Who is the manufacturer of RCT700?

Ray Co., Ltd. filed the 510(k) submission for RCT700 (K160525).

What is the FDA product code for RCT700?

OAS. It is classified under 21 CFR 892.1750 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for RCT700?

510(k) clearance (submission type: Traditional).

What are the predicate devices for RCT700?

RAYSCAN α-Expert3D (K122981); RAYSCAN α-Expert3D (K142247).

Who can help prepare an FDA 510(k) submission like RCT700?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

RCT700

K160525 · Ray Co., Ltd. · OAS · Jun 20, 2016 · Radiology

Device Facts

Record ID	K160525
Device Name	RCT700
Applicant	Ray Co., Ltd.
Product Code	OAS · Radiology
Decision Date	Jun 20, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1750
Device Class	Class 2
Attributes	Pediatric

Intended 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.

Device Story

Extraoral dental X-ray system (CBCT, panoramic, cephalometric) for imaging teeth, jaw, and oral structures. Uses rotating C-arm with X-ray generator and flat panel detector to capture 2D projections; PC software reconstructs data into 3D volumes or 2D panoramic/cephalometric images. Operated by dentists in clinical settings. System includes adjustable patient positioning (height) and console PC for image display. Provides diagnostic images for implantology, TMJ studies, and orthodontics. Benefits include high-resolution maxillofacial visualization for treatment planning.

Clinical Evidence

Bench testing only. Clinical images were provided for illustrative purposes to confirm system functionality but were not required to establish substantial equivalence. Two licensed practitioners verified clinical image quality as acceptable for diagnostic purposes.

Technological Characteristics

Extraoral X-ray system; Class II; Product Code OAS. Detectors: Indirect (CsI, GADOX) and Direct (CdTe) types. Connectivity: Giga-Ethernet. Standards: IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-63, IEC 60601-1-2. DICOM 3.0 compatible. Wall or floor mount.

Indications for Use

Indicated for dental radiographic examination of teeth, jaw, and oral structures, including panoramic, implantology, TMJ studies, and cephalometry in patients over 5 years old. No restrictions on gender, weight, or health condition.

Regulatory Classification

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.

Predicate Devices

RAYSCAN α-Expert3D (K122981)
RAYSCAN α-Expert3D (K142247)

Reference Devices

PAPAYA plus (K130419)
RAYSCAN α-Expert3D (K131695)

Related Devices

K232287 — RAYSCAN a-Expert3D · Ray Co., Ltd. · Aug 31, 2023
K142247 — RAYSCAN A-EXPERT 3D · Ray Co., Ltd. · Apr 17, 2015
K200688 — hyperion X5, NewTom GO, X-RADiUS COMPACT · Cefla S.C. · Apr 9, 2020
K132983 — TON-95LH, PAX-I3D ORTHO · VATECH Co., Ltd. · Aug 7, 2014
K222666 — X-View 3D Pan/X-View 2D Pan · Trident S.R.L · Jul 10, 2023

Submission Summary (Full Text)

{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) | | | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------| | <table><tr><td><div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div></td></tr><tr><td><div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div></td></tr></table> | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | | | | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | | | #### 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.,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 | Changhwan Lee e-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 | | | |----------------------|-------------------------------------|-------------------------------------|--| | | K122981 Traditional 510k | K142247 Traditional 510k | | | Classification name | Computed tomography x-ray system | Computed tomography x-ray system | | | 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 predicate device #1 | | | | Scintillator Material | 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 | | | | | | | | | | | | Limiting resolution | 3.3lp/mm | 2.5lp/mm | | | | | Power supply/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 | | | | | Scintillator Material | | CsI (Indirect type) | | | | | Total pixel area | | 6.0(W)x1512(H)mm | | | | PANO-1 | Total pixel | Same as predicate device #1 | 60x1512 | Same as predicate device #1 | | | | 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 | Thales | | | | | | Model | SiX 650HD-E | | | | | | Scintillator Material | 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 | | | | | | Limiting resolution | 3.3lp/mm | | | | | | Power supply/Main | 5VDC / 7.5W | | | | | | MTF | 60% at 1LP/mm | | | | | | DQE | 0.45 at 1LP/mm | | | | | PANO-3 | Manufacturer | i3System | | | | | | Model | XID-C15DP | | | | | | Scintillator Material | 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 (scan type) | Manufacturer | | N/A | i3System | | | | Model | | | XID-C24DS | | | | Scintillator Material | | | CdTe (Direct type) | | | | Total pixel area | | | 4.8(W)x240(H)mm | | | | Total pixel | Same as predicate device #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 | | | | Scintillator Material | | SDX-4336CP | GADOX (Indirect type) | | | Ceph (One shot )-1, Large Size | Total pixel area | Same as predicate device #2 | | 43.2 x 36.0 cm | 427(W)x356(H)mm | | | Total pixel | | | 2880 x 2400 | 3072x2560 | | | Pixel size | | | 150 um | 139um | | | Limiting resolution | | | 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 predicate device #2 | | PaxScan 2530C | | | Ceph (One shot)-2, Standard Size | Scintillator Material | | | GADOX (Indirect type) | | | | Total pixel area | | | | | | | Total pixel | | | | | | | Pixel size | | | | 139um | | | Limiting resolution | | | | 3.6lp/mm | {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ | Power supply/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 cleared 510(k) number. | |---------------|------------------|--------------|----------------------|--------------------------------------------------------------------------------------------------| | CT | SiX 650HD-E | Thales | No | 1) System name: Unknown 2) Manufacturer: Unknown 3) 510(K) Number: Unknown | | Pano-1 | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D 2) Manufacturer: RAY CO., LTD 3) 510(K) Number: K122981 | | Pano-2 | SiX 650HD-E | Thales | No | 1) System name: Unknown 2) Manufacturer: Unknown 3) 510(K) Number: Unknown | | Pano-3 | XID-C15DP | i3System | No | 1) System name: PAPAYA plus 2) Manufacturer: Genoray 3) 510(K) Number: K130419 | | 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: RAYSCAN α-Expert3D 2) Manufacturer: RAY CO., LTD 3) 510(K) Number: K142247 | | One shot Ceph | PaxScan 2530C | Varian | No | 1) System name: RAYSCAN α-Expert3D 2) Manufacturer: RAY CO., LTD 3) 510(K) Number: K142247 | {11}------------------------------------------------ # Statement of Substantial Equivalence | Parameter | Proposed Device | Predicated Device | Predicated Device | | Ceph (Optional) | Posterior/Anterior Lateral SMV Carpus Reverse Town's Waters Lateral wide | PA,AP Lateral SMV Carpus Reverse Town's Waters | Posterior/Anterior Lateral SMV Carpus Reverse Town's Waters Lateral wide | | Touch monitor (panel) | Touch monitor (panel) | Touch monitor (panel) | | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------|--------------------------------------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------| | Manufacturer | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. | Detector Type | CT | SIX 650HD-E | C10900D | C10900D | Detector | Detector - CT SIX 650HD-E - PANO C10500D SIX 650HD-E XID-C15DP - Ceph XID-C24DS(Scan) PaxScan 4336X(One shot, Large Size) PaxScan 2530C(One shot, Standard Size) | Detector - CT C10900D - PANO C10500D - Ceph SDX-4336CP (One shot) | Detector - CT C10900D - PANO C10500D - Ceph XID-C24DS(Scan) PaxScan 4336X(One shot, Large Size) PaxScan 2530C(One shot, Standard Size) | | | 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 | | | 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 | | | XID-C15DP | | | Automatic Collimator | Automatic Collimator | Automatic Collimator | Automatic Collimator | | | Indications for use | RCT700, 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 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 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. | | Ceph (Scan) | XID-C24DS | | XID-C24DS | Exposure switch | Exposure switch | Exposure switch | Exposure switch | | | Mode of Operation | Continuous operation with intermittent, stated permissible loading | Continuous operation with intermittent, stated permissible loading | Continuous operation with intermittent, stated permissible loading | | 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 beam Computed Tomography | CBCT Cone beam Computed Tomography | CBCT Cone beam Computed Tomography | | | PaxScan 2530C | | PaxScan 2530C | Console PC set | Console PC set | Console PC set | Console PC set | | | Performance Specification | | 1) CBCT Computed tomography 2) Panoramic 3) Cephalometric(optional) - One shot type - Scan type | 1) CBCT Computed tomography 2) Panoramic 3) Cephalometric(optional) - One shot type | 1) CBCT Computed tomography 2) Panoramic 3) Cephalometric(optional) - One shot type - Scan type | Exposure switch Type | | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | Automatic Collimator | CT exams Panoramic exams Cephalometric exams | CT exams Panoramic exams Cephalometric exams | CT exams Panoramic exams Cephalometric exams | | Functional Option | | Refer to Device Designation table in description section of 510K summary. | 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 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) | Main Components | | 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 | | Exam Mode | CT | Jaw(Standard) Jaw-Fast Surgical guide Facial Teeth Endodontics TMJ Sinus Airway | Standard Surgical guide Implant surgery Endo treatment TMJ Sinus | Jaw(Standard) Surgical guide Implant surgery Endo treatment TMJ Sinus | | | Vertical Carriage | Vertical Carriage | Vertical Carriage | 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 | | | PANO | Standard(Normal) TMJ Sinus Segmentation (Individual Tooth) Bitewing Orthogonal | Normal(Adult) Pedodontics(Children) TMJ Sinus | Standard(Normal) TMJ Sinus Segmentation (Individual Tooth) Bitewing Orthogonal | | | Rotator | Rotator | Rotator | Focal size | 0.5 | 0.5 | 0.5 | | X-RAY Generator | X-RAY Generator | X-RAY Generator | | | | | | | |…