STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS

K100703 · Comed Co., Ltd. · MQB · Dec 21, 2010 · Radiology

Device Facts

• Record ID: K100703
• Device Name: STATIONARY X-RAY SYSTEM (DETECTOR) MODEL: ALTAS
• Applicant: Comed Co., Ltd.
• Product Code: MQB · Radiology
• Decision Date: Dec 21, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system. The Atlas is not intended for mammography.

Device Story

ATLAS is a digital X-ray detector integrated into stationary radiography systems. It captures X-ray signals using a single CCD detector with a scintillator, converting them into high-resolution digital images. The device eliminates the need for film, chemistry, cassettes, or imaging plates. Operated by physicians or technologists in clinical settings, the system supports various patient positions (sitting, standing, prone, supine). The output is a digital radiographic image displayed on a workstation, allowing for diagnostic review. By providing high-resolution digital capture with 98% pixel fill factor, the device enables efficient image acquisition and potentially lower radiation doses compared to conventional film systems. It is intended for general-purpose diagnostic procedures.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Digital X-ray detector; single CCD sensor with scintillator; 3,103 x 3,085 pixel array (9 Megapixel); 144-micron pixel size; 16-bit capture; 98% fill factor. Standards: EN ISO 14971, EN 60601-1, EN 60601-1-2, EN 60601-1-4. Connectivity: Integrated into stationary radiography systems.

Indications for Use

Indicated for diagnostic radiographic imaging of skull, spine, chest, abdomen, and extremities in adult and pediatric patients. Not for mammography.

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

• Xaminer (K061595)
• QXR-9 (K073056)

Submission Summary (Full Text)

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K100703

# 510(K) SUMMARY

[as required by 807.92(c)]

DEC 2 1 2010

## A. 510k Number:

## B. Applicant:

Company name: PATS CORP Address: 49 Candlewood Way, Buena Park, CA 90621, USA Contact person: Mr Brandon Choi Phone: [phone] Fax: [phone]

C. Proprietary and Established Names: COMED CO LTD Address: #58, Hakdong-Ri, Chowol-Eup, Gwangju-City, Gyeonggi-Do, Korea

# D. Requlatory Information

Classification : Class II CFRcord : 892 . 1680 , Regular Name : Stationary X-ray system Product cord : MQB

### E. Intended Use

The ATLAS is integrated into the user`s stationary radiography system. This typical configuration permits a qualified/trained doctor or technicolgosist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient. Applications can be performed with patient sitting, standing of lying in the prone or supine positions in an integrated system. The ATLAS is not intended for mammography.

### F. Device Description

The Atlas is provided high resolution radiographic images in a digital format without use of film , chemistry, cassettes or expensive imaging plates. With 98% of fill factor in each pixel, there is a maximum efficiency and lower dose required for image capture. It has single CCD detector.

- G. Substantial Equivalence Information
- 1. Predicate Device
- 1) Xaminer (K061595)
- 2) QXR-9 (K073056)

For the technological characteristics the Company is relying on the above mentioned

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ATLAS. COMED Co., Ltd. believes that ATLAS is substantially equivalent in intended use, principles of operation, and technological characteristics to the predicate devices presented above and any differences with Xaminer (K061595), QXR-9 (K073056) do not raise new types of safety or effectiveness issues, as further discussed below.

| Model Name | ATLAS | Xaminer | QXR-9 |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | Not yet | K061595 | K073056 |
| Classification | Class II Device /<br>MQB (21 CFR 892.1650) | Class II Device /<br>MQB (21 CFR 892.1650) | Class II Device /<br>MQB (21 CFR 892.1650) |
| INTENDED USE | The ATLAS is integrated into the user's<br>stationary radiography system.<br>This typical configuration permits a<br>qualified/trained doctor or technologist<br>to take a range of head-to-toe diagnostic<br>radiographic exposures of the skull,<br>spinal column, chest abdomen, extremities,<br>and other body parts on both<br>adult and pediatric patients. Applications can<br>be performed with patient. Applications can be<br>performed with patient sitting standing of<br>lying in the prone or supine positions in an<br>intergrated system<br>The ATLAS is not intended for mammography | The Xaminer (510k submission device) is<br>integrated into the user's stationary radiography<br>system This typical configuration permits a<br>qualified/trained doctor or technologist to take a<br>range of head-to-toe diagnostic radiographic<br>exposures of the skull spinal column, chest<br>abdomen, extremities, and other body parts on<br>both adult and pediatric patients. Applications<br>can be performed with patient sitting, standing or<br>lying in the prone or supine positions in an<br>integrated system<br>The Xaminer (510k submission device) is not<br>intended for mammography | QXR-9 Digital Radiography system is<br>indicated for digital imaging solution<br>designed for general radiographic system for<br>human anatomy. It is intended to replace film<br>or screen based radiographic systems in all<br>general purpose diagnostic procedures. Not<br>to be used for mammography. |
| Feature | The Atlas is provided high resolution<br>radiographic images in a digital format without<br>use of film, chemistry, cassettes or expensive<br>imaging plates. With 98% of fill factor in each<br>pixel there is a maximum efficiency and lower<br>dose required for image capture. It has single<br>CCD detector | The Xaminer is the latest version of Xplorer<br>digital radiographic detectors. It includes<br>features and functions that have been developed<br>since the introduction of the original Xplorer<br>1000 (predicate device). Xaminer provides high<br>resolution radiographic images at 3.2 lp/mm<br>in a digital format without use of film, chemistry,<br>cassettes or expensive imaging plates. With 98 %<br>of fill factor in each pixel there is a maximum<br>efficiency and lower dose required for image<br>capture. It has single CCD detector with 9 mega<br>pixel digitized at 14 bits per pixels | The QXR-9 Digital Radiography Systems is a<br>high-resolution digital imaging system<br>designed for digital radiography. It is<br>designed to replace conventional film<br>radiography techniques. This system consists<br>of Detector Power Supply Unit, Accessories,<br>and S/W. The S/W is operated at a<br>workstation that is using Windows XP based<br>OS as its operating system. The system allows<br>the operator to acquire and display<br>images(Image size 3072x3072 pixels) or<br>1600 x 1200 high resolution monitor.<br>Various features of S/W such as image<br>inversion, image processing, zooming,<br>panning, window level adjustment, contrast<br>adjustment etc enable the operator to view<br>diagnostic details difficult to see using<br>conventional non-digital techniques. |
| STANDARD | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-4<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-4<br>EN 60601-1-2 | EN ISO 14971<br>EN 60601-1<br>EN 60601-1-2 |
| Sensor | CCD+ scintillator | CCD- scintillator | CCD- scintillator |
| Imaging Pixels | 3,103 x 3,085(9 Megapixel) | 3,072 x 3,072 (9 Megapixel) | 3,072 x 3,072 (9 Megapixel) |

#### Comparison with predicate 2.

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| Active Image Size | 17" x 17" | 43 cm x 43 cm (17" x 17") | 43 cm x 43 cm (17" x 17") |
|----------------------------|---------------------|---------------------------|---------------------------|
| Pixel Size | 144 microns | 144 microns | 144 microns |
| Nyquist Resolution | 3.5 lp/mm | 3.2 lp/mm | 3.5 lp/mm |
| Bit Depth | 16Bit capture | 14 bit capture | 14 bit capture |
| Fill Factor | 98% | 100% | << |
| Preview Image | Less than 5 seconds | Less than 5 seconds | Less than 3 5 seconds |
| Imaging Detector<br>Weight | 45kg-50kg | 75 kg (165 lb) | << |

# 3. Conclusion

Based on the above, we conclude that the Digital X-ray Detector ATLAS has substantial equivalent intended use as the-market-cleared Xaminer (K061595), QXR-9 (K073056) and has substantial equivalent technological and performance characteristics. After analyzing both bench as well as laboratory testing to applicable standards, it is the conclusion of ATLAS is as safe and effective as the predicate devices, has few technological differences, but there are no new indications for use and without raising any new safety and/or effectiveness concerns.

Consequently, it is clear that it substantially equivalent to the predicate devices.

# H. Performance Characteristics (If/when applicable)

Applied by standard of

- Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
- IEC 980:2003, Graphical symbols for use in the labeling of medical devices
- IEC1041:1998, Information supplied by the manufacturer with medical devices
- · ISO 13485:2003. Medical devices Quality management systems -Requirements for requlatory purposes
- ISO 14155-1:2003, Clinical investigation of medical devices for human subjects - Part 1: General requirements
- ISO 14971:2007, Medical devices Application of risk management to medical devices
- · IEC 60601-1 Medical electrical equipment Part 1:General requirements for safety (IEC 60601-1:1988/A1:91/A2:95)
- IEC 60601-1-2:2001/A1:2006, Medical electrical equipment Part 1: General requirements for safety - Collateral standard: Electromagnetic compatibility -
- Requirements and tests
- IEC 60601-1-4:1996+A1:1999:1999, Medical electrical equipment. Part 1-4: General requirements for safety- Collateral standard: Programmable electrical medical systems

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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is an emblem of a stylized eagle with its wings spread. The eagle is facing to the left and has three lines representing its wings.

## 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

COMED Co., Ltd. c/o Mr. Brandon Choi Representative PATS Corporation 49 Candlewood Way BUENA PARK CA 90621

DEC 2 1 2010

K100703 Trade Name: ATLAS (Digital X-Ray Detector) Regulation Number: 21 CFR § 892,1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MBQ Dated: November 5, 2010 Received: November 10, 2010

Dear Mr. Choi:

Re:

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. Iisting 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,

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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Indications for Use

510(k) Number (if known):

Device Name: ATLAS (Digital X-Ray Detector)

Indications For Use: The ATLAS is integrated into the user's stationary radiography system. This typical configuration permits a qualified/trained doctor or technologist to take a range of head-to-toe diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions in an integrated system.

The Atlas is not intended for mammography.

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)

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### Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Radiological Devices

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K100703