(13 days)
Not Found
No
The summary describes standard digital image processing and does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets.
No
The device processes medical images and transmits information; it does not directly treat or diagnose a medical condition.
Yes
The device performs digital image processing to derive certain information or new images from medical image sets, which are then transmitted to other devices. Although it does not directly provide a diagnosis, it processes images that are critical for diagnostic interpretation by healthcare professionals, making it an integral part of the diagnostic workflow.
No
The device description explicitly states that the AquariusAPS Server utilizes standard "off the shelf" personal computer systems as its hardware platform, indicating it is not solely software.
Based on the provided text, 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 AquariusAPS server processes medical images (EBT, CT, MRI, etc.) acquired from medical imaging devices. It performs digital image processing to derive information or new images.
- No Biological Samples: The device does not interact with or analyze biological samples from a patient. Its input is image data.
- Intended Use: The intended use is described as "time-saving pre-processing of images" and "optimize the use of the user's time." This is related to image workflow and efficiency, not diagnostic testing of biological samples.
Therefore, the AquariusAPS server falls under the category of medical image processing software or a medical image management system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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."
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
EBT, CT, MRI, and other volumetric or planar medical imaging modalities
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Aquarius Workstation-K011142, AquariusNET Server- K012086, Lung CAR-K041807, Colon CAR-K042674, Fusion 7D-K020546
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
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):
-
- Aquarius Workstation-K011142 by TeraRecon Inc.
-
- AquariusNET Server- K012086 by TeraRecon Inc.
-
- Lung CAR-K041807 by Medicsight PLC.
-
- Colon CAR-K042674 by Medicsight PLC.
-
- 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:
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.
K061214
payl-1f2
1
Hardware & Software Information
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.
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 | Aquarius
APS | Aquarius
NET Server | Aquarius
Workstation | Lung CAR
Medicsight | Colon CAR
Medicsight | Fusion 7D
Mirada
Solutions |
|------------------------------------------------------------------------------------------------------------------------------|-----------------|------------------------|-------------------------|------------------------|-------------------------|----------------------------------|
| 2D, 3D Image Review | No | Yes | Yes | No | No | No |
| Removal of the CT table
from a CT examination | Yes | Yes | Yes | No | No | No |
| Removal of bony structures
from a CT examination | Yes | Yes | Yes | No | No | No |
| Calculation of a centerline
through a hollow organ or
structure, or vessels, for a
CT or MR scan | Yes | Yes | Yes | No | No | No |
| Isolation of tissue in the
vicinity of and including the
heart from a CT scan | Yes | No | Yes | No | No | No |
| Calculation of a parametric
color overlay map for time-
dependent a MR or CT scan | Yes | No | Yes | No | No | No |
| Identifying locations of
sphere-like structures in a
CT scan | Yes | No | Yes
(Manual) | Yes | Yes | No |
| Calculation of a set of
images in certain
orientations or planes using
MPR, MIP, VR or other
rending techniques. | Yes | Yes | Yes | No | No | No |
| Calculation of a
transformation to register
one set of images to another | Yes | Yes (Manual) | No | No | No | Yes |
| Calculation of the volume
of a certain structure,
possibly with time
dependence | Yes | No | Yes | No | No | No |
| Receiving images using
DICOM transfer protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Sending Images and other
data using DICOM transfer
protocols | Yes | Yes | Yes | Yes | Yes | Yes |
| Performing actions based
on DICOM tags contained
in images received by
DICOM | Yes | Yes | No | No | No | No |
| Administration control
through a browser-based
interface | Yes | Yes | No | No | No | No |
| Export of images and image
sequences in a variety of
formats | Yes | Yes | Yes | Yes | Yes | Yes |
Feature Comparison Table
2
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
3
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
4
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