K Number
K142058
Device Name
RAYSCAN A-EXPERT
Manufacturer
Date Cleared
2015-04-22

(267 days)

Product Code
Regulation Number
872.1800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.
Device Description
The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system. The machine is made of X-ray generator and arms in which transfers X-ray signals to a sensor in 2D. 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 unit has to be adjustable depending on height of a patient and PC system to reconstruct an image. Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, or Panorama only system depending on the needs. 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.
More Information

Not Found

No
The description focuses on the hardware and basic image processing (reconstruction, archiving) without mentioning AI/ML algorithms for image analysis or interpretation.

No.
The device is used for diagnosis of diseases, not for therapy or treatment.

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the system is "intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." The term "diagnosis" directly indicates a diagnostic purpose.

No

The device description explicitly details hardware components like an X-ray generator, arms, sensor, and detector, indicating it is a physical system, not software only.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
  • Device Function: The RAYSCAN a- Expert Dental X-Ray System is an imaging device that uses X-rays to create images of the teeth, jaw, and oral structures within the patient's body. It does not analyze samples taken from the body.
  • Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures," which is a form of medical imaging, not in vitro testing.

The device description, input imaging modality (X-ray), anatomical site, and intended user all point to it being a medical imaging device, not an IVD.

N/A

Intended Use / Indications for Use

The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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

MUH

Device Description

RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.

Detector Options:

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

RAYSCAN α-P: PANO(model-C10500D) RAYSCAN α-SC: PANO(model-C10500D)+Scan Ceph(model-XID-C24DS) RAYSCAN α-OCL: PANO(model-C10500D)+One shot ceph(model-PaxScan 4336X) RAYSCAN α-OCS: PANO(model-C10500D)+One shot ceph(model-PaxScan 2530C)

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 as preferred to diagnose in a monitor.

Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, 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.

Mentions image processing

Acquired resulting image is displayed on the monitor by the PC Software.
SMARTDent software for processing and archiving is optional.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

teeth, jaw, and oral structures, head

Indicated Patient Age Range

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

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.

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".

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-OCL and RAYSCAN α-OCS system's new sensor and compared with the predicate device with regard to Modulation Transfer Function (MTF) and Device Quantum Efficiency (DQE).

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

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-OCL and OCS on any protocols with random patient age, gender, and size.

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

Bench Testing:
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).
Performance (Imaging performance) testing was conducted according to standard of IEC 61223-3-4 and IEC 61223-3-5.
Non-clinical test results for imaging performance for the proposed detector were satisfactory.
MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) were tested and measured by IEC 62220-1. Based 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 Testing:
Clinical images were provided. For clinical testing, two licensed practitioners/clinicians observed and verified that dental X ray system from RAYSCAN α. The clinical test images were gathered from the new 2 one shot ceph detector installed with RAYSCAN α-OCL and OCS 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.

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.

K122918, K131693

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

§ 872.1800 Extraoral source x-ray system.

(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem consists of three profiles facing right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

April 22, 2015

Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405

Re: K142058

Trade/Device Name: RAYSCAN a-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-ray System Regulatory Class: II Product Code: MUH 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.

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 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

2

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142058

Device Name

RAYSCAN a-Expert

Indications for Use (Describe)

The RAYSCAN a- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric Xray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

5. 510(K) Summary

4

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:

APPLICANTRAY Co.,Ltd
ADDRESS#332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823,
Korea
ManufacturerRAY 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 PersonKyungha Seo
e-mail : Kyungha.seo@raymedical.co.kr

Device Name

Trade/Proprietary Name: RAYSCAN α–Expert Common Name: Dental panoramic and cephalometric X-ray system

Classification

Classification Name: Extraoral source x-ray system Regulatory Number: 21 CFR 872.1800 Product Code: MUH Device Class: II Review Panel: Radiology

5

ParameterPredicated Device-1Predicated Device-2
Device NameRAYSCAN α-ExpertRAYSCAN α-Expert
ManufacturerRAY Co., LtdRAY Co., Ltd
510(K) NumberK122918
Traditional 510kK131693
Special 510k
Classification nameExtraoral source x-ray systemExtraoral source x-ray system
Regulation number872.1800872.1800
Primary product codeMUHMUH

Predicate device

Description

RAYSCAN α-OC, SC, OCS, and OCL are designed for panoramic scanning of teeth, jaw and oral cavity, used to create and control the X-ray beam.

And as a dental digital panoramic X-ray system with X-ray located on outer part of the oral cavity, includes the Cephalometric scanning function, as an option, for acquiring images of the head.

RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.

Detector Options:

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

RAYSCAN α-P: PANO(model-C10500D) RAYSCAN α-SC: PANO(model-C10500D)+Scan Ceph(model-XID-C24DS) RAYSCAN α-ΟCL: PANO(model-C10500D)+One shot ceph(model-PaxScan 4336X) RAYSCAN α-ΟCS: PANO(model-C10500D)+One shot ceph(model-PaxScan 2530C)

Non-clinical & clinical consideration report for all types of Detectors included in the Ray Co.,Ltd Page 3 of 17

6

RAYSCAN α- Expert 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-OCL [One shot Ceph] is the PaxScan 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-OCL [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

The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental panoramic and optional cephalometric X-ray system intended to produce X-rays for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures.

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.

Device functions

7

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 as preferred to diagnose in a monitor.

Panorama is to diagnose the structures in a panoramic view. Cephalometric allows for orthodontic treatment. These 2 functions could be in 1 system, 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-OC in Predicate devices RAYSCAN α-Expert[K122918, Traditional] and RAYSCAN α-Expert[K131693, special] is SDX-4336CP (model name).

Whereas the One shot Ceph type mounted in the proposed RAYSCAN α-Expert [K142058, Traditional] offers 2 models depending on the detector size.

In RAYSCAN α-OCL, PaxScan 4336X(size: 42.4cm*35.3cm) detector is mounted and in

8

RAYSCAN α-OCS, PaxScan 2530C(24.9cm*30.2cm) detector is installed.

Meaning if One shot Ceph option is limited to RAYSCAN α-OC in the predicate devices RAYSCAN α–Expert [K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] then

The One shot Ceph option for the proposed device RAYSCAN α-Expert[K142058, Traditional] offers 2 models RAYSCAN α-OCL and RAYSCAN α-OCS according to the detector size.

The detector installed in the Predicate device RAYSCAN α-OC and Proposed devices RAYSCAN α-OCL and RAYSCAN α-OCS 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-OC of the Predicate device and detectors PaxScan 4336X and PaxScan 2530C mounted in the Proposed device models RAYSCAN α-OCL and RAYSCAN α-OCS are shown in the following table.

The detector for 2 newly added models RAYSCAN α-OCL(PaxScan 4336X) and RAYSCAN α-OCS(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-OCL(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[K122918, Traditional] and RAYSCAN α-Expert3D[K131693, special] of the Predicate device, basic(RAYSCAN α-P) and scan type(RAYSCAN α-SC) are completely identical.

| Division | | Proposed Device | Predicate Device
#1 | Predicate Device
#2 |
|--------------------------------------------------------|--------------------------|--------------------------------|----------------------------------------|----------------------------------------|
| | | RAYSCAN α-Expert | RAYSCAN α-Expert | RAYSCAN α-
Expert |
| | | K142058 | K122918 | K131693 |
| | | RAY Co., Ltd. | RAY Co., Ltd. | RAY Co., Ltd. |
| | | Traditional | Traditional | Special |
| PANO
detector | Manufacturer | | Hamamatsu | |
| | Model | | C10500D | |
| | Scintillator
Material | Same as predicate
device #1 | CsI (Indirect type) | Same as predicate
device #1 |
| | Total pixel area | | 6.0(W)x1512(H)mm | |
| | 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 Scan
Ceph) | i3System |
| | Model | | | XID-C24DS |
| | Scintillator
Material | | | CdTe (Direct type) |
| | Total pixel area | | | 4.8(W)x240(H)mm |
| Ceph
(Scan)
detector | 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 | Varian | | Samsung Mobile
Display |
| | Model | PaxScan 4336X | | SDX-4336CP |
| | Scintillator
Material | GADOX (Indirect
type) | | CsI (Indirect type) |
| Ceph
(One
shot,
Large
Size)
detector | Total pixel area | 427(W)x356(H)mm | Same as predicate
device #1 | 43.2 x 36.0 cm |
| | Total pixel | 3072x2560 | | 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 | N/A
(No attached one shot
CEPH.) | N/A
(No attached one
shot CEPH.) |
| | Model | PaxScan 2530C | | |
| | Scintillator
Material | GADOX (Indirect
type) | | |
| Ceph
(One
shot,
Standard
Size)
detector | Total pixel area | 302(W)x249(H)mm | | |
| | Total pixel | 2176x1792 | | |
| | 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 | | |

9

10

| Division | Model | Manufacturer | Own 510(K)
number | System in which it was cleared
510(k) number. |
|---------------|------------------|--------------|----------------------|--------------------------------------------------------------------------------------------------|
| Pano | C10500D | Hamamatsu | No | 1) System name: RAYSCAN α-Expert3D
2) Manufacturer: RAY CO., LTD
3) 510(K) Number: K122981 |
| 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: Multix Fusion
2) Manufacturer: Siemens
3) 510(K) Number: K121513 |
| One shot Ceph | PaxScan
2530C | Varian | No | 1) System name: Unknown
2) Manufacturer: Unknown
3) 510(K) Number: Unknown |

Information for detector own 510(K) number or system in which it was cleared 510(K) number.

11

Statement of Substantial Equivalence

ParameterProposed DevicePredicated DevicePredicated Device
ManufacturerRAY Co., Ltd.RAY Co., Ltd.RAY Co., Ltd.
Device nameRAYSCAN α-ExpertRAYSCAN α-ExpertRAYSCANα-Expert
510(K)
NumberK142058
Traditional 510kK122918
Traditional 510kK131693
Special 510k
Common
NameDental panoramic and
cephalometric X-ray systemDental panoramic and
cephalometric X-ray systemDental panoramic and
cephalometric X-ray system
Indications
for useThe RAYSCAN α- Expert Dental X-Ray System is an
extraoral source dental panoramic and optional
cephalometric X-ray system intended to produce X-
rays for
dental radiographic examination and
diagnosis of diseases of the teeth, jaw, and oral
structures.The RAYSCAN α- Expert Dental X-Ray System is an
extraoral source dental panoramic and optional
cephalometric X-ray system intended to produce X-rays for dental radiographic examination and
diagnosis of diseases of the teeth, jaw, and oral
structures.The RAYSCAN α- Expert Dental X-Ray System is an
extraoral source dental panoramic and optional
cephalometric X-ray system intended to produce X-
rays for dental radiographic examination and
diagnosis of diseases of the teeth, jaw, and oral
structures.
Mode of
OperationContinuous operation with
intermittent, stated permissible
loadingContinuous operation with
intermittent, stated permissible
loadingContinuous operation with
intermittent, stated permissible
loading
Performance
Specification1) Panoramic
  1. Cephalometric(optional)
  • One shot type
  • Scan type | 1) Panoramic
  1. Cephalometric(optional)
  • One shot type | 1) Panoramic
  1. Cephalometric(optional)
  • One shot type
  • Scan type | |
    | Functional
    Option | | Base
    RAYSCAN α-P :
    PANO
    Option(CEPH)
    RAYSCAN α-SC:
    PANO + SCAN CEPH
    RAYSCAN α-OCS:
    PANO + One shot(9.8 X 11.9 inch)
    RAYSCAN α-OCL:
    PANO + One shot(16.8 X 14.0 inch) | Base
    RAYSCAN α-P :
    PANO
    Option(CEPH)
    RAYSCAN α-OC:
    PANO + One shot | Base
    RAYSCAN α-P :
    PANO
    Option(CEPH)
    RAYSCAN α-SC:
    PANO + SCAN CEPH
    RAYSCAN α-OC:
    PANO + One shot |
    | Exam | PAN
    O | Standard(Normal)
    TMJ
    Sinus
    Segmentation (Individual Tooth)
    Bitewing
    Orthogonal | Standard (Normal)
    TMJ
    Sinus | Standard(Normal)
    TMJ
    Sinus
    Segmentation (Individual Tooth)
    Bitewing
    Orthogonal |
    | mode | Ceph
    (Opti
    onal) | Posterior/Anterior
    Lateral
    SMV
    Carpus
    Reverse Town's
    Waters
    Lateral wide | Posterior/Anterior
    Lateral
    SMV
    Carpus
    Reverse Town's
    Waters | Posterior/Anterior
    Lateral
    SMV
    Carpus
    Reverse Town's
    Waters
    Lateral wide |
    | | 1) Pano: | 1) Pano: | 1) Pano: | |
    | | Flat panel X-ray sensor | Flat panel X-ray sensor | Flat panel X-ray sensor | |
    | Detector
    Type | 2) Ceph(Option):
  • Scan type: CdTe Direct flat panel sensor
  • One shot type: Amorphous Silicon | 2) Ceph(Option):
  • One shot type: Flat panel X-ray sensor | 2) Ceph(Option):
  • Scan type: CdTe Direct flat panel sensor
  • One shot type: Flat panel X-ray sensor | |
    | Exposure
    switch
    Type | "Deadman" Button type | "Deadman" Button type | "Deadman" Button type | |
    | | Ceph Apparatus | Ceph Apparatus | Ceph Apparatus | |
    | | Vertical Carriage | Vertical Carriage | Vertical Carriage | |
    | | Rotator | Rotator | Rotator | |
    | Main
    Components | 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 | Detector | Detector | |
    | | - Panoramic | - Panoramic | - Panoramic | |
    | | - Scan type Cephalometric | - One shot type Cephalometric | - Scan type Cephalometric | |
    | | - One shot 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 | | | |
    | | Chinrest | Chinrest | Chinrest | |
    | | 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 | |
    | Automatic | Panoramic exams | Panoramic exams | Panoramic exams | |
    | Collimator | Cephalometric exams | Cephalometric exams | Cephalometric exams | |
    | | | | | |
    | Display Type | TFT LCD type(Normally black) | TFT LCD type(Normally black) | TFT LCD type(Normally black) | |
    | | *1280x800 pixel | *1280x800 pixel | *1280x800 pixel | |
    | | | | | |
    | | Class I with type B applied parts | Class I with type B applied parts | Class I with type B applied parts | |
    | Class | according to IEC 60601-1 | according to IEC 60601-1 | according to IEC 60601-1 | |
    | | | | | |
    | Focal size | 0.5 | 0.5 | 0:5 | |
    | | | | | |
    | Field of
    View(CT) | 90x90mm | 90x90mm | 90x90mm | |
    | X-ray Voltage | 6090kVp | 6090kVp | 6090kVp | |
    | X-ray Current | 4
    17mA | 417mA | 417mA | |
    | Total
    Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | 2.6 mm Al equivalent | |
    | Detector Pixel
    size | Pano: 100 μm | Pano: 100 μm | Pano: 100 μm | |
    | | Ceph[Scan type]: 100 μm | Ceph[One shot type]: 150 μm | Ceph[One shot type]: 150 μm | |
    | | Ceph[One shot type, installed in α-M3DS]: 139 μm | | | |
    | | Ceph[One shot type, installed in α-M3DL]: 139 μm | | | |
    | Magnification | 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 | Pano : below 14sec | Pano : below 14sec | Pano : below 14sec | |
    | | Ceph[Scan type] : below 18sec

Ceph[One shot type, α-M3DS]:
below 2sec

Ceph[One shot type, α-M3DL]:
below 2sec | Ceph[One shot type, α-Multi3D]:
0.3sec~3.0sec | Ceph[Scan type] : below 18sec

Ceph[One shot type, α-Multi3D]:
0.3sec~3.0sec | |
| Format
compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| Image
acquisition | Giga-Ethernet Network | Giga-Ethernet Network | Giga-Ethernet Network | |
| Total Height | Max 2,296mm | Max 2,296mm | Max 2,296mm | |
| | 1) Panoramic(PANO)=148kg(326lb) ± 10% | 1) Panoramic(PANO)=148kg(326lb) ± 10% | 1) Panoramic(PANO)=148kg(326lb) ± 10% | |
| | 2) Panoramic(PANO) + Cephalostic (Scan type) =
164kg (362lb) ± 10% | 2) Panoramic(PANO) + Cephalostic (One shot
type)=165kg(364lb) ± 10% | 2) Panoramic(PANO) + Cephalostic (Scan
type)=164kg (362lb) ± 10% | |
| Weight | 3) Panoramic(PANO) + Cephalostic (One shot type,
installed in α-M3DS)= 166kg (366lb) ± 10%

  1. Panoramic(PANO) + Cephalostic (One shot type,
    installed in α-M3DL)= 166kg (366lb) ± 10% | | 3) Panoramic(PANO) + Cephalostic (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 | |

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| Applicable

Standards
IEC 60601-1
IEC 60601-1-3
IEC 60601-2-28
IEC 60601-2-63
IEC 60601-1-2IEC 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 60601-1-2IEC 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
Certificate
ProductCE0120(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-OCL and RAYSCAN α-OCS 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

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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-OCL and OCS 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

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