FLAATZ 500

K091747 · Drtech Corp. · KPR · Jul 1, 2009 · Radiology

Device Facts

• Record ID: K091747
• Device Name: FLAATZ 500
• Applicant: Drtech Corp.
• Product Code: KPR · Radiology
• Decision Date: Jul 1, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The FLAATZ 500 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, anglographic, and mammographic applications).

Device Story

FLAATZ 500 is a radiographic image acquisition system; functions as a direct conversion digital detector. System components: detector panel (a-Se layer for x-ray photon absorption), control box (buffer/power supply), switch box (signal transfer/LED status), and API. Operated by technicians in radiology clinics. Input: x-ray photons; output: digital radiographic images. API performs image data capture and defect correction. System replaces traditional film/screen radiography; provides digital images for clinical review; facilitates diagnostic procedures.

Clinical Evidence

Bench testing only. The device was evaluated per FDA's 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and met applicable electromagnetic compatibility (EMC) requirements.

Technological Characteristics

Direct conversion digital detector; amorphous selenium (a-Se) layer for x-ray photon absorption. System includes detector panel, control box, switch box, and API. Connectivity via interconnecting cables. Software-based image data capture and defect correction.

Indications for Use

Indicated for generating radiographic images of human anatomy for 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 DRTECH Corporation (K080064)

Submission Summary (Full Text)

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K091747

# 510(k) Summary

JUL - 1 2009

Submitter

DRTECH Corporation 333-1 Sangdaewon1 Dong, Seongnam City Gyeonggi-do, Korea (462-807) www.drtech.co.kr

Contact Person

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3. Date Prepared ::

Device Name

5. Reason for Submission

6. Classification

7. Product Code

8. Predicate Device

New Device

May 25, 2009

FLAATZ 500

Baom Jin Moon Vice President [e-mail] + 82-31-730-6800

21 CFR 6892 1680

FLAATZ 750 DRTECH Corporation

510(k) No :: K080064

9. Device Description

The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated limage capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The ELAATZ: 500 system Includes a Detector Panel, Control Box, Switch Box, Unterconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in wrich the input x-ray photons are absorbed in an a-Sellayer: 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 tights. Finally, the API contains for image data capture and correction of defects on the image data.

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Prematket Notification: FLAATZ-500

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### 10. Intended Use

The FLAATZ 500 is indicated for use in generating radiographic images of human analomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammographic applications).

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Premarket Notification: FLAATZ 500

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### 1. Functional and Safety Testing

The FLAATZ 500 has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises" and has shown good performance, substantially equivalent to the predicate device. る。 1975年 .. . . . . . . . .. .. ...

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The ELAATZ 600 has also met applicable Electro Magnetic Compatibility (EMO) requirements,

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# 12, Conclusion

The FLAATZ 500 is substantially equivalent to the Predicate Device in design and performance

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DRTECH Corporation % Mr. Marc M. Mouser CAS Manager II/Office Coordinator Underwriters Laboratories. Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K091747

Trade/Device Name: FLAATZ 500 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 1, 2009 Received: June 16, 2009

#### Dear Mr. Mouser:

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 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 of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use Statement

510(k) Number (if known):

K091747

Device Name: FLAATZ 500

Indications for Use

The FLAATZ 500 is indicated for use in generating radiographic 100 a 0 le s anatomy. It is intended to replace radiographic film/screen systems in all purpose diagnostic procedures (excluding fluoroscopic, anglograph mammographic applications).

Preseription Use GVer- The AND/OH (Part 21 CFR-801 Subpart D) 21 6 8 8 8 8 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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anggunian and a (Division Sign-Off) (Division of Reproductive, Abdominal and Radiological Devices K096747 510(k) Number

Premarket Notification: