(12 days)
Not Found
No
The summary describes a PACS system with advanced visualization and processing features, but there is no mention of AI or ML algorithms being used for image analysis, interpretation, or any other function. The listed features are standard for advanced medical image processing software.
No
The device is described as a software application for display, visualization, storage, and processing of medical image data; it does not produce medical images itself nor does it describe any function that directly treats or diagnoses a condition.
Yes
SonoView Pro™ is designed for the "display and 3D visualization of medical image data" from various sources, and typical users are "trained professionals, including physicians, nurses, and technicians," to "access and manage medical imaging studies." It supports "distance/area/angle measurements" and provides "3D rendering modes." While it does not produce original images, it allows for processing and viewing images from diagnostic modalities, making it an essential tool for interpretation and diagnosis.
Yes
The device is described as a software application and an Internet-based software picture archiving and communications system. It explicitly states it utilizes commercially available computer platforms and operating systems and does not produce original medical images, relying on images from DICOM compliant modalities. The description focuses solely on software functionalities for image processing, display, storage, and communication.
Based on the provided information, SonoView Pro™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- SonoView Pro™'s Function: SonoView Pro™ is a software application that processes, displays, and visualizes medical images derived from various imaging modalities (Ultrasound, CT, MRI, etc.). It does not interact with or analyze biological specimens.
- Intended Use: The intended use is for the display and 3D visualization of medical image data for trained professionals. This is distinct from analyzing biological samples.
Therefore, SonoView Pro™ falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
SonoView Pro™ by Medison Co. Ltd. is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
SonoView Pro™ by Medison Co. Ltd. is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
SonoView Pro™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. SonoView Pro™ includes features to access and manage medical imaging studies from ultrasound (US), cat-scan (CT), magnetic radiography (MR), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.
SonoView Pro™ is deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000/XP). The system does not produce any original medical images. All images located on SonoView Pro™ have been received from DICOM compliant imaging modalities and/or PACS components or systems. SonoView Pro™ provides the advanced process functions, such as :
- Supports the freehand scanning, 3D image acquisition, and 3D reconstruction. -
- Acquires images from ultrasound system in real time. -
- -Supports the ultrasound image storage and ultrasound multi-frame image storage.
- Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, -Gamma correction, and thumbnail.
- -Provides the DICOM query and retrieve services (images and presentation states).
- -Displays the cut planes of 3D image along the long axis or the short axis.
- Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine.
- -Supports distance/area/angle measurements.
- Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound (US), cat-scan (CT), magnetic radiography (MR), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
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.
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
K 031886
JUN 3 0 2003
510(k) Summary of Safety and Effectiveness
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
May 5, 2003
Submitter's Information: 21 CFR 807.92(a)(1)
Medison Co. Ltd. Medison Venture Tower, 997-10 Daechi-dong, Kangnam-gu, Seoul 135-280, Korea
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | SonoView Pro™ by Medison Co. Ltd. |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K022692 |
| Device Name | VoxelPlus™ PACS |
| Applicant | Mevisys Co. Ltd. |
| EE&CS Bldg. Room 4203, KAIST | |
| 373-1 Guseong-dong Yuseong-gu | |
| Daejeon 305-701 Korea | |
| Product Code | 90 LLZ |
| Date Received | 08/13/2002 |
| Decision Date | 10/11/2002 |
Device Description: 21 CFR 807 92(a)(4)
SonoView Pro™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. SonoView Pro'™ includes features to access and manage medical imaging studies from ultrasound (US), cat-scan (CT), magnetic radiography (MR), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities.
1
Image /page/1/Picture/0 description: The image shows the word "medison" in a bold, sans-serif font. Below the word, there are three curved lines that resemble brush strokes. The lines are arranged in a parallel fashion, with the top line being the shortest and the bottom line being the longest.
SonoView Pro™ is deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000/XP). The system does not produce any original medical images. All images located on SonoView Pro™ have been received from DICOM compliant imaging modalities and/or PACS components or systems. SonoView Pro™ provides the
advanced process functions, such as :
- Supports the freehand scanning, 3D image acquisition, and 3D reconstruction. -
- Acquires images from ultrasound system in real time. -
- -Supports the ultrasound image storage and ultrasound multi-frame image storage.
- Supports the GUI functions: zoom, pan, pseudo-color setting, threshold setting, -Gamma correction, and thumbnail.
- -Provides the DICOM query and retrieve services (images and presentation states).
- -Displays the cut planes of 3D image along the long axis or the short axis.
- Provides 3D rendering modes: MIP, X-ray, translucent, surface, slicing, and 3D cine.
- -Supports distance/area/angle measurements.
- Supports Tele-medicine (audio, video, and text) between regional medicine center and remote clients.
Indications for Use: 21 CFR 807 92(a)(5)
SonoView Pro™ by Medison Co. Ltd. is a software application for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including physicians, nurses, and technicians.
Technological Characteristics: 21 CFR 807 92(a)(6)
The device is a software application and does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.
Conclusion: 21 CFR 807 92(b)(1)
- The 510(k) Pre-Market Notification for SonoView Pro™ contains adequate . information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
- 프 The device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey.
- 미 The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of three curved lines that resemble a human figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 0 2003
Medison Co., Ltd. % Mr. Ned Devine Responsible Third Party Entela, Inc. 3033 Medison Ave. SE GRAND RAPIDS MI 49548 Re: K031886 Trade/Device Name: SonoView ProTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 13, 2003 Received: June 18, 2003
Dear Mr. Devine:
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.
3
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 the 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" (21CFR Part 807.97) you may obtain. 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
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Image /page/4/Picture/0 description: The image shows the word "medison" in a stylized font. Below the word are three curved lines that appear to be a design element. The word is in lowercase letters and has a bold appearance. The overall design is simple and clean.
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(Indications for Use Form)
510(k) Number:
Device Name: SonoView Pro™ by Medison Co. Ltd.
Indications for Use:
SonoView Pro™ by Medison Co. Ltd. is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. Ultrasound, CT scanners, MRI scanners). Images and data can be acquired, stored, communicated, processed, printed, rendered, and displayed within the system and or across computer networks at distributed locations.
Typical users of this system are trained professionals, including physicians, nurses, and technicians.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
Daniel R. Segerson
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K031886
(Optional Format 1-2-96)