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.

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.

AI/ML Overview

The provided text describes a 510(k) summary for the SanteView-3001C, a digital flat panel X-ray detector, to demonstrate its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, detailed study designs, or comprehensive performance data as typically found in a clinical study report for a new AI-powered diagnostic device.

It mainly focuses on declaring the device's technical specifications, indications for use, and a general statement about safety and effectiveness.

Therefore, many of the requested sections below cannot be populated from the provided text.

Acceptance Criteria and Device Performance

The document does not explicitly state specific quantitative acceptance criteria or detailed performance metrics. It makes a general statement about "concurrence study" but provides no details of what was measured or what the targets were.

Acceptance Criterion	Reported Device Performance
Not specified	"The result of concurrence study shows that the new device is safe and effective as the predicate device."

Study Details

The provided text mentions a "concurrence study," but it lacks sufficient detail to answer most of the questions about its methodology.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified.
- Data Provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not specified.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC comparative effectiveness study is mentioned, nor is any AI component indicated in the device description. The device is a "Digital Flat Panel X-ray Detector" which captures digital images for conventional radiographic examinations.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The SanteView-3001C is a hardware device (X-ray detector). The concept of "standalone algorithm performance" as typically applied to AI/software is not relevant here. The device's performance is likely evaluated in terms of image quality metrics compared to predicate devices, but these details are not provided.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not specified. The "concurrence study" likely involved comparing images from the SanteView-3001C to images from predicate devices, potentially using image quality assessment, but the specific ground truth method is not described.
The sample size for the training set:
- Not applicable, as this is a hardware device (X-ray detector) and not an AI algorithm that undergoes training in the conventional sense.
How the ground truth for the training set was established:
- Not applicable.

Summary

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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

1. 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

1. 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
1. 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)

1. Description:
  The SanteView-3001C is a solid state x-ray imager which has 440x440mm

510(k) Submission.

510(k) summary , 1 / 2 page

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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:

Comparison to substantially equivalent devices:

The proposed and the predicate devices utilize similar technology and materials, and are similar in design and construction.

1. 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

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

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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

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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

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Indications for Use

510(k) Number (if known): K111312

Device Name: SanteView-3001C

Indications for Use:

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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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.