FLAATZ 760

K111655 · Drtech Corp. · KPR · Nov 30, 2011 · Radiology

Device Facts

• Record ID: K111655
• Device Name: FLAATZ 760
• Applicant: Drtech Corp.
• Product Code: KPR · Radiology
• Decision Date: Nov 30, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The FLAATZ 760 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 760 is a radiographic image acquisition system; functions as a direct conversion detector using an amorphous selenium (a-Se) layer to absorb x-ray photons. System components include a detector panel, control box, switch box, interconnecting cables, and API. Control box buffers data between detector and PC while providing power; switch box manages signals between control box and x-ray generator. Used in radiology environments by technicians to replace film/screen systems. API performs image data capture and defect correction. Output is digital radiographic images for clinical review. Benefits include digital workflow integration and diagnostic image quality equivalent to predicate systems.

Clinical Evidence

Clinical study involved 5 experts reviewing images from the FLAATZ 760. Results concluded that the device produces diagnostic images of equivalent quality to the predicate FLAATZ 750.

Technological Characteristics

Amorphous Selenium (a-Se) direct conversion detector; 43x43 cm active area; 168 µm pixel pitch; 14-bit dynamic range; DICOM 3.0 compliant. Power: 100-240V, 50/60 Hz. Standards: IEC 60601-1, IEC 60601-1-2. Connectivity via API for image capture and defect correction.

Indications for Use

Indicated for generating radiographic images of human anatomy in general-purpose diagnostic procedures. Excludes fluoroscopic, angiographic, and mammographic applications. Intended for use by technicians in radiology environments.

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 750 (K080064)

Submission Summary (Full Text)

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K111655

# NOV 3 0 2011

# 510(k) Summary

| 1. Submitter | DRTECH Corporation<br>333-1 Sangdaewon1-Dong, Seongnam City<br>Gyeonggi-do, Korea [462-807]<br>http://drtech.co.kr |
|------------------------------------------|--------------------------------------------------------------------------------------------------------------------|
| 2. Contact Person<br>[e-mail] | Choul-Woo Shin<br>Vice President<br>+ 82-31-730-6823 |
| 3. Date Prepared | March 31, 2011 |
| 4. Device Name | FLAATZ 760 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | KPR |
| 8. Predicate Device | FLAATZ 750<br>DRTECH Corp. South Korea<br>510(k) No.: K080064 |

#### 9. Device Description

The FLAATZ 760 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 760 system includes a Detector Panel, Control 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 Control 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 Control 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.

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### 10. Intended Use

The FLAATZ 760 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).

- 11. Substantial Equivalence
The FLAATZ 760 is substantially equivalent to the FLAATZ 750 cleared on Jan 28 2008 via 510k K080064.

| | | FLAATZ 760 | FLAATZ 750 |
|------------------------------|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | | Pending | K080064 |
| | Indication for Use | The FLAATZ 760 is indicated<br>for use in general radiographic<br>images of human anatomy. It<br>is intended to replace<br>radiographic film/screen<br>systems in all general-purpose<br>diagnostic procedures<br>(excluding fluoroscopic,<br>angiographic, and<br>mammographic applications) | The FLAATZ 750 system<br>generates digital X-ray images<br>that can be used for general X-<br>ray system. The FLAATZ 750<br>system can interface to<br>traditional X-ray generator and<br>get digital X-ray image. The<br>FLAATZ 750 is intended to be<br>used in same clinical application<br>as traditional film-screen based<br>general radiography system. |
| | Panel Shape | Square Panel | Square Panel |
| | Detector Size | 43 x 43 (cm) | 43 x 43 (cm) |
| | Dimensions (W/L/H) | 460 x 460 x 15 (mm) | 482 x 482 x 35 (mm) |
| Design | Pixel Pitch | 168 x 168 (µm) | 168 x 168 (μm) |
| | Image Size | 2,560 x 2,560 (pixels) | 2,560 x 2,560 (pixels) |
| | Weight (Detector) | 4.6 (kg) | 6.2 (kg) |
| | Fill Factor | 83% | 83% |
| Materials | | Amorphous Selenium<br>(a-Se) Detector | Amorphous Selenium<br>(a-Se) Detector |
| | DQE | 45.1% @ 0.5lp/mm | 40% @ 0.5 lp/mm |
| | MTF | 78% @ 3lp/mm | 77.7% @ 3lp/mm |
| | Resolution | 3.0 lp/mm | 3.0 lp/mm |
| Performance | Ghosting | <1% @ RQA5 Condition | <1% @ RQA5 Condition |
| | Defect<br>Compensation | By Calibration | By Calibration |
| | Dynamic Range | 14bit | 14bit |
| | DICOM Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| Anatomical Sites | | General Radiography | General Radiography |
| Energy Used and/or Delivered | | The Control Box has the<br>following Power Requirement:<br>100~240V~, 50/60 Hz, Max<br>2A, Single Phase | The Control Box has the<br>following Power Requirement:<br>100~240V~, 50/60 Hz, Max 2A,<br>Single Phase |

Image /page/1/Picture/6 description: The image is a black and white photograph with a high contrast. The image is mostly white with some black spots and lines. The black spots and lines are scattered throughout the image, and they do not seem to form any recognizable pattern or shape. The image is blurry and out of focus.

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| | | FLAATZ 760 | FLAATZ 750 |
|--------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility<br>with<br>Environment<br>and other<br>Devices | EMC | Suitable for EMI and EMS test. | Suitable for EMI and EMS test. |
| | Operating<br>Temperature | +5 to +35 °C | +5 to +35 °C |
| | Storage<br>Temperature | +0 to +40 °C | +0 to +40 °C |
| Electrical Safety | | Acceptable electrical safety level. | This is suitable for electrical safety. |
| Thermal Safety | | Acceptable thermal safety level. | This is suitable for thermal safety. |
| Standards Met | | IEC 60601-1<br>Medical electrical equipment - Part 1<br>General Requirements for safety.<br>IEC 60601-1-2<br>Medical electrical equipment - Part 1-2<br>General requirements for safety<br>Collateral standard:<br>Electromagnetic compatibility - Requirements and tests | IEC 60601-1<br>Medical electrical equipment - Part 1<br>: General Requirements for safety.<br>IEC 60601-1-2<br>Medical electrical equipment - Part 1-2<br>: General requirements for safety<br>Collateral standard:<br>Electromagnetic compatibility - Requirements and tests |
| Non-clinical test report | | Performance test (MTF, DQE,<br>Line Resolution) were done for<br>FLAATZ 760 and the result<br>concludes FLAATZ 760 can<br>display similar images as<br>FLAATZ 750. | Performance test (MTF, DQE,<br>Line Resolution) were done for<br>FLAATZ 750 and the result<br>concludes FLAATZ 760 can<br>display similar images as<br>FLAATZ 750. |
| Clinical test report | | Various parts of FLAATZ 760<br>images were shown to 5<br>experts and clinical study:<br>concludes FLAATZ 760<br>diagnostic images of<br>equivalent quality as FLAATZ<br>750 | Various parts of FLAATZ 750<br>images were shown to 5<br>experts and clinical study<br>concludes FLAATZ 760<br>diagnostic images of<br>equivalent quality as FLAATZ<br>750 |

### 12. General Safety and Effectiveness Concerns

The FLAATZ 760 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 760 has also met applicable Electro Magnetic Compatibility (EMC) requirements.

- 13. Conclusion
The FLAATZ 760 is substantially equivalent to the Predicate Device in design and Performance.

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central emblem.

# 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

# NOV 3 0 2011

Mr. Choul-woo Shin Vice President DRTECH Corporation 333-1 Sangdaewon1-Dong 462-807 SEONGNAM-CITY GYEONGGI-DO KOREA

Re: K111655

Trade/Device Name: FLAATZ 760 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: KPR Dated: October 28, 2011 Received: November 4, 2011

#### Dear Mr. 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, 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 [phone]. 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/ReportalProblem/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/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 Statement

510(k) Number (if known):

Device Name: FLAATZ 760

Indications for Use:

The FLAATZ 760 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generaldiagnostic procedures (excluding purpose fluoroscopic, angiographic, and mammographic applications).

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

.

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510K K111 655

DRTECH

CONFIDENTIAL

Premarket Notification: FLAATZ 760