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.

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as specific performance metrics. The underlying claim is substantial equivalence to a cleared predicate device.	The Ultravisual™ software is stated to have features previously cleared in Vortex™ (K012097) and 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.
The device must not pose new issues of safety and effectiveness compared to its predicate.	The device is deemed substantially equivalent to the original Vortex 130 software, 510(k) K012097, and does not pose any new issues of safety and effectiveness.
Compliance with general controls and regulations (registration, listing, GMP, labeling, etc.)	The FDA's substantial equivalence determination allows marketing, subject to general controls and existing major regulations.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations.	Explicitly stated as a condition for use.
Mammographic images may only be interpreted using an FDA-approved monitor that offers at least 5 Mpixel resolutions and other technical specifications reviewed and accepted by FDA.	Explicitly stated as a condition for use.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set or a study with a test set for evaluating the performance of the Ultravisual™ software against defined performance criteria. The submission relies on substantial equivalence to a previously cleared device. Therefore, details about sample size or data provenance for a direct performance study are not applicable or provided.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since no new performance study with a test set is described, this information is not available.

4. Adjudication Method for the Test Set

As no specific test set or performance study is described, adjudication method information is not available.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is described in the provided text. The submission focuses on substantial equivalence based on the predicate device's features and the addition of digital mammography display capability. Therefore, this information is not available.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone performance study for the Ultravisual™ software is described. The device's primary function is an image processing, communication, and visualization workstation intended for human interpretation. Therefore, this information is not available.

7. The Type of Ground Truth Used

As no new performance study is described, information on the type of ground truth used is not available. The basis for clearance is substantial equivalence.

8. The Sample Size for the Training Set

The document does not describe a training set as it relies on substantial equivalence and does not detail the development of a de novo algorithm requiring new training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is described, this information is not available. The device's validation and effectiveness are explicitly linked to the procedures documented in the predicate device's 510(k) (K012097), suggesting that any software development and testing followed a similar approach, focusing on functionality and safety rather than a new discriminative algorithm requiring a separate training set and ground truth.

Summary

{0}------------------------------------------------

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: 608 256 7775 Fax: 608 256 7779 Email: Inger.Hanson@emageon.com
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: 608 256 7775 Fax: 608 256 7779 Email: Inger.Hanson@emageon.com
1.3 Date of Submission
June 29th, 2004
Device Name 1.4
Classification Name: Image Processing System, 21 CFR $892.2050, ProCode LLZ

{1}------------------------------------------------

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

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.

{2}------------------------------------------------

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

{3}------------------------------------------------

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.

{4}------------------------------------------------

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	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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

{5}------------------------------------------------

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

Indications for use:

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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510(k) Number

Prescription Use	✓
AND/OR Over-The-Counter Use

David A. Repass

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

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
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.(b)
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).