RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBCT technique, to generate dentomaxillofacial 3D images.

The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.

2D Image is obtained using the standard narrow beam technique.

Device Description

RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth.

By rotating the c-arm which is embedded with high voltage generator all-in-one x-ray tube and a detector on each end, fault surface image of whole body is attained by recombining data from the same level that are scanned from different angle. Panoramic image scanning function for attaining image of whole teeth, and cephalometric scanning option for attaining cephalic image are included.

Detector Options:

Specific models according to the detector type; CT, Pano and Ceph mounted in the RAYSCAN α- Expert 3D system are classified as shown below.

RAYSCAN α-3D: CT(model-C10900D)+PANO(model-C10500D) RAYSCAN α-SM3D: CT(model-C10900D)+PANO(model-C10500D)+ Scan Ceph(model-XID-C24DS) RAYSCAN α-M3DL: CT(model-C10900D)+PANO(model-C10500D)+ One shot ceph(model-PaxScan 4336X) RAYSCAN α-M3DS: CT(model-C10900D)+PANO(model-C10500D) + One shot ceph(model-PaxScan 2530C)

AI/ML Overview

The provided text describes the RAYSCAN a-Expert 3D, a dental X-ray system. Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" for performance metrics in a pass/fail format. Instead, it compares the proposed device's detector specifications (mainly for the new one-shot cephalometric models, PaxScan 4336X and PaxScan 2530C) against those of the predicate devices. The implicit acceptance criterion is that the new detectors should have comparable or better imaging performance metrics (MTF, DQE, limiting resolution, pixel size) to the predicate devices, and that the overall system performs as intended.

Here's a table summarizing the relevant performance specifications for the new one-shot Ceph detectors and their closest predicate counterparts:

Parameter	Acceptance Criteria (Predicate Device SDX-4336CP)	Reported Device Performance (Proposed Device PaxScan 4336X)	Reported Device Performance (Proposed Device PaxScan 2530C)
Ceph (One shot, Large Size) Detector
Manufacturer	Samsung Mobile Display	Varian	N/A (different size for this comparison)
Model	SDX-4336CP	PaxScan 4336X	N/A
Scintillator Material	CsI (Indirect type)	GADOX (Indirect type)	N/A (GADOX)
Total pixel area	43.2 x 36.0 cm	427(W)x356(H)mm (42.7 x 35.6 cm)	N/A (Smaller size, 30.2 x 24.9 cm for 2530C)
Total pixel	2880 x 2400	3072x2560	N/A (2176x1792 for 2530C)
Pixel size	150 um	139 um	N/A (139 um for 2530C)
Limiting resolution	3.3 lp/mm	3.6 lp/mm	N/A (3.6 lp/mm for 2530C)
MTF (at 1LP/mm)	45%	54%	N/A (54% for 2530C)
DQE (at 1P/mm)	0.41	0.2	N/A (0.2 for 2530C)

Summary of Performance:
The proposed detectors (PaxScan 4336X and 2530C) show a higher limiting resolution (3.6 lp/mm vs 3.3 lp/mm) and a smaller pixel size (139 um vs 150 um) compared to the predicate's one-shot Ceph detector (SDX-4336CP). The MTF (Modulation Transfer Function) is also higher (54% vs 45%). However, the DQE (Detective Quantum Efficiency) is lower (0.2 vs 0.41), indicating less efficient X-ray photon utilization for image quality. The overall conclusion states that "the diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety." This implies the lower DQE was deemed acceptable in the context of other improved metrics and overall system performance.

Study Details

Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: The document mentions "clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices." It also states "clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-M3DL and M3DS on any protocols with random patient age, gender, and size." However, a specific number of cases or images for the clinical test set is not provided.
- Data Provenance: Not explicitly stated, but implies real-world clinical data as the images were gathered from "2 offices" where the proposed devices were installed. It's likely prospective for these specific tests as it references "random patient age, gender, and size," suggesting real-time image acquisition for the test. However, the overarching context of a 510(k) submission might involve retrospective review of other data.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: "two licensed practitioners/clinicians"
- Qualifications of Experts: "licensed practitioners/clinicians" - no further details provided (e.g., specialty, years of experience).
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 suggests that the two practitioners independently reviewed the images and determined their diagnostic acceptability, likely reaching a consensus or individual affirmation of acceptability, rather than a formal adjudication process like 2+1 or 3+1 for conflicting interpretations. The method is not detailed beyond "observed and verified."
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a direct MRMC comparative effectiveness study is not explicitly mentioned. The study focuses on comparing technical specifications and verifying diagnostic acceptability of the proposed device's images. There's no mention of human readers' performance with and without AI assistance, as this is an imaging device, not an AI diagnostic tool.
Standalone (Algorithm Only) Performance Study:
- Yes, a standalone performance study was done for the detector components. Bench testing (IEC 61223-3-4, IEC 61223-3-5, FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State Xray Imaging Devices") was conducted to assess imaging performance metrics like MTF and DQE. This is a technical performance evaluation of the hardware, not an AI algorithm. The device itself is an X-ray imaging system, which inherently has "standalone" image generation capability without human interpretation during the image creation phase.
Type of Ground Truth Used:
- Clinical Diagnoses/Acceptability: For the clinical image evaluation, the ground truth was established by "licensed practitioners or clinician diagnoses of the images" determining if "the clinical diagnosis and structures are acceptable in the region of interests." This implies a form of expert consensus or clinical expert opinion on the diagnostic utility of the images. It's not explicitly stated as pathology or outcomes data.
Sample Size for the Training Set:
- Not Applicable / Not Provided. This device is an X-ray imaging system, not an AI algorithm that typically requires a large training set of labeled data for machine learning. The "software of RAYSCAN α-Expert3D has been validated" but no training set for the imaging capabilities of the X-ray system itself is mentioned, as its function is image acquisition, not autonomous interpretation.
How the Ground Truth for the Training Set Was Established:
- Not Applicable / Not Provided. As above, there is no mention of a "training set" in the context of an AI algorithm or diagnostic model here. The system's function is image acquisition based on physics and engineering principles, not learning from labeled data.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 17, 2015

Ray Co., Ltd. % Mr. Andrew Paeng, Consultant 4747 Hoen Ave Santa Rosa. CA 95405

Re: K142247

Trade/Device Name: RAYSCAN a-Expert 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: OAS Dated: March 20, 2015 Received: March 23, 2015

Dear Mr. Paeng:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Paeng

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert A Ochs

Robert Ochs, Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142247

Device Name

RAYSCAN a-Expert3D

Indications for Use (Describe)

The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations.

2D Image is obtained using the standard narrow beam technique.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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5. 510(K) Summary

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510(k) Summary

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

Date:

APPLICANT	RAY Co.,Ltd
ADDRESS	#332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,Korea
Manufacturer	RAY Co.,Ltd332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,KoreaTEL : +82-31-605-1000FAX : +82-2-6280-5534
Contact Person	Kyungha Seoe-mail : Kyungha.seo@raymedical.co.kr

Device Name

Trade/Proprietary Name: RAYSCAN α-Expert 3D Common Name: Dental panoramic/tomography and cephalometric x-ray system

Classification

Classification Name: Computed tomography x-ray system (21 CFR 892.1750) Class : II Product code : OAS Panel : Radiology

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Parameter	Predicated Device-1	Predicated Device-2
Device Name	RAYSCAN α-Expert3D	RAYSCAN α-Expert3D
Manufacturer	RAY Co., Ltd	RAY Co., Ltd
510(K) Number	K122981Traditional 510k	K131695Special 510k
Classification name	Computed tomography x-raysystem	Computed tomography x-raysystem
Regulation number	892.1750	892.1750
Primary product code	OAS	OAS

Predicate device

Description

System purpose RAYSCAN α-3D, SM3D, M3DS and M3DL are 3D computed tomography for scanning hard tissues like bone and teeth.

Detector Options:

Specific models according to the detector type; CT, Pano and Ceph mounted in the RAYSCAN α- Expert 3D system are classified as shown below.

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Non-clinical & clinical consideration report for all types of Detectors included in the RAYSCAN α- Expert3D system are prepared in compliance with 21CFR807.92(a)(7) of the FDA.

The Detector model mounted in our Dental X-ray system RAYSCAN α-M3DL [One shot Ceph] is the PaxSca 4336X model. The Non-clinical report provided by Varian, manufacturer of the Detector, was submitted in place of the Non-clinical report regarding the Solid state Detectors required by FDA.

The Non-clinical report provided by the manufacturer Varian includes and describes the Non-Clinical Data for both models PaxScan 4336W and PaxScan 4336WX. In particular the PaxScan 4336W model includes a wireless detector function however PaxScan 4336X, the detector mounted in our RAYSCAN α-M3DL [One shot Ceph] system is a detector without the wireless function, therefore the data for wireless function is not attached.

SMARTDent software for processing and archiving is optional.

Indication for use

RAYSCAN α-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the CBVT technique, to generate dento-maxillo-facial 3D images.

The device uses cone shaped x-ray beam projected on to a flat panel detector, and the examined volume image is reconstructed to be viewed in 3D viewing stations. 2D Image is obtained using the standard narrow beam technique.

"CAUTION: Federal law restricts this device to sale by or on the order of a dentist.

Patient population

The patient population can be the possible person who can be taken X-ray diagnostic radiation exposure.

There is no restriction for ethnic group, Gender, weight, health, or condition. We recommend patients for x-ray diagnostic radiation exposure to be over 5 years old.

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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 functioning and formations are as following. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. Also, an object that has a magnification is required in a distance. Moreover, the unit has to be adjustable depending on height of a patient and PC system to reconstruct an image.

The arm parts are controlled for rotating and linear moving to synchronize between the sensor and X-ray generator to get the image of interests. The purpose of this mechanism is to provide the images in 2D or/and 3D as preferred to diagnose in a monitor. CBCT provides in 3D images as reconstructed and Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 3 functions could be in 1 system, Panorama with Cephalometric, or Panorama only system depending on the needs. To provide the features as mentioned above, digital transferring from permeated X-ray to absorbing to the sensor is essential and all the process are proceed in Detector. Detector transfers X-ray to light depending on the structure materials. Detector is separated into indirect method that the light is changed to digital signals on photodiode and direct method in which the light is directly transferred to digital signal. This unit is using both direct and indirect method depending on the interior structure materials.

Operating principle of the detector

X-ray data entered into the detector from an outside source is converted to visible ray by detector's Scintillator and The visible ray is transferred to CMOS ASIC and converted to an Electric signal to form an image signal.

Then the signal is changed to a Digital form and through the high speed LAN cable, the acquired image data is transmitted to the PC.

Acquired resulting image is displayed on the monitor by the PC Software.

Comparison of the detector

One shot ceph detector installed on the One shot ceph option RAYSCAN α-Multi3D in Predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α

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Expert3D[K131695, special] is SDX-4336CP (model name).

Whereas the One shot Ceph type mounted in the proposed RAYSCAN α-Expert 3D[K142247, Traditional] offers 2 models depending on the detector size.

In RAYSCAN α-M3DL, PaxScan 4336X(size: 42.4cm35.3cm) detector is mounted and in RAYSCAN α-M3DS, PaxScan 2530C(24.9cm30.2cm) detector is installed.

Meaning if One shot Ceph option is limited to RAYSCAN α-Multi3D in the predicate devices RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K131695, special] then

The One shot Ceph option for the proposed device RAYSCAN α-Expert 3D[K142247, Traditional] offers 2 models RAYSCAN α-M3DL and RAYSCAN α-M3DS according to the detector size.

The detector installed in the Predicate device RAYSCAN α-Multi3D and Proposed devices RAYSCAN α-M3DL and RAYSCAN α-M3DS presents no differences in the technical principle and characteristics and only the manufacturer of the detector and part of the specification were changed.

Differences in the detector SDX-4336CP installed in RAYSCAN α-Multi3D of the Predicate device and detectors PaxScan 4336X and PaxScan 2530C mounted in the Proposed device models RAYSCAN α-M3DL and RAYSCAN α-M3DS are shown in the following table.

The detector for 2 newly added models RAYSCAN α-M3DL(PaxScan 4336X) and RAYSCAN α-M3DS(PaxScan 2530C) share the same manufacturer as well as the same technical characteristics, only difference in the detector is its size. Detector in the RAYSCAN α-M3DL(PaxScan 4336X) has the size 42.4 (V)cm x 35.3 (H) cm and size of the detector in RAYSCAN α-M3DS is 24.9(V)cm x 30.2(H)cm.

In addition, among the detector option of the RAYSCAN α-Expert3D included in RAYSCAN α-Expert 3D[K122981, Traditional] and RAYSCAN α-Expert3D[K131695, special] of the Predicate device, basic(RAYSCAN α-3D) and scan type(RAYSCAN α-SM3D) are completely identical.

Division		Proposed Device	Predicate Device #1	Predicate Device #2
		RAYSCAN α-Expert3D	RAYSCAN α-Expert3D	RAYSCAN α-Expert3D
		K142247	K122981	K131695
		RAY Co., Ltd.	RAY Co., Ltd.	RAY Co., Ltd.
		Traditional	Traditional	Special
CTdetector	Manufacturer	Same as predicatedevice #1	Hamamatsu	Same as predicatedevice #1
	Model	C10900D

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	Scintillator Material			CsI (Indirect type)
	Total pixel area			124.8(W)x124.8(H)mm
	Total pixel			624x624
	Pixel size			200um
	Limiting resolution			2.5lp/mm
	Power supply/Main			5VDC / 1250mA
	MTF			60% at 1 LP/mm
	DQE			0.23 at 1 LP/mm
	VOXEL(at Jaw protocol)			280μm
	Manufacturer			Hamamatsu
	Model		Same as predicatedevice #1	C10500D
PANOdetector	Scintillator Material			CsI (Indirect type)
	Total pixel area			6.0(W)x1512(H)mm	Same as predicatedevice #1
	Total pixel			60x1512
	Pixel size			100um
	Limiting resolution			5.0lp/mm
		Power supply/Main		5VDC / 1100mA
	MTF			70% at 1LP/mm
	DQE			0.5 at 1LP/mm
	Manufacturer		N/A(No attached ScanCeph)	i3System
	Model			XID-C24DS
	Scintillator Material			CdTe (Direct type)
Ceph(Scan)detector	Total pixel area	Same aspredicatedevice #2		4.8(W)x240(H)mm
	Total pixel			48x2400
	Pixel size			100um
	Limiting resolution			5.0lp/mm
	Power supply/Main			5VDC / 2A
	MTF			75% at 1LP/mm
	DQE			0.88 at 1LP/mm
Ceph(Oneshot,LargeSize)detector	Manufacturer	Varian		Samsung Mobile Display
	Model	PaxScan 4336X		SDX-4336CP
	Scintillator Material	GADOX (Indirect type)		CsI (Indirect type)
	Total pixel area	427(W)x356(H)mm		43.2 x 36.0 cm
	Total pixel	3072x2560	Same as predicate device #1	2880 x 2400
	Pixel size	139um		150 um
	Limiting resolution	3.6lp/mm		3.3 lp/mm
	Power supply/Main	100-240VAC, 47-63Hz		100-240VAC, 50/60Hz
	MTF	54% at 1LP/mm		45% at 1LP/mm
	DQE	0.2 at 1LP/mm		0.41 at 1P/mm
	Manufacturer	Varian
	Model	PaxScan 2530C
Ceph(Oneshot,StandardSize)detector	Scintillator Material	GADOX (Indirect type)		N/A(No attached one shot CEPH.)
	Total pixel area	302(W)x249(H)mm
	Total pixel	2176x1792	N/A(No attached one shot СЕРН.)
	Pixel size	139um
	Limiting resolution	3.6lp/mm
	Power supply/Main	100-240VAC, 47-63Hz
	MTF	54% at 1LP/mm
	DQE	0.2 at 1LP/mm

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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.

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CT	C10900D	Hamamatsu	No	1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K122981
Pano	C10500D	Hamamatsu	No	1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K122981
Scan Ceph	XID-C24DS	i3System	No	1) System name: RAYSCAN α-Expert3D2) Manufacturer: RAY CO., LTD3) 510(K) Number: K131695
One shot Ceph	PaxScan4336X	Varian	No	1) System name: Multix Fusion2) Manufacturer: Siemens3) 510(K) Number: K121513
One shot Ceph	PaxScan2530C	Varian	No	1) System name: Unknown2) Manufacturer: Unknown3) 510(K) Number: Unknown

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Statement of Substantial Equivalence

Parameter	Proposed Device	Predicated Device	Predicated Device
Manufacturer	RAY Co., Ltd.	RAY Co., Ltd.	RAY Co., Ltd.
Device name	RAYSCAN α-Expert3D	RAYSCAN α-Expert3D	RAYSCANα-Expert3D
510(K)Number	K142247Traditional 510k	K122981Traditional 510k	K131695Special 510k
CommonName	Dental panoramic/tomography andcephalometric x-ray system	Dental panoramic/tomography andcephalometric x-ray system	Dental panoramic/tomography andcephalometric x-ray system
Indicationsfor use	RAYSCAN α-Expert 3D panoramic x-rayimaging system with cephalostat, is anextraoral source x-ray system, which isintended for dental radiographic examination of theteeth, jaw, and oral structures, specifically forpanoramic examinations and implantology and forTMJ studies and cephalometry, and it has thecapability, using the CBVT technique, to generatedento-maxillo-facial 3D images.The device uses cone shaped x-ray beam projectedon to a flat panel detector, and the examined volumeimage is reconstructed to be viewed in 3D viewingstations.2D Images are obtained using thestandard narrow beam technique.	RAYSCAN α-Expert 3D, panoramic x-ray imagingsystem with cephalo Traditional 510k stat, is anextraoral source x-ray system, which is intended fordental radiographic examination of the teeth, jaw,and oralstructures, specifically for panoramic examinationsand implantology and for TMJ studies andcephalometry, and it has the capability, using theCBVT technique, to generate dento-maxillo-facial 3Dimages.The device uses cone shaped x-ray beam projectedon to a flat panel detector, and the examined volumeimage is reconstructed to be viewed in 3D viewingstations.2D Images are obtained using the standardnarrow beam technique.	RAYSCAN α-Expert 3D panoramic x-rayimaging system with cephalostat, is anextraoral source x-ray system, which isintended for dental radiographic examination of theteeth, jaw, and oral structures, specifically forpanoramic examinations and implantology and forTMJ studies and cephalometry, and it has thecapability, using the CBVT technique, to generatedento-maxillo-facial 3D images.The device uses cone shaped x-ray beamprojected on to a flat panel detector, andthe examined volume image is reconstructed to beviewed in 3D viewing stations.2D Images are obtained using thestandard narrow beam technique.
Mode ofOperation	Continuous operation withintermittent, stated permissibleloading	Continuous operation withintermittent, stated permissibleloading	Continuous operation withintermittent, stated permissibleloading
3Dtechnology	CBCT Cone beamComputed Tomography	CBCT Cone beamComputed Tomography	CBCT Cone beamComputed Tomography
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
FunctionalOption	BaseRAYSCAN α-3D :CT+PANOOption(CEPH)RAYSCAN α-SM3D:CT + PANO + SCAN CEPHRAYSCAN 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)	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 + SCANRAYSCAN α-Multi 3D:CT + PANO + One shot

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		Standard	Standard	Standard
		Implant	Implant	Implant
		Surgical guide	Surgical guide	Surgical guide
	CT	Endo	Endo	Endo
		Sinus	Sinus	Sinus
		TMJ	TMJ	TMJ
		Standard(Normal)	Normal(Adult)	Standard(Normal)
		TMJ	Pedodontics(Children)	TMJ
	PAN	Sinus	TMJ	Sinus
Exam	O	Segmentation (Individual Tooth)	Sinus	Segmentation (Individual Tooth)
mode		Bitewing		Bitewing
		Orthogonal		Orthogonal

		Posterior/Anterior	PA,AP	Posterior/Anterior
		Lateral	Lateral	Lateral
	Ceph	SMV	SMV	SMV
	(Opti	Carpus	Carpus	Carpus
	onal)	Reverse Town's	Reverse Town's	Reverse Town's
		Waters	Waters	Waters
		Lateral wide		Lateral wide
		1) Computed Tomography(CT) :	1) Computed Tomography(CT) :	1) Computed Tomography(CT) :
Detector		Flat panel X-ray sensor	Flat panel X-ray sensor	Flat panel X-ray sensor
		2) Pano:	2) Pano:	2) Pano:
		Flat panel X-ray sensor	Flat panel X-ray sensor	Flat panel X-ray sensor
Type		3) Ceph(Option):	3) Ceph(Option):	3) Ceph(Option):
		- Scan type: CdTe Direct flat panel sensor	- One shot type: Flat panel X-ray sensor	- Scan type: CdTe Direct flat panel sensor
		- One shot type: Amorphous Silicon		- One shot type: Flat panel X-ray sensor

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ExposureswitchType	"Deadman" Button type	"Deadman" Button type	"Deadman" Button type
MainComponents	Ceph Apparatus	Ceph Apparatus	Ceph Apparatus
	Vertical Carriage	Vertical Carriage	Vertical Carriage
	Rotator	Rotator	Rotator
	X-RAY Generator	X-RAY Generator	X-RAY Generator
	X-ray tube	X-ray tube	X-ray tube
	High Frequency Generator	High Frequency Generator	High Frequency Generator
	Column	Column	Column
	Touch monitor (panel)	Touch monitor (panel)	Touch monitor (panel)
	Detector- CT- Panoramic- Scan type Cephalometric- One shot type Cephalometric:24.9(V) x 30.2(H) cm- One shot type Cephalometric:42.4 (V) x 35.3 (H) cm	Detector- CT- Panoramic- One shot type Cephalometric	Detector- CT- Panoramic- Scan type Cephalometric- One shot type Cephalometric
	Chinrest	Chinrest	Chinrest

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	Head rest	Head rest	Head rest
	Automatic Collimator	Automatic Collimator	Automatic Collimator
	Exposure switch	Exposure switch	Exposure switch
	Emergency stop switch	Emergency stop switch	Emergency stop switch
	Console PC set	Console PC set	Console PC set
AutomaticCollimator	CT examsPanoramic examsCephalometric exams	CT examsPanoramic examsCephalometric exams	CT examsPanoramic examsCephalometric exams
Display Type	TFT LCD type(Normally black)*1280x800 pixel	TFT LCD type(Normally black)*1280x800 pixel	TFT LCD type(Normally black)*1280x800 pixel
Class	Class I with type B applied 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
Focal size	0:5	0:5	0:5
Field ofView(CT)	90x90mm	90x90mm	90x90mm
X-ray Voltage	60~90kVp	60~90kVp	60~90kVp
X-ray Current	4~17mA	4~17mA	4~17mA
TotalFiltration	2.6 mm Al equivalent	2.6 mm Al equivalent	2.6 mm Al equivalent
Detector Pixelsize	Computed Tomography(CT): 200 μm	Computed Tomography(CT): 100 μm	Computed Tomography(CT): 100 μm
	Pano: 100 μm	Pano: 100 μm	Pano: 100 μm
	Ceph[Scan type]: 100 μm	Ceph[Scan type]: 100 μm	Ceph[Scan type]: 100 μm
	Ceph[One shot type, installed in α-M3DS]: 139 μm	Ceph[One shot type]: 150 μm	Ceph[One shot type]: 150 μm
	Ceph[One shot type, installed in α-M3DL]: 139 μm
Magnification	CT : 1.39	CT : 1.39	CT : 1.39
	Pano : 1.31	Pano : 1.31	Pano : 1.31
	Ceph[Scan type] : 1.11		Ceph[Scan type] : 1.11
	Ceph[One shot type, α-M3DS] : 1.12	Ceph[One shot type, α-Multi3D]:: 1.13	Ceph[One shot type, α-Multi3D]:: 1.13
	Ceph[One shot type, α-M3DL] : 1.13
Scan time	CT : below 14sec	CT : below 14sec	CT : below 14sec
	Pano : below 14sec	Pano : below 14sec	Pano : below 14sec
	Ceph[Scan type] : below 18sec		Ceph[Scan type] : below 18sec
	Ceph[One shot type, α-M3DS]:	Ceph[One shot type, α-Multi3D]:	Ceph[One shot type, α-Multi3D]:
	below 2sec	0.3sec~3.0sec	0.3sec~3.0sec
	Ceph[One shot type, α-M3DL]:below 2sec
Formatcompatible	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Imageacquisition	Giga-Ethernet Network	Giga-Ethernet Network	Giga-Ethernet Network
Total Height	Max 2,296mm	Max 2,296mm	Max 2,296mm
Weight	1) Computed Tomography(CT) +Panoramic(PANO)=148kg(326lb) ± 10%	1) Computed Tomography(CT) +Panoramic(PANO)=148kg(326lb) ± 10%	1) Computed Tomography(CT) +Panoramic(PANO)=148kg(326lb) ± 10%
	2) Computed Tomography(CT) + Panoramic(PANO) +Cephalostic (Scan type)= 164kg (362lb) ± 10%	2) Computed Tomography(CT) + Panoramic(PANO) +Cephalostic (One shot type)=165kg(364lb) ± 10%	2) Computed Tomography(CT) + Panoramic(PANO) +Cephalostic (Scan type)=164kg (362lb) ± 10%
	3) Computed Tomography(CT) + Panoramic(PANO)+ Cephalostic (One shot type, installed in α-M3DS)=166kg (366lb) ± 10%		3) Computed Tomography(CT) + Panoramic(PANO)+ Cephalostic (One shot type)=165kg(364lb) ± 10%
	4) Computed Tomography(CT) + Panoramic(PANO)+ Cephalostic (One shot type, installed in α-M3DL)=166kg (366lb) ± 10%
Type ofinstallation	Wall or floor mount	Wall or floor mount	Wall or floor mount

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Patientposition	Standing / Wheelchair	Standing / Wheelchair	Standing / Wheelchair
ApplicableStandards	IEC 60601-1IEC 60601-1-3IEC 60601-2-28IEC 60601-2-63IEC 60601-1-2	IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-2-44IEC 60601-1-2	IEC 60601-1IEC 60601-1-1IEC 60601-1-3IEC 60601-2-7IEC 60601-2-28IEC 60601-2-32IEC 60601-2-44IEC 60601-1-2
	CertificateProduct	CE0120(MDD93/42/EEC)	CE0120(MDD93/42/EEC)	CE0120(MDD93/42/EEC)

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Safety and Effectiveness Information

Electrical, mechanical and environmental safety testing according to standard of

IEC 60601-1: 2005 + CORR.1(2006) + CORR.2(2007), IEC 60601-1-3: 2008(Second Edition), IEC 60601-2-28: 2010(Second Edition) and IEC 60601-2-63: 2012(first Edition) were performed.

EMC testing was conducted in accordance with the standard IEC 60601-1-2: 2007(Edition 3.0).

The software of RAYSCAN α-Expert3D has been validated according to FDA "Guidance for the Content d Premarket Submissions for Software Contained in Medical Devices" and applicable requirements contained in the quidance document.

Bench testing was conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 18, Performance Testing – Bench"

Bench testing is used to assess whether or not the parameter measured required for describing functionalities related to imaging properties of the dental X-ray device and patient dosage satisfies the designated tolerance.

Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.

All test results were satisfactory.

Non-clinical and test was conducted for imaging performance of the proposed detector in accordance with FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State Xray Imaging Devices".

All test results were satisfactory.

Both of the predicate device and proposed device are based on Csi scintillator designed for general radiography. MTF (Modulation Transfer Function) and DOE (Detective Quantum Efficiency) were test and measured by IEC 62220-1.

RAYSCAN α-M3DL and RAYSCAN α-M3DS system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF) and Device Quantum Efficiency (DQE). Base on the Non-clinical test result, even though the new Csi detector differs in term of the pixel size and active area, the diagnostic image quality of the new detector is equal or better than those of the predicate device and there is no significant difference in efficiency and safety.

Clinical considerations were conducted according to FDA Guidance "Format for Traditional and Abbreviated 510(k)s, section 20".

Clinical images were provided these images were not necessary to establish substantial equivalence based on the modifications to the device but they provide further evidence in

Ray Co.,Ltd

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addition to the laboratory performance data to show that the complete system works as intended.

For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RAYSCAN α.

The clinical imaging samples are collected from the new 2 one shot detector on propose device at the 2 offices where the predicate device is installed on clinical consideration report for the clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-M3DL and M3DS on any protocols with random patient age, gender, and size. As licensed practitioners or clinician diagnoses of the images, it might be proved that the clinical diagnosis and structures are acceptable in the region of interests.

The manufacturing facility is in conformance with the relevant EPRC standards as specified in 21 CFR 1020.30, 31, and 33 and the records are available for review.

Conclusions

Based on a comparison of intended use, indications, constructions, construction materials, principal of Operation, features and technical data, the RAYSCAN α-Expert 3D system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device.

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.