FLAATZ 750

K080064 · Drtech Corp. · MQB · Jan 23, 2008 · Radiology

Device Facts

• Record ID: K080064
• Device Name: FLAATZ 750
• Applicant: Drtech Corp.
• Product Code: MQB · Radiology
• Decision Date: Jan 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

The FLAATZ 750 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 750 is a radiographic image acquisition system used in radiology environments by technicians. It captures X-ray photons using a direct conversion detector panel with an a-Se (amorphous selenium) layer. The system includes a detector panel, control box, switch box, and interconnecting cables. The control box buffers data between the detector and an operating PC while providing power; the switch box manages signal transfer with the X-ray generator and provides status via LED indicators. An API performs image data capture and defect correction. The system replaces traditional film/screen systems, providing digital images for clinical review to support diagnostic decision-making.

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 demonstrated performance substantially equivalent to the predicate device. EMC testing was also performed.

Technological Characteristics

Direct conversion detector panel using an a-Se (amorphous selenium) layer. System components: detector panel, control box, switch box, interconnecting cables, and API. Connectivity: interfaces with X-ray generator and operating PC. Software includes image capture and defect correction functions.

Indications for Use

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

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

• Saturn 9000 (K063710)

Submission Summary (Full Text)

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## 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>+ 82-31-730-6804 |
| 3. Date Prepared | December 5, 2007 |
| 4. Device Name | FLAATZ 750 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | MQB |
| 8. Predicate Device | Saturn 9000<br>New Medical Co., LTD.<br>510(k) No.: K063710 |

#### 9. Device Description

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The FLAATZ 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment

The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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.

CONFIDENTIAL

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### 10. Intended Use

The FLAATZ 750 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. Functional and Safety Testing

The FLAATZ 750 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 750 has also met applicable ElectroMagnetic Compatibility (EMC) requirements.

### 12. Conclusion

The FLAATZ 750 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 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

DRTECH Corporation % Mr. Ned Devine Senior Staff Engineer/Program Reviewer Underwriters Laboratories. Inc. 333 Pfingsten Road NORTHBROOK IL 60062

AUG 2 3 2013

Re: K080064

Trade/Device Name: FLAATZ 750 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 20, 2007 Received: January 10, 2008

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of January 23, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the encreations of 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, devices mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, and 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 that I Drims made a actives and regulations administered by other Federal agencies. You must or any I cacial statutes and regarations, 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 11 you dostro openio an 100 co 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 I va may other valle guits guiners, 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 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): Ko80064

Device Name: FLAATZ 750

Indications for Use:

The FLAATZ 750 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 × (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)

Lust Het Witz

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

**DRTECH**

CONFIDENTIAL

Premarket Notification000063

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