KRYSTALRAD 560 (FLAATZ 560)

K102284 · Medicatech USA · KPR · Jan 3, 2011 · Radiology

Device Facts

• Record ID: K102284
• Device Name: KRYSTALRAD 560 (FLAATZ 560)
• Applicant: Medicatech USA
• Product Code: KPR · Radiology
• Decision Date: Jan 3, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The KrystalRad 560 (FLAATZ 560) Digital X-Ray Systems is indicated for use in general 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

KrystalRad 560 (FLAATZ 560) is a flat-panel digital X-ray detector; captures projection radiographic images in electronic format. Replaces traditional film/screen systems; eliminates chemical processing. System includes detector panel, control box, and OmniVision software. Operated by clinicians in diagnostic settings. Captures X-ray signals; converts to digital images for display, storage, and electronic adjustment at a workstation. Enables image duplication and transmission via network; supports DICOM-compliant output for integration with existing infrastructure. Benefits include faster image availability, reduced need for repeat exposures, and optimized viewing of anatomy.

Clinical Evidence

Bench testing only. Performance evaluated via DQE, MTF, resolution, and ghosting metrics. Electrical and mechanical safety verified per EN/IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, and 60601-2-32. EMC testing conducted per EN/IEC 60601-1-2 and 60601-2-22.

Technological Characteristics

Flat-panel detector using Amorphous Selenium (a-Se) photoconductor. Dimensions: 383 x 460 x 15 mm. Pixel pitch: 139 µm. Image size: 3072 x 2560 pixels. Power: 100-240V, 50/60 Hz. Connectivity: DICOM-compliant. Software: OmniVision. Standards: EN/IEC 60601 series.

Indications for Use

Indicated for general radiographic imaging of human anatomy. Intended to replace film/screen systems 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

• DRTech FLAATZ 750 (K080064)

Submission Summary (Full Text)

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# 510(k) Summary K102284 This 510k summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

- 3 2010

| Initial Importer/Distributor | MedicaTechUSA | |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------|-----|
| Address: | 50 Maxwell<br>Irvine, CA 92618 | JAN |
| Phone number: | [phone] | |
| Fax number: | [phone] | |
| Manufacturer | DRTECH CORP.<br>333-1, Sangdeawon 1-Dong<br>Jungwon-gu<br>Seongnam-shi, Gyeonggi-do 462-807<br>Republic of Korea. | |
| Phone number: | [phone] | |
| Fax number: | [phone] | |
| Contact Person | George Makar | |
| Email: | [e-mail] | |
| Phone: | [phone] | |
| Cell: | [phone] | |
| Fax: | [phone] | |
| Device Name and Classification | | |
| Trade name/Product Name: | KrystalRad 560 (FLAATZ 560) System | |
| Classification name: | Stationary X-ray System | |
| Common name: | General purpose diagnostic X-ray System | |
| Classification Panel: | Radiology | |
| Product Code: | MQB | |
| Regulation Number: | 892.1680 | |

Date Prepared

Substantial Equivalence claimed to:

DRTech FLAATZ 750 (K080064)

## Device Description

The KrystalRad 560 (FLAATZ 560) System is a flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire X-ray film or an image plate as an image capture medium. The KrystalRad 560 (FLAATZ 560) device differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector Panel is used to capture the image in electronic form.

Once the system captures a radiographic image and subsequently displaying and storing an image, radiologists or physicians can adjust the image electronically to optimize the view of the desired anatomy at a work station. .1

15.2010

The system enables a user to duplicate images without having to take additional exposures so that the user can easily transmit a duplicate to the second physician who needs the duplicate image through the network.

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Hardcopy images can also be made from digital printers, optimizing for the user's preference. The system can have DICOM-compliant output to ensure compatibility with existing imaging network infrastructure.

## Indications for Use

The KrystalRad 560 (FLAATZ 560) Digital X-Ray System is indicated for use in general 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).

### Substantial Equivalence

The KrystalRad 560 (FLAATZ 560) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. X-ray generation used with the KrystalRad 560 (FLAATZ 560) is identical to the DRTech 750. The KrystalRad 560 (FLAATZ 560) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM Omni Vue software to control the system and manage digital images collected

| 510(k) Number | DRTech Corporation<br>(K080064) | KrystalRad 560 (FLAATZ 560) | |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------|
| Indication for Use | The FLAATZ 750 is indicated for use<br>in general radiographic images of<br>human anatomy. It is intended to<br>replace radiographic film/screen<br>systems in all general-purpose<br>diagnostic procedures (excluding<br>fluoroscopic, angiographic, and<br>mammographic applications). | Same as predicate. | |
| User Interface | Software Driven<br>Touch Panel LCD +<br>remote control unit +<br>remote console | Same as predicate. | |
| Software | ECOM OmniVue | OmniVision<br>FDA cleared via 510k K101315 | |
| Design | Panel Shape | Square | Rectangle |
| | Detector Size | 42.9 x 42.9 (cm) | 35x43 cm |
| | Dimensions<br>(W x L x H) | 482 x 482 x 35 (mm) | 383 X 460 X15mm |
| | Pixel Pitch | 168 (um) | 139 um |
| | Image Size | 3072 x 3072 (pixels) | 3072 x 2560 pixel |
| | Selenium<br>Thickness | 500 (μm) | 500 (μm) |
| | Weight<br>(Detector) | 6.2 (kg) | 3.8kg |
| Materials | | Amorphous Selenium<br>(a-Se) Detector | Amorphous Selenium<br>(a-Se) |
| Performance | DQE | 48.5% @ 0.5lp/mm | 52.5% @ .5lp/mm |
| | MTF | 78% @ 3.5lp/mm | 77% @ 3.5lp/mm |
| | Resolution | 3.6lp/mm | 3.5lp/mm |

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| 510(k) Number | DRTech Corporation<br>(K080064). | KrystalRad 560 (FLAATZ 560) |
|---------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Ghosting | <1% @ RQA5 Condition | <1% @RAQ5 conditions |
| Anatomical Sites | General Radiography | General Radiography |
| Energy Used and/or<br>Delivered | The Control Box has the following<br>Power Requirement:<br>100~240V~, 50/60 Hz, Max 2A, Single<br>Phase | The Control Box has the following<br>Power Requirement:<br>100~240V~, 50/60 Hz, Max 2A,<br>Single Phase |

# General Safety and Effectiveness Concerns

Electrical, mechanical safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-2-22 was
test results were satisfactory. In accordance with standard EN/IEC 60601-1-2(2001).

# Conclusion

The results of all testing demonstrate that the KrystalRad 560 (FLAATZ 560) does not raise any new significant issues of safety, effectiveness or performance of the device when compare to the existing predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines that suggest movement and freedom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the bird symbol.

# 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

Medicatech USA % Mr. Daniel Kamm New Submission Correspondent Kamm & Associates 8870 Ravello Ct NAPLES FL 34114

JAN - 3 2010

Re: K102284

Trade/Device Name: KrystalRad 560 (FLAATZ 560) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: December 16, 2010 Received: December 21, 2010

#### Dear Mr. Kamm:

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 (reporting of medical

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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.

Dan

David G. Brown, Ph.D. 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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JAN - 3 2010

510(k) Number (if known): Klo2284

Device Name: KrystalRad 560 (FLAATZ 560) System

Indications For Use:

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・

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The KrystalRad 560 (FLAATZ 560) Digital X-Ray Systems is indicated for use in general 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).

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Devices
Concessor () — La Grossic Devices Evaluation and Safety

510K K102284

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