(150 days)
No
The summary describes standard digital image processing for an X-ray detector and does not mention AI, ML, or related concepts.
No.
The device is indicated for diagnostic procedures, specifically digital imaging and X-ray image digitalization for radiography diagnosis, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is intended to replace film or screen based radiographic systems in all general purposes of diagnostic procedures." Additionally, the "Device Description" mentions that the device is used "for radiography diagnostic" and enables "considerably efficient diagnosis."
No
The device description explicitly details hardware components (scintillator, photo-detectors) that intercept X-ray photons and convert them to electrical signals, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "digital imaging solution designed as a general radiographic system for human anatomy." This describes an in-vivo imaging device, not a device used to examine specimens taken from the body (in vitro).
- Device Description: The description details how the device captures X-ray photons and converts them into digital images for display and diagnosis. This is consistent with an in-vivo imaging system.
- Input Imaging Modality: The input modality is X-ray, which is used for imaging the inside of the body directly, not for analyzing samples.
IVD devices are used to examine specimens such as blood, urine, or tissue outside of the body to diagnose diseases or other conditions. This device operates by imaging the human body directly with X-rays.
N/A
Intended Use / Indications for Use
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is 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
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW 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, and image information sharing on the network.
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW are digital X-ray flat panel detectors, and each model has a 10 x 12 inch imaging area.
FXRD-1012NA and FXRD-1012NB communicate by using a wired communication feature (Gigabit Ethernet communication method by connecting to a tether cable), while FXRD-1012NAW and FXRD-1012NBW communicate by using a wireless communication feature (IEEE 602.lla/b/g/n).
The scintillator used in FXRD-1012NA and FXRD-1012NAW is Csl. Gadox was used for FXRD-1012NB and FXRD-1012NBW.
The FXRD-1012N series is designed to be used with any certified X-ray generators that features DR Trigger mode and is marketed legally. When the DR Trigger mode is not desired, then the connection with the generator can be maintained with AED mode. FXRD-1012N is not designed to function as an X-ray control. The AED mode does not require integration procedure since there is no connection requirement between the X-ray System and the detector. The subject device can receive any types of x-ray signals without SW.
For the DR Trigger mode, the generator interface cable connects the SCU and the X-ray generator. The head of the cable is connected with one of the port (EXT-INF) of the SCU, and the other end of the cable (which is stripped) is connected to the generator's socket.
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: Single-blinded concurrence study.
Sample Size: Not specified.
Data Source: Not specified.
Annotation Protocol: Not specified.
Standalone Performance: Not specified.
Key Results: The study confirmed that the new x-ray detectors FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW provide images of equivalent diagnostic capability to the predicate device (K122865), the ViVIX-S wireless (FXRD-1417WA and FXRD-1417WB), and its results demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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, 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 26, 2016
Vieworks Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 2651 E. Chapman Avenue, Suite 110 FULLERTON CA 92831
Re: K152855
Trade/Device Name: VIVIX-S 1012N Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: January 28, 2016 Received: February 2, 2016
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.
1
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
2
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) K152855
Device Name
VIVIX-S 1012N
Indications for Use (Describe)
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) is 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.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
3
510(k) Summary
[As required by 21 CFR 807.92] (K152855)
This 510(k) summary of safety and effectiveness information is prepared in accordance with 21 CFR807.92
1. Date Prepared [21 CFR 807.92(a) (1)]
01/28/2016
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: | Im, Yoonjae / RAQA team Manager |
| 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 1012N |
|---|---|
| Model Name: | FXRD-1012NA |
| FXRD-1012NB | |
| FXRD-1012NAW | |
| FXRD-1012NBW | |
| 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)]
Primary Predicate Device:
.
510(k) Number: K122866 Product Code: MQB Applicant: Vieworks Co., Ltd. Trade Name: ViVIX-S with VXvue
4
| Model Name: | FXRD-1417SA |
|---|---|
| FXRD-1417SB | |
| FXRD-1717SA | |
| FXRD-1717SB | |
| Decision Date: | 01/11/2013 |
Reference Predicate Device
| • 510(k) Number: | K122865 |
|---|---|
| Product Code: | MQB |
| Applicant: | Vieworks Co., Ltd. |
| Trade Name: | ViVIX-S Wireless |
| Model Name: | FXRD-1417WA |
| FXRD-1417WB | |
| Decision Date: | 02/01/2013 |
5. Description of the Device [21 CFR 807.92(a) (4)]
General Description o
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW 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, and image information sharing on the network.
Differences between models O
Models FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW are digital X-ray flat panel detectors, and each model has a 10 x 12 inch imaging area.
FXRD-1012NA and FXRD-1012NB communicate by using a wired communication feature (Gigabit Ethernet communication method by connecting to a tether cable), while FXRD-1012NAW and FXRD-1012NBW communicate by using a wireless communication feature (IEEE 602.lla/b/g/n).
The scintillator used in FXRD-1012NA and FXRD-1012NAW is Csl. Gadox was used for FXRD-1012NB and FXRD-1012NBW.
The FXRD-1012N series is designed to be used with any certified X-ray generators that features DR Trigger mode and is marketed legally. When the DR Trigger mode is not desired, then the connection with the generator can be maintained with AED mode. FXRD-1012N is not designed to function as an X-ray control. The AED mode does not require integration procedure since there is no connection requirement between the X-ray System and the detector. The subject device can receive any types of x-ray signals without SW.
For the DR Trigger mode, the generator interface cable connects the SCU and the X-ray generator. The head of the cable is connected with one of the port (EXT-INF) of the SCU, and the other end of the cable (which is stripped) is connected to the generator's socket.
5
6. Intended Use [21 CFR 807.92(a)(5)]
VIVIX-S 1012N (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW)is 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.
7. Technological Characteristics [21 CFR 807.92(a) (6)]
Comparisons with the predicate, devices show the technological characteristics of the proposed FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW 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 (K122865 andK122866),the FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW presented in this submission have the same:
- · Intended Use
- Technological characteristics
- Operating principle
- · Design features
- Communication Method
- ScintillatorMaterials
- Resolution
There are similar performance characteristics as follow.
- Performance (MTF)
- Performance (DQE)
There are no significant difference between the FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW and the predicate devices 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 | Reference Predicate
Devices | Primary Predicate
Devices | Subject Device |
|---------------|--------------------------------|----------------------------------------------|-----------------------------------------------|
| 510(k) Number | K122865 | K122866 | K152855 |
| Manufacturer | Vieworks Co., Ltd. | | |
| Model Name | FXRD-1417WA,
FXRD-1417WB | FXRD-1417SA,
FXRD-1417SB,
FXRD-1717SA, | FXRD-1012NA,
FXRD-1012NB,
FXRD-1012NAW, |
6
| Common Name | FXRD-1717SB | FXRD-1012NBW | ||||
|---|---|---|---|---|---|---|
| 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 | The VIVIX-S Wireless is | |||||
| 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. | VIVIX-S with VXvue is | |||||
| indicated for digital | ||||||
| imaging solution | ||||||
| designed for general | ||||||
| radiographic system | ||||||
| for human anatomy. It | ||||||
| is intended to replace | ||||||
| film or screen based | ||||||
| radiographic systems | ||||||
| in all general purpose | ||||||
| diagnostic procedures. | ||||||
| Not to be used for | ||||||
| mammography. | FXRD-1012NA, FXRD- | |||||
| 1012NB, FXRD- | ||||||
| 1012NAW and FXRD- | ||||||
| 1012NBW 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 | Square Panel | ||
| Field of View | 14 x 17inch | 14 x 17inch | ||||
| 17 x 17inch | 10 x 12inch | |||||
| Dimensions | ||||||
| (H x W x D) | 444 x 460 x15mm | 444 x 460 x15 mm 470 | ||||
| x 470x 35mm | 287.0 x 350.0 x | |||||
| 15.0mm | ||||||
| Pixel Pitch | 0.14mm | 0.14mm | 0.124mm | |||
| Materials Scintillator | Csl: TI, | |||||
| Gd2O2S:Tb | Csl: TI, | |||||
| Gd2O2S:Tb | Csl: TI, | |||||
| Gd2O2S:Tb | ||||||
| Performance | DQE | - | Csl | Csl | ||
| 0.5 lp/mm | - | 59 | 59 | |||
| 1 lp/mm | - | 53 | 53 | |||
| 2 lp/mm | - | 45 | 45 | |||
| 3 lp/mm | - | 27 | 34 | |||
| DQE | - | Gadox | Gadox | |||
| 0.5 lp/mm | - | 37 | 37 | |||
| 1 lp/mm | - | 31 | 31 | |||
| 2 lp/mm | - | 20 | 20 | |||
| 3 lp/mm | - | 9 | 11 | |||
| MTF | - | Csl | Csl | |||
| 0.5 lp/mm | - | 81 | 87 | |||
| 1 lp/mm | - | 58 | 71 | |||
| 2 lp/mm | - | 28 | 43 | |||
| 3 lp/mm | - | 15 | 22 |
7
| MTF | - | Gadox | Gadox |
|---|---|---|---|
| 0.5 lp/mm | - | 80 | 80 |
| 1 lp/mm | - | 56 | 56 |
| 2 lp/mm | - | 24 | 26 |
| 3 lp/mm | - | 10 | 11 |
| Resolution | - | 3.5 lp/mm | 4.0 lp/mm |
| Communication Method | Wireless | Wired | Wired, |
| Wireless |
9. Summary of Non-Clinical Data
A comparison test was conducted between the subject devices (FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW) and the predicate device (K122866) on the items such as DQE, MTF and spatial resolution.Test results support that the subject device is substantially equivalent to the predicate device.
These detectors comply with the following international and FDA-recognized consensus standards:
| [IEC 60601-1 2005, Edition 3.0] | 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 |
| [ETSI] [EN 300 328 1.8.1] | Electromagnetic compatibility and Radio spectrum Matters
(ERM); Wideband transmission systems; Data transmission
equipment operating in the 2,4 GHz ISM band and using
wide band modulation techniques; Harmonized EN
covering the essential requirements of article 3.2 of the
R&TTE Directive |
| [ETSI EN 301 893 1.7.1] | Broadband Radio Access Networks (BRAN); 5 GHz high
performance RLAN; Harmonized EN covering the essential
requirements of article 3.2 of the R&TTE Directive |
| [IEC 62133, Edition 2.0] | IEC 62133 Edition 2.0 2012-12 Secondary Cells And
Batteries Containing Alkaline 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) |
8
10. Summary of Clinical Data
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-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW provide images of equivalent diagnostic capability to the predicate device(K122865), the ViVIX-S wireless (FXRD-1417WA and FXRD-1417WB), and its results demonstrate substantial equivalence.
11. Conclusion [21 CFR 807.92(b) (3)]
The FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW Digital X-ray detectors are substantially equivalent to the currently marketed and predicate devices (K122865, and K122866) 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.
The results of these tests demonstrate that FXRD-1012NA, FXRD-1012NB, FXRD-1012NAW and FXRD-1012NBW 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.