RAPIDIACOLON

K041761 · Infinitt Co., Ltd. · LLZ · Jul 13, 2004 · Radiology

Device Facts

• Record ID: K041761
• Device Name: RAPIDIACOLON
• Applicant: Infinitt Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Jul 13, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

Device Story

RapidiaColon is a software-based Picture Archiving and Communication System (PACS) for 2D and 3D medical image manipulation. Input: digital DICOM-compliant images from CT and MRI scanners. Processing: graphics rendering technology performs 3D volume rendering (VR), multi-planar reconstruction (MPR), and virtual endoscopy. Output: rendered images and clinical reports. Usage: operated by radiologists, clinicians, and referring physicians on standard PC hardware in clinical settings. Healthcare providers use the output to review and analyze diagnostic studies, facilitating clinical decision-making through enhanced visualization of anatomical data.

Clinical Evidence

Bench testing only. Validation testing confirmed the device performs all input/output functions and required actions according to the Software Requirements Specification (SRS). No clinical data provided.

Technological Characteristics

Software-based image processing system; operates on standard PC hardware. Conforms to DICOM Version 3. Features include 3D volume rendering, multi-planar reconstruction, and virtual endoscopy. Software hazard analysis classified as 'minor' level of concern.

Indications for Use

Indicated for radiologists, clinicians, and referring physicians for display and 3D visualization of medical data from CT and MRI scanners; used to acquire, process, render, review, store, print, and distribute DICOM-compliant image 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

• plug 'n view 3d, version 1.0 (K992654)

Submission Summary (Full Text)

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KOHINGI

JUL 1 3 2004

Image /page/0/Picture/2 description: The image shows the word "INFINITT" in white letters against a black background. The font is bold and sans-serif, giving the word a strong and clear presence. The letters are evenly spaced and aligned, creating a balanced and symmetrical appearance. The contrast between the white text and the black background makes the word highly visible and easy to read.

#### 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 20, 2004

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Samuel Choi, Director INFINITT CO.,LTD Taesuk Bldg. 9F, 275-5 Yangjae-Dong Seocho-Gu, Seoul, South Korea 137-943 Fax: [phone] Email: [e-mail]

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

| Trade Name: | RapidiaColon™ System |
|------------------------|-----------------------------------------|
| Common Name: | Picture Archiving Communications System |
| Device Classification: | 892.2050 |
| Name: | System, Image Processing |

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

RapidiaColon ™ system is substantially equivalent to the:

| Manufacturer: | Voxar Limited<br>Bonnington Bond, 2 Anderson Place<br>Edinburgh, UK EH6 5 NP | |
|-----------------------------|------------------------------------------------------------------------------|--|
| Device Name: | plug 'n view 3d, version 1.0 | |
| 510(k) Number: | K 992654 | |
| Decision Date: | 11/05/1999 | |
| Decision: | Substantially Equivalent | |
| Panel Code reviewed by: | Radiology | |
| Panel Code classified by: | Radiology | |
| Product Code: | LLZ | |
| Device Classification Name: | SYSTEM, IMAGE PROCESSING, RADIOLOGICAL | |
| Regulation Number: | Class II - 892.2050 | |

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

RapidiaColon™ is a software device for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of digital DICOM compliant images using graphics rendering technology. The software device provides 3D volume rendering (VR), multi-planar reconstruction (MPR), virtual endoscopy, and issues reports.

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

RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from digital modalities (CT and MRI scanners). It is intended

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Image /page/1/Picture/0 description: The image shows the word "INFINITT" in white letters against a black background. The letters are bold and sans-serif. The word appears to be a logo or brand name. The image is simple and high contrast.

for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware.

#### Technological Characteristics: 21 CFR 807 92(a)(6)

The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant CT images. The proposed and predicate software can be operated from a personal computer. Differences between the proposed and predicate devices are limited to the availability of certain image viewing and editing features.

The proposed RapidiaColon software conforms to DICOM (Digital Imaging and Communications in Medicine) Version 3. Validation testing was provided that confirms that RapidiaColon performs all input functions, output functions, and all required actions according to the functional requirements specified in the Software Requirements Specification (SRS).

#### Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification for the RapidiaColon™ device contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.

The RapidiaColon™ device has been and 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".

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL 1 3 2004

INFINITT Co., Ltd. % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K041761 Trade/Device Name: RapidiaColon™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: June 14, 2004

Received: June 30, 2004

Dear Ms. 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 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.

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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 | [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" (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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brygdon

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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# Indications for Use

510(k) Number (if known): KOHI 76 |

Device Name: RapidiaColon TM

Indications for Use:

RapidiaColon ™ is a software application for the display and 3D visualization of medical data derived from CT and MRI scanners. It is intended for use by radiologists, clinicians and referring physicians to acquire, process, render, review, store, print, and distribute DICOM compliant image studies using standard PC hardware

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (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)

Nancy C. Hogdon

(Division Sign Off) Division of Reproductive, Ab and Radiological Devices 510(k) Number