(10 days)
Not Found
No
The summary describes a standard PACS system with image viewing and processing tools, but there is no mention of AI or ML capabilities.
No
This device is a Picture Archiving and Communications System (PACS) software that receives, stores, communicates, processes, and displays medical images. It does not provide any therapy or treatment.
No
The device is described as a Picture Archiving and Communications System (PACS) that handles medical images (including mammograms) for storage, communication, processing, and display. Its primary functions are image management and viewing, not providing a medical diagnosis or aiding a clinician in forming one. It's a tool for managing and viewing images, which are then interpreted by trained professionals.
Yes
The device description explicitly states that 3viseon™ is a "software based application" and details its functionalities as software capabilities for image management, viewing, and processing. There is no mention of accompanying hardware components included as part of the device itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description of 3viseon™ clearly states it receives and processes medical images and data, not biological samples.
- The intended use is for viewing, storing, communicating, and processing medical images. This aligns with the function of a Picture Archiving and Communication System (PACS), which is a type of medical device, but not an IVD.
- The users are trained professionals who interpret medical images. This is consistent with the use of a PACS in a clinical setting.
The device is a medical image management and processing system, not a diagnostic test performed on biological samples.
N/A
Intended Use / Indications for Use
3viseon™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated processed and displayed within the system or across computer networks at distributed locations. 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. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
3viseon™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, fransfer, display, storage, and digital processing of medical images (including digital Mammograms).
The 3viseon software allows you to select patient series from various data sources, view them in 2D or 3D mode and process the images with the help of a comprehensive set of tools:
- Data Management for a detailed description on how to select patient studies | from one or more data sources;
- । 2D Viewing Mode - for a detailed description on how to view images in 2D mode and process them:
- -3D Viewing Mode - for 3D imaging.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
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
NOV 1 9 2004
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: September 22, 2004
Submitter's Information: 21 CFR 807.92(a)(1)
Frank Wessels, CEO 3mensio Medical Imaging BV Jan Steenlaan 3 3723 BS Bilthoven Netherlands Email: frank.wessels@3mensio.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Trade Name: | 3viseon™ |
|---|---|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 LLZ |
| Name: | System, Image Processing |
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | System, Image Processing, Radiology |
|---|---|
| Regulation Number | 892.2050 |
| 510(k) Number | K992654 |
| Device Name | Plug" n View 3D™ |
| Applicant | Voxar Limited |
| Product Code | LLZ |
| Decision | SUBSTANTIALLY EQUIVALENT (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
Device Description: 21 CFR 807 92(a)(4)
3viseon™ is a software based application for picture archiving and communications system that provides users with capabilities relating to the acceptance, fransfer, display, storage, and digital processing of medical images (including digital Mammograms).
The 3viseon software allows you to select patient series from various data sources, view them in 2D or 3D mode and process the images with the help of a comprehensive set of tools:
- Data Management for a detailed description on how to select patient studies | from one or more data sources;
1
- । 2D Viewing Mode - for a detailed description on how to view images in 2D mode and process them:
- -3D Viewing Mode - for 3D imaging.
Indications for Use: 21 CFR 807 92(a)(5)
3viseon™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated processed and displayed within the system or across computer networks at distributed locations. 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. Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants,
Technological Characteristics: 21 CFR 807 92(a)(6)
3viseon™ is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device 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 3viseon™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
3viseon™ will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "minor".
2
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 9 2004
3mensio Medical Imaging-BV % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548
Re: K043097
Trade/Device Name: 3viseon™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: October 29, 2004 Received: November 9, 2004
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 (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.
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 (OS) 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 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/dsmaldsmamain.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
4
Image /page/4/Picture/0 description: The image shows the logo for 3mensio Medical Imaging. The text "3mensio" is in a bold, sans-serif font, with a small dot above the "i". Below "3mensio", the words "MEDICAL IMAGING" are written in a smaller, sans-serif font.
(Indications for Use Form)
Page 1 of -1
510(k) Number: 长643097
Device Name: 3viseon™
Indications for Use:
3viseon™ is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored. communicated, processed and displayed within the system or across computer networks at distributed locations.
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.
Typical users of this system are trained professionals, i.e. physicians, radiologists, nurses, medical technicians, and assistants.
Prescription Use AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segeum
(Division Sian-Off) Division of Reproductive, Abdor and Radiological Devices 510(k) Number __