K Number

Device Name

VIVIX-S 1417N

Manufacturer

VIEWORKS CO., LTD.

Date Cleared

2017-02-08

(41 days)

Product Code

MQB

Regulation Number

892.1680

Intended Use

VIVIX-S 1417N Series is used for the general-purpose diagnostic procedures, and as well as intended to replace radiographic film / screen systems. The VIVIX-S 1417N Series is not intended for mammography applications. FXRD-1417NAW and FXRD-1417NBW are indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.

Device Description

Models FXRD-1417NAW and FXRD-1417NBW intercept X-ray photons, and the scintillator emits visible spectrum photons that illuminate an array of photo (a-SI)-detectors that create an electrical signals. After the electrical signals are generated, these are converted to a digital value, and an image will be displayed on the monitor. These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic. Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

KDVIVIX-S 1717N, K152894

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "Advanced digital image processing" but does not explicitly mention AI, ML, or related terms like deep learning or neural networks. The performance studies focus on traditional imaging metrics and equivalence to a predicate device without any mention of AI/ML-specific validation.

Therapeutic

No
The device is described as being for "general-purpose diagnostic procedures" and "to digitalize X-ray images and transfer the digitalized images for radiography diagnostic," indicating it is used for diagnosis, not therapy.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is used for the general-purpose diagnostic procedures" and "replace film or screen based radiographic systems in all general purposes of diagnostic procedures."

SaMD (Software as a Medical Device)

The device description explicitly states that the device intercepts X-ray photons and converts them to electrical signals using an array of photo-detectors, which are hardware components. It also mentions integration with an operating PC and an X-Ray generator.

IVD (In Vitro Diagnostic)

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 VIVIX-S 1417N Series (including models FXRD-1417NAW and FXRD-1417NBW) is an X-ray detector. It intercepts X-ray photons and converts them into digital images for diagnostic purposes.
Intended Use: The intended use is for general-purpose diagnostic procedures using X-ray imaging of human anatomy. It replaces traditional film/screen systems for radiography.
No Sample Analysis: The device does not analyze samples taken from the body. It directly captures images generated by X-rays passing through the body.

Therefore, the function and intended use of this device clearly fall outside the scope of In Vitro Diagnostics. It is a medical imaging device used for diagnostic radiography.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

FXRD-1417NAW and FXRD-1417NBW are indicated for digital imaging solution designed as a general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures. It is not to be used for mammography.

Product codes

MQB

Device Description

These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.

Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.

Models FXRD-1417NAW and FXRD-1417NBW are digital X-ray flat panel detectors, and each model has a 14 x 17 inch imaging area.

Both FXRD-1417NAW and FXRD-1417NBW communicate by using a wireless communication feature (IEEE 602.Ila/b/g/n).

The scintillator used in FXRD-1417NAW is Csl andGadox was used for FXRD-1417NBW.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

human anatomy

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)

A comparison test was conducted between the subject devices (FXRD-1417NAW and FXRD-1417NBW) and the predicate device (K152894) on the items such as DQE, MTF and spatial resolution.

These detectors comply with the following international and FDA-recognized consensus standards:
[IEC 60601-1 2005, Edition 3.1] Medical Electrical Equipment -- Part 1: General Requirements For Basic Safety And Essential Performance
[IEC 60601-1-2, Edition 3] Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements And Tests
[IEC 62220-1, Edition 1.0] Medical electrical equipment - Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
[NEMA PS 3.1 - 3.20 2011] Digital Imaging and Communications in Medicine (DICOM) Set
[IEC 62133, Edition 2.0] IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Or Other Non-Acid Electrolytes•Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)

A single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices was conducted, and the study confirmed that the new x-ray detectors FXRD-1417NAW and FXRD-1417NBW provide images of equivalent diagnostic capability to the predicate devices, the VIVIX-S 1717N, and its results demonstrate substantial equivalence.

Clinical images were provided; these images were not necessary to establish substantial equivalence based on the differences from the predicate but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended.

The results of these tests demonstrate that FXRD-1417NAW and FXRD-1417NBW Digital X-ray detectors meet the acceptance criteria and are adequate for this intended use. The comparison of technological characteristics, non-clinical performance data, safety testing, and clinical image concurrence data demonstrates that the device is as safe, as effective, and performs as well the predicate devices.

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

Sensitivity linearity: Csl Linear, Gadox Linear
MTF: Csl min. 68 (typ. 72), Gadox min. 58 (typ. 60)
DQE: Csl min. 47 (typ.50), Gadox min. 25 typ.(27)
NPS: Csl 0.9, Gadox 1.09
Spatial Resolution: Csl 4.1-4.3, Gadox 3.8-4.1
Minimum Dose: Csl 0.2 uGy (2.5-2.8 cycles/mm), Gadox 0.3 uGy(2.5-2.8 cycles/mm)
Lag: Csl None, Gadox None
Quantum Limited Performance: CsI 0.004 (mR), Gadox 0.008(mR)
Image Acquisition: 2.0-2.5 sec
Black Level: 800-1,600

Predicate Device(s)

K152894

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Summary

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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 8, 2017

Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Suite 417 IRVINE CA 92620

Re: K163703

Trade/Device Name: VIVIX-S 1417N Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 5, 2017 Received: January 9, 2017

Dear Ms. Chung:

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.

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

Indications for Use

510(k) Number (if known)

K163703

Device Name VIVIX-S 1417N

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

__ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

[As required by 21 CFR 807.92]

This 510(k) summary information is prepared in accordance with 21 CFR807.92.

1. Date Prepared [21 CFR 807.92(a) (1)]

02/06/2017

2. Submitter's Information [21 CFR 807.92(a) (1)]

Name of Sponsor:	Vieworks Co., Ltd.
Address:	(Gwanyang-dong) 41-3, Burim-ro 170beon-gil, Dongan-gu
Anyang-si, Gyeonggi-do, 431-060 Republic of Korea
Contact Name:	Kim, Jordin / Regulatory AffairsAssociate
Registration Number:	3006013411
Name of Manufacturer:	Same as Sponsor

3. Trade Name, Common Name, Classification [21 CFR 807.92(a) (2)]

Trade Name:	VIVIX-S 1417N
Model Name:	FXRD-1417NAW
FXRD-1417NBW
Common Name:	Digital Flat Panel X-ray Detector
Classification Name:	Stationary x-ray system
Classification Panel:	Radiology
Classification Regulation:	21 CFR 892.1680
Product Code:	MQB
Device Class:	2

4. Identification of Predicate Device(s) [21 CFR 807.92(a) (3)]

510(k) Number:	K152894
Product Code:	MQB
Classification Name:	Stationary x-ray system
Classification Regulation:	21 CFR 892.1680
Applicant:	Vieworks Co., Ltd.
Trade Name:	VIVIX-S 1717N
Model Name:	FXRD-1717NA
FXRD-1717NB
FXRD-1717NAW
FXRD-1717NBW
Decision Date:	02/26/2016
Type:	Traditional

5. Description of the Device [21 CFR 807.92(a) (4)]

General Description o

These devices should be integrated with an operating PC and an X-Ray generator to digitalize Xray images and transfer the digitalized images for radiography diagnostic.

Advanced digital image processing allows considerably efficient diagnosis, all kinds of information management, andimage information sharing on the network.

Differences between models O

Models FXRD-1417NAW and FXRD-1417NBW are digital X-ray flat panel detectors, and each model has a 14 x 17 inch imaging area.

Both FXRD-1417NAW and FXRD-1417NBW communicate by using a wireless communication feature (IEEE 602.Ila/b/g/n).

The scintillator used in FXRD-1417NAW is Csl andGadox was used for FXRD-1417NBW.

Mode	Description
AED	The detector detects X-ray exposure from the generator automatically and then performs image acquisition without any cable connection.
DR Trigger	The detector and generator receive and send their signal to each other for image acquisition. SCU and X-ray generator should be connected with the generator interface cable.

Device Integration21 CFR 1020.30 (a) (1)(ii) O

6. Intended Use [21 CFR 807.92(a)(5)]

7. Technological Characteristics [21 CFR 807.92(a) (6)]

Comparisons with the predicate, devices show the technological characteristics of the proposed FXRD-1417NAW and FXRD-1417NBW devices to be substantially equivalent to the predicate devices. The proposed devices are functionally identical to the predicate devices.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92]

When compared to the predicate devices (K152894), the FXRD-1417NAW and FXRD-1417NBW presented in this submission has the same:

Intended Use
Operating principle
· Design features
Communication Method
Scintillator Materials
Resolution

There is similar performance as follow.

· Performance (MTF)
Performance (DQE)

There are no significant difference between the FXRD-1717NAW and FXRD-1717NBW and the predicate device that would adversely affect the use of the product. It is substantially equivalent to these devices in design, function, materials, operational principles and intended use.

Parameter	Predicate Devices	Subject Device
510(k) Number	K152894	K163703
Manufacturer	Vieworks Co., Ltd.
Model Name	FXRD-1717NA,
FXRD-1717NB,
FXRD-1717NAW,
FXRD-1717NBW	FXRD-1417NAW,
FXRD-1417NBW
Common Name	Digital Flat Panel X-ray Detector
Classification Name	Solid State X-Ray Imager (Flat Panel/Digital Imager)

Classification Panel	Radiology
Classification Regulation	21 CFR 892.1680
Product Code	MQB
Device Class	2
Intended Use	FXRD-1717NA, FXRD-1717NB,
FXRD-1717NAW and FXRD-
1717NBW are indicated for
digital imaging solution designed
as a general radiographic system
for human anatomy. It is
intended to replace film or
screen based radiographic
systems in all general purposes
of diagnostic procedures. It is
not to be used for
mammography.	FXRD-1417NAW and FXRD-
1417NBW are indicated for
digital imaging solution designed
as a general radiographic system
for human anatomy. It is
intended to replace film or
screen based radiographic
systems in all general purposes
of diagnostic procedures. It is not
to be used for mammography.
Design	Panel Shape	Square Panel	Square Panel
	Field of View	17 x 17inch	14 x 17inch
	Dimensions
(H x W x D)	460.0 x 460.0 x 15.5mm	384mm x 460mm x 15.0mm
	Pixel Pitch	0.14mm	0.14mm
	Materials Scintillator	Csl: TI,
Gd2O2S:Tb	Csl: TI,
Gd2O2S:Tb
Data
Transmission	Wired	Max. 1Gbps	Max. 1Gbps
	Wireless	• IEEE802.11n: Max. 300Mbps
(MIMO 2X2)	• IEEE802.11n: Max. 450Mbps
(MIMO 3X3)
• IEEE802.11ac: Max.
1300Mbps (MIMO 3X3)
	Communication Method	Wired only
Wireless & Wired	Wireless & Wired
Performance	DQE	FXRD-1717NAW:
min. 47 (typ.50)
FXRD-1717NBW:
min. 25 typ.(27)	FXRD-1417NAW:
min. 47 (typ.50)
FXRD-1417NBW:
min. 25 typ.(27)
	MTF	FXRD-1717NAW:
min. 68 (typ. 72)
FXRD-1717NBW:
min. 58 (typ. 60)	FXRD-1417NAW:
min. 68 (typ. 72)
FXRD-1417NBW:
min. 58 (typ. 60)
	Resolution	3.5 lp/mm	3.5 lp/mm
	Sensitivity
linearity	FXRD-1717NAW:
Linear
FXRD-1717NBW:
Linear	FXRD-1417NAW:
Linear
FXRD-1417NBW:
Linear
	NPS	FXRD-1717NAW:
0.9
FXRD-1717NBW:	FXRD-1417NAW:
0.9
FXRD-1417NBW:
	1.09	1.09
Spatial
Resolution	FXRD-1717NAW:
4.1-4.3	FXRD-1417NAW:
4.1-4.3
	FXRD-1717NBW:
3.8-4.1	FXRD-1417NBW:
3.8-4.1
Minimum
Dose	FXRD-1717NAW:
0.2 uGy (2.5-2.8 cycles/mm )	FXRD-1417NAW:
0.2 uGy (2.5-2.8 cycles/mm )
	FXRD-1717NBW:
0.3 uGy(2.5-2.8 cycles/mm)	FXRD-1417NBW:
0.3 uGy(2.5-2.8 cycles/mm)
Lag	FXRD-1717NAW:
Non	FXRD-1417NAW:
Non
	FXRD-1717NBW:
Non	FXRD-1417NBW:
Non
Quantum
Limited
Performance	FXRD-1717NAW:
0.004 (mR)	FXRD-1417NAW:
0.004 (mR)
	FXRD-1717NBW:
0.008(mR)	FXRD-1417NBW:
0.008(mR)
Image
Acquisition	2.0-2.5 sec	2.0-2.5 sec
Black Level	800-1,600	800-1,600

9. Summary of Non-Clinical Data

A comparison test was conducted between the subject devices (FXRD-1417NAW and FXRD-1417NBW) and the predicate device (K152894) on the items such as DQE, MTF and spatial resolution.

These detectors comply with the following international and FDA-recognized consensus standards:

| [IEC 60601-1 2005, Edition 3.1] | Medical Electrical Equipment -- Part 1: General
Requirements For Basic Safety And Essential Performance |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| [IEC 60601-1-2, Edition 3] | Medical Electrical Equipment - Part 1-2: General
Requirements For Basic Safety And Essential Performance -
Collateral Standard: Electromagnetic Compatibility -
Requirements And Tests |
| [IEC 62220-1, Edition 1.0] | Medical electrical equipment - Characteristics of digital X-
ray imaging devices - Part 1: Determination of the detective
quantum efficiency |
| [NEMA PS 3.1 - 3.20 2011] | Digital Imaging and Communications in Medicine (DICOM)
Set |

[IEC 62133, Edition 2.0] IEC 62133 Edition 2.0 2012-12 Secondary Cells And Batteries Containing Alkaline Or Or Other Non-Acid Electrolytes•Safety Requirements For Portable Sealed Secondary Cells, And For Batteries Made From Them, For Use In Portable Applications [Including: Corrigendum 1 (2013)

Test Item	Type	Subject Device	Predicate Device
Sensitivity
linearity	Csl	Linear	Linear
	Gadox	Linear	Linear
MTF	Csl	min. 68 (typ. 72)	min. 68 (typ. 72)
	Gadox	min. 58 (typ. 60)	min. 58 (typ. 60)
DQE	Csl	min. 47 (typ.50)	min. 47 (typ.50)
	Gadox	min. 25 typ.(27)	min. 25 typ.(27)
NPS	Csl	0.9	0.96
	Gadox	1.09	1.165
Spatial
Resolution	Csl	4.1-4.3	4.3-4.5
	Gadox	3.8-4.1	4.3-4.5
Minimum
Dose	Csl	0.2 uGy (2.5-2.8 cycles/mm)	0.2 uGy (2.5-2.8 cycles/mm )
	Gadox	0.3 uGy(2.5-2.8 cycles/mm)	0.3 uGy(2.5-2.8 cycles/mm)
Lag	Csl	None	None
	Gadox	None	None

| Quantum
Limited

Performance	CsI	0.004 (mR)	0.008 (mR)
	Gadox	0.008(mR)	0.014 (mR)
Image
Acquisition	-	2.0-2.5 sec	2.0-2.5 sec
Black Level	-	800-1,600	1,400-1,500

10. Summary of Clinical Data

11. Conclusion [21 CFR 807.92(b) (3)]

The FXRD-1417NAW and FXRD-1417NBW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices(K152894) in terms of design features, fundamental scientific technology, indications for use, and safety and effectiveness.

Additionally, Substantial equivalence was demonstrated through the non-clinical performance, which complied with the requirements specified in the international and FDA-recognized consensus standards, IEC60601-1-2, IEC62220-1 and NEMA PS 3.1 - 3.20, IEC 62133 and the clinical test, which complied with the requirements specified in the CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices.