Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the hardware and basic image processing steps (scanning, digitizing, displaying, saving) without mentioning any AI/ML algorithms for image analysis, interpretation, or enhancement beyond standard digital radiography processing. The performance studies also focus on traditional imaging metrics (MTF, DQE) rather than AI/ML performance metrics.

Therapeutic

No
The device is an imaging system designed to capture, display, and store diagnostic radiographic images, not to treat a condition or disease.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section explicitly states that the system "captures, displays and sores diagnostic intraoral radiographic images." This directly indicates its diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "Computed radiography system" and describes hardware components like imaging plates, a scanner with a laser, and a physical connection for data transmission. While it involves software for image processing and display, it is fundamentally a hardware system.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the system is for capturing, displaying, and storing diagnostic intraoral radiographic images. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (which is the definition of an IVD).
Device Description: The description details a system for processing X-ray images from imaging plates. This aligns with a radiographic imaging system, not an IVD.
Input Imaging Modality: The input is X-ray, which is a form of medical imaging, not a method for analyzing biological samples.
Anatomical Site: The anatomical site is the intraoral complex of the skull, which is imaged directly, not through the analysis of a specimen.

IVDs are devices used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform such tests. It is a medical imaging device used to visualize anatomical structures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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

MUH

Device 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.
RIOScan digital scanner doesn't have a wireless option for data transmission

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Intraoral dental

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Dentists and dental sub-specialists

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

MTF of detector shows the resolution more than 92% at 1 1p/mm and The DQE of detector shows the resolution more than 45% at 1 1p/mm.

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.

K133231, K131442

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.

K143000

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

Regulation Number and Section

§ 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.

Summary

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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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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
332-7, Samsung 1-ro, Hwaseong-si, Gyeonggi-do, 443-823, Korea
	TEL: +82-31-605-1000
FAX: +82-2-6280-5534
Contact Person	Changwhan.Lee
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
1. 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
er	RAY Co., Ltd	PaloDEx Group Oy	3D Imaging & Simulations Corp
Device
Name	RIOScan	DIGORA® Optime (DXR-60)	FireCR DENTAL IMAGING
SYSTEM
510(K)
Number	-	K133231	K131442
Feature	Image: RIOScan	Image: DIGORA® Optime (DXR-60)	Image: FireCR DENTAL IMAGING SYSTEM

Intended
use	The RIOScan(Model RPS500)is a
digital intraoral dental radiographic
imaging system intended for use by
dentists and dental sub-specialists.
The system captures, digitizes,
displays and stores diagnostic
intraoral radiographic images.	SOREDEX® DIGORA® Optime
system is intended to be used only
by dentist and other qualified
dental professional to process x-
ray images exposed to the imaging
plates from the intraoral complex
of the skull	The FireOR Dental imaging
system is indicated for capturing,
digitization and processing of intra
oral x-ray images stored in
imaging plate recording media
Indications
for use	The RIOScan scanner system is
indicated for capturing, digitization
and processing of intra oral x-ray
images stored in imaging plate
recording media.	The DIGORAO® Optime imaging
system is indicated for capturing,
digitization and processing of intra
oral x-ray images stored in
imaging plate recording media.	The FireCR Dental imaging
system is indicated for capturing,
digitization and processing of intra
oral x-ray images stored in
imaging plate recording media
Device
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. RIOScan digital
scanner doesn't have a wireless
option for data transmission	DIGORA® Optime(DXR-60) is a
digital radiography system for intra
oral imaging plates located in
disposable bags. The system may
be used with all x-ray equipment
which is designed for intra oral
radiography. The image is
recorded on reusable imaging plate
which substitutes for conventional
x-ray film or digital sensor. The x-
ray energy absorbed in the imaging
plate remains stored as a latent
image. When fed to the device the
stored energy is released as an
optical emission proportional to
the stored energy when the
imaging plate is stimulated pixel
by pixel by a scanning laser. An
optical system collects the
emission for photo electronic
system, which converts the
emission to digital electronic
signals. These signals are
processed in a computer system
which formats and stores the
signals.
Further image processing, display
and achieving are carried out with
auxiliary software.	The FireCR Dental is Computed
Radiography Reader which
produces the X-ray diagnostic
image in digital format instead of
using traditional screens and film.
This device utilizes reusable X-ray
storage phosphor plate (imaging
Plate) that is sensitive to X-ray and
stores latent image when it is
exposed to X-ray. After X-ray
exposure to the X-ray storage
phosphor plate, X-ray storage
phosphor plate is scanned by
means of laser in the device. Latent
image in the X-ray storage
phosphor plate is released in a
form of light by laser scanning.
Then the light is collected and
converted into a form of digital
image. The signal processing is
made to the digital image data such
as the digital filtering, the gain &
offset correction and flat fielding.
The image can then be viewed on a
computer workstation, adjusted if
necessary, then stored locally, sent
to an archive, printed or sent to
PACS system. After acquisition of
latent image from the X-ray
storage phosphor plate, it is erased
thoroughly to be reused.
Available
Image plate	Size: 0, 1, 2, 3, 4	Size: 0, 1, 2, 3	Size: 0, 1, 2, 3
Image plate
size	Size 0
22 x 35 mm
Size 1
24 x 40 mm
Size 2
31 x 41 mm
Size 3
27 x 54 mm	Size 0
22 x 31 mm
Size 1
24 x 40 mm
Size 2
31 x 41 mm
Size 3
27 x 54 mm	Size 0
22 x 31 mm
Size 1
24 x 40 mm
Size 2
31 x 41 mm
Size 3
27 x 54 mm
Resolution
(Theoretica

```
  | HS
```

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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
Resolution	1280 X 800 or higher	1280 X 800 or higher
Graphic	Video RAM over
512MB	Video RAM over
512MB
Language	C#	C#
Development
Library
& Platform	Net Framework 4.0
Microsoft DirectX SDK	Net Framework 4.0
Microsoft DirectX SDK
Configuration
Intraoral
sensor type	RIO Sensor
(RIS 500 -K143000)	RIOSensor
(RIS 500 -K143000)
RIOScan	Add the device
(RIOScan)
Image
Processing	RIOSensor Image Func.	RIOSensor Image Func.
RIOScan Image Func.	Add the device
(RIOScan)
Export	CD/DVD export
USB export	CD/DVD export
USB export
Print	Paper print and
DICOM print	Paper print and
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 shows the resolution more than 45% at 1 1p/mm.

Base on the Non-Clinical Test report, Even though the pixel size and active area of predicate detectors are different, the diagnostic image quality of RPS500 detector is equal or better than that of predicate device and there is no significant difference in efficiency and safety.

Conclusions

In accordance with the federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification. RAY Co., LTD concludes that the RPS500 is safe and effective to perform its intended use as well as substantially equivalent to the predicate device.