The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Device Description

The FLAATZ 600 Series (FLAATZ 600/601) is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment. The FLAATZ 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Power Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for image data capture and correction of defects on the image data.

AI/ML Overview

The FLAATZ 600 Series (FLAATZ 600/601) is a digital X-ray detector with some changes compared to its predicate device, the FLAATZ 560. The primary modification is the change in data communication methods to Ethernet & Wireless. There are no changes to the product performance specifications or intended use.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state quantitative acceptance criteria for clinical performance or a direct comparison table against such criteria. Instead, it focuses on demonstrating substantial equivalence to the predicate device, FLAATZ 560, primarily by showing equivalent image quality and technical performance.

Acceptance Criterion (Implicit)	Reported Device Performance
Diagnostic Equivalency to Predicate Device	"FLAATZ 600 Series (FLAATZ 600/601) produces diagnostic images of equivalent quality as the predicate device (FLAATZ 560)"
DQE (Detective Quantum Efficiency) Performance	"The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of DQE" (evaluated according to IEC 62220-1:2003 Standard)
MTF (Modulation Transfer Function) Performance	"The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of [...] MTF" (evaluated according to IEC 62220-1:2003 Standard)
Safety and EMC Standards Compliance	"FLAATZ 600 Series is in accordance with Safety, EMC and DICOM standards (IEC 606001-1:2005, IEC 60601-1- 2:2007 and NEMA PS 3.1-3.20:2011)" and "The FLAATZ 600 Series (FLAATZ 600/601) has also met applicable Electro Magnetic Compatibility (EMC) requirements."
Compliance with FDA Guidance for Solid State X-ray Imaging	"The FLAATZ 600 Series (FLAATZ 600/601) has been evaluated as per FDA's 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and has shown good performance, substantially equivalent to the predicate device."

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

Sample Size: The clinical study tested for "eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee)". The exact number of images or patient cases for each body part is not specified in the provided text.
Data Provenance: The text does not specify the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text.

4. Adjudication Method for the Test Set

This information is not provided in the given text.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

A MRMC comparative effectiveness study, in the sense of evaluating human reader performance with and without AI assistance, was not performed, nor is it applicable here. This device is an X-ray detector, not an AI-powered diagnostic aid for radiologists. The clinical study aimed to demonstrate diagnostic equivalency of the new detector to a predicate detector.

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

Yes, a form of standalone performance evaluation was done through non-clinical testing of technical parameters.

Non-Clinical Testing: DQE and MTF were evaluated according to IEC 62220-1:2003 Standard. These are objective measures of image quality for the device itself.
Clinical Testing: The clinical study to investigate diagnostic equivalency (comparing images from the new device to the predicate device) can be considered a standalone assessment of the device's image output, without human-in-the-loop diagnostic assistance being part of its intended use.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was established by comparing the images produced by the FLAATZ 600 Series to those of the predicate device (FLAATZ 560) to assess "diagnostic equivalency." This implies a comparison of perceived diagnostic quality by potentially expert readers, but the explicit nature of this "ground truth" (e.g., expert consensus on specific findings, pathology, or outcomes) is not detailed. It is more focused on the quality of the image for diagnosis rather than the correctness of a specific diagnosis derived from the image.

For the non-clinical testing (DQE, MTF), the ground truth is established by the specifications and methodologies outlined in the IEC 62220-1:2003 Standard for X-ray detector performance.

8. The Sample Size for the Training Set

This information is not applicable as this is not an AI/Machine Learning device that requires a training set. It's a hardware device (X-ray detector).

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

This information is not applicable for the same reason as point 8.

Summary

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K132842
Page 1 of 3

510(k) Summary

FEB 2 1 2014

	1. Submitter	DRTECH CorporationSuite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil,Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of KoreaPost code: 462-807www.drtech.co.kr
	2. Contact Person	Name: Choul-Woo ShinPosition: Vice PresidentE-mail: cwshin@drtech.co.krTelephone: + 82-31-784-8856
	3. Date Prepared	August 16, 2013
	4. Device Classification Name	Stationary x-ray system
	5. Device Name	Digital X-Ray DetectorFLAATZ 600 Series (FLAATZ 600/601)
	6. Reason for Submission	New Device
	7. Classification	21 CFR 892.1680
	8. Product Code	MQB
	9. Predicate Device	FLAATZ 560DRTECH Corporation510(k) No. K111583

10. Device Description

The FLAATZ 600 Series (FLAATZ 600/601) system includes a Detector Panel, Case, Grid, Power Box, Switch Box, Interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a rectangular plate in which the input x-ray photons are absorbed in an a-Se layer. The Power Box functions as a buffer between the Detector

DRTECH

CONFIDENTIAL Premarket Notification: FLAATZ 600 Series

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Panel and Operating PC while also supplying power to the Detector Panel. The Switch Box transfers signals between the Power Box and X-ray Generator and also indicates the status of the panel using LED lights. . Finally, the API contains functions for image data capture and correction of defects on the image data.

1. Intended Use
  The FLAATZ 600 Series (FLAATZ 600/601) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
1. Summary of the Technological Characteristics to the Predicate Device
  The modification to the predicate device is the change of data communication methods as Ethernet & Wireless type. There are no changes to the product performance specifications, device indications for use/intended use.
1. Summary of Non-Clinical Testing
  The performance of Detector can be evaluated by DQE and MTF according to IEC 62220-1:2003 Standard.DQE & MTF have been tested by acquiring the X-ray image with designated devices. Moreover, FLAATZ 600 Series is in accordance with Safety, EMC and DICOM standards (IEC 606001-1:2005, IEC 60601-1- 2:2007 and NEMA PS 3.1-3.20:2011) The test results conclude that FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent compared to the predicate device (FLAATZ 560)
1. Summary of Clinical Testing
  Clinical study is to investigate the diagnostic equivalency of detector panels with. the same a-Se technology and same pixel sizes. We've tested for eight body parts (Chest, Shoulder, L-Spine L, L-Spine_AP, Hand, Forearm, Foot and Knee) compared to the predicate device. The result of tests, FLAATZ 600 Series (FLAATZ 600/601) produces diagnostic images of equivalent quality as the predicate device (FLAATZ 560)
1. Substantial Equivalence
  The proposed FLAATZ 600 Series (FLAATZ 600/601) has identical indication for use / intended use, the principal of operation and user environment. The proposed FLAATZ 600 Series (FLAATZ 600/601) has similar performance in terms of DQE, MTF and is the same physical characteristics as using Amorphous Selenium (a-Se) material. Moreover, FLAATZ Series (FLAATZ 600/601) is the upgraded model of its

DRTECH

CONFIDENTIAL Premarket Notification: FLAATZ 600 Series

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K1327842
Page 3 of 3

previous model FLAATZ 560. TFT panel and main components are almost same.

1. Functional and Safety Testing
  The FLAATZ 600 Series (FLAATZ 600/601) has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.

The FLAATZ 600 Series (FLAATZ 600/601) has also met applicable Electro Magnetic Compatibility (EMC) requirements.

1. Conclusion
  The FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent to the Predicate Device in design and performance.
1. Manufacturing Facility
- DRTECH Corporation Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil, Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea Post code: 462-807

Establishment Registration Number: 3005172103

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with text around the perimeter. Inside the circle is a stylized design featuring three overlapping shapes that resemble human figures or abstract forms. The text around the circle reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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

February 21, 2014

DRTECH Corporation % Choul-Woo Shin 333-1, Sangdaewon 1-Dong Jungwon-Gu Seongnam-Shi, Gyeonggi-Do, 462-807 SOUTH KOREA

Re: K132842

Trade/Device Name: FLAATZ 600 Series (FLAATZ 600/601) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: January 13, 2014 Received: January 24, 2014

Dear Choul-Woo Shin:

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. Drue, 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), 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

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Page 2- Choul-Woo Shin

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director. Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K132842

Device Name

FLAATZ 600 Series (FLAATZ 600/601)

Indications for Use (Describe)

The FLAATZ 600 Series (FLAATZ 60060) is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, and mammographic applications).

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Smh.f)

FORM FDA 3881 (1/14)

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.