(90 days)
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No
The document describes a standard digital workstation for viewing, storing, and analyzing ultrasound images. It mentions "processing" but does not include any terms related to AI, ML, deep learning, or neural networks, nor does it describe any AI/ML-specific features or performance metrics.
No.
The device is described as an Ultrasound Workstation used for the capture, storage, review, analysis, display, and processing of ultrasound images, and for functional diagnosis. It does not actively treat or prevent a disease or condition, which are characteristic functions of a therapeutic device.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images."
No
The device description explicitly states that the unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor, and connecting cables, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the capture, storage, review, and analysis of ultrasound images. It supports "functional diagnosis" by processing and analyzing these images. This is focused on interpreting images generated from the body, not on analyzing samples from the body (like blood, urine, or tissue).
- Device Description: The description confirms it's a workstation connected to an ultrasound scanner, designed for viewing, annotating, and analyzing image data.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is centered around the processing and analysis of medical images, which falls under the category of medical imaging devices or image processing software, not IVD.
N/A
Intended Use / Indications for Use
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The UIWS-300A, Ultrasound Workstation, is an all digital workstation that can be connected to Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor and connecting cables.
Mentions image processing
Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data.
Mentions AI, DNN, or ML
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Input Imaging Modality
ultrasound images
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Nova MicroSonics, Image View DCR
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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).
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§ 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) Summary
K98 2976
| Date: | 25 August 1998 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Tustin, CA 92781-2068 | |
| Submitter's Contact: | Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | Ultrasound Workstation, UIWS-300A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Nova MicroSonics, Image View DCR |
| Reason For Submission | New Product |
Description of this Device:
The UIWS-300A, Ultrasound Workstation, is an all digital workstation that can be connected to Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, monitor and connecting cables.
Summary of Intended Uses:
This device is to serve as a workstation for the capture, storage, review and analysis of ultrasound images, both still and dynamic. This devices is designed to support functional diagnósis by performing display, processing, measurement and analysis of ultrasound images.
Comparison to Predicate Device
The user features of the UIWS-300A Ultrasound Workstation and the Nova MicroSonics Image Vue DCR (K) are very similar.
Conformance to Standards
The following standards apply to the design and manufacture of the UIWS-300A Ultrasound Workstation:
| Image Storage: | DICOM SCU Storage |
|---|---|
| Monitor Testing: | JIS C6101 |
| Safety: | IEC 60601-1-1 (AMD1) [1992] |
| Image Compression: MJPEG: | Compressed -AVI format |
| Non-compressed - IMG format |
1
Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a bird-like figure with three overlapping profiles, suggesting a sense of community or interconnectedness.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 24 1998
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Drive PO Box 2068 Tustin, CA 92781-2068
Re:
Ultrasound Workstation, UIWS-300A Dated: August 25, 1998 Received: August 26, 1998 Regulatory class: II 21 CFR 892,2050/Procode: 90 LLZ
Dear Mr. Biggins:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 and additionally 809.10 for in yitn diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrt/dsmaldsmamain.html".
Sincerely yours,
Lillian Yin, Ph.D.
Director, Division of Reproductiv Abdominal, Ear, Nose and Thro and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page ____ of _________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence/off CDRH, Office of Device Evaluation (ODE)
Vorid a. Seym
(Division Sign-Off) Division of Reproductive, Abdominal, EN and Radiological Devices 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________
(Optional Format 1-2-96)