FLAATZ 560

K111583 · Drtech Corp. · MQB · Oct 4, 2011 · Radiology

Device Facts

Record IDK111583
Device NameFLAATZ 560
ApplicantDrtech Corp.
Product CodeMQB · Radiology
Decision DateOct 4, 2011
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 892.1680
Device ClassClass 2

Intended Use

The FLAATZ 560 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 560 is a radiographic image acquisition system; captures x-ray photons via amorphous selenium (a-Se) detector panel. System includes detector, control box, switch box, and API. Control box buffers data and provides power; switch box manages signal transfer to x-ray generator. API performs image data capture and defect correction. Used in radiology environments by technicians. Output is digital radiographic image; assists clinicians in diagnostic decision-making. Benefits patient by providing digital imaging alternative to traditional film/screen systems.

Clinical Evidence

Clinical evaluation involved 5 experts reviewing images produced by the FLAATZ 560. Study concluded that the device provides diagnostic images of equivalent quality to the predicate device.

Technological Characteristics

Direct conversion digital radiography detector; Amorphous Selenium (a-Se) photoconductor layer. Dimensions: 383 x 460 x 15 mm; Pixel pitch: 139 x 139 μm; Image size: 2,560 x 3,072 pixels. Power: 100-240V, 50/60 Hz. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC).

Indications for Use

Indicated for generating radiographic images of human anatomy in 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

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ | 1. Submitter | DRTECH Corporation<br>333-1 Sangdaewon1-Dong, Seongnam City<br>Gyeonggi-do, Korea [462-807]<br>www.drtech.co.kr | |--------------------------|-----------------------------------------------------------------------------------------------------------------| | 2. Contact Person | Choul-Woo Shin<br>Vice President<br>cwshin@drtech.co.kr<br>+ 82-31-788-7653 | | 3. Date Prepared | March 25, 2011 | | 4. Device Name | FLAATZ 560 | | 5. Reason for Submission | New Device | | 6. Classification | 21 CFR §892.1650 | | 7. Product Code | MQB | | 8. Predicate Device | KRYSTALRAD 560 (FLAATZ 560) SYSTEM<br>Medicatech USA,<br>510(k) No.: K102284 | #### 9. Device Description The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment. The FLAATZ 560 system includes a Detector Panel, Case, Grid, 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. {1}------------------------------------------------ - K 111 583 - 10. Intended Use The FLAATZ 560 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 560 is substantially equivalent to the KRYSTALRAD 560 (FLAATZ 560) cleared on Jan 3, 2011 via 510k k102284. Those two systems include same detector, FLAATZ 560, so technological characteristics are equivalent. | | FLAATZ 560 | KRYSTALRAD 560<br>(FLAATZ 560) SYSTEM | | |------------------------------|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | 510(k) Number | | Pending | K102284 | | Indication for Use | | The FLAATZ 560 is indicated<br>for use in general radiographic<br>images of human anatomy too.<br>It is the upgraded model of<br>previous FLAATZ<br>500(K091747), also intended to<br>replace radiographic film/screen<br>systems in all general-purpose<br>diagnostic procedures | Same as predicate | | | Panel Shape | Rectangular Panel | Rectangular Panel | | | Detector Size | 353 x 424 (mm) | 353 x 424 (mm) | | Design | Dimensions<br>(W x L x H) | 383 x 460 x 15 (mm) | 383 x 460 x 15 (mm) | | | Pixel Pitch | 139 x 139 (μm) | 139 x 139 (μm) | | | Image Size | 2,560 x 3,072 (pixels) | 2,560 x 3,072 (pixels) | | | Se Thickness | 500 (μm) | 500 (μm) | | | Weight (Detector) | 3.0(kg) | 3.0 (kg) | | Materials | | Amorphous Selenium<br>(a-Se) Detector | Amorphous Selenium<br>(a-Se) Detector | | | DQE | 49.3% @ 0.5lp/mm | 48.5% @ 0.5 lp/mm | | Performance | MTF | 78% @3lp/mm | 78% @3lp/mm | | | Resolution | 3.6 lp/mm | 3.6 lp/mm | | | Ghosting | <1% @ RQA5 Condition | <1% @ RQA5 Condition | | 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 2A,<br>Single Phase | The Control Box has the<br>following Power Requirement:<br>100~240V~, 50/60 Hz, Max 2A,<br>Single Phase | #### Comparison between FLAATZ 560 and KRYSTALRAD 560 (FLAATZ 560) SYSTEM {2}------------------------------------------------ - KIIIS83 Page 3 of 3 | | | FLAATZ-560 | KRYSTALRAD 560<br>(FLAATZ 560) SYSTEM | |--------------------------------------------------------------|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Compatibility<br>with<br>Environment<br>and other<br>Devices | EMC<br>Operating<br>Temperature | Suitable for EMI and EMS test. | Suitable for EMI and EMS test. | | | Storage<br>Temperature | +0 to +40 °C | +0 to +40 °C | | Electrical Safety | | Acceptable electrical safety<br>level. | Acceptable electrical safety<br>level. | | Thermal Safety | | Acceptable thermal safety<br>level. | Acceptable thermal safety<br>level. | | 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<br>- 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<br>- Requirements and tests | | Non-clinical test report | | Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 560 and the result concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 (FLAATZ 560). | Performance test (MTF, DQE, Line Resolution) were done for FLAATZ 560 and the result concludes FLAATZ 560 can display similar images as KRYSTALRAD 560 (FLAATZ 560). | | Clinical test report | | Various parts of FLAATZ 560 images were shown to 5 experts and clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560) | Various parts of FLAATZ 560 images were shown to 5 experts and clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560) | # 12. General Safety and Effectiveness Concerns The FLAATZ 560 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 560 has also met applicable Electro Magnetic Compatibility (EMC) requirements. ### 13. Conclusion The FLAATZ 560 is substantially equivalent to the Predicate Device in design and Performance. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. Inside the circle is an abstract image of an eagle. The eagle is facing to the right and has its wings spread. 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 DRTECH Corporation % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826 4 2311 Re: K111583 Trade/Device Name: FLAATZ 560 Regulation Number: 21 CFR 892.1650 Regulation Name: Intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MOB Dated: September 9, 2011 Received: September 15, 2011 Dear Mr. Mack: 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 {4}------------------------------------------------ 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 {5}------------------------------------------------ # KIII583 ## Indications for Use Statement 510(k) Number (if known): ponding K (1) 583 Device Name: FLAATZ 560 Indications for Use: The FLAATZ 560 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generaldiagnostic procedures purpose (excluding 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) Mary Spatill Division Sign Off Division of Radiologica Office of In Vitro Diagnostic De 510K. K111583 DRTECH " " CONFIDENTIAL Premarket Notification: FLAATZ 560
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