(172 days)
Not Found
No
The summary does not mention AI, ML, or related terms, and the description of the software focuses on processing and archiving, not advanced analytical capabilities.
No
The device is used for diagnosis of diseases, not for therapy/treatment.
Yes
The 'Intended Use' section 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" clearly indicates its diagnostic purpose.
No
The device description clearly states it is an "extraoral source dental panoramic and optional cephalometric X-ray system" and includes components that "create and control the X-ray beam," indicating it is a hardware device with integrated software. The performance studies also include electrical, mechanical, and environmental safety testing, which are relevant to hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The RAYSCAN α- Expert Dental X-Ray System is an imaging device that uses X-rays to create images of the teeth, jaw, and oral structures. It does not perform tests on biological samples.
- Intended Use: The intended use is for "dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures," which is achieved through imaging, not laboratory testing.
Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The RAYSCAN a- 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
RAYSCAN a- 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.
RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital X-ray
Anatomical Site
teeth, jaw, and oral structures, head.
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)
Electrical, mechanical, environmental safety and performance testing according to standard 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Orthophos XG 105 DS/Ceph Dental X-ray system(K033073)
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
MAR 1 5 2013
K122968
Page 1 of 4
510(k) Submission- RAYSCAN a - Expert
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date:
| APPLICANT | RAY Co.,Ltd |
|---|---|
| ADDRESS | #362-43 (218 Maeyoung Rd.) 3rd & 4th Floor, |
| Wonchun-dong, Youngtong-gu, Suwon-si, Gyeonggi-do, Korea | |
| Manufacturer | RAY Co., Ltd |
| #362-43 (218 Maeyoung Rd.) 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 |
| e-mail : yunjung.ha@raymedical.co.kr | |
| TEL : +82-31-605-1000 | |
| FAX : +82-2-6280-5534 |
Device Name
Trade/Proprietary Name : RAYSCAN a - 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
Orthophos XG 105 DS/Ceph Dental X-ray system(K033073)
Description
RAYSCAN a- 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.
RAYSCAN a- Expert offers digital imaging with or without the optional cephalometric attachment. The system includes processing, and archiving "SMARTDent "software(Optional)
Indication for use
The RAYSCAN a- 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.
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KI22918
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Statement of Substantial Equivalence
| | Parameter | RAYSCAN α-Expert
RAY Co.,Ltd | Orthophos XGPlus DS/Ceph
K033073 |
|-------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Common name | Dental panoramic and
cephalometric X-ray system | Dental panoramic and cephalometric X-
ray system |
| | 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. | The Orthophos XGPlus DS/Ceph 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
Operation | Continuous operation with
intermittent,
stated permissible loading | Continuous operation with
intermittent load |
| | Performance
Specification | Panoramic
Cephalometric(optional) | Panoramic
Cephalometric(optional) |
| | Imaging modality | Digital only | Digital only |
| Exam
mode | PANO | Normal
Pedodontics
TMJ
Sinus | Standard panorama
Standard panorama without ascending
branches
Pediatric program
Lateral
Axial
Sinus
Program for posterior teeth |
| | Ceph | PA, AP
Lateral
SMV
Carpus
Reverse Town's
Waters | PA
AP
Carpus |
| | Optional | | TSA(Transversal layers based on wide-
beam tomography) |
| | Detector
Type | Pano : Flat panel X-ray sensor
Ceph : Flat panel X-ray sensor | Pano : CCD X-ray sensor
Ceph : CCD X-ray sensor |
| | Control Panel | Touch monitor(Panel) | Easy Pad(Touch type) |
| | Main Component | Ceph Apparatus
Vertical Carriage
Rotator
X-RAY Generator
X-ray tube
High Frequency Generator
Column | Ceph Apparatus
Vertical Carriage
Rotator
X-ray Generator
X-ray tube
High Frequency Generator
Column |
| | | Touch monitor (panel) | Easy Pad (Touch type) |
| | | | |
| | Detector(Panoramic,
Cephalometric) | Detector(Panoramic,
Cephalometric) | |
| | Chinrest | Chinrest | |
| | Head rest | Head rest | |
| | Automatic Collimator | Collimator | |
| | Exposure switch | Exposure switch | |
| | Emergency stop switch | Emergency stop switch | |
| Automatic
Collimator | Yes | Yes | |
| | Bite block | Bite block | |
| Accessories | Chinrest(Patient support of the
stand type)
Chinrest(TMJ, Sinus and etc:) | Chinrest
(Patient support of the stand type) | |
| | Head rest | Head rest
(included temple support) | |
| | X-ray push button with
extensible cable | X-ray push button | |
| | Earload | Earplugs with holders | |
| | Nasal bar | Nose support | |
| | Remote controller(Optional) | Remote controller(Optional) | |
| Rated power | 110-240 V~, 50 / 60 Hz, 2.3kVA | 100-120 V, 220-240 V, 50/60Hz,
2.8kW | |
| | 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 | |
| Focal size | 0.5mm | 0.5mm | |
| X-ray Voltage | 6090kVp | 6090kVp | |
| X-ray Current | 417mA | 316mA | |
| Total Filtration | 2.6 mm Al equivalent | 2.5 mm Al equivalent | |
| Detector Pixel | Pano : 100 μm | Pano : 27 μm | |
| size | Ceph : 150 μm | Ceph : 27 μm | |
| Magnification | Pano : 1.31 | Pano : 1.25 | |
| | Ceph : 1.13 | Ceph : 1.25 | |
| | | Pano : 14.2sec | |
| Scan time | Pano : 14sec | Pano(Quickshot) : 9.1sec | |
| | Ceph : 0.3sec-3sec | Ceph : 9.14sec | |
| | | Ceph(Quickshot) : 4.7sec | |
| Format
compatible | DICOM 3.0 Format compatible | DICOM 3.0 Format compatible | |
| PC technical
Specifications
(Requirements
for PC system) | - OS : Windows 7, 32Bit
- CPU : Intel Dual core and over
- RAM : 4GB and over
- HDD : 500GB and over
- Network : Gigabit Ethernet
- Display : 32 bit color display
- Resolution : 1366x768 and over | - OS : Windows 2000 Workstation ,
Windows XP Professional Workstation
or Vista - RAM min. 256 MB
- HDD: > 4 GB/database
-
50 MB/SIDEXIS installation
- Network : 10/100 MBit Ethernet
- Resolution : 1024x768 and over | |
| Dimension | Panoramic
: 1,118mm x 1,481mm x 2,296mm
(WxDxH)
Panoramic +Cephalostic (optional)
: 1,672mmx 1,481mm x 2,296mm
(WxDxH) | Panoramic
: 1,042mm x 1,371mm x 2,249mm
(WxDxH)
Panoramic+Cephalostic(optional)
: 1,955mm x 1,371mm x 2,249mm
(WxDxH) | |
| Weight | Panoramic
: 147kg(324lb)
Panoramic+Cephalostic(optional)
: 164kg(361lb) | Panoramic
: 120kg(264lb)
Panoramic+Cephalostic(optional)
: 141kg(310lb) | |
| Type of
installation | Wall or floor mount | Wall or floor mount | |
| Patient position | Standing / Wheelchair | Standing / Wheelchair | |
| Applicable
Standards | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-1
IEC 60601-1-3
IEC 60601-2-7
IEC 60601-2-28
IEC 60601-2-32
IEC 60601-1-2 | |
| Certificate
Product | CE0120(MDD93/42/EEC) | CE0086(MDD93/42/EEC), FDA,SFDA | |
·
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K122918
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510(k) Submission - RAYSCAN a - Expert
Page 3 / 4
3
K1229.18
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510(k) Submission- RAYSCAN a - Expert
RAYSCAN a- Expert have 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 devices.
Safety and Effectiveness Information
Electrical, mechanical, environmental safety and performance testing according to standard 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 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, construction materials, principal of Operation, features and technical data, the RAYSCAN a- Expert system is safe and effective to perform its intended use as well as substantially equivalent to the Predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or supporting three abstract shapes, possibly representing people or services.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 15, 2013
Ray, Co., Ltd. % Mr. Andrew Paeng Consultant 8920 Wilshire Blvd., Suite 603 BEVERLY HILLS CA 90211
Re: K122918
Trade/Device Name: RAYSCAN α-Expert Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH 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. Iisting 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
5
Page 2 - Mr. 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 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Smh7)
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K122918
Device Name: RAYSCAN a- Expert
Indications for Use:
The RAYSCAN «- 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K122918 510(k)
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