RTR-2000/RTR-4000

K974307 · Terarecon,Inc. · JAK · Feb 13, 1998 · Radiology

Device Facts

• Record ID: K974307
• Device Name: RTR-2000/RTR-4000
• Applicant: Terarecon,Inc.
• Product Code: JAK · Radiology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The intended use of the device is to provide solutions to various medical image reconstruction throughput problems through the application of high speed image image processing devices and software, specifically. 2D and 3D reconstructions for CT scanners, MRI scanners and Ultrasound and other related radiological image host systems. It will allow for near real-time viewing, in turn, supporting existing system clinical uses by offering enhanced operator flexibility.

Device Story

RTR-2000 is a stand-alone high-performance image processing workstation; functions as an upgrade to existing CT, MRI, and ultrasound imaging systems. Device acquires raw medical image data from host scanners; performs high-speed 2D and 3D image reconstruction; outputs images for near real-time viewing. Used in clinical settings by radiologists or technologists to monitor examination progress; allows immediate detection of patient movement during scans. Real-time feedback enables clinicians to decide if re-scanning is necessary during the procedure, thereby optimizing scanning accuracy and reducing patient radiation exposure. System serves as an alternative viewing means without replacing the host system's native reconstruction capabilities.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Stand-alone image processing workstation; high-speed 2D/3D reconstruction software; interfaces with CT, MRI, and ultrasound host systems. Connectivity via integration with existing radiological imaging host systems. Technical details regarding specific hardware materials or software architecture are not provided.

Indications for Use

Indicated for use in radiological examinations where immediate visual feedback of scanned medical images is required to monitor for patient movement, maximize scanning accuracy, and minimize patient radiation dose by enabling real-time visualization of images instead of waiting for standard reconstruction times.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Toshiba TSFX-001A, Real-Time Reconstruction System Option for Xpress/SX CT System (K950973)

Submission Summary (Full Text)

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510(k) Summary

K974307

| Date: | November 13, 1997 |
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| Submitter: | Gary J. Allsebrook, Regulatory Affairs<br>for/ TERARECON, INC.<br>280 Utah Avenue<br>Suite 100<br>South San Francisco, CA 94080 |
| Contact: | Gary J. Allsebrook, Regulatory Affairs<br>TEL: [phone] FAX: [phone] |
| Device Name: | RTR-2000 Medical Image Reconstruction and<br>Processing Systems |
| Common Name: | Image Processing Workstation |
| Classification Name: | System, Image Processing |
| Classification: | Class II |
| Procode: | 90LLZ |
| Establishment<br>Registration Number: | Application in Process |
| Predicate Device: | Toshiba TSFX-001A, Real-Time Reconstruction<br>System Option for Xpress/SX CT System, K950973 |

Device Description: The TERARECON, INC. RTR-2000 real-time image reconstruction system acquires medical image data from such medical imaging devices as CT and reconstructs the "raw" data into visible images. The RTR-2000 system reconstructs images with such high performance that the images This stand-alone high performance image are viewed in real-time. reconstruction system is offered as an upgrade to existing imaging devices, and is not intended to replace the devices' existing reconstruction system. Rather, it is intended to serve as an alternative means of viewing medical images, particularly where real-time visualization of images is beneficial.

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Intended Use of this Device: The intended use of the device is to provide solutions to various medical image reconstruction throughput problems through the application of high speed image image processing devices and software, specifically. 2D and 3D reconstructions for CT scanners, MRI scanners and Ultrasound and other related radiological image host systems. It will allow for near real-time viewing, in turn, supporting existing system clinical uses by offering enhanced operator flexibility.

Comparison to Predicate Device: The RTR-2000 is similar to the Toshiba Real-Time Reconstruction System Model TSXF-001A, K950972, in that it is an upgraded version (supplement) of the host viewing system. As in the predicate device, the features provide user flexibility and improvements to the image processing throughput. Other than dramatically speeding up the image reconstruction process, there are no perceived or imagined new intended uses which will affect the safety and effectiveness of the host system.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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FEB 1 3 1998

TeraRecon, Inc. c/o Gary J. Allesbrook Regulatory Management Services 16303 Panoramic Way San Leandro, CA 94578-1116

Re:

K974307 RTR-2000 (Image Processing Workstation ) Dated: November 13, 1997 Received: November 17, 1997 Regulatory class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Allesbrook:

We have reviewed your Section 510K) 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 interstate in interstate commerce prior to May 28, 1976, the enactment date of the Medical 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 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 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 requirement, 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 Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your 100(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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question 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/cdrb/dsmamain.html" -- ------------------------------------------------------------------------------------------

Sincerely yours,

William Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known):

Device Name: TeraRecon RTR-2000 Image Reconstruction System

Indications for Use:

The TeraRecon RTR-2000 Image Reconstruction System should be used when it is desirable to view scanned medical images immediately, rather than wait long periods of time for reconstruction. Indications would include monitoring of radiological examinations for patient movement. It is possible that patient movement during the middle of an examination, which may require re-scanning, would not be detected until after the completion of the exam when all of the images are reconstructed and thus visualized. High speed image reconstruction allows for real-time visualization of the images. Such real-time visualization of images gives the immediate visual feedback necessary to monitor the progress of examinations in efforts to maximize scanning accuracy and minimize radiation dose to the patient.

In short, real-time visualization of images is indicated in cases where the user prefers immediate visual feedback as opposed to having to wait long periods of time for image reconstruction.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 901.109)

Over-the-Counter Use

David A. Siyer (Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdominal, El and Radiological Devic

510(k) Number _

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