(144 days)
No
The summary describes a standard dental X-ray system with hardware and software updates for image acquisition and processing, but there is no mention of AI or ML capabilities.
No
The device is described as an X-ray system intended for diagnosis and examination, not for treating or providing therapy.
Yes
The "Intended Use / Indications for Use" 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 of diseases" directly indicates a diagnostic purpose.
No
The device description explicitly states it is an extraoral source dental panoramic and optional cephalometric X-ray system, which includes hardware components like an X-ray source, sensors, and a system for creating and controlling the X-ray beam. While it includes software, it is not solely software.
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 for diagnosis, monitoring, or screening.
- Device Function: The RAYSCAN α- Expert Dental X-Ray System is an extraoral source dental X-ray system. It produces X-rays that pass through the patient's body to create images. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures." This is an imaging modality, not an in vitro diagnostic test.
Therefore, based on the provided information, the RAYSCAN α- Expert Dental X-Ray System is a medical imaging device, not an IVD.
N/A
Intended Use / Indications 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.
Product codes
MUH
Device Description
Modified RAYSCAN α- Expert is 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.
The modifications are as following:
- Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor.
- Updated Software including:
- Additional protocol for new CEPH sensor (Scan type): Lateral wide
- Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal
RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.
Detector Options:
Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH
The system includes processing, and archiving "SMARTDent "software(Optional)
Mentions image processing
The system includes processing, and archiving "SMARTDent "software(Optional)
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
teeth, jaw, and oral structures
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system.
All tests met requirements demonstrating that the modified device performed as expected.
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 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2.
Non-clinical & Clinical considerations according to FDA Guidance "Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices" were performed.
All test results were satisfactory.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
NOV 0 1 2013
K131693
Page 1 of 5
510(k) Submission- RAYSCAN a-Expert
Special 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, Korea | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 | |
| Contact Person | Yun-Jung. HA/Manager |
| e-mail : yunjung.ha@raymedical.co.kr |
Device Name
Trade/Proprietary Name : RAYSCAN α – Expert Common Name: Dental panoramic and cephalometric X-ray system
Classification
Extraoral source dental X-ray system (21 CFR 872.1800) Class : II Product code : MUH Panel : Radiology
Predicate device
RAYSCAN a-Expert (K122918)
1
Description
Modified RAYSCAN α- Expert is 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.
The modifications are as following:
- Hardware: Added option CEPH sensor (Scan type). In addition to the one-shot type CEPH sensor of original device (K122918), the modified device offers an additional Scan type CEPH sensor.
- · Updated Software including:
- Additional protocol for new CEPH sensor (Scan type): Lateral wide
- Additional PANO protocols: Segmentation (Individual Tooth), Bitewing, and Orthogonal
RAYSCAN α- Expert offers digital imaging with or without the optional One-shot type & Scan type cephalometric attachment.
Detector Options:
Base: RAYSCAN α-P: PANO Option: RAYSCAN α-OC: PANO+One-shot CEPH Option: RAYSCAN α-SC: PANO+SCAN CEPH
The system includes processing, and archiving "SMARTDent "software(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.
2
ﺎ ﺳ
| Parameter | RAYSCAN α-Expert
[Modified] | RAYSCANα-Expert
[K122918] | Remarks |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Common Name | Dental panoramic and
cephalometric X-ray system | Dental panoramic and
cephalometric X-ray system | Same |
| Indications
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. | 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. | Same |
| Performance
Specification | Panoramic
Cephalometric(optional)
- One_shot type
- Scan type | Panoramic
Cephalometric(optional)
-One_shot type | Additional
Scan type
Cephalometric
(Optional) |
| Detector type | α-OC
: PANO+One-shot CEPH(option)
α -P : PANO
α -SC: PANO+SCAN CEPH(option) | α-OC
:PANO+One-shotCEPH(option)
α -P: PANO | Additional
Scan type
Cephalometric
(Optional) |
| Detector
Type | Pano: Flat panel X-ray sensor
Ceph(Optional) - Flat panel X-ray sensor
[One-shot type] - CdTe Direct flat panel
sensor[Scan type] | Pano: Flat panel X-ray sensor
Ceph(Optional) - Flat panel X-ray sensor | Additional
Scan type
Cephalometric
(Optional) |
| Focal size | 0.5mm | 0.5mm | Same |
| X-ray Voltage | 6090kVp | 6090kVp | Same |
| X-ray Current | 417mA | 417mA | Same |
| Total Filtration | 2.6 mm Al equivalent | 2.6 mm Al equivalent | Same |
| Magnification | Pano : 1.31
Ceph[One-shot type] : 1.13 | Pano : 1.31
Ceph[One-shot type] : 1.13 | Same |
| | Ceph[Scan type] : 1.11 | | Additional
specification
of Scan type
Cephalometric
(Optional) |
| Scan time | Pano : 14sec | Pano : 14sec | Same |
| | Ceph[One-shot type] : | Ceph | Same |
| | 0.3sec3.0sec | : 0.3sec3.0sec | |
| | Ceph[Scan type] : below 18sec | | Additional
specification
of Scan type
Cephalometric
(Optional) |
| Applicable
Standards | IEC 60601-1 | IEC 60601-1 | Same |
| | IEC 60601-1-1 | IEC 60601-1-1 | |
| | IEC 60601-1-3 | IEC 60601-1-3 | |
| | IEC 60601-2-7 | IEC 60601-2-7 | |
| | IEC 60601-2-28 | IEC 60601-2-28 | |
| | IEC 60601-2-32 | IEC 60601-2-32 | |
| | IEC 60601-1-2 | IEC 60601-1-2 | |
| Certificate
Product | CE0120(MDD93/42/EEC) | CE0120(MDD93/42/EEC) | Same |
Statement of Substantial Equivalence
·
3 / 5
.
3
510(k) Submission- RAYSCAN a-Expert
Safety details, for instance the non-clinical performance, in regards to intended use, safety characteristics, PANORAMA sensor (Detector) and One-shot CEPH sensor(Detector) are equivalent. The only difference is the additional option of Scan type CEPH sensor. The safety & effectiveness reports for the added Scan type cephalometric sensor is provided separately.
Remaining sensors are the same, the non-clinical considerations thereof are also equivalent, and the report regarding non-clinical & clinical consideration for the added Scan CEPH sensor is provided separately.
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.
Based on the non-clinical and clinical consideration and the outcome of an expert review of image comparisons for both devices, new RAYSCAN α-Expert is substantially equivalent, in terms of safety and effectiveness, with RAYSCAN α- Expert[K122918].
4 / 5
4
510(k) Submission- RAYSCAN a-Ex
K131693
Page 5 of 5
Safety and Effectiveness Information
Software verification testing and validation testing was performed to confirm that the modified device performed as intended and that changes made to the hardware and software had no adverse impact on the functionality of the system.
All tests met requirements demonstrating that the modified device performed as expected.
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 and IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with the standard IEC 60601-1-2.
Non-clinical & Clinical considerations according to FDA Guidance "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, construction materials, principal of Operation, features and technical data, the RAYSCAN &-Expert system are safe and effective to perform its intended use as well as substantially equivalent to the predicate device
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized emblem of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the emblem. The text is in all capital letters and is in a sans-serif font.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1, 2013
Ray Co., Ltd. % Mr. Andrew Paeng Consultant 4747 Hoen Avenue SANTA ROSA CA 95405
Re: K131693
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: October 1. 2013 Received: October 11, 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 device-related adverse events) (21 CFR 803): good manufacturing practice requirements as set
6
Page 2 - Mr. Andrew Paeng
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 contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/orYou/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.goy/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/Industrv/default.htm.
Sincerely yours.
Mekael D. D'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
K131693 510(k) Number (if known):
Device Name: RAYSCAN α-Expert
Indications 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.
Prescription Use X AND/OR Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Michael D. O'Hara
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiolgical Health Page 1 of 510(k) ======================================================================================================================================================================= K131693