ULTRAVISUAL

K042008 · Emageon Uv, Inc. · LLZ · Sep 3, 2004 · Radiology

Device Facts

• Record ID: K042008
• Device Name: ULTRAVISUAL
• Applicant: Emageon Uv, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by modality and user; rotate images in 90-degree increments; flip image horizontally or vertically; customize display of on-screen user and patient demographics; sharpen, edge and blur filters; key image creation for communicating with other physicians, and multiple display support. Images can be displayed in any configuration or format the user specifies and associates with that specific user's profile. All display protocols and user configurable settings follow the user throughout the enterprise. Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA. Intended users of the image distribution system include radiologists, referring physicians, tertiary care physicians, medical technologists, and information technology professionals.

Device Story

Ultravisual is a client-server software package for Picture Archiving and Communication Systems (PACS). It receives digital mammography images via DICOM standard. The software provides visualization tools including real-time pan, zoom, window/level, scroll, rotation, flipping, and image filters (sharpen, edge, blur). It supports multi-monitor configurations and user-specific display profiles that roam across the enterprise. Used by radiologists, referring physicians, and technologists in clinical settings to view and interpret medical images. The device facilitates clinical decision-making by providing configurable, high-resolution image display and communication tools (key image creation). It benefits patients by enabling efficient, enterprise-wide access to diagnostic-quality mammography images for timely review.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and validation procedures consistent with the predicate device (K012097).

Technological Characteristics

Integrated client-server software architecture. Operates on off-the-shelf computer hardware. Supports DICOM standard for image communication. Features include grayscale/pseudo-color lookup tables, image filters (sharpen, edge, blur), and multi-display support. Designed for use with FDA-approved 5 Mpixel resolution monitors for mammography interpretation.

Indications for Use

Indicated for the display of presentation quality mammography images for interpretation by radiologists and other clinicians. Contraindicated for primary image interpretation of lossy compressed or digitized screen film mammographic images. Requires use of FDA-approved monitors with at least 5 Mpixel resolution.

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

• Vortex™ (K012097)

Submission Summary (Full Text)

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K042008

SEP - 3 2004

# 510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990, Emageon UV.. Inc. is providing a summary of safety and effectiveness information regarding the Ultravisual™ software.

- l . I Company Identification
Emageon UV, Inc. 131 W. Wilson Street Suite 700 Madison WI 53703 Establishment Registration Number: 2135350 Contact: Inger Couture Tel: [phone] Fax: [phone] Email: [e-mail]

- 1.2 Official Correspondent
Inger Couture Director of Regulatory Affairs and Quality Assurance Emageon UV, Inc. 131 W. Wilson Street Suite 700 Madison WI 53703 Establishment Registration Number: 2135350 Tel: [phone] Fax: [phone] Email: [e-mail]

- 1.3 Date of Submission
June 29th, 2004

- Device Name 1.4
Classification Name: Image Processing System, 21 CFR \$892.2050, ProCode LLZ

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Common/Usual Name: Picture Archiving and Communication System

Proprietary Name: Ultravisual™ (formerly Vortex TM)

Cleared Device(s): Vortex™ , 510(k): K012097

#### Device Description and Intended Use 1.5

Emageon UV, Inc.'s Ultravisual™ software is integrated client-server software package comprised of features that were previously cleared in Vortex TM 510(k): K012097. The main difference is that the software will now allow display of presentation quality digital mammography images, sent via the DICOM standard in order to make viewing of these images more convenient for the user.

- 1.6 Software Development
Emageon UV, Inc. certifies that the Ultravisual™ software is designed. developed, tested and validated in accordance with the same procedures as documented in the initial Vortex™ 510(k). K012097.

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#### 1.8 Safety and Effectiveness

## General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and indications for use.

The hardware components specified (and/or optionally supplied) are all "off the shelf" computer components.

## Validation and Effectiveness:

As documented in the initial Vortex™ 510(k): K012097.

### Substantial Equivalence:

The intended use of Emageon UV, Inc.'s Ultravisual™ software is substantially equivalent in the opinion of Emageon UV, Inc. to the feature set described in the original Vortex 130 software, 510(k) K012097 and do not pose any new issues of safety and effectiveness

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 2004

Emageon UV, Inc. % Ms. Laura Danielson Responsible Third Party TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K042008

Trade/Device Name: UltraVisual™ Image Processing, Communication and Visualization Workstation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: August 19, 2004 Received: August 20, 2004

Dear Ms. Danielson:

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 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.

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) I result et 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. Brydon

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

Enclosure

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Device Name: Emageon UV, Inc., Ultravisual ™ Image Processing, Communication and Visualization Software Supporting Workstation

Indications for use:

Presentation quality mammography images sent via the DICOM standard can be displayed using features that are native to Emageon UV Inc.'s software. Other standard tools include intuitive tools for real-time pan, zoom, window/level and scroll; drag and drop series thumbnails for intuitive navigation; comprehensive set of grayscale and pseudo-color lookup tables; fully configurable magnifying glass; customizable window/level and zoom presets stored by modality and user; rotate images in 90-degree increments; flip image horizontally or vertically; customize display of on-screen user and patient demographics; sharpen, edge and blur filters; key image creation for communicating with other physicians, and multiple display support. Images can be displayed in any configuration or format the user specifies and associates with that specific user's profile. All display protocols and user configurable settings follow the user throughout the enterprise.

Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a FDA approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.

Intended users of the image distribution system include radiologists, referring physicians, tertiary care physicians, medical technologists, and information technology professionals.

(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)

510(k) Number

| Prescription Use | <div> <span style="text-decoration: overline;">✓</span> </div> |
|-----------------------------|----------------------------------------------------------------|
| AND/OR Over-The-Counter Use | <div> <span style="text-decoration: overline;"></span> </div> |

David A. Repass

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices 10/1/2008