CYPHER DICOM PRINT SOLUTION

K092280 · Virtual Imaging, Inc. · LMC · Oct 16, 2009 · Radiology

Device Facts

• Record ID: K092280
• Device Name: CYPHER DICOM PRINT SOLUTION
• Applicant: Virtual Imaging, Inc.
• Product Code: LMC · Radiology
• Decision Date: Oct 16, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2040
• Device Class: Class 2

Intended Use

This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.

Device Story

Cypher DICOM Print Solution acts as a gateway/interface device; receives digital image data via DICOM services; processes and formats data for output to a Windows-compatible printer (specifically Canon imagePRESS C1). Used in clinical settings by radiologists and imaging specialists. Hardware consists of Intel 945GSE Mini-ITX board in a shielded enclosure; user interface managed via attached monitor or Windows XP remote desktop. Provides high-quality black and white or color hardcopy prints for diagnostic use and referral. Benefits include standardized hardcopy documentation of digital imaging studies.

Clinical Evidence

Bench testing only. Evidence includes software validation and evaluation of hardcopy output quality. Electrical safety verified via use of UL-listed power supply. No clinical data presented.

Technological Characteristics

Intel 945GSE Mini-ITX board; shielded enclosure; external UL-listed 12V power supply. DICOM-compatible interface; Windows XP-based software environment. Connectivity via DICOM services to Windows-compatible printers. Form factor: standalone unit.

Indications for Use

Indicated for medical radiologists, imaging modality specialists, and referring physicians requiring high-resolution hardcopy prints of digital medical images (radiography, nuclear medicine, ultrasound, CT, MRI, CR, Radiation Therapy). Contraindicated for mammography.

Regulatory Classification

Identification

A medical image hardcopy device is a device that produces a visible printed record of a medical image and associated identification information. Examples include multiformat cameras and laser printers.

Special Controls

*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern). The device 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

• Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA PRINTERS (K060440)
• Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA PRINTERS (K042232)

Submission Summary (Full Text)

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K092280

# 510(k) SUMMARY

Image /page/0/Picture/2 description: The image shows the logo for Virtual Imaging, a Canon USA company. The logo features a stylized "V" shape on the left, followed by the words "VIRTUAL IMAGING" in bold, block letters. Below the company name, the text "A CANON USA Company" is written in a smaller font size.

Image /page/0/Picture/3 description: The image shows the word "Canon" in a bold, sans-serif font. The letters are black, and the background is white. The word is slightly distorted, with some of the letters appearing to be slightly blurred.

ANON USA Company

### 720 S. Powerline Road, Suite E Deerfield Beach, FL 33442 954-428-6191 (Office)

OCT 1 6 2009

954-428-6195 (Fax) Page 1 of 2, 510(k) Summary: Cypher DICOM Print Solution

| Date Prepared | July 20, 2009 |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary prepared by: | Chris Duca, Chief Operating Officer |
| Device Name | Medical Image Hardcopy Device (Printer) |
| Trade Name | Cypher DICOM Print Solution |
| Common Name | Printer |
| Classification | Class: II<br>Product Code: LMC<br>Regulation: 21 CFR 892.2040; |
| Identification of<br>Predicate Devices and<br>Summary of Substantial<br>Equivalence | Horizon® Series MEDICAL IMAGE HARDCOPY MULTIMEDIA<br>PRINTERS, K060440 and K042232, manufactured by Codonics, |
| Device Description | CYPHER implements the necessary DICOM services to receive<br>DICOM print jobs and provides an interface for printing the<br>received data on a Windows™ printer. The device is designed for<br>use with the CANON imagePRESS™ C1 Digital Print System. It<br>consists of an Intel® 945GSE Mini-ITX Board in a shielded<br>enclosure. The user interface is implemented on either an<br>attached monitor or via the remote desktop function inherent in<br>Windows XP. Power is supplied via an external UL listed 12 volt<br>power supply. |

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| Intended Use and<br>Indications | This device is intended for high resolution hard copy imaging of<br>digital image source material (DICOM). The hardcopy output<br>includes however is not limited to, digital radiography, nuclear<br>medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning;<br>Images are suitable for medical image diagnosis use and referral.<br>The system is intended for use by medical radiologists, imaging<br>modality specialists, and communications to referring physicians.<br>Not for mammography use. |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technological<br>Characteristics and<br>Substantial Equivalence | Comparison with the predicate shows the technological<br>characteristics of the Cypher DICOM Print Solution are equal to or<br>better than the predicate device. Both units are DICOM<br>compatible (optional on the predicate) and produce high quality<br>hardcopy printouts in black & white and color. |
| Performance<br>Testing/Data | Tests were performed on the device which demonstrated that the<br>device is safe and effective, performs comparably to and is<br>substantially equivalent to the predicate device.<br>Tests include: Software Validation and evaluation of hardcopy<br>output. Electrical safety is assured via use of a UL listed power<br>supply. |

Page 2 of 2, 510(k) Summary: Cypher DICOM Print Solution

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

### 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

Virtual Imaging, Inc. % Mr. Daniel Kamm Principal Consultant Kamm & Associates 333 Milford Road DEERFIELD IL 60015

### OCT 1 6 2009

Re: K092280

Trade/Device Name: Cypher DICOM Print Solution Regulation Number: 21 CFR 892,2040 Regulation Name: Medical image hardcopy device Regulatory Class: II Product Code: LMC Dated: July 21, 2009 Received: July 28, 2009

#### 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 mav 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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device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Janina M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## INDICATIONS FOR USE

#### 510(k) Number (if known): K09-2290 Device Name: Cypher DICOM Print Solution

This device is intended for high resolution hard copy imaging of digital image source material (DICOM). The hardcopy output includes however is not limited to, digital radiography, nuclear medicine, ultrasound, CT, MRI, CR and Radiation Therapy planning; Images are suitable for medical image diagnosis use and referral. The system is intended for use by medical radiologists, imaging modality specialists, and communications to referring physicians. Not for mammography use.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Norm B. Khan

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Deviceş
510(k) Number. K092280

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