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

Device Description

The AquariusAPS server receives medical images from medical imaging acquisition devices adhering to the DICOM protocol for image transfer such as EBT, CT, MRI, and other volumetric or planar medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA."

The intended use of the device is to provide time-saving pre-processing of images to remove the need for an image review system to perform these activities while a user is waiting for processing to complete, to optimize the use of the user's time.

The AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform. The software requires the use of the Windows 2000 operating system, and a Pentium III - class processor or equivalent.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the TeraRecon AquariusAPS Server. It is a regulatory document and does not contain information about acceptance criteria or a specific study designed to prove the device meets those criteria.

The document primarily focuses on:

Device identification: Trade name, common name, classification, establishment name, and contact information.
Substantial Equivalence: Listing equivalent devices (predicates) and claiming equivalence based on basic design, features, and intended use.
Device Description: What the device does (receives and processes medical images, transmits derived information).
Intended Use Statement: To provide time-saving pre-processing of images.
Hardware & Software Information: Operating system, processor requirements, and compliance with FDA guidance for software.
Feature Comparison Table: A table comparing the AquariusAPS Server's features to those of the predicate devices. This table highlights what features the AquariusAPS Server possesses, but it doesn't provide performance metrics or acceptance criteria for those features.
FDA Approval Letter: Officially confirming the substantial equivalence determination.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance because that data is not present in the provided text. The document is primarily a statement of equivalence for regulatory purposes, not a performance study report.

Summary

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510(k) Premarket Notification

AquariusAPS Server Trade Name:

Common/Usual Name: Server for image processing and communication Classification Name: System, Image Processing

MAY 15 2006

Establishment Name and Registration Number:

Name: TeraRecon, Inc. Number: 2954793

Classification:

21 CFR § 892.2050, Picture Archiving and Communications System, Class II, proposed exempt, final rule pending.

90-LLZ ProCode:

Equivalent Device(s):

1. Aquarius Workstation-K011142 by TeraRecon Inc.
1. AquariusNET Server- K012086 by TeraRecon Inc.
1. Lung CAR-K041807 by Medicsight PLC.
1. Colon CAR-K042674 by Medicsight PLC.
1. Fusion 7D-K020546 by Mirada Solutions, Ltd.

Parts of these devices are substantially equivalent in terms of basic design, features and intended use.

Applicant/Sponsor Name/Address:

TeraRecon Inc.

2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: (650) 372-1100 FAX: 650-372.1101

Contact Person:

Emilly Tojima Quality Assurance and Regulatory Affairs Manager TeraRecon Inc. 2955 Campus Drive, Suite 325 San Mateo, CA 94403 Tel: (650) 372-1100

Description of the Device:

K061214
payl-1f2

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Hardware & Software Information

The software designed to control and manipulate the diagnostic images are based upon information and guidance found in the list of standards provided in Appendix III. In accordance with TeraRecon's software development procedures, the level of concern relative to this software has been determined through information obtained from the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).

Feature	AquariusAPS	AquariusNET Server	AquariusWorkstation	Lung CARMedicsight	Colon CARMedicsight	Fusion 7DMiradaSolutions
2D, 3D Image Review	No	Yes	Yes	No	No	No
Removal of the CT tablefrom a CT examination	Yes	Yes	Yes	No	No	No
Removal of bony structuresfrom a CT examination	Yes	Yes	Yes	No	No	No
Calculation of a centerlinethrough a hollow organ orstructure, or vessels, for aCT or MR scan	Yes	Yes	Yes	No	No	No
Isolation of tissue in thevicinity of and including theheart from a CT scan	Yes	No	Yes	No	No	No
Calculation of a parametriccolor overlay map for time-dependent a MR or CT scan	Yes	No	Yes	No	No	No
Identifying locations ofsphere-like structures in aCT scan	Yes	No	Yes(Manual)	Yes	Yes	No
Calculation of a set ofimages in certainorientations or planes usingMPR, MIP, VR or otherrending techniques.	Yes	Yes	Yes	No	No	No
Calculation of atransformation to registerone set of images to another	Yes	Yes (Manual)	No	No	No	Yes
Calculation of the volumeof a certain structure,possibly with timedependence	Yes	No	Yes	No	No	No
Receiving images usingDICOM transfer protocols	Yes	Yes	Yes	Yes	Yes	Yes
Sending Images and otherdata using DICOM transferprotocols	Yes	Yes	Yes	Yes	Yes	Yes
Performing actions basedon DICOM tags containedin images received byDICOM	Yes	Yes	No	No	No	No
Administration controlthrough a browser-basedinterface	Yes	Yes	No	No	No	No
Export of images and imagesequences in a variety offormats	Yes	Yes	Yes	Yes	Yes	Yes

Feature Comparison Table

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAY 15 2005

TeraRecon, Inc. % Mr. Daniel W. Lehtonen Responsible Third Party Official Intertek Testing Services NA, Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087

Re: K061214

Trade/Device Name: AquariusAPS Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 1, 2006 Received: May 2, 2006

Dear Mr. Lehtonen:

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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" in the center. The logo also includes the years "1906-2006" at the top. There are stars at the bottom of the logo. The text is surrounded by a circular border with additional text.

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 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.

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.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/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

San 1942 2

Enclosure

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DEVICE NAME: AquariusAPS

INDICATIONS FOR USE:

The AquariusAPS server receives medical images from medical imaging acquisition devices The Aquartish D server rocercol for image transfer such as EBT, CT, MRI, and other adming to the Droom medical imaging modalities, and performs digital image processing to derive certain information or new images from these image sets. The information or new images thus derived is transmitted using the DICOM protocol to other devices supporting this standard protocol.

Lossy compressed mammographic images and digitized film screen images must not be reviewed LUSS voluptessou interpretations. Mammographic images may only be interpreted using an FDA 101 primal y migrous at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

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

Over-The-Counter Use (21 CFR 801 Subpart C)

一次的一个人,一个人生

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Chroydon
(Division Sign-Off)

Division of Reproductive, Abd and Radiological Devices 510(k) Number

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).