(14 days)
Not Found
No
The summary describes standard image processing techniques (MPR, 3D rendering, threshold-based segmentation) and does not mention AI, ML, or related terms.
No.
The device is a software workstation for clinical review and analysis of medical images to aid in diagnosis, not to apply therapy.
No
The device is described as a soft-copy reading workstation for clinical review of CT images, allowing image acquisition, transmission, and review, and supporting HD ROI analysis. While images may be interpreted by a trained physician to inform diagnosis, the device itself is a tool for viewing and analyzing images, not for making a diagnosis.
Yes
The device description explicitly states "UroCARE1.0 software product is a soft-copy reading workstation" and "It is a self-contained software package". The functions described (image display, MPR, 3D views, HD ROI analysis) are all software-based image processing and analysis features. There is no mention of any accompanying hardware components being part of the device itself.
Based on the provided information, the UroCARE1.0 device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- UroCARE1.0 Function: The description clearly states that UroCARE1.0 is a "soft-copy reading workstation intended for clinical review of CT abdominal (urology) images." It processes and displays medical images.
- No Sample Analysis: There is no mention of the device analyzing biological samples or performing tests on bodily fluids or tissues. Its function is centered around the visualization and analysis of medical images acquired through a CT scanner.
Therefore, UroCARE1.0 falls under the category of medical imaging software or a picture archiving and communication system (PACS) component, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.
Product codes
LLZ
Device Description
UroCARE1.0 software product is a soft-copy reading workstation for clinical review of CT abdominal (urology) images. It is a self-contained software package and provides general features of 2D image display, standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering. An additional feature, HD ROI analysis, allows for segmentation of high density regions in terms of user-defined threshold within a user-given ROI as well as display and quantitative analysis of the segmented HD ROI.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
abdominal (urology)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / clinical review
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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
16090552
MAR 1 6 2009
Neusoft
510(k)
Attachment 1
Summary of Safety and Effectiveness
Page 1 of 2
This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)
General Information:
| Trade Name: | UroCARE1.0 |
|---|---|
| CFR Section: | 21 CFR Part 892.2050 |
| Classification Name: | Picture Archiving and Communication System (PACS) |
| Product Code: | LLZ |
| Device Class: | Class II |
| Applicable Standard: | DICOM 3.0 |
| Manufacturer and | |
| Distributor: | Neusoft Medical Systems Co., Ltd. |
| No.3-11,Wenhua Road, Heping District, | |
| Shenyang, China | |
| Post Code : 110004 | |
| Submitter: | Contact : Tian Yanfang |
| Title : Manager of Quality Management Department | |
| Tel : 86-24-83660649 | |
| Fax : 86-24-83780480 | |
| E-Mail : Tianyanfang@neusoft.com |
Summary prepared : Nov.18,2008
1
Neusoft
510(k)
Page 2 of 2
Safety and Effectiveness Information
Intended Uses:
The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.
Device Description:
UroCARE1.0 software product is a soft-copy reading workstation for clinical review of CT abdominal (urology) images. It is a self-contained software package and provides general features of 2D image display, standard Multi-Planar Reformation (MPR) views and 3D views of Volume Rendering. An additional feature, HD ROI analysis, allows for segmentation of high density regions in terms of user-defined threshold within a user-given ROI as well as display and quantitative analysis of the segmented HD ROI.
Predicate Device:
K052995 : Advantage Workstation 4.3 K041521 : Volume Viewer Plus
Statement of Substantial Equivalence:
The Neusoft UroCARE1.0 is comparable and substantially equivalent to the Advantage Workstation 4.3 (K052995) and the Volume Viewer Plus Aquarius Workstation (K0141521).
The UroCARE1.0 and the Advantage Workstation 4.3 share similar technological specifications. Both of them support DICOM protocol for communication of images with other medical imaging devices. Furthermore, they both provide various tools for physicians to view images.
The UroCARE1.0 has the similar technological characteristics with the Volume The Oroon RE 1.0 how provide functions such as standard MPR, 3D display of volume rendering, and they both provide the function of ROI segmentation of volume rendering, and they boll as display and quantitative analysis of the ROI and quantitative analysis.
According to the comparison based on the requirements of 21.CFR 807.87, we state that these devices are substantially equivalent.
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA."
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Neusoft Medical Systems Co., Ltd. % Mr. Daniel W. Lehtonen Technical Reviewer Intertek Testing Services NA. Inc. 2307 East Aurora Rd., Unit B7 TWINSBURG OH 44087
MAR 1 6 2009
Re: K090552
Trade/Device Name: UroCARE1.0 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 26, 2009 Received: March 2, 2009
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 (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.
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 os 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.xxx | (Gastroenterology/Renal/Urology) | (240) 276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | (240) 276-0115 |
| 21 CFR 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.
Sincerely yours,
Laura B. Morris
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Neusoft
Attachment 2
Indications for Use Statement
510(k) Number: _ K090552
Device Name: UroCARE1.0
The UroCARE1.0 is a soft-copy reading workstation intended for clinical review of CT abdominal (urology) images which allows easy acquisition, transmission and review of the medical images and supports HD ROI (High Density Region of Interest) analysis. Images may be interpreted by a trained physician to obtain information that may be useful in the determination of a diagnosis, except in the case of mammography images.
Prescription Use YES (Part 21 CFR 801 Subpart D) Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF DEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Helene Remen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number