(75 days)
Not Found
No
The summary describes a standard digital workstation for image capture, storage, review, and analysis, without mentioning any AI or ML capabilities. The "Analysis of ultrasound images" and "Reconstruction and display of three dimensional images" are typical functions of such workstations and do not inherently imply AI/ML.
No
The device is a workstation for image capture, storage, review, display, and analysis of ultrasound images, supporting functional diagnosis. It does not provide treatment or alter the body structure or function.
Yes
The "Intended Use / Indications for Use" states that the device is "designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images." This directly indicates a diagnostic function for the device.
No
The device description explicitly states that the unit is comprised of a standard desktop type personal computer, keyboard, mouse, 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:
- 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 description clearly states the device's function is to capture, store, review, and analyze ultrasound images. Ultrasound is an in vivo (within the living body) imaging modality, not an in vitro diagnostic test.
- Intended Use: The intended use focuses on the processing and analysis of ultrasound images for functional diagnosis, which is based on the visual and quantitative assessment of the images themselves, not on the analysis of biological samples.
The device is a workstation for managing and analyzing medical images obtained from an ultrasound scanner, which is a diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images Reconstruction and display of three dimensional images.
Product codes (comma separated list FDA assigned to the subject device)
90LLZ
Device Description
The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, and connecting cables.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
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): 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.
Toshiba Workstation, UIWS-300A (K982976), Dicomit Image Manager (K990248), Tomtec Echo-Scan (K963807)
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.
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
K99.2886
NOV - 9 1999
| 510(k) Summary | |
|---|---|
| -- | ---------------- |
| Date: | 25 August 1999 |
|---|---|
| Submitter's Name: | Toshiba America Medical Systems, Inc. |
| Submitter's Address: | P.O. Box 2068, 2441 Michelle Drive, |
| Submitter's Contact: | Tustin, CA 92781-2068 |
| Paul Biggins, Regulatory Affairs Specialist, (714)730-5000 | |
| Establishment Registration | |
| Number: | 2020563 |
| Device Proprietary Name: | PowerView Ultrasound Workstation, UIDM-400A |
| Common Name: | Picture Archiving and Communications System |
| Regulatory Class: | Class II per 21 CFR § 892.2050; 90LLZ |
| Predicate Device: | Toshiba Workstation, UIWS-300A (K982976) |
| Dicomit Image Manager (K990248) | |
| Tomtec Echo-Scan (K963807) | |
| Reason For Submission | New Product |
Description of this Device:
The UIDM-400A. PowerView Ultrasound Workstation, is an all digital workstation that can be integrated with the Toshiba PowerVision diagnostic ultrasound scanners. Its function is to provide the user with the ability to view images, annotate images, store image data and perform analysis on image data. The unit is comprised of a standard desktop type personal computer, keyboard, mouse, 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 device is designed to support functional diagnosis by performing display, processing, measurement and analysis of ultrasound images.
Comparison to Predicate Device
The user features of the UIDM-400A PowerView Ultrasound Workstation are similar to the functions included in the three predicate device does not offer any new functions that have not received previous market clearance from the Agency.
Safety Considerations:
The UIDM-400A is comprised of a personal computer that is mounted into the Toshiba PowerVision Ultrasound System. The software is comprised of various vendor programs that have received previous 510k clearances. The verification and validation testing is equivalent to that of the testing reported in previous 510k submissions. This system poses no new safety concerns or efficacy concerns that were not addressed in previous submissions. The manufacturing facility is ISO-9001 certified and follows the Quality System Regulations as administered by the Food and Drug Administration.
1
Re:
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 9 1999
Paul Biggins Regulatory Affairs Specialist Toshiba America Medical Systems, Inc. 2441 Michelle Dr. Tustin, CA 92781
K992886 PowerView Ultrasound Workstation Model UIDM-400A Dated: August 25, 1999 Received: August 26, 1999 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 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). 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 vour device is classified (see above) into either 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 vitro 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/cdrh/dsma/dsmamain.html".
Sincerely yours,
[signature]
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat. and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page __ 1 __ of ______________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): ___________________________________________________________________________________________________________________________________________________
Device Name: __ PowerView Ultrasound Workstation, UIDM-400A
Indications for Use:
Retrieval and storage of both passive and active ultrasound images Analysis of ultrasound images Reconstruction and display of three dimensional images.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use _
David b. Glynn
(Division Sign-Off) Division of Reproductive, Abdominal, E and Radiological De 510(k) Number
(Optional Format 1-2-96)