(115 days)
No
The document describes a standard digital X-ray detector and image processing system. There is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The "advanced digital imaging process" is a general term and does not specifically indicate AI/ML.
No
The device is described as a 'digital X-ray flat panel detector' for 'general purpose diagnostic procedures' and transfers 'digitalizing X-ray images' for 'radiography diagnostic', indicating it is used for diagnostic imaging, not therapy.
Yes
The device is described as being intended for "general purpose diagnostic procedures" and for facilitating "considerably efficient diagnosis," directly indicating its role in the diagnostic process.
No
The device description explicitly states it is a "digital X-ray flat panel detector" which is a hardware component that intercepts X-ray photons and converts them into electrical signals. While it includes software (VXvue) for image processing and display, it is not solely software.
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 for general radiographic system for human anatomy." This describes a device used for in vivo imaging (imaging within a living organism), not in vitro testing (testing outside of the body, typically on biological samples).
- Device Description: The description details a digital X-ray flat panel detector that captures X-ray photons and converts them into digital images. This is consistent with a medical imaging device used on patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or performing tests on specimens outside of the body, which are hallmarks of IVD devices.
Therefore, the ViVIX-S with VXvue is a medical imaging device, specifically a digital X-ray detector, and not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MQB
Device Description
ViVIX-S with VXvue is a digital X-ray flat panel detector which has 43x43cm (FXRD-1717SA, FXRD-1717SB) or 35.8x43cm (FXRD-1417SA, FXRD-1417SB) imaging area.
The device intercepts 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, it is converted to digital value, and the images will be displayed on monitors.
This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, and sharing of image information on network.
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
Clinical study: A concurrence study of 30 clinical images was conducted to compare the performance of the ViVIX-S with VXvue to the predicate device (K120020). There were no significant differences between the images of the ViVIX-S with VXvue and the predicate device images.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
K 12 28 bb
510(k) Summary
JAN 1 1 2013
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: SEP. 11, 2012_
Company and Correspondent making the submission:
Name - Vieworks Co., Ltd.
Address - #604, Suntechcity 2, 307-2, Sangdaewon-dong, Jungwon-gu,
Seongnam-city, Gyeonggi-do, 462-806 South Korea
Telephone – +82-70-7011-6176
Fax - +82-31-737-4953 ·
Contact - Ms. Sungwhie Kim
Internet – http://www.vieworks.com
Proposed Device :
| Trade/ Proprietary Name | : VIVIX-S with VXvue |
|---|---|
| Classification Name | : Solid State X-ray Image |
| Product Code | : MQB |
| Device Class | : 2 |
| Regulation Number | : 892.1680 |
Predicate Device :
| Manufacturer | : Vieworks Co., Ltd. |
|---|---|
| Trade/ Proprietary Name | : VIVIX-S |
| Classification Name | : Solid State X-ray Imager |
| Product Code | : MQB |
| Device Class | : 2 |
| 510(k) Number | : K120020 |
1
Description:
ViVIX-S with VXvue is a digital X-ray flat panel detector which has 43x43cm (FXRD-1717SA, FXRD-1717SB) or 35.8x43cm (FXRD-1417SA, FXRD-1417SB) imaging area.
The device intercepts 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, it is converted to digital value, and the images will be displayed on monitors.
This device should be integrated with an operating PC and an X-Ray generator to utilize as digitalizing X-ray images and transfer for radiography diagnostic. Advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, and sharing of image information on network.
Intended use:
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.
Comparison with predicate device:
The imaging principle, intended use, technology and materials of ViVIX-S with VXvue are substantially equivalent to the predicate device, ViVIX-S of Vieworks Co., Ltd. for the specified indications and satisfy the FDA regulatory requirements for a 510(k).
Safety, EMC and Performance Data:
· Electricl safety and EMC testing
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed, and EMC testing was conducted in accordance with standard IEC 60601-1-2. All test results were satisfactory.
· Non-clinical study
The following non-clinical studies have been performed and the results show that the ViVIX-S with VXvue is substantially equivalent to the predicate devices in the
2
market.
-Detective quantum efficiency(DQE), Quantum limited performance, Modulation transfer function(MTF), Effects of aliasing, Sensitivity linearity, Lag(Erasure thoroughness), Change in detection sensitivity, Dose requirement and reciprocity changes, Stability of device characteristics with time, Uniformity of device characteristic, Noise power spectrum(NPS), Spatial resolution, Minimum dose, Image Acquisition time, & Black level.
· Clinical study
A concurrence study of 30 clinical images was conducted to compare the performance of the ViVIX-S with VXvue to the predicate device (K120020). There were no significant differences between the images of the ViVIX-S with VXvue and the predicate device images.
Conclusions :
Based on the result of the non-clinical and the clinical study performed, we conclude that the ViVIX-S with VXvue is safe, effective, and substantially equivalent to the predicate devices.
END
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract eagle or bird-like figure, composed of three curved lines.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
January 11, 2013
Vieworks Co., Ltd. C/O Ms. Priscilla Chung Regulatory Affairs Consultant 951 Starbuck St. Unit J FULLERTON CA 04300
Re: K122866
Trade/Device Name: ViVIX-S with VXvue Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: November 26, 2012 Received: November 29, 2012
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), 1 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.
4
Page 2-Ms. Chung
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,
Sean MBoyd -S for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K122866
Device Name: ViVIX-S with VXvue
Indications for Use:
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 and/or for fluoroscopy.
Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C) re
(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)
Sean M. Boyd -S
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K122866 510(k)
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