RAPIDIA

K012290 · 3D Med Co., Ltd. · LLZ · Sep 28, 2001 · Radiology

Device Facts

• Record ID: K012290
• Device Name: RAPIDIA
• Applicant: 3D Med Co., Ltd.
• Product Code: LLZ · Radiology
• Decision Date: Sep 28, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.

Device Story

Rapidia is a software-based image processing and 3D visualization system. It accepts DICOM-compliant CT and MR image data as input. The software performs image processing tasks including volume rendering (VR), maximum/minimum intensity projection (MIP/MinIP), surface shaded display (SSD), multi-planar reconstruction (MPR), virtual endoscopy, 2D image editing, and segmentation. It generates 2D/3D visualizations and clinical reports. The device is intended for use by healthcare professionals on a personal computer. It assists clinicians in diagnostic assessment and surgical planning by providing advanced visualization of anatomical structures.

Clinical Evidence

Bench testing only. Validation testing confirmed the software performs all input/output functions and actions according to the Software Requirements Specification (SRS). Conforms to DICOM Version 3 standards.

Technological Characteristics

Software-based image processing system. Operates on standard personal computers. Compatible with DICOM Version 3. Features include volume rendering, MIP/MinIP, SSD, MPR, virtual endoscopy, and 2D segmentation.

Indications for Use

Indicated for clinicians requiring viewing and manipulation of DICOM-compliant CT and MR medical images for diagnostic purposes.

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 (K993654)

Submission Summary (Full Text)

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K012290
Page 1 of 2

# SEP 2 8 2001

## 510(k) SUMMARY 3D Med Co., Ltd. Rapidia®

### Submitter Name and Address 1.

Mr. Jae Jeong Choi 3D Med Co., Ltd. 940-319 Research Park SNU, San 4-8 Bongcheon-dong, Gwanak-gu Seoul 151-818 REPUBLIC OF KOREA

82-2-889-1765 Telephone: Date Prepared: July 19, 2001

#### Device Name 2.

Rapidia® Proprietary Name: Common/Usual Name: Image processing and 3D visualization system Picture archiving and communications system Classification Name:

#### Predicate Device 3.

Plug'n View 3D (K993654)

#### 4. Intended Use

The Rapidia® is a software package intended for viewing and manipulating DICOM-compliant medical images from CT (computerized tomography) and MR (magnetic resonance) scanners. Rapidia can be used for real-time viewing, image manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and reporting.

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#### Device Description ನ.

K012290
Page 2 of 2

Rapidia® is a fast, practical and accurate tool for 3D (three dimensional) and 2D (two dimensional) viewing and manipulation of CT and MRI images using the most advanced graphics rendering technology. The proposed software provides volume rendering (VR), maximum/minimum intensity projection 3D (MIP/MinIP), surface shaded display (SSD), multi-planar reconstruction (MPR), virtual endoscopy, 2D image editing and segmentation (2D), and issues reports.

#### Technological Characteristics 6.

The proposed and predicate devices are both software programs that can be used for manipulation of DICOM-compliant CT and MRI 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.

#### 7. Performance Testing

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

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 8 2001

3D Med Co., Ltd. % Cynthia J. M. Nolte, Ph.D., RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760 Re: K012290

Trade/Device Name: Rapidia® Image Processing System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II

Product Code: 90 LLZ Dated: July 19, 2001 Received: July 20, 2001

Dear Dr. Nolte:

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.

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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 11 you attime 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 of 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. Brogdon

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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Kol2290 510(k) Number (if known):

Rapidia® Device Name:

Indications For Use:

Rapidia® is a software package intended for viewing and manipulating DICOM-compliant Rapidia - is a software paring - Rapidia® can be used for real-time viewing, moded manipulation, segmentation, 3D volume and surface rendering, virtual endoscopy, and issuing reports.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012290

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

3D Med Co., Ltd. 510(k) Rapidia®

July 19, 2001