusSegmentation (Individual Tooth)BitewingOrthogonal | Rotator | Rotator | Rotator | Focal size | 0.5 | 0.5 | 0.5 | |||
| 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 |
{12}------------------------------------------------
{13}------------------------------------------------
{14}------------------------------------------------
{15}------------------------------------------------
| Field ofView(CT) | 160x100mm (Max.) | 90x90mm | 90x90mm | |
|---|---|---|---|---|
| X-ray Voltage | 60~90kVp | 60~90kVp | 60~90kVp | |
| X-ray Current | 4~17mA | 4~17mA | 4~17mA | |
| Total Filtration | 2.75 mm Al equivalent | 2.6 mm Al equivalent | 2.6 mm Al equivalent | |
| Detector Pixelsize | CT | SIX 650HD-E: 150μmC10500D: 100μm | C10900D: 200μmC10500D: 100μm | C10900D: 200μmC10500D: 100μm |
| PANO | SIX 650HD-E: 150μmXID-C15DP: 100μm | |||
| Ceph (Scan) | XID-C24DS: 100μm | XID-C24DS: 100μm | ||
| Ceph(One shot) | PaxScan 4336X: 139μmPaxScan 2530C: 139μm | SDX-4336CP: 150μm | PaxScan 4336X: 139μmPaxScan 2530C: 139μm | |
| Magnification | CT | SIX 650HD-E: 1.39C10500D: 1.31 | C10900D: 1.39C10500D: 1.31 | C10900D: 1.39C10500D: 1.31 |
| PANO | SIX 650HD-E: 1.31XID-C15DP: 1.31 | |||
| Ceph (Scan) | XID-C24DS: 1.11 | XID-C24DS: 1.11 | ||
| Ceph(One shot) | PaxScan 4336X: 1.13PaxScan 2530C: 1.12 | SDX-4336CP: 1.13 | SDX-4336CP: 1.13 | |
| Scan time | CT : below 14secPano : below 14sec | CT : 14secPano : 14sec | CT : 14secPano : 14sec | |
| Ceph[Scan type] : below 18sec | Ceph [One shot type, a-Multi3D]:0.3sec~3.0sec | Ceph[Scan type]: below 18secCeph [One shot type, a-Multi3D]:0.3sec~3.0sec | ||
| Ceph [One shot type]:below 2sec | ||||
| Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| Image Viewing Software | RayScan | RayScan | RayScan | |
| 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)=150kg(331lb) ±10%2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)= 166kg (366lb) ± 10%3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Standardsize)= 166kg (366lb) ± 10%4) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type, installed in Large size)166kg (366lb) ± 10% | 1) Computed Tomography(CT) +Panoramic(PANO)=148kg(326lb) ±10%2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type)=165kg(364lb) ± 10% | 1) Computed Tomography(CT) +Panoramic(PANO)=148kg(326lb) ±10%2) Computed Tomography(CT) +Panoramic(PANO) + Ceph(Scan type)=164kg (362lb) ± 10%3) Computed Tomography(CT) +Panoramic(PANO) + Ceph(One shot type)=165kg(364lb) ± 10% | |
| Type ofinstallation | Wall or floor mount | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | Standing / Wheelchair |
{16}------------------------------------------------
{17}------------------------------------------------
| 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 60601-1-3IEC 60601-2-28IEC 60601-2-63IEC 60601-1-2 |
|---|---|---|---|
| ------------------------- | ----------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------- |
{18}------------------------------------------------
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 RCT700 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 guidance 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 considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices". All test results were satisfactory.
Both of the predicate device and proposed devices were test and measured by IEC 6220-1. RCT700 system's new sensor and compared with the predicate device with reqard to Modulation Transfer Function (MTF) and Device Quantum Efficiency (DQE) and Noise to power spectrums (NPS).
Based on Non-Clinical Test results of the new detector SiX-650HD-E of the subject device, the measured pixel sizes of the new sensor (SiX-650HD-E) are similar to that of the predicate device (C10900D). Therefore, compared to the predicate device, the test patterns of the new sensor images show the test subjects without aliasing phenomenon throughout the same spatial frequency as the predicate device. Moreover, the new SiX-650HD-E sensor has performed similarly or better than the predicate device in terms of the overall NPS performance, give the NPS variation in low frequency (~0.6 lp/mm). The new sensor also exhibits consistently better performances in terms of MTF.
For the new detector XID-C15DP of RCT700, the Non-Clinical test results demonstrated the similar characteristics in terms of MTF, NPS, and DQE performance compared to C10500D detector of the subject and predicate device. All performance parameter for both detectors have shown similar results.
In conclusion, the diagnostic image quality of the new sensor is equal or better than those of the predicate device and there is no significant in efficiency and safety.
RCT710 complies with FDA standards such as 21 CFR 1202.30 and 21 CFR 1020.31 and CFR 1020.33.
{19}------------------------------------------------
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 RCT700.
The clinical imaging samples are collected from the new detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images. These images were gathered from the new detector installed with RCT700 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
The proposed device and the predicate device have the same indications for use and demonstrate the similar technical characteristics. As demonstrated in the non-clinical considerations and bench test, the RCT700 performed similar the predicate device in various performance parameters such as DQE, MTF and NPS. The electrical requirement of the new device is evaluated and mitigated in electrical safety test, EMC test. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. Ray Co., Ltd. concludes that RCT700 is safe and effective and substantially equivalent to the predicate device as described herein.
§ 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.