FLAATZ 600 SERIES (FLAATZ 600/601)

K132842 · Drtech Corp. · MQB · Feb 21, 2014 · Radiology

Device Facts

• Record ID: K132842
• Device Name: FLAATZ 600 SERIES (FLAATZ 600/601)
• Applicant: Drtech Corp.
• Product Code: MQB · Radiology
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

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).

Device Story

FLAATZ 600 Series is a digital radiographic image acquisition system. It uses a direct conversion detector panel with an amorphous selenium (a-Se) layer to absorb X-ray photons and convert them into digital images. The system includes a detector panel, case, grid, power box, switch box, and interconnecting cables. Operated by technicians in radiology environments, the system routes image data to an operating PC via Ethernet or wireless connection. The API provides image capture and defect correction functions. Healthcare providers use the resulting images for diagnostic purposes, replacing traditional film/screen systems. The device benefits patients by providing digital diagnostic imaging for various body parts, including chest, spine, and extremities.

Clinical Evidence

Clinical study compared the FLAATZ 600 Series to the predicate FLAATZ 560 across eight body parts: chest, shoulder, L-Spine (lateral and AP), hand, forearm, foot, and knee. Results demonstrated that the FLAATZ 600 Series produces diagnostic images of equivalent quality to the predicate device.

Technological Characteristics

Direct conversion digital X-ray detector using amorphous selenium (a-Se) layer. Connectivity via Ethernet and wireless. Complies with IEC 62220-1:2003 (DQE/MTF), IEC 60601-1:2005 (Safety), IEC 60601-1-2:2007 (EMC), and NEMA PS 3.1-3.20:2011 (DICOM).

Indications for Use

Indicated for generating radiographic images of human anatomy for general-purpose diagnostic procedures. Excludes fluoroscopic, angiographic, and mammographic applications.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FLAATZ 560 (K111583)

Submission Summary (Full Text)

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K132842
Page 1 of 3

# 510(k) Summary

FEB 2 1 2014

| | 1. Submitter | DRTECH Corporation<br>Suite No. 2, 3 Floor, 29, Dunchon-daero541beon-gil,<br>Jungwon-gu, Seongnam-si, Gyeonggi-do, Republic of Korea<br>Post code: 462-807<br>www.drtech.co.kr |
|--|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. Contact Person | Name: Choul-Woo Shin<br>Position: Vice President<br>E-mail: [e-mail]<br>Telephone: + 82-31-784-8856 |
| | 3. Date Prepared | August 16, 2013 |
| | 4. Device Classification Name | Stationary x-ray system |
| | 5. Device Name | Digital X-Ray Detector<br>FLAATZ 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 560<br>DRTECH Corporation<br>510(k) No. K111583 |

### 10. 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

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.

- 11. 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).

- 12. 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.

- 13. 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)

- 14. 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)

- 15. 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
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previous model FLAATZ 560. TFT panel and main components are almost same.

- 16. 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.

- 17. Conclusion
The FLAATZ 600 Series (FLAATZ 600/601) is substantially equivalent to the Predicate Device in design and performance.

- 18. 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 [phone] or [phone] 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 [phone] or [phone] 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)