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 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 a-Expert 3D is a 3D computed tomography for scanning hard tissues such as bones and teeth. By rotating the c-arm which includes the high voltage generator all-in-one x-ray tube and a detector on each end, CBCT image of whole dentomaxillofacial is attained by recombining data from the same level that are scanned from different angles. Panoramic image scanning function for attaining images of the entire teeth and cephalometric scanning option for attaining the cephalic images are included. The system includes processing, and archiving "SMARTDent "software(Optional)

AI/ML Overview

The provided text is a 510(k) submission for the RAYSCAN α-Expert 3D device. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, this document does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in terms of diagnostic accuracy or clinical effectiveness involving human subjects or AI performance metrics.

The document focuses on demonstrating substantial equivalence to a predicate device (Rotagraph EVO 3D, K111152) primarily through a comparison of technical specifications and intended use.

Here's a breakdown of the information that is present and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided. The document includes a table comparing technical specifications of the RAYSCAN α-Expert 3D with the predicate device. This table lists parameters like detector pixel size, scan time, X-ray voltage, etc., but it does not present specific acceptance criteria (e.g., minimum spatial resolution, contrast-to-noise ratio) nor does it provide a direct "reported device performance" against such criteria. The comparison simply shows the values for both devices.

Parameter	RAYSCAN α-Expert 3D (New Device)	Rotagraph EVO 3D (Predicate Device)
Focal size	0.5mm	0.5mm
Field of View (CT)	90x90mm	85x85mm
X-ray Voltage	60~90kVp	60~86kVp
X-ray Current	4~17mA	6~12 mA
Total Filtration	2.6 mm Al equivalent	2.5 mm Al equivalent
CT Detector Pixel size	100 μm	127 μm
Pano Detector Pixel size	100 μm	127 μm
Ceph Detector Pixel size	150 μm	48 μm
CT Magnification	1.39	1.25 (Open/close mouth TMJ)
Pano Magnification	1.31	1.28
Ceph Magnification	1.13	1.10
CT Scan time	14sec	Max 20sec
Pano Scan time	14sec	Max 13.8sec
Ceph Scan time	0.3sec~3.0sec	15sec
CT Grey level	14bit	14bit
Pano Grey level	14bit	14bit
Ceph Grey level	14bit	12bit
Rotation angle	360°	200°

2. Sample Size Used for the Test Set and Data Provenance:

Not provided. The document mentions "Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed, but no details about participants, data provenance (country of origin, retrospective/prospective), or a specific test set for evaluation are given. The submission focuses on technical and safety equivalence, not clinical performance data from a specific study population.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable/Not provided. Since there's no clinical performance study involving a test set described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication Method:

Not applicable/Not provided. As no clinical performance study is detailed, no adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC study or any comparison of human readers with vs. without AI assistance. The device as described is an imaging system, not an AI-powered diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable/Not provided. This is an imaging device, and its approval is based on its ability to produce images comparable to a predicate device, not on the performance of a standalone algorithm for diagnosis.

7. Type of Ground Truth Used:

Not applicable/Not provided. Without a described performance study, there's no mention of ground truth (e.g., pathology, expert consensus). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate device, to which the new device is being compared for "substantial equivalence."

8. Sample Size for the Training Set:

Not applicable/Not provided. The device is an X-ray imaging system, not an AI model that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set was Established:

Not applicable/Not provided. As above, this is an imaging device, not an AI model requiring a training set and corresponding ground truth.

Summary of the Study Mentioned:

The document states: "Electrical, mechanical, environmental safety and performance testing according to standards IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2. Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed. All test results were satisfactory."

This indicates that the device underwent bench testing and compliance testing with recognized international safety and performance standards for medical electrical equipment and specific X-ray equipment. These tests are designed to ensure the device functions as intended from an engineering and safety perspective, and meets regulatory requirements for radiation safety and electrical safety. The "Non-clinical & Clinical considerations" refer to review against FDA guidance, which might involve analysis of image quality metrics typically reviewed for X-ray devices (e.g., spatial resolution, contrast, noise, dose efficiency), but specific details of such studies (sample size, methodology, acceptance criteria) are not included in this summary.

Conclusion from the document:

The conclusion drawn by the manufacturer is that "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."

Therefore, the "study" that proves the device meets (implicitly, safety and effectiveness) criteria is essentially the technical comparison and independent testing against recognized standards to establish substantial equivalence to the predicate device, rather than a clinical performance study with specific diagnostic accuracy metrics.

Summary

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MAR 1 2 2013

K122981
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510(k) Submission- RAYSCAN a-Expert 3D

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	#362-43 (218 Maeyoung St.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea
Manufacturer	RAY Co.,Ltd#362-43 (218 Maeyoung St.) 3rd & 4th Floor,Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, KoreaTEL : +82-31-605-1000FAX : +82-2-6280-5534
Contact Person	Yun Jung. HAe-mail : yunjung.ha@raymedical.co.kr

Device Name

Trade/Proprietary Name : RAYSCAN α-Expert 3D

Common Name: Dental panoramic/tomography and cephalometric x-ray system

Classification

x-ray, tomography, computed, dental (21 CFR 892.1750)

Class : Il

Product code : OAS

Panel : Radiology

Predicate device

Rotagraph EVO 3D(K111152)

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K122981
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510(k) Submission- RAYSCAN a-Expert 3D

Description

Panoramic image scanning function for attaining images of the entire teeth and cephalometric scanning option for attaining the cephalic images are included.

The system includes processing, and archiving "SMARTDent "software(Optional)

Indication for use

RAYSCAN a-Expert 3D, panoramic x-ray imaging system with cephalostat, is an extraoral source x-ray system, which is intended for dental radiographic examination of the teeth, jaw, and oral structures, specifically for panoramic examinations and implantology and for TMJ studies and cephalometry, and it has the capability, using the 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 (US) law restricts the sale of this device to, or on the order of, licensed professionals."

Parameter	RAYSCAN α-Expert 3DRAY Co.,Ltd	Rotograph EVO 3DK111152
CommonNameIndicationsfor use	Dental panoramic/tomography andcephalometric x-ray systemRAYSCAN α-Expert 3D, panoramic x-rayimaging system with cephalostat, is anextraoral source x-ray system, which isintended for dental radiographicexamination of the teeth, jaw, and oralstructures, specifically for panoramicexaminations and implantology and forTMJ studies and cephalometry, and it hasthe capability, using the CBVT technique,to generate dento-maxillo-facial 3Dimages.The device uses cone shaped x-ray beamprojected on to a flat panel detector, andthe examined volume image isreconstructed to be viewed in 3D viewingstations.2D Images are obtained usingthe standard narrow beam technique."CAUTION: Federal (US) lawrestricts the sale of this device to,or on the order of, licensedprofessionals."	Dental panoramic/tomography andcephalometric x-ray systemRotograph EVO 3D, panoramic x-rayimaging system with cephalostat, is anextraoral source x-ray system, which isintended for dental radiographicexamination of the teeth, jaw, and oralstructures, specifically for panoramicexaminations and implantology and forTMJ studies and cephalometry, and ithas the capability, using the CBVTtechnique, to generatedentomaxillofacial 3D images.The device uses cone shaped x-raybeam projected on to a flat paneldetector, and the examined volumeimage is reconstructed to be viewed in3D viewing stations. 2D Images areobtained using the standard narrowbeam technique.The device is to be operated and usedby dentists, radiologists and other
		legally qualified health careprofessionals.

Statement of Substantial Equivalence

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K122981
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510(k) Submission- RAYSCAN α--Expert 3D

Mode ofOperation		Continuous operation withintermittent, stated permissibleloading	Continuous operation withintermittent load
		CBCT Cone beam Computed	CBCT Cone beam Computed
3D technology		Tomography	Tomography
		CBCT Computed tomography	CBCT Computed tomography
PerformanceSpecification		Panoramic	Panoramic
		Cephalometric(optional)	Cephalostic(optional)
			Full Dentition
		Standard
		Implant	Left Jaws
	CT	Surgical guide
		EndoSinus	Right Jaws
		TMJ
			SinusAdult Panoramic
		Normal	Child Panoramic
	PANO	TMJ	Open-closed mouth lateral TMJ
Exam		Sinus	P-A Sinus (rotational)
mode		PA,AP
		Lateral	Lateral Ceph
	Ceph	SMV	A-P and P-A Ceph
		Carpus	Carpus (hand)
		Reverse Town'sWaters
			Half Panoramic adult
			Half Panoramic child
	Other		Orthogonal Projection
			Low Dose Panoramic
		Computed Tomography(CT) :	Frontal DentitionComputed Tomography(CT) :
Detector		Flat panel X-ray sensor	Flat panel X-ray sensor
Type		Pano : Flat panel X-ray sensor	Pano : Flat panel X-ray sensor
		Ceph : Flat panel X-ray sensor	Ceph : CCD Sensor
		Ceph Apparatus	Ceph Apparatus
		Vertical Carriage	Vertical Carriage
		Rotator	Rotator
		X-RAY Generator	X-ray Generator
		X-ray tube	X-ray tube
		High Frequency Generator	High Frequency Generator
Main		Column	Column
Components		Touch monitor (panal)	Keyboard
		Detector(CT/Panoramic,	Detector(CT/Panoramic,
		Cephalometric)	Cephalometric)
		ChinrestHead rest	ChinrestHead rest
		Automatic Collimator	Collimator
		Exposure switch	Exposure switch
		Emergency stop switch	Emergency stop switch
			CT exams	CT exams(Volumetric)
Automatic		Panoramic exams	Panoramic exams
Collimator			Cephalometric exams	Cephalometric exams

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K122981
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510(k) Submission- RAYSCAN a-Expert 3D

		Bite stick
	Bite blockChinrest(Patient support of thestand type)	Chinrest(Patient support of the standtype)
	Chinrest(TMJ, Sinus and etc.)	Head rest
	Head rest	X-ray push button with extensiblecable
Accessories	X-ray push button withextensible cable	Disposable byte protectivesleeves
	Disposable byte protectivesleeves	10ear centring pins for ceph
	Remote controller	10 disposable head strips for 3Dexams
Display Type	TFT LCD type(Normally black)*1280x800 pixel	Alphanumeric"OLED"Display of2 lines of 20 characters
	Touch monitor (panel).	Alpanumeric "OLED" Display.
	Exposure button.	x-ray push button with extensiblecable.
	Operating PC screen.	Operating PC screen.
	Every operation is guided bymessages shown on the display.	Every operation is guided bymessages shown on the display.
	Selectable language : English	Selectable languages : Italian,English, French, Spanish, German,Turkish, Portuguese, Dutch.
	Operation S/W-RayScan(Workstation)	Operation S/W(Workstation)
Rated power	110-240 V~, 50 / 60 Hz, 2.5kVA	110-120/220-240V~,50/60Hz,1.5 kVA
Class	Class I with type B applied partsaccording to IEC 60601-1	Class I with type B applied partsaccording to IEC 60601-1
Focal size	0.5mm	0.5mm
Field ofView(CT)	90x90mm	85x85mm
X-ray Voltage	60~90kVp	60~86kVp
X-ray Current	4~17mA	6~12 mA
Total Filtration	2.6 mm Al equivalent	2.5 mm Al equivalent
Detector Pixelsize	Computed Tomography(CT) : 100 μmPano : 100 μmCeph : 150 μm	Computed Tomography(CT) : 127 μmPano : 127 μmCeph : 48 μm
		CTOpen/close mouth TMJ : 1.25
Magnification	CT : 1.39Pano : 1.31Ceph : 1.13	Sinus : 1.27Pano : 1.28Ceph : 1.10 in the mid-sagittal plane inLL projection
Scan time	CT : 14secPano : 14secCeph : 0.3sec~3.0sec	CT : Max 20secPano : Max 13.8secCeph : 15sec
Grey level	CT : 14bitPano : 14bitCeph : 14bit	CT : 14bitPano : 14bitCeph : 12bit
Formatcompatible	DICOM 3.0 Format compatible	DICOM 3.0 Format compatible
Image acquisition	Giga-Ethernet Network	Giga-Ethernet Network
Rotation angle	360°	200°

PC technicalspecifications	- OS : Windows 7, 32Bit- CPU : Intel Dual core and over- RAM : 4GB and over- HDD : 250GB and over- Network : Gigabit Ethernet- Resolution : 1366x768 and over	- OS : Windows 7, 32Bit- CPU: Intel® Core™ i5-750- RAM: 4GB- HDD: 1TB- Network : Gigabit Ethernet- Resolution : 1440x900
Total Height	Max 2,296mm	Max 2,450mm
Weight	Computed Tomography(CT)+Panoramic: 148kg(326lb)Computed Tomography(CT)+Panoramic+Cephalostic(optional): 165kg(363lb)	Computed Tomography(CT)+Panoramic: 161kg(354lb)Computed Tomography(CT)+Panoramic+Cephalostic(optional): 186kg(409lb)
Type ofinstallation	Wall or floor mount	Wall or floor mount
Patient position	Standing / Wheelchair	Standing / Wheelchair
ApplicableStandards	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)	CE0051(MDD93/42/EEC), FDA

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K122981)
Page 5 of 5

510(k) Submission- RAYSCAN a-Expert 3D

RAYSCAN a-Expert 3D has the same indication for use as the predicate devices. It shares the same technological characteristics as the predicate devices. Minor technological differences do not raise any new questions regarding safety or effectiveness of the device.

Safety and Effectiveness Information

Electrical, mechanical, environmental safety and performance testing according to standards IEC 60601-1, IEC 60601-1-1, IEC 60601-1-3, IEC 60601-2-7, IEC 60601-2-28, IEC 60601-2-32 and IEC 60601-2-44 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2.

Non-clinical & Clinical considerations according to FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.

All test results were satisfactory.

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.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is black and white.

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

March 12, 2013

Ray, Co., Ltd. % Mr. Andrew Paeng Consultant 8920 Wilshire Blvd., Suite 603 BEVERLY HILLS CA 90211

Re: K122981

Trade/Device Name: RAYSCAN a-Expert 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: OAS Dated: January 14, 2013 Received: February 06, 2013

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

{6}------------------------------------------------

Page 2 - Mr. Paeng

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

$\left(m\right)$

for

Janine M. Morris 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):

Device Name: RAYSCAN a-Expert 3D

Indications For Use:

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

AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

sinh.7)

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health 510 (k) :

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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.