(122 days)
Not Found
No
The summary describes a standard digital X-ray detector and image processing, with no mention of AI or ML capabilities.
No.
The device is described as a digital X-ray flat panel detector intended for general diagnostic procedures, specifically to replace film or screen-based radiographic systems in imaging human anatomy. Its function is to convert X-ray photons into digital images for display and diagnostic interpretation, not to treat a condition or disease.
Yes
The device is intended to replace existing systems used in "general purpose diagnostic procedures" and its output "can do to utilize as digitalizing x-ray images and transfer for radiography diagnostic." It also explicitly states that "Advanced digital imaging process allows considerably efficient diagnosis."
No
The device description explicitly states it is a "digital X-ray flat panel detector" and describes its physical components and how it intercepts X-ray photons and converts them to electrical signals. This indicates it is a hardware device, not software-only.
Based on the provided information, the ViVIX-S device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ViVIX-S is for "digital imaging solution designed for general radiographic system for human anatomy." This describes a device used for imaging the internal structures of the human body using X-rays.
- Device Description: The description details a "digital X-ray flat panel detector" that captures X-ray photons and converts them into digital images for display and diagnosis. This is consistent with medical imaging equipment, not IVD.
- 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. The ViVIX-S does not perform any such tests on biological samples.
The ViVIX-S is a medical imaging device used for diagnostic radiology, which is a different category of medical device than IVD.
N/A
Intended Use / Indications for Use
ViVIX-S 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.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
ViVIX-S 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. It can do 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, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical study: The following non-clinical studies have been performed and the results show that the ViVIX-S is substantially equivalent to the predicate devices in these characteristics.
- 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 to the predicate device (K090742). There were no significant differences between the images of the ViVIX-S and the predicate device images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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
§ 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
510(k) Summary (K120020)
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: May 2, 2011
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. JungMi Kim / Compliance Officer
Internet – http://www.vieworks.com
Proposed Device :
| Trade/ | Proprietary | Name | : ViVIX- |
|---|---|---|---|
| Shttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?start_search=1 | |||
| &ProductCode=MLR | |||
| Common Name | : Digital Flat Panel X-ray Detector | ||
| Classification Name | : Solid State X-ray Imager | ||
| Product Code | : MOB |
| Device Class | : 2 |
|---|---|
| Regulation Number | : 892.1650 |
Predicate Device :
| Manufacturer | : VARIAN Medical Systems Inc. |
|---|---|
| Trade/ Proprietary Name | : Paxscan 4030 Medical Digital Imaging System |
| Common Name | : Flat Panel Digital Imager |
| Classification Name | : Solid State X-ray Imager |
| Product Code | : MQB |
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| Device Class | : 2 |
|---|---|
| 510(k) Number | : K024147 |
| Manufacturer | : Samsung Mobile Display Co., Ltd. |
| Trade/ Proprietary Name | : LTX-240AA01-A |
| Common Name | : Digital Plate Panel X-ray Detector |
| Classification Name | : Solid State X-ray Imager |
| Product Code | : MQB |
| Device Class | : 2 |
| 510(k) Number | : K090742 |
Description :
ViVIX-S 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. It can do 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, sharing of image information on network.
Intended use :
ViVIX-S 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.
Comparison with predicate device:
The imaging principle, intended use, technology and materials of ViVIX-S are substantially equivalent to the predicated devices, Paxscan 4030R of VARIAN Medical Systems Inc. and LTX240AA01-A of Samsung Mobile Display Co., Ltd. for the specified indications and satisfy the FDA regulatory requirements for a 510(k).
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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 is substantially equivalent to the predicate devices in these characteristics.
-
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 to the predicate device (K090742). There were no significant differences between the images of the ViVIX-S and the predicate device images.
Conclusions :
Based on the results of the non-clinical and the clinical studies performed, we conclude that the ViVIX-S is effective, and substantially equivalent to the predicate devices.
END
Vieworks Co., Ltd.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
MAY - 4 2012
Vieworks Co., Ltd. Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 951 Starbuck Street, Unit J FULLERTON CA 92833
Re: K120020
Trade/Device Name: ViVIX-S Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: April 24, 2012 Received: April 26, 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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.fdaggov/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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K120020
Device Name: ViVIX-S
Indications For Use:
ViVIX-S 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
MhD'O'M
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number Klaaaaaa
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