VOXELPLUS PACS

K022692 · Mevisys Co., Ltd. · LLZ · Oct 11, 2002 · Radiology

Device Facts

• Record ID: K022692
• Device Name: VOXELPLUS PACS
• Applicant: Mevisys Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Oct 11, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. 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.

Device Story

VoxelPlus™ is a PC-based software application for medical image management and visualization. It imports DICOM-formatted images from CT and MRI scanners. Core functions include 3D volume rendering, multi-planar reconstruction (MPR), and 2D analysis tools. The system manages patient data, examination requests, and image distribution across high-speed facility networks. Used by physicians, nurses, and technicians in clinical settings to review and process diagnostic images. The software does not contact the patient or control life-sustaining equipment; it serves as a diagnostic aid where a physician interprets the displayed information to inform clinical decision-making.

Clinical Evidence

Bench testing only. No clinical data provided. Hazard analysis performed with potential hazards classified as Minor.

Technological Characteristics

PC-based software application. DICOM-compliant. Functions include 3D volume rendering, MPR, and 2D analysis. Network-enabled for image communication. Does not contact patient. No life-sustaining control. Software-only device.

Indications for Use

Indicated for display and 3D visualization of medical image data (CT, MRI) for trained professionals including physicians, nurses, and technicians.

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

• PLUG 'N VIEW 3D (K992654)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the word "MEVISYS" in bold, black letters. Below the word "MEVISYS" is the word "(주)메비시스" in a smaller font. The letters in "MEVISYS" are thick and blocky, while the letters in "(주)메비시스" are thinner and more delicate.

# 510(k) Summary of Safety and Effectiveness

K022692

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: July 25, 2002

Submitter's Information: 21 CFR 807.92(a)(1) Mevisys, Co., Ltd. Alumni Venture Hall, Room 5103 KAIST, 400 Gusongdong Yusonggu Daejon 305-701 Korea

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) VoxelPlus™ Trade Name: Common Name: Picture Archiving Communications System Device Classification: 892.2050 System, Image Processing Name:

Predicate Device: 21 CFR 807. 92(a)(3)

| Device Classification Name | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL |
|----------------------------|---------------------------------------------------------------------------|
| Regulation Number | 892.2050 |
| 510(k) Number | K992654 |
| Device Name | PLUG 'N VIEW 3D |
| Applicant | VOXAR LIMITED<br>BONNINGTON BOND, 2 ANDERSON PL<br>EDINBURGH, UK EH6 5 NP |
| Contact | ROB MACKEAN |
| Product Code | LLZ |
| Date Received | 08/09/1999 |
| Decision Date | 11/05/1999 |

#### Device Description: 21 CFR 807 92(a)(4)

Mevisys VoxelPlus™ is a PC-based software application that imports medical images (i.e. CT, MRI modalities) in a DICOM format and provides various functions for rapid and easy review. It includes 3D volume rendering, various MPR, and many 2D analysis tools. The tools manage images, requests, patients, examination etc. over a high-speed network to allow information and images flow throughout a user facility.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "MEVISYS" in a bold, sans-serif font. The first part of the word, "MEVI," is in solid black, while the "SYS" portion is outlined in black. Below the word "MEVISYS" is the Korean text "(주) 메비시스".

### Indications for Use: 21 CFR 807 92(a)(5)

The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. 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.

#### 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 VoxelPlus™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. VoxelPlus™ 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 potential hazards have been classified as Minor.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" written around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of three curved lines, giving it a modern and abstract appearance. The seal is black and white.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

**OCT 11 2002**

Mevisys Co., Ltd. % Mr. Carl Alletto 1100 Lakeview Blvd. DENTON TX 76208 Re: K022692

Trade/Device Name: VoxelPlus™ PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system

Regulatory Class: II Product Code: 90 LLZ Dated: June 27, 2002 Received: August 13, 2002

Dear Mr. Alletto:

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 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:

| 8xx.1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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 Part 807.97). 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Hogdon

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 word "MEViSYS" in a stylized font. The letters "MEV" are solid black, while the letters "SYS" are outlined in black with a white fill. The "i" in "MEViSYS" is dotted with a small circle.

(주)메비시스

Page 1 of -1

## (Indications for Use Form)

510(k) Number: Ko 22 6 9 2

Device Name:

VoxelPlus™ by MEViSYS Co. Ltd.

Indications for Use:

The VoxelPlus™ is a software application for the for the display and 3D visualization of medical image data derived from various sources (i.e. 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)

(Optional Format 1-2-96)

Daniel li. Lennon

510(k) Number