AQUARIUSNET SERVER

K012086 · Terarecon,Inc. · LLZ · Sep 13, 2001 · Radiology

Device Facts

• Record ID: K012086
• Device Name: AQUARIUSNET SERVER
• Applicant: Terarecon,Inc.
• Product Code: LLZ · Radiology
• Decision Date: Sep 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The AquariusNET Server acquires, stores, transmits, and enables compatible medical images from medical scanning devices computers on a network to display patient reports of various types. Teleradiology, such as EDT, CT of MRI and archiving, image manipulation, 3D and 4D visualization are supported. Calcium scoring from whole body computed tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

Device Story

AquariusNET is a DICOM server and teleradiology system; receives/stores images from PACS or scanning modalities; archives data; serves images to remote thin-client PCs/notebooks. Features integrated 2D/3D streaming engine for interactive review, 3D reconstruction, and full-color volume rendering. Includes semi-automated calcium scoring tools for atherosclerotic plaque quantification; allows user override of identified regions; generates reports. Used in clinical settings by healthcare providers to review images and perform measurements. Output facilitates clinical decision-making by providing visualization and quantitative analysis of CT data, aiding in non-invasive assessment of cardiovascular disease.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Utilizes off-the-shelf PC hardware with Pentium III-class processor; Windows 2000 OS. DICOM-compliant server architecture. Supports 2D/3D streaming, volume rendering, and calcium scoring. Software developed per ISO/IEC 12207:1995. Networked connectivity via DICOM protocols.

Indications for Use

Indicated for medical imaging workstations to acquire, store, transmit, and display medical images for diagnostic review. Supports non-invasive detection and quantification of atherosclerotic plaque via calcium scoring from whole-body CT scans. Intended for prescription use.

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

• Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903)
• TeraRecon IiVS™ Integrated image Viewing Station (K994329)

Submission Summary (Full Text)

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SEP 1 3 2001

## 510(k) Premarket Notification Summary of Safety and Effectiveness Information

AquariusNET Server Trade Name:

Image communication and storage system Common Name:

## Classification

System, Digital Image Communication, Teleradiology System Name:

Establishment Name & Registration Number: TeraRecon, Inc. Name: Number: Pending

### Classification:

\$ 892.2020, System, Image Processing. Class I, proposed exempt, final rule pending.

8 892.2050, Picture Archiving and Communication System. Class I, proposed exempt, final rule pending.

90-LLZ & 90-LMD ProCode(s):

#### Equivalent Device(s):

- Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903). 1.
IiVS™ Integrated image Viewing Station (K994329). 2.

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

### Description of the Device:

AquariusNET is a device consisting of a DICOM server that receives and stores images from a PACS or other image giving modalities. It archives images in a scalable storage medium and delivers them in response to DICOM Query/Retrieve requests from other DICOM devices on the network (not part of AquariusNET). It also serves image requests to its remote "thin clients", which act as the graphical user interface to the AquariusNET server. The server can host multiple concurrent sessions from remote "thin clients". AquariusNET features an integrated 2D/3D streaming engine which allows regular PCs or notebooks to control the server, and to review 2D images and 3D reconstructions interactively over a network. AquariusNET is capable of image review, communications, archiving, database maintenance, reporting and basic 3D capabilities described elsewhere in this document. It is also capable of full-color Volume Rendering and Calcium Scoring.

### Applicant/Sponsor Name / Address:

TeraRecon, Inc. 2955 Campus Drive, Suite 325, San Mateo, CA 94403 650.372.2668

### Contact Person:

Mr. Robert Taylor Executive Vice President TeraRecon Inc., 2955 Campus Drive, Suite 325, San Mateo, CA 94403 650.372.2668

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#### Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 / 925.356.2854 FAX

### Hardware & Software Information:

The AquariusNET Server utilizes standard "off the shelf" personal computer systems and s The AquariasNET Server utinzes standard "On the Sheat" portuges and windows 2000 operating system, and a Pentium III - class processor or equivalent.

The software designed to control and manipulate the diagnostic images follows the international standard ISO/TEC 12207: 1995 Information Technology - Software Life Cycle Processes Incoment wind standard "ISO/ILC" 12207. 1775 "mormation" Toothers relative to this software has been determined using the decision tree provided in Version 1 of the FDA Software Guidance.

| Feature Comparison Table: | | | | |
|---------------------------|--|--|--|--|
|---------------------------|--|--|--|--|

| Feature | AquariusNET Server | Imatron Ultra<br>Access 972903 | TeraRecon IiVS<br>K994329 |
|----------------------------------------------------------------------------|--------------------|--------------------------------|---------------------------|
| 2D Image Review | Yes | Yes | Yes |
| Multiplanar reformatting | Yes | Yes | Yes |
| 3D Volume Rendering | Yes | Yes | Yes |
| Maximum Intensity<br>Projection | Yes | Yes | Yes |
| Image Archiving | Yes | Yes | Yes |
| Image Filming | Yes | Yes | Yes |
| Image Transfer or<br>Network Connectivity | Yes | Yes | Yes |
| Examination of 2D image<br>data from a calcium scan | Yes | Yes | Yes |
| Examination of calcium scan<br>as a 3D volume | Yes | Yes | Yes |
| Semi-automated identification<br>of regions that are considered<br>calcium | Yes | Yes | No |
| User override of<br>automatically identified<br>regions | Yes | Yes | No |
| Automatic calculation of<br>calcium score | Yes | Yes | No |
| Ability to measure CT<br>numbers on a 2D image | Yes | Yes | Yes |
| Saving of calcium data with<br>patient exam data | Yes | Yes | No |
| Creation of a paper calcium<br>report | Yes | Yes | No |
| Comparison of multiple scans | Yes | Yes | Yes |
| Indications for use - general<br>medical imaging workstations | Yes | Yes | Yes |

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TeraRecon, Inc. % Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 PLEASANT HILL CA 94523-3389 Re: K012086

Trade/Device Name: AguariusNET Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System

Regulatory Class: II Product Code: 90 LLZ Dated: June 26, 2001 Received: July 3, 2001

Dear Mr. Schlerf:

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 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.

SEP 1 3 2001

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This letter will allow you to begin marketing your device as described in your 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:

| 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" (21 CFR Part 807.97). 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. 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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Page 1 of 1

# 510(k) NUMBER: _______________________________________________________________________________________________________________________________________________________________

DEVICE NAME : AquariusNET Server

### INDICATIONS FOR USE:

The AquariusNET Server acquires, stores, transmits, and enables compatible The AquariasNET - Bervor "acquires, dical images from medical scanning devices computers on a fictwork to display tient reports of various types. Teleradiology, such as EDT, CT of NIN and parchiving, image manipulation, 3D and 4D Calcium scoring from whole body computed visualization are supported. visualization are Supported.
tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Snowdon

(Division Sign-Off)/
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012086

**Prescription Use**
(Per 21 CFR 801.109) √

OR

Over-The-Counter Use (Optional format 1-2-96)