The Clear Vision DR 2000 product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

Device Description

The Clear Vision DR2000 system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

The detector which is used proposed device is QXR9 (K073056) and QXR16 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 510(k).

AI/ML Overview

The provided 510(k) summary for the Clear Vision DR 2000 does not contain information about explicit acceptance criteria for diagnostic performance, nor does it detail a specific study proving the device meets such criteria in terms of clinical accuracy or reader performance.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through technical specifications, safety, and electromagnetic compatibility (EMC) testing. The "performance data" mentioned refers to these engineering and safety tests rather than clinical performance for diagnostic accuracy.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The submission focuses on demonstrating technical compliance and substantial equivalence to predicate devices, not on quantitative diagnostic performance metrics.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. There is no mention of a clinical "test set" for diagnostic performance evaluation. The "testing" referred to in the document pertains to electrical safety, mechanical, and EMC tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No ground truth establishment for diagnostic performance is described.

4. Adjudication Method for the Test Set

Not applicable. No diagnostic performance test set or adjudication method is described.

5. 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

Not applicable. The Clear Vision DR 2000 is a digital radiography X-ray system, not an AI-powered diagnostic tool. Therefore, an MRMC study assessing AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. The Clear Vision DR 2000 is a hardware system for image acquisition, not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

Not applicable. No diagnostic performance evaluation requiring ground truth is described.

8. The Sample Size for the Training Set

Not applicable. The Clear Vision DR 2000 is a medical imaging acquisition device; it does not inherently involve a "training set" in the context of machine learning or AI algorithms for diagnostic purposes.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As no training set is mentioned in the context of diagnostic algorithms, the establishment of ground truth for such a set is not relevant.

Summary of the Study Discussed in the 510(k) Submission:

The study detailed in this 510(k) submission is a series of engineering and safety tests to ensure the Clear Vision DR 2000 system meets relevant industry standards and is substantially equivalent to predicate devices. These tests include:

Electrical, mechanical, environmental safety and performance testing according to standards EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28, and EN/IEC 60601-2-32.
EMC testing in accordance with standard EN/IEC 60601-1-2(2007).

The acceptance criteria for these tests would be compliance with the specific requirements outlined in each of those EN/IEC standards. The reported device performance is that "All test results were satisfactory," indicating that the device met the specified engineering and safety criteria for each standard.

The focus of this 510(k) is to demonstrate that the device is safe and effective for its intended use as a digital radiography X-ray system, primarily by showing that its technical characteristics and safety features align with established standards and legally marketed predicate devices, rather than through a clinical study of diagnostic accuracy. The use of pre-cleared detectors (QXR9 and QXR16) also supports the claim of substantial equivalence.

Summary

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K101779

510 (k) Summary

MAY 16 2011

October 12, 2010

1. Company and Correspondant Making the Submission: Name: Jungwon Precision Ind. Co,. LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/
1. Identification of Device

Classification Name:	Stationary X-ray System
Common Name:	Digital Radiography X-ray System
Trade/Proprietary Name:	Clear Vision DR 2000

1. Predicate Device

Manufacturer:	Choongwae Medical Corporation
Device:	CXD-DR80D
510(k) Number:	K083640 (Decision Date Jul 29, 2009)
Manufacturer:	Vieworks Co., Ltd
Device:	QXR 9
510(k) Number:	K073056 (Decision Date Nov 13, 2007)
Manufacturer:	Vieworks Co., Ltd
Device:	QXR 16
510(k) Number:	K080553 (Decision Date Apr 16, 2008)

1. Product Classification Names and Citations
  Regulatory Number: 21 CFR 892.1680 Regulatory Class: II Product Code: 90 KPR
1. Description:
  The Clear Vision DR2000 system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film

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radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

The detector which is used proposed device is QXR9 (K073056) and QXR16 (K080553) of Vieworks Co., Ltd. These detectors are cleared by FDA 510(k).

1. Indication for use
  The Clear Vision DR 2000 product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting. standing, or lying in the prone or supine position.

The Clear Vision DR 2000 system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes,

1. Comparison with Predicate Device:
  JUNGWON PRECISION IND. CO., LTD, believes that the Clear Vision DR2000 is substantially equivalent to the CDX-DR80D of Choongwae Medical Corporation and QXR 9, QXR 16 of Vieworks Co., Ltd.
1. Safety, EMC and Performance Data
  Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.
1. Conclusions:
  In accordance with the Federal Food. Drug and Cosmetic Act. 21 CFR Part 807 and based on the information provided in this premarket notification JUNGWON PRECISION IND. concludes that Clear Vision DR 2000 is safe and effective and substantially equivalent to predicate devices as described herein.
1. JUNGWON PRECISION IND. CO., LTD. will update and include in this summary any other information deemed seasonably necessary by the FDA.

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

JPI Healthcare Co., Ltd. % Mr. William Little Product Specialist JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803

MAY 16 2011

Re: K101779

Trade/Device Name: Clear Vision DR 2000/Digital Radiography X-Ray System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: April 5, 2011 Received: April 7, 2011

Dear Mr. Little:

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 (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.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 Pastel

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):

Device Name: Clear Vision DR 2000 / Digital Radiography X-ray System

Indications for Use:

Prescription Use >> Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mary Slater

Page 1 of 1

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K161779

510K. K101779

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.