(88 days)
No
The summary describes standard medical image visualization software and does not mention AI, ML, or related concepts.
No
The device is a software application for displaying and visualizing medical image data, intended for diagnostic use by healthcare professionals. It does not provide any treatment or therapy.
Yes
The device is described as software for the display and 3D visualization of medical image data for use by radiologists, clinicians, and referring physicians, which is a common function of diagnostic devices. Additionally, the predicate device (K980648) is named "Pro Vision Diagnostic Workstation," directly indicating its diagnostic intent.
Yes
The device description explicitly states "Plug 'n View 3D is a software application" and that it utilizes "standard PC hardware," indicating it is a software-only device running on general-purpose computing hardware.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. This data comes from imaging modalities, not from samples taken from the body.
- Intended Use: The intended use is for radiologists, clinicians, and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies. This is focused on image management and visualization, not on analyzing biological samples.
Therefore, Plug 'n View 3D falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
Product codes
LLZ
Device Description
Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT and MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists, clinicians and referring physicians
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 - 5 1999
510(k) Summary
1. Company Identification
Voxar Ltd Bonnington Bond 2 Anderson Place Edinburgh, EH6 5NP UK
2. Official Correspondent
Conrad Chin Head of Engineering
3. Date of Submission
August 6, 1999
4. Device Name
Classification Name
Common Name
Proprietary Name
Picture Archiving and Communications System (Image Processing Sub-System) (892.2050) Image processing, management and 3D visualization system Plug 'n View 3D
5. Predicate Device
Pro Vision Diagnostic Workstation (K980648), manufactured by Algotec Systems Ltd.
6. Device Description and Intended Use
Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
1
| Feature | Plug 'n View 3D | Pro Vision |
|---|---|---|
| Computer platform | Pentium MMX, under | |
| Windows 95, 98 or NT. | Silicon Graphics O2, under | |
| IRIX. | ||
| DICOM compliance | DICOM-3 compliance for | |
| CT, MRI, NM, CR, SC and | ||
| Ultrasound (Single Frame) | ||
| images. | DICOM-3 compliance for | |
| CT, MRI, NM, CR, RF and | ||
| SC images. | ||
| 2D imaging | 2D image viewer with | |
| real-time window-level, | ||
| zoom, pan, rotate, flip | ||
| and cine. | ||
| • Multiple grid layouts. | Same. | |
| Measurement | 2D measurement tools | |
| including line, angle and | ||
| ROI statistics. | Same. | |
| Multi-Planar | ||
| Reformatting (MPR) | MPR into any user-defined | |
| linear plane. | MPR into any user-defined | |
| linear or curved plane. | ||
| Volume Rendering | Volume rendering with | |
| interactive opacity / | ||
| transparency control, | ||
| clipping volume of interest | ||
| (VOI), zoom, pan and rotate. | Same. | |
| Maximum Intensity | ||
| Projection (MIP) | MIP with interactive | |
| window-level, clipping VOI, | ||
| zoom, pan and rotate. | Same. | |
| Image editing | Tools for removal of | |
| obscuring anatomy. | Same. | |
| Printing | Printing to standard | |
| Windows printers. | • DICOM printing. | |
| • Printing to all major non- | ||
| DICOM laser imagers. | ||
| Ease of use | • Visualization presets. | |
| • Semi-automated steps for | ||
| typical image review | ||
| procedures | Customized presets per | |
| imaging procedure. |
7. Substantial Equivalence Comparison Table
2
Image /page/2/Picture/0 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 1999
Rob Mackean Director Voxar Ltd. Bonnington Bond 2 Anderson Place Edinburgh, Scotland EH6 SNP U.K.
Re:
K992654 Plug' n View 3D, Version 1.0 Dated: August 6, 1999 Received: August 9, 1999 Regulatory class: II 21 CFR 892.2050/Procode: 90 LLZ
Dear Mr. Mackean:
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 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 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,
APT 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
3
Indications for Use
Applicant:
Voxar Ltd., Bonnington Bond, 2 Anderson Place, Edinburgh EH6 5NP, UK
510(k) Number (if known)
Unknown
Device Name
Plug 'n View 3D
Indications For Use
Plug 'n View 3D is a software application for the display and 3D visualization of medical image data derived from CT and MRI scans. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
Umid C. Begum
uctive, Abdominal, ENT:
Radiological Devices
umber K492654
Prescription Use (Per 21 CFR 801.109)