RIOScan (RPS500)
Device Facts
| Record ID | K160788 |
|---|---|
| Device Name | RIOScan (RPS500) |
| Applicant | Ray Co., Ltd. |
| Product Code | MUH · Dental |
| Decision Date | Apr 15, 2016 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.1800 |
| Device Class | Class 2 |
Indications for Use
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental subspecialists. The system captures, displays and sores diagnostic intraoral radiographic images.
Device Story
RIOScan (RPS500) is a computed radiography scanner for dental intraoral applications. It processes reusable storage phosphor imaging plates exposed to x-rays. The device uses a laser to scan the plates, releasing stored energy as light, which is converted into digital image data. The system automatically erases the plate for reuse. It connects to a PC via Ethernet (RJ-45) for image display and storage. Operated by dentists or dental subspecialists in a clinical setting, the device provides digital images that assist in diagnostic decision-making. It lacks wireless transmission capabilities.
Clinical Evidence
Bench testing only. No clinical images were required. Performance was validated through non-clinical testing including MTF (Modulation Transfer Function) and DQE (Detective Quantum Efficiency) of the detector, showing >92% MTF and >45% DQE at 1 lp/mm. Electrical, mechanical, and environmental safety testing performed per IEC 60601-1; EMC testing per IEC 60601-1-2.
Technological Characteristics
Computed radiography scanner using storage phosphor plates. Laser scanning principle. Connectivity: Ethernet RJ-45 10/100 Mbs. Power: 24 VDC (external PSU 100-250 Vac). Laser safety: Class 1 (EN60825-1:2014). Image bit depth: 14-bit. Dimensions: 170 x 260 x 278 mm. Weight: 3.5 kg. Software: C# based, Windows 7/8 compatible.
Indications for Use
Indicated for capturing, digitization, and processing of intraoral x-ray images stored in imaging plate recording media for use by dentists and dental subspecialists.
Regulatory Classification
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.
Predicate Devices
Reference Devices
- RIOSensor (RIS500) (K143000)
Submission Summary (Full Text)
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 15, 2016
RAY Co. Ltd. % Mr. Changhwan Lee Regulatory Affairs Manager 332-7 Samsung 1-ro, Hwaseong-si 445-330 Gyeonggi-do REPUBLIC OF KOREA
Re: K160788
Trade/Device Name: RIOScan (RPS500) Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 15, 2016 Received: March 22, 2016
Dear Mr. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (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.
Michael D.'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
# Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K160788
Device Name Trade Name: RIOScan Proprietary Name: RPS500 Common Name: Computed radiography scanner system
### Indications for Use (Describe)
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental subspecialists. The system captures, displays and sores diagnostic intraoral radiographic images.
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.*
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FORM FDA 3881 (8/14)
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# 510(k) Summary
The summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR Part 807.92.
| Date: | February 15, 2016 |
|----------------|-------------------------------------------------------------------------------|
| APPLICANT | RAY Co., Ltd |
| ADDRESS | #332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea |
| Manufacturer | RAY Co., Ltd<br>332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea |
| | TEL: +82-31-605-1000<br>FAX: +82-2-6280-5534 |
| Contact Person | Changwhan.Lee<br>e-mail: ch0406.lee@raymedical.co.kr |
# Device Name
Trade Name: RIOScan Proprietary Name: RPS500 Common Name: Computed radiography scanner system.
# Classification
Regulation Name: Extraoral Source X-ray System. Classification name: X-ray, Extraoral, Source, Digital Regulatory Number: 21 CFR 872.1800 Class: II Product code: MUH Panel: Radiology
# Description
RIOScan(Model RPS500) is Computed radiography system for dental intraoral applications. Imaging plates (i.e, storage phorsphor plates) are exposed in the same way as traditional x-ray film. The x-ray images on these plates are then fed into a small computed radiography system and scanned using a laser. The scanned image data form the plates is digitized and the images are displayed on a monitor and saved to computer.
RPS500 is capable of scanning the X-ray exposed imaging plates at various speed, sizes and resolutions. Once an imaging is scanned, the image data is automatically erased form the plate and the plate ejected reuse.
Ray Co.,Ltd
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RIOScan digital scanner doesn't have a wireless option for data transmission
# Indication for use
This system is a digital intraoral dental radiographic imaging system intended for use by dentists and dental sub-specialists. The system captures, digitizes, displays and sores diagnostic intraoral radiographic images.
# Predicate device
- 1) Predicate device-1 Manufacturer: PaloDEx Group Oy Device: DIGORA Optime (DXR-60) 510(k) Number: K133231
- 2) Predicate device-2 Manufacturer: 3D Imaging & Simulations Corp Device: FireCR Dental Imaging SYstem 510(k) Number: K131442
# Statement of Substantial Equivalence
| Parameter | Proposed Device | Predicated Device | Predicated Device |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufactur<br>er | RAY Co., Ltd | PaloDEx Group Oy | 3D Imaging & Simulations Corp |
| Device<br>Name | RIOScan | DIGORA® Optime (DXR-60) | FireCR DENTAL IMAGING<br>SYSTEM |
| 510(K)<br>Number | - | K133231 | K131442 |
| Feature | Image: RIOScan | Image: DIGORA® Optime (DXR-60) | Image: FireCR DENTAL IMAGING SYSTEM |
| | | | |
| Intended<br>use | The RIOScan(Model RPS500)is a<br>digital intraoral dental radiographic<br>imaging system intended for use by<br>dentists and dental sub-specialists.<br>The system captures, digitizes,<br>displays and stores diagnostic<br>intraoral radiographic images. | SOREDEX® DIGORA® Optime<br>system is intended to be used only<br>by dentist and other qualified<br>dental professional to process x-<br>ray images exposed to the imaging<br>plates from the intraoral complex<br>of the skull | The FireOR Dental imaging<br>system is indicated for capturing,<br>digitization and processing of intra<br>oral x-ray images stored in<br>imaging plate recording media |
| Indications<br>for use | The RIOScan scanner system is<br>indicated for capturing, digitization<br>and processing of intra oral x-ray<br>images stored in imaging plate<br>recording media. | The DIGORAO® Optime imaging<br>system is indicated for capturing,<br>digitization and processing of intra<br>oral x-ray images stored in<br>imaging plate recording media. | The FireCR Dental imaging<br>system is indicated for capturing,<br>digitization and processing of intra<br>oral x-ray images stored in<br>imaging plate recording media |
| Device<br>Description | RIOScan(Model RPS500) is<br>Computed radiography system<br>for dental intraoral applications.<br>Imaging plates (i.e, storage<br>phorsphor plates) are exposed<br>in the same way as traditional<br>x-ray film. The x-ray images on<br>these plates are then fed into a<br>small computed radiography<br>system and scanned using a<br>laser. The scanned image data<br>form the plates is digitized and<br>the images are displayed on a<br>monitor and saved to computer.<br>RPS500 is capable of scanning<br>the X-ray exposed imaging<br>plates at various speed, sizes<br>and resolutions. Once an<br>imaging is scanned, the image<br>data is automatically erased<br>form the plate and the plate<br>ejected reuse. RIOScan digital<br>scanner doesn't have a wireless<br>option for data transmission | DIGORA® Optime(DXR-60) is a<br>digital radiography system for intra<br>oral imaging plates located in<br>disposable bags. The system may<br>be used with all x-ray equipment<br>which is designed for intra oral<br>radiography. The image is<br>recorded on reusable imaging plate<br>which substitutes for conventional<br>x-ray film or digital sensor. The x-<br>ray energy absorbed in the imaging<br>plate remains stored as a latent<br>image. When fed to the device the<br>stored energy is released as an<br>optical emission proportional to<br>the stored energy when the<br>imaging plate is stimulated pixel<br>by pixel by a scanning laser. An<br>optical system collects the<br>emission for photo electronic<br>system, which converts the<br>emission to digital electronic<br>signals. These signals are<br>processed in a computer system<br>which formats and stores the<br>signals.<br>Further image processing, display<br>and achieving are carried out with<br>auxiliary software. | The FireCR Dental is Computed<br>Radiography Reader which<br>produces the X-ray diagnostic<br>image in digital format instead of<br>using traditional screens and film.<br>This device utilizes reusable X-ray<br>storage phosphor plate (imaging<br>Plate) that is sensitive to X-ray and<br>stores latent image when it is<br>exposed to X-ray. After X-ray<br>exposure to the X-ray storage<br>phosphor plate, X-ray storage<br>phosphor plate is scanned by<br>means of laser in the device. Latent<br>image in the X-ray storage<br>phosphor plate is released in a<br>form of light by laser scanning.<br>Then the light is collected and<br>converted into a form of digital<br>image. The signal processing is<br>made to the digital image data such<br>as the digital filtering, the gain &<br>offset correction and flat fielding.<br>The image can then be viewed on a<br>computer workstation, adjusted if<br>necessary, then stored locally, sent<br>to an archive, printed or sent to<br>PACS system. After acquisition of<br>latent image from the X-ray<br>storage phosphor plate, it is erased<br>thoroughly to be reused. |
| Available<br>Image plate | Size: 0, 1, 2, 3, 4 | Size: 0, 1, 2, 3 | Size: 0, 1, 2, 3 |
| Image plate<br>size | Size 0<br>22 x 35 mm<br>Size 1<br>24 x 40 mm<br>Size 2<br>31 x 41 mm<br>Size 3<br>27 x 54 mm | Size 0<br>22 x 31 mm<br>Size 1<br>24 x 40 mm<br>Size 2<br>31 x 41 mm<br>Size 3<br>27 x 54 mm | Size 0<br>22 x 31 mm<br>Size 1<br>24 x 40 mm<br>Size 2<br>31 x 41 mm<br>Size 3<br>27 x 54 mm |
| Resolution<br>(Theoretica<br>1) | HS<br>9 lp/mm<br>16 lp/mm<br>HR<br>21 lp/mm<br>SHR | 16.7 lp/mm | HS<br>7.8 lp/mm<br>HR<br>14.3 lp/mm |
| Pixel size<br>(selectable) | 24 um (High speed)<br>32 um (Super resolution)<br>56 um (Super High resolution) | 30 um (Super resolution)<br>60 µm (High resolution) | 35 um (Super resolution)<br>64 um (High resolution) |
| Image data<br>bit depth | 14 bit | 14 bit | 16bit |
| Operating<br>voltage | 24 VDC (External PSU 100-250<br>Vac, 50/60Hz) | 24 VDC (External PSU 100-250<br>Vac, 50/60Hz) | 24 VDC (External PSU 100-250<br>Vac, 50/60Hz) |
| Laser<br>safety<br>classificatio<br>n | Class 1 laser product EN60825-<br>1:2014(Third Edition) | Class 1 las er product EN60825-<br>1:2007 | Class 1 laser product EN60825-<br>1:2007 |
| Interface | Ethernet RJ-45 10/100 Mbs LAN | Ethernet RJ-45 10/100 Mbs LAN | Ethernet RJ-45 10/100 Mbs LAN |
| MTF | More than 35% at 3 lp/mm | 32% at 3 lp/mm | 34% at 3 lp/mm |
| DQE | More than 10% at 3 lp/mm | 10% at 2.4 lp/mm | 10% at 2.6 lp/mm |
| Erasing | Auto | Auto | Auto |
| Dimensions<br>(W x H x<br>D) | 170 mm x 260 mm x 278 mm | 152 mm x 227 mm x 308 mm | 265 mm x 120 mm x 318 mm |
| Weight | 3.5 kg | 3.5 kg | 4.7 kg |
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The intended use, constructions, construction materials, technical characteristics and safety characteristics between RPS500 and Its predicate device are same.
Accordingly we can claim the substantially equivalence of RPS500 to the predicate device.
# Safety and Effectiveness Information:
Electrical, mechanical and environmental safety testing according to standard of IEC 60601-1(2005+ CORR.1(2006)+CORR.2(2007) was performed. EMC testing was conducted in accordance with the standard IEC 60601-1-2(2007).
The software of RPS500 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 guidance document.
The software of RPS500 is based on a RIOSenser software(K143000).
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# Software release version
| Ver 1.0.0.0 | Ver 1.1.1.0 |
|----------------------------------------|--------------------------------------|
| Initial release for RIOSensor (RIS500) | Initial release for RIOScan (RPS500) |
| K143000 | K160788 |
## Compares the characteristics
| | Ver 1.0.0.0 | Ver 1.1.1.0 | Remark |
|-------------------------------------------|--------------------------------------------|----------------------------------------------|-----------------------------|
| Resolution | 1280 X 800 or higher | 1280 X 800 or higher | |
| Graphic | Video RAM over<br>512MB | Video RAM over<br>512MB | |
| Language | C# | C# | |
| Development<br>Library<br>& Platform | Net Framework 4.0<br>Microsoft DirectX SDK | Net Framework 4.0<br>Microsoft DirectX SDK | |
| Configuration<br>Intraoral<br>sensor type | RIO Sensor<br>(RIS 500 -K143000) | RIOSensor<br>(RIS 500 -K143000)<br>RIOScan | Add the device<br>(RIOScan) |
| Image<br>Processing | RIOSensor Image Func. | RIOSensor Image Func.<br>RIOScan Image Func. | Add the device<br>(RIOScan) |
| Export | CD/DVD export<br>USB export | CD/DVD export<br>USB export | |
| Print | Paper print and<br>DICOM print | Paper print and<br>DICOM print | |
| OS | Window 7,8(32or 64bit) | Window 7,8(32or 64bit) | |
## Similarities:
In case of the RioView Ver1.0.0.0 for RioSensor(RIS500) and RioView Ver 1.1.1.0 for RioScan(RPS500), similarities exist in the resolution, graphic, OS, method of export and print. Both software version operating principles and operating methods are also similar, power is supplied through the USB interface port for operation and Data is transmitted to a personal PC.
### Differences:
There are no difference between RioView Ver 1.0.0.0 for RioSenser(RIS500) and RioView Ver 1.1.1.0 for RioScan(RPS500) as far as purpose of use, operating principles and operating methods are concerned.
The main differences exist in available device, have been added the RioScan(RPS500) to available device in RioView Ver 1.1.1.0.
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Non-clinical considerations were conducted in accordance with FDA Guidance for the submissions of 510(k)'s for Solid State X-ray Imaging Devices".
"In the case of the RioScan system, clinical images are not necessary to establish substantial equivalence, and the non-clinical performance data alone show that the device works as intended. All test results were satisfactory."
The tests include the MTF(Modulation Transfer Function) and DQE(Detective Quantum Efficiency) of detector. MTF of detector shows the resolution more than 92% at 1 1p/mm and The DQE of detector sh…
