(64 days)
Not Found
No
The summary describes a digital x-ray imager that converts x-ray photons to digital images for display. There is no mention of AI, ML, or advanced image processing beyond basic signal conversion and display. The performance study focuses on concurrence with predicate devices, not on AI/ML-driven performance metrics.
No
The device is described as an imager for diagnostic procedures, which captures images but does not provide any therapy or treatment.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "all general purpose diagnostic procedures."
No
The device description explicitly states it is a "solid state x-ray imager" with a physical imaging area and describes the process of converting x-ray photons to electrical signals, indicating it is a hardware device.
Based on the provided information, the SanteView-3001C 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.
- SanteView-3001C Function: The description clearly states that the SanteView-3001C is an x-ray imager that captures digital images for conventional film/screen radiographic examinations. It works by intercepting x-ray photons and converting them into digital images displayed on monitors.
- No Mention of Samples: There is no mention of the device being used to test samples taken from the body. Its function is solely related to capturing images generated by x-ray radiation passing through the body.
Therefore, the SanteView-3001C falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The SanteView-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
Product codes
MQB, MOB
Device Description
The SanteView-3001C is a solid state x-ray imager which has 440x440mm imaging area. The SanteView-3001C intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
Not Found
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)
EMC testing was conducted in accordance with standard EN/IEC 60601-1-2: All test results were satisfactory. The result of concurrence study shows that the new device is safe and effective as the predicate device
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
510(k) Summary
1115
This summary of 510(K) -- safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 05/06/2011
-
- Company making the submission
| Submitter | |
|---|---|
| Name | SEHYUN Co., Ltd. |
| Address | #709, 1 dong, Innoplex #343, Wonchon-dong, Youngtong-gu, |
| Suwon, Gyeonggi-do, 443-823, Korea | |
| Phone | +82-31-8002-2000 |
| Fax | +82-33-8002-2017 |
-
- U.S Agent/Contact Person
َ ُ ُ َ َ Consulting Group 951 Starbuck St. Unit J, Fullerton, CA 92833 Priscilla Chung Phone: 714-869-3080 Fax: 714-409-3357 Email: info@LKconsultinggroup.com
- U.S Agent/Contact Person
-
- Device
- · Trade Name: SanteView-3001C
- Common Name: Digital Flat Panel X-ray Detector
- · Classification: Class II
- · Classification regulation: 21 CFR 892.1650
- · Product Code: MQB
4. Predicate Device:
•PaxScan 4030 Medical Digital Imaging System by Varian Medical System (K024147) .CXDI-60C by Canon USA, Inc.(K091545)
•Pixium 4600 (cleared under the name, Philips Bucky Vision) by Trixell (K982795)
-
- Description:
The SanteView-3001C is a solid state x-ray imager which has 440x440mm
- Description:
510(k) Submission.
510(k) summary , 1 / 2 page
1
imaging area. The SanteView-3001C intercepts x-ray photons and the scintillator emits visible spectrum photons that illuminate an array of photo-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.
- Indication for use:
The SanteView-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for ·· mammography applications.
- Comparison to substantially equivalent devices:
The proposed and the predicate devices utilize similar technology and materials, and are similar in design and construction.
-
- Safety, EMC and Performance Data:
EMC testing was conducted in accordance with standard EN/IEC 60601-1-2: All test results were satisfactory. The result of concurrence study shows that the new device is safe and effective as the predicate device
- Safety, EMC and Performance Data:
9. Conclusion
SEHYUN Co., Ltd. concludes that the SanteView-3001C is substantially equivalent to the currently marketed devices. It does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or ·safety risks.
ﺮ ۰۰
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
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
JUL 1 3 2011
SEHYUN Co., Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group 951 Starbuck St., Unit J FULLERTON CA 92833
Re: K111312
Trade/Device Name: SanteView-3001C Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: May 6, 2011 Received: May 10, 2011
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
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 5.10(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 Viro 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.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/cdrh/industry/support/index.html.
Sincerely Yours.
Mary Patel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K111312
Device Name: SanteView-3001C
Indications for Use:
The SanteView-3001C provides digital image capture for conventional film/screen radiographic examinations. The device is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.
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)
Mary S. Posth
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number K141312
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