FLAATZ 750E

K102474 · Drtech Corp. · MQB · Mar 4, 2011 · Radiology

Device Facts

• Record ID: K102474
• Device Name: FLAATZ 750E
• Applicant: Drtech Corp.
• Product Code: MQB · Radiology
• Decision Date: Mar 4, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The FLAATZ 750E 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 750E is a digital radiographic image acquisition system; replaces film/screen systems. Components: Detector Panel (a-Se layer for x-ray photon absorption), Control Box (power/buffer), Switch Box (signal transfer/LED status), and API. Used in radiology environments by technicians. System captures x-ray signals, converts to digital data, and performs image correction via API. Output is digital radiographic image for clinician review; supports diagnostic decision-making. Benefits include transition from analog to digital imaging workflow.

Clinical Evidence

Bench testing only. Device evaluated per FDA's 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices'. Met applicable Electro Magnetic Compatibility (EMC) requirements.

Technological Characteristics

Direct conversion detector panel with a-Se (amorphous selenium) layer. Includes control box, switch box, and API for image capture/correction. Connectivity via interconnecting cables. Operates as a digital radiographic acquisition system.

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 750 (K080064)

Submission Summary (Full Text)

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# MAR - 4 2011

## 510(k) Summary

| 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 | Beom-Jin Moon<br>Vice President<br>[e-mail]<br>+ 82-31-788-7653 |
| 3. Date Prepared | June 25, 2010 |
| 4. Device Name | FLAATZ 750E |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | KPR |
| 8. Predicate Device | FLAATZ 750<br>DRTECH Corporation<br>510(k) No.: K080064 |

### 9. Device Description

The FLAATZ 750E is a radlographic image ecquisition 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 750E 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 square 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 Delector 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.

#### DRTECH

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CONFIDENTIAL

Premarket Notification: FLAATZ 750

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#### 10. Intended Use

The FLAATZ 750E 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).

#### 11. Functional and Safety Testing

The FLAATZ 750E has been evaluated as per FDA's "Guldance for the Submission of 510(k)s for Solld State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.

The FLAATZ 750E has also met applicable Electro Magnetic Compatibility (EMC) requirements.

- 12. Conclusion
The FLAATZ 750E is substantially equivalent to the Predicate Device in design and performance.

DRTECH

CONFIDENTIAL

Premarket Notification: FLAATZ 750

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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

Re: K102474

Trade/Device Name: FLAATZ 750E Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 18, 2011 Received: February 25, 2011

AUG 2 3 2013

Dear Mr. Mack:

This letter corrects our substantially equivalent letter of March 4, 2011.

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/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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Janine M. Morri Acting 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 750E

Indications for Use:

The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. (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 Bewine Evaluation (ODE) CCVI

Mary Scott

Division of Radio Offica of in Vitro Diagno

510K K102474

DRTECH

Confidential

Premarket Notification: FLAATZ: 750E