(72 days)
Not Found
No
The summary describes image processing, archiving, and visualization tools, but there is no mention of AI, ML, or related concepts like deep learning, neural networks, or training/test sets.
No.
The device is described as a server and software for acquiring, storing, transmitting, displaying, and manipulating medical images and patient reports. It performs image processing, including 3D and 4D visualization and calcium scoring, but it does not directly apply therapy or intervene in a patient's treatment. Its function is diagnostic support and image management.
Yes
This device performs calcium scoring, which is a method of non-invasive detection and quantification of atherosclerotic plaque, indicating a diagnostic function.
Yes
The device description explicitly states that AquariusNET is a device consisting of a DICOM server and remote "thin clients" which act as the graphical user interface. It handles image acquisition, storage, transmission, display, manipulation, and analysis, all of which are software functions. While it interacts with hardware (medical scanning devices, PACS, PCs/notebooks), the core device being described and submitted for 510(k) is the software system itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The AquariusNET Server primarily deals with the acquisition, storage, transmission, and display of medical images from scanning devices. While it performs analysis on these images (like calcium scoring and histogram analysis), this analysis is performed on the images themselves, not on biological samples taken from the patient.
- Intended Use: The intended use describes the device's function in relation to medical images and patient reports, supporting teleradiology, archiving, visualization, and analysis of image-derived data.
- Device Description: The description reinforces that the device works with images received from imaging modalities and serves them to clients for review and manipulation.
The analysis performed by the AquariusNET Server, such as calcium scoring and histogram analysis, is a form of image analysis or medical image processing, which falls under the scope of medical devices, but not specifically in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
90-LLZ, 90-LMD
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
medical scanning devices, whole body computed tomography
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
Access 972903 | TeraRecon IiVS
K994329 |
|----------------------------------------------------------------------------|--------------------|--------------------------------|---------------------------|
| 2D Image Review | Yes | Yes | Yes |
| Multiplanar reformatting | Yes | Yes | Yes |
| 3D Volume Rendering | Yes | Yes | Yes |
| Maximum Intensity
Projection | Yes | Yes | Yes |
| Image Archiving | Yes | Yes | Yes |
| Image Filming | Yes | Yes | Yes |
| Image Transfer or
Network Connectivity | Yes | Yes | Yes |
| Examination of 2D image
data from a calcium scan | Yes | Yes | Yes |
| Examination of calcium scan
as a 3D volume | Yes | Yes | Yes |
| Semi-automated identification
of regions that are considered
calcium | Yes | Yes | No |
| User override of
automatically identified
regions | Yes | Yes | No |
| Automatic calculation of
calcium score | Yes | Yes | No |
| Ability to measure CT
numbers on a 2D image | Yes | Yes | Yes |
| Saving of calcium data with
patient exam data | Yes | Yes | No |
| Creation of a paper calcium
report | Yes | Yes | No |
| Comparison of multiple scans | Yes | Yes | Yes |
| Indications for use - general
medical imaging workstations | Yes | Yes | Yes |
2
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
3
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 | (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" (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 (800) 638-2041 or (301) 443-6597 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
4
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)