PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM

K024147 · Varian Medical Systems, Inc. · MQB · Feb 12, 2003 · Radiology

Device Facts

• Record ID: K024147
• Device Name: PAXSCAN 4030 MEDICAL DIGITAL IMAGING SYSTEM
• Applicant: Varian Medical Systems, Inc.
• Product Code: MQB · Radiology
• Decision Date: Feb 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended Use

The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view. This device is intended for use by qualified medical personnel trained in radiology

Device Story

PaxScan 4030 is a digital X-ray imaging system; utilizes amorphous silicon flat panel sensor array with gadolinium oxysulfide scintillator to capture X-ray signals. System includes Pentium-based computer, road runner card, trigger board, and imaging software. Operates by converting X-ray input into digital images displayed in approximately five seconds. Used in clinical settings by qualified medical personnel trained in radiology. Output is a high-quality radiographic image viewed on a graphical user interface; assists clinicians in diagnostic imaging of human anatomy. Replaces traditional film/screen or computed radiography systems.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and technical comparison of imaging performance characteristics including spatial resolution, dynamic range, and image processing time.

Technological Characteristics

Amorphous silicon flat panel imager; gadolinium oxysulfide scintillator; 40 x 30 cm field of view; 127-micron pixel size; 2232 x 3200 element matrix; 12-bit dynamic range; 3.94 lp/mm spatial resolution. Connectivity: DICOM 3.0. Platform: Pentium-based PC running Windows NT/2000. Power: 100-240 VAC, 50/60 Hz.

Indications for Use

Indicated for generating radiographic images of human anatomy in extremity and general-purpose procedures. Intended for use by qualified medical personnel trained in radiology. Contraindicated when, in the physician's judgment, procedures are contrary to the patient's best interests.

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

• Philips Bucky Vision (K982795)
• Canon X-Ray Digital Camera (K981556)
• Fuji CR System (K993861)
• Infimed Stingray DR (K992794)

Submission Summary (Full Text)

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## FEB 1 2 2003

#### 510(k) Summary

K024/47

The following information is provided following the format of 21 CFR 807.92 for the PaxScan 4030 Medical Digital Imaging System.

| 1. Submitter: |
|--------------------------------------------|
| Varian Medical Systems |
| 3100 Hansen Way M/S H055 |
| Palo Alto, CA 94304-1129 |
| Contact Name: Linda S. Nash |
| Corporate Director, Regulatory Affairs and |
| Quality Assurance |
| Phone: [phone] |
| Fax: [phone] |
| Email: [e-mail] |
| Date: November 21, 2002 |

2. Device Name:

| Classification Name: | Solid State X-ray Imaging Device |
|----------------------|---------------------------------------------|
| Common/Usual Name: | Flat Panel Digital Imager |
| Proprietary Name: | PaxScan 4030 Medical Digital Imaging System |

3. Equivalent Devices:

| Proprietary Names: | Philips Bucky<br>Vision | Canon X-Ray<br>Digital Camera | Fugi CR<br>System | Infimed<br>Stringray DR |
|--------------------|-------------------------------|-------------------------------|-------------------|-------------------------|
| 510(K) Numbers: | K982795 | K981556 | K993861 | K992794 |
| Common Name: | Solid State X-Ray Imager | | | |
| Regulatory Class: | Class II, 21 CFR 892.6150/630 | | | |
| Panel: | Radiology | | | |
| Product Code: | 90MQB | | | |

4. Device Description:

The PaxScan 4030 Medical Digital Imaging System is composed of an amorphous silicon flat planel imager, Pentium based computer, road runner card, trigger board, imaging software and a power supply. The digital imager uses a large-area amorphous silicon sensor array with a gadolinium oxysulfide scintillator. The 40 x 30 cm panel will display high quality images in approximately five seconds over a wide range of dose settings.

5. Statement of Intended Use:

The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.

6. Comparison to substantially equivalent devices: The PaxScan 4030 is substantially equivalent to:

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Philips Bucky Vision Canon X-Ray Digital Camera Fuji CR System Infimed Stingray DR

510(k) No. K982795 510(k) No. K981556 510(k) No. K993861 510(k) No. K992794

The following comparison chart depicts the comparison characteristics.

| | Varian 4030R<br>Flat Panel Imager | Philips Bucky<br>Vision | Canon X-Ray<br>Digital Camera | Fuji CR System | InfiMed Stingray DR |
|-------------------------------|------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| 510(k)<br>Number | N/A | K982795 | K981556 | K993861 | K992794 |
| Flat Panel<br>Producer | Varian Medical<br>Systems | Trixell | Canon | Fuji | Trixell |
| Detector<br>Material | Amorphous Silicon<br>Sensor Array with<br>Gadolinium<br>Oxysulfide<br>Scintillator | Amorphous Silicon<br>Sensor Array with<br>Gadolinium<br>Oxysulfide<br>Scintillator | Scintillator over<br>Amorphous<br>Silicon Sensor<br>with thin film<br>Transistor Array | Photostimulable<br>phosphor imaging<br>plate europium<br>activated barium<br>flurohalide<br>compounds in<br>crystal form | Amorphous Silicon<br>Sensor Array with<br>Gadolinium<br>Oxysulfide Scintillator |
| Dimensions | 16" x 11.5" | 17" x 17" | 17" x 17" | 17" x 17" | 17" x 17" |
| Pixel Size | 127 x 127 microns | 143 x 143 microns | 160 x 160<br>microns | Standard mode<br>200 microns ;<br>high density<br>mode 100 microns | 143 x143 microns |
| Detector<br>Element<br>Matrix | 2232 x 3200 | 2981 x3021 | 2688 x 2688 | 2140 x 2140 | 2981 x 3021 |
| Dynamic<br>Range | 12 bits | 14 bits | 14 bits | 10 bits | 14 bits |
| Spatial<br>Resolution | 3.94 lp/mm | 3.5 lp/mm | 3.1 lp/mm | 4.0+ lp/mm | 3.5 lp/mm |
| External<br>Connectivity | DICOM 3.0<br>Compatible | DICOM 3.0<br>Compatible | DICOM 3.0<br>Compatible | DICOM 3.0<br>Compatible | DICOM 3.0<br>Compatible |
| Operator<br>Console | Graphical User<br>Interface Based<br>Pentium PC | Graphical User<br>Interface Based<br>Sun Ultra SPARC | Graphical User<br>Interface Based<br>Pentium PC | Graphical User<br>Interface Based<br>Pentium PC | Graphical User<br>Interface Based<br>Pentium PC |
| Image<br>Processor | Hard Drive | Hard Drive | Hard Drive | Hard Drive | Hard Drive |
| Image Storage | Hard Drive | Hard Drive | Hard Drive | Hard Drive | Hard Drive |
| Operating<br>System | Windows NT,<br>2000 | UNIX | Windows NT | Windows 98, NT | Windows NT |
| Image<br>Processing<br>Time | 5 Seconds per<br>Image | 8 Seconds per Image | 30 Seconds per<br>Image | 3-5 Minutes per<br>Image | 8 Seconds per Image |
| Power<br>Requirements | 100-240 VAC<br>50/60 Hz | 230 V 50/60 Hz | 110/120 V &<br>230/240 V 50/60<br>Hz | 200-240 V 50/60<br>Hz<br>100-120 V 50/60<br>Hz | 110/120 V & 230/240<br>V 50/60 Hz |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# FEB 1 2 2003

Ms. Linda S. Nash Corporate Director, Regulatory Affairs and Quality Assurance Varian Medical Systems, Inc. 3100 Hansen Way PALO ALTO CA 94304-1038

Re: K024147 Trade/Device Name: PaxScan 4030 Medical Digital Imaging System Regulation Number: 21 CFR 892.1630 Regulation Name: Electrostatic x-ray imaging system Regulatory Class: II

Product Code: 90 MQB Dated: November 20, 2002 Received: December 16, 2002

Dear Ms. Nash:

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

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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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Page 2

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### Statement of Indications for Use

#### 510(k) Number (if known): K024147

| Device Name: | PaxScan 4030 Medical Digital Imaging System |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use: | The PaxScan 4030 Medical Digital Imaging System is intended for use in generating radiographic images of human anatomy. It is intended to replace film/screen or computed radiography in extremity and general-purpose procedures appropriate to the input field of view.<br>This device is intended for use by qualified medical personnel trained in radiology |
| Contraindications for Use: | The use of the PaxScan 4030 Medical Digital Imaging System are contraindicated when, in the judgment of the physician, procedures would be contrary to the best interests of the patient. |

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use L (Per 21 CFR 801.109)

OR

Over-The-Counter Use (Optional Format 1-2-96)

Naruse Brogdon

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