PLUG 'N VIEW 3D, VERSION 1.0

K992654 · Voxar Limited · LLZ · Nov 5, 1999 · Radiology

Device Facts

• Record ID: K992654
• Device Name: PLUG 'N VIEW 3D, VERSION 1.0
• Applicant: Voxar Limited
• Product Code: LLZ · Radiology
• Decision Date: Nov 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Plug 'n View 3D is a software application for medical image visualization; inputs DICOM 3.0 compliant CT and MRI scan data; operates on standard PC hardware (Pentium MMX, Windows 95/98/NT). Transforms raw image data into 2D views, multi-planar reformats (MPR), volume renderings, and maximum intensity projections (MIP). Features include real-time window-leveling, zoom, pan, rotate, cine, and anatomy removal tools. Used by radiologists and clinicians in clinical settings for image review and diagnostic support. Output is displayed on PC monitors or printed; assists clinicians in visualizing anatomical structures to inform diagnostic and treatment decisions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Software-based image processing system; runs on standard PC hardware (Pentium MMX, Windows 95/98/NT). Supports DICOM 3.0 standard. Features include 2D viewer, MPR, volume rendering, and MIP. Connectivity via standard PC interfaces for DICOM image acquisition and printing.

Indications for Use

Indicated for radiologists, clinicians, and referring physicians for the display and 3D visualization of medical image data derived from CT and MRI scans. Intended for acquisition, processing, rendering, review, storage, printing, and distribution of DICOM 3.0 compliant studies.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• Pro Vision Diagnostic Workstation (K980648)

Submission Summary (Full Text)

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NOV - 5 1999

# 510(k) Summary

#### 1. Company Identification

K992654

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.

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| Feature | Plug 'n View 3D | Pro Vision |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| Computer platform | Pentium MMX, under<br>Windows 95, 98 or NT. | Silicon Graphics O2, under<br>IRIX. |
| DICOM compliance | DICOM-3 compliance for<br>CT, MRI, NM, CR, SC and<br>Ultrasound (Single Frame)<br>images. | DICOM-3 compliance for<br>CT, MRI, NM, CR, RF and<br>SC images. |
| 2D imaging | 2D image viewer with<br>real-time window-level,<br>zoom, pan, rotate, flip<br>and cine.<br>• Multiple grid layouts. | Same. |
| Measurement | 2D measurement tools<br>including line, angle and<br>ROI statistics. | Same. |
| Multi-Planar<br>Reformatting (MPR) | MPR into any user-defined<br>linear plane. | MPR into any user-defined<br>linear or curved plane. |
| Volume Rendering | Volume rendering with<br>interactive opacity /<br>transparency control,<br>clipping volume of interest<br>(VOI), zoom, pan and rotate. | Same. |
| Maximum Intensity<br>Projection (MIP) | MIP with interactive<br>window-level, clipping VOI,<br>zoom, pan and rotate. | Same. |
| Image editing | Tools for removal of<br>obscuring anatomy. | Same. |
| Printing | Printing to standard<br>Windows printers. | • DICOM printing.<br>• Printing to all major non-<br>DICOM laser imagers. |
| Ease of use | • Visualization presets.<br>• Semi-automated steps for<br>typical image review<br>procedures | Customized presets per<br>imaging procedure. |

# 7. Substantial Equivalence Comparison Table

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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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

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# Indications for Use

### Applicant:

Voxar Ltd., Bonnington Bond, 2 Anderson Place, Edinburgh EH6 5NP, UK

510(k) Number (if known)

K992654

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.

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Umid C. Begum

uctive, Abdominal, ENT:
Radiological Devices

umber K492654

Prescription Use (Per 21 CFR 801.109)