OPAL-RAD

K063337 · Viztek, Inc. · LLZ · Dec 12, 2006 · Radiology

Device Facts

• Record ID: K063337
• Device Name: OPAL-RAD
• Applicant: Viztek, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

Opal-RAD™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used. Typical users of this system are trained professionals, nurses, and technicians.

Device Story

Opal-RAD is a web-based PACS software suite for DICOM image management. Inputs include digital images/data from modalities like CT, MR, US, CR, and DR. Software enables viewing, manipulation, annotation, transmission, printing, animation, and storage of DICOM data. Deployed on standard Intel Pentium-based hardware using Windows OS (2000, NT, 98) over conventional healthcare networks. Operated by trained professionals, nurses, and technicians in clinical settings. Physicians use the interface to interpret displayed images for clinical decision-making. System does not generate original medical images; provides infrastructure for image access and review.

Clinical Evidence

No clinical data. Bench testing only. Hazard analysis performed; software level of concern classified as minor.

Technological Characteristics

Software-only PACS; runs on Intel Pentium-based PCs with Windows 2000/NT/98. Supports DICOM protocol for image transmission, storage, and display. Networked via conventional healthcare infrastructure. No patient contact; no life-sustaining function. Hazard analysis conducted; minor level of concern.

Indications for Use

Indicated for trained professionals, nurses, and technicians to receive, store, communicate, process, and display digital medical images (CT, MR, US, R/F, CR/DR) across networks. Contraindicated for diagnostic review of lossy compressed mammographic images; mammographic images require FDA-approved monitors; primary diagnosis requires DICOM "for presentation" images.

Regulatory Classification

Identification

A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.

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).

Predicate Devices

• RATTAN IMACS BY RATTAN INFORMATION CORPORATION (K032176)

Submission Summary (Full Text)

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KN-337

## 510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: November 2, 2006

Submitter's Information: 21 CFR 807.92(a)(1) Viztek, Inc 6491 Powers Ave. Jacksonville, FL 32217 Phone: [phone] Email: [e-mail]

DEC 1 2 2006

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Trade Name: Opal-RAD™ Common Name: Picture Archiving Communications System Device Classification: 892.2050 Classification Name: System, Image Processing

Predicate Device: 21 CFR 807. 92(a)(3) Opal-RAD™ is substantially equivalent to:

| 510(k) Number | K032176 |
|-----------------------------|---------------------------------------------------|
| Regulation Number | 892.2050 |
| Device Name | RATTAN IMACS BY RATTAN INFORMATION<br>CORPORATION |
| Applicant | RATTAN INFORMATION CORPORATION |
| Classification Product Code | LLZ |
| Decision Date | 09/25/2003 |
| Decision | substantially equivalent (SE) |

Device Description: 21 CFR 807 92(a)(4)

Opal - RAD is a software suite of web based PACS applications that was developed specifically to handle the DICOM protocol, for both transmitting and viewing DICOM images and data elements. The applications were developed so that access to the PACS can occur from any Microsoft Windows computer with internet capabilities, and offer an interface that users find to be quite intuitive after some initial learning. The Opal-RAD applications deal with all manner of DICOM images and modalities, including MR, CT, CR, US, and many others. These images can be viewed, manipulated, annotated, transmitted to other facilities, printed, animated and stored using the Opal-RAD suite.

The device is designed to be deployed over conventional networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating

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## 510(k) Summary of Safety and Effectiveness

systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images.

Indications for Use: 21 CFR 807 92(a)(5)

Opal-RAD™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

Tvpical users of this system are trained professionals, nurses, and technicians.

Technological Characteristics: 21 CFR 807 92(a)(6)

The device does not contact the patient, nor does it control any life sustaining devices.

A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for Opal-RAD™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

Opal-RAD™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Viztek, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 1600 Manchester Way CORINTH TX 76210

DEC 1 2 2006

Re: K063337

Trade/Device Name: Opal-RADTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 2, 2006 Received: November 8, 2006

Dear Mr. Alletto:

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 (Premarket Approval), it may be subject to such 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.

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Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complics 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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 |
|----------------|---------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.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

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## (Indications for Use Form)

## K063337 510(k) Number:

Device Name: Opal-RAD™

Indications for Use:

Opal-RAD™ is a software device that receives digital images and data from various sources (i.e. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging mateways or other imaging sources). Images and data can be stored, communicated, grocessed and displayed within the system and or across computer networks at distributed locations.

Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDR for viewing mammographic images. For primary diagnosis, post process DICOM "for presentation" images must be used.

Typical users of this system are trained professionals, nurses, and technicians.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

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

David R. Lyman

(Division Sian-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________