KRYSTALRAD (ATAL8)

K102285 · Medicatech USA · KPR · Jan 3, 2011 · Radiology

Device Facts

• Record ID: K102285
• Device Name: KRYSTALRAD (ATAL8)
• 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 (ATAL8) 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 general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

Device Story

KrystalRAD (ATAL8) is a flat-panel digital X-ray detector capturing projection radiographic images in electronic format. It replaces traditional film/screen systems. The system consists of a detector panel, control box, and workstation. Radiologists/physicians use the workstation to display, store, and electronically adjust images to optimize anatomical views. The system supports DICOM-compliant output for network transmission and digital printing. It enables image duplication without additional patient exposure. Used in clinical settings, it facilitates diagnostic decision-making by providing immediate digital access to radiographic images, potentially reducing patient radiation exposure by eliminating retakes associated with film processing.

Clinical Evidence

Bench testing only. Performance testing included electrical and mechanical safety (EN/IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-23) and EMC testing (EN/IEC 60601-1-2). Comparative bench data provided for DQE (68% vs 48.5%), MTF, resolution, and ghosting.

Technological Characteristics

Flat-panel detector using Amorphous Silicon (a-Si) technology. Dimensions: 500 x 500 x 40 mm. Pixel pitch: 143 µm. Image size: 3072 x 3072 pixels. Power: 90-260V, 47/63 Hz. Connectivity: DICOM-compliant. Software: OmniVision.

Indications for Use

Indicated for general radiographic imaging of human anatomy in patients requiring diagnostic procedures, excluding 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 K102285

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

| Initial Importer/Distributor | MedicaTechUSA |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Address: | 50 Maxwell<br>Irvine, CA 92618 |
| Phone number: | [phone] |
| Fax number: | [phone] |
| | JAN - 3 |
| Contact Person | George Makar |
| Email: | [e-mail] |
| Phone: | [phone] |
| Cell: | [phone] |
| Fax: | [phone] |
| Manufacturer | Atlaim<br>1018/19 Sicox Tower Sangdaewon<br>Seongnam Gyeonggi<br>462-120, Republic of Korea<br>Tel #: [phone]<br>Fax #: [phone] |
| Device Name and Classification | |
| Trade name/Product Name: | KrystalRAD (ATAL8) 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 | December 15, 2010 |
| Substantial Equivalence claimed to: | DRTech FLAATZ 750 (K080064) |

## Device Description

The KrystalRAD (ATAL8) 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 (ATAL8) device differs from traditional Xray systems in that, instead of exposing a film and chemically processing it to create a hard convenial 71 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.

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. 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 11 : 33m .

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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 (ATAL8) 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 general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).

## Substantial Equivalence

The KrystalRAD (ATAL 8) is substantially equivalent to the commercially available DRTech FLAATZ 750 system cleared on January 23, 2010 via 510k K080064. Bench testing and electrical safety further substantiate equivalence to the predicate. The KrystalRAD (ATAL 8) utilizes OmniVision Software while the DRTech FLAATZ 750 system utilizes the proprietary ECOM OmniVue software to control the system and manage digital images collected.

| 510(k) Number | | DRTech Corporation<br>(K080064) | KrystalRAD (ATAL8) |
|---------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| | Indication for Use | The FLAATZ 750 is indicated for<br>use in general radiographic images<br>of human anatomy. It is intended<br>to 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 |
| Design | Panel Shape | Square | Square Panel |
| | Detector Size | 42.9 x 42.9 (cm) | 43 x 43 cm |
| | Dimensions<br>(W x L x H) | 482 x 482 x 35 (mm) | 500 X 500 X 40mm |
| | Pixel Pitch | 168 (um) | 143 um |
| | Image Size | 3072 x 3072 (pixels) | 3072 x 3072 pixel |
| | Selenium Thickness | 500 (µm) | no selenium |
| | Weight (Detector) | 6.2 (kg) | 12.7 kg |
| Materials | | Amorphous Selenium<br>(a-Se) Detector | Amorphous Silicon (a-Si) |
| Performance | DQE | 48.5% @ 0.5 lp/mm | 68%@ .5 lp/mm |

#### + 1 . 1411 Substantial Equivalence Table

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| 510(k) Number | DRTech Corporation<br>(K080064) | | KrystalRAD (ATAL8) |
|------------------------------|-------------------------------------------------------------------------------------------------------------|----------------------|---------------------------------------------------------------------------------------------------------|
| | MTF | 78% @ 3.5 lp/mm | 525 @ 3.5 lp/mm |
| | Resolution | 3.6 lp/mm | 3.5 lp/mm |
| | Ghosting | <1% @ RQA5 Condition | <1% @ RA5 condition |
| Anatomical Sites | | General Radiography | General Radiography |
| Energy Used and/or Delivered | The Control Box has the following<br>Power Requirement:<br>100~240V~, 50/60 Hz, Max 2A,<br>Single Phase<br> | | The Control Box has the following<br>Power Requirement:<br>90V - 260V, 47/63 Hz, 3.15A,<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/EC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-23 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-12202 All test results were satisfactory. 学大利:"%。

## Conclusion

The results of all testing demonstrate that the KrystalRAD (ATAL8) 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 contains the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the HHS emblem, which is a stylized caduceus, a symbol often associated with medicine and healthcare. The emblem is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

## 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: K102285

Trade/Device Name: KrystalRad (ATAL8) 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 Mav 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,

signature

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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Image /page/5/Picture/0 description: The image shows the logo for "medicatechUSA MEDICAL SYSTEMS". The logo features a stylized graphic to the left of the text. The graphic is a black, wavy line that resembles a double helix. The text is in black, with "medicatechUSA" in a larger font than "MEDICAL SYSTEMS".

510(k) Number (if known):

JAN - 3 2010

Device Name: KrystalRAD (ATAL8) System

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Indications For Use:

The KrystalRAD (ATAL8) 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 X (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 Radiolo Office of In