Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard CBCT/panoramic/cephalometric x-ray system with image reconstruction and viewing capabilities. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on the hardware (x-ray tube, detector, c-arm) and basic image processing (reconstruction).

Therapeutic

No.

The device is an imaging system (CBCT, panoramic x-ray imaging system) intended for dental radiographic examination and generating 2D/3D images, which is diagnostic, not therapeutic.

Diagnostic

Yes

The device is an x-ray imaging system intended for dental radiographic examination, specifically for panoramic examinations, implantology, TMJ studies, and cephalometry, and generates dental maxillofacial 3D images. These examinations are for diagnostic purposes, as indicated by "x-ray diagnostic radiation exposure" and "clinical diagnosis and structures are acceptable".

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "extra oral source x-ray system" and describes physical components like a "c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector". This indicates it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The description clearly states that this device is an extra oral source x-ray system used for dental radiographic examination. It generates images of the teeth, jaw, and oral structures using X-rays.
No Sample Analysis: The device does not analyze any biological samples taken from the patient. It directly images the anatomical structures using radiation.

Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

OAS

Device Description

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.

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 (CT, Panoramic, Cephalometric)

Anatomical Site

teeth, jaw, and oral structures

Indicated Patient Age Range

We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.

Intended User / Care Setting

dentist

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

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.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Study Type: Bench testing and Non-clinical considerations

Key Results:

Bench testing: Used to assess whether the parameter measured satisfies the designated tolerance for functionalities related to imaging properties and patient dosage. All test results were satisfactory.
Performance (Imaging performance) testing: Conducted according to IEC 61223-3-4 and IEC 61223-3-5. All test results were satisfactory.
Non-clinical considerations: 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.
Comparison with predicate device (IEC 6220-1):
- SiX-650HD-E (new sensor): Measured pixel sizes are similar to the predicate device (C10900D). Test patterns show test subjects without aliasing phenomenon throughout the same spatial frequency. Overall NPS performance is similar or better, considering NPS variation in low frequency (~0.6 lp/mm). Exhibits consistently better performance in terms of MTF.
- XID-C15DP (new detector): Demonstrated similar characteristics in terms of MTF, NPS, and DQE performance compared to the C10500D detector of the subject and predicate device. All performance parameters showed similar results.
Overall Conclusion: The diagnostic image quality of the new sensor is equal or better than those of the predicate device, and there is no significant difference in efficiency and safety.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K122981, K142247

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

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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

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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)

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510(k) Summary

The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.

Date:	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

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	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.

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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 |

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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

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 | 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 | | | | | | | | | | | |
| 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 of

View(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
Detecto
r Pixel
size	CT	SIX 650HD-E: 150μm
C10500D: 100μm	C10900D: 200μm
C10500D: 100μm	C10900D: 200μm
C10500D: 100μm
	PANO	SIX 650HD-E: 150μm
XID-C15DP: 100μm
	Ceph (Scan)	XID-C24DS: 100μm		XID-C24DS: 100μm
	Ceph(One shot)	PaxScan 4336X: 139μm
PaxScan 2530C: 139μm	SDX-4336CP: 150μm	PaxScan 4336X: 139μm
PaxScan 2530C: 139μm


Magnifi
cation	CT	SIX 650HD-E: 1.39
C10500D: 1.31	C10900D: 1.39
C10500D: 1.31	C10900D: 1.39
C10500D: 1.31
	PANO	SIX 650HD-E: 1.31
XID-C15DP: 1.31
	Ceph (Scan)	XID-C24DS: 1.11		XID-C24DS: 1.11
	Ceph(One shot)	PaxScan 4336X: 1.13
PaxScan 2530C: 1.12	SDX-4336CP: 1.13	SDX-4336CP: 1.13

Scan time		CT : below 14sec
Pano : below 14sec	CT : 14sec
Pano : 14sec	CT : 14sec
Pano : 14sec
	Ceph[Scan type] : below 18sec	Ceph [One shot type, a-Multi3D]:
0.3sec~3.0sec	Ceph[Scan type]: below 18sec
Ceph [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%

Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)= 166kg (366lb) ± 10%
Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type, installed in Standard
size)= 166kg (366lb) ± 10%
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%
Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type)=165kg(364lb) ± 10% | 1) Computed Tomography(CT) +
Panoramic(PANO)=148kg(326lb) ±
10%
Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(Scan type)=164kg (362lb) ± 10%
Computed Tomography(CT) +
Panoramic(PANO) + Ceph
(One shot type)=165kg(364lb) ± 10% | |
| Type of
installation | Wall or floor mount | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | Standing / Wheelchair | |

16

17

| 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 60601-1-3
IEC 60601-2-28
IEC 60601-2-63
IEC 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.