OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE

{0}------------------------------------------------ K981475 ## 510(k) Premarket Notification # SUMMARY OF SAFETY AND EFFECTIVENESS 2636923 Bruce Clark - 1. DEVICE NAME: Model Number: Trade/Proprietary Name: Magnetic Resonance Diagnostic Device Accessory MRT-600 OPART™ ESTABLISHMENT REGISTRATION: 2. - U.S. AGENT NAME AND ADDRESS: 3. CONTACT PERSON: MANUFACTURING SITE: 4. - 5. DATE OF SUBMISSION: 6. DEVICE DESCRIPTION: (650)872-2722 ext. 6068 280 Utah Avenue Toshiba America MRI, Inc. Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco, CA 94080 South San Francisco, CA 94080 April 20, 1998 Versions 2 (V2) software is a combination of modifications and the addition of new sequences to the existing software, which facilitate the acquisition and reconstruction of MR images. 0.35 Tesla ### 7. ## SAFETY PARAMETERS: Maximum static field strength: Rate of change of magnetic field: 19T/second Maximum radio frequency power deposition (SAR): <0.4 Watt/kg Acoustic noise levels (maximum): 98.4 dB (A) | 8. | IMAGING PERFORMANCE PARAMETERS: | | | | |----|---------------------------------|-------|----------|--| | | Specification volume: | Head: | 10cm dsv | | | | | Body: | 20cm dsv | | Sample phantom images and clinical images are presented for new sequences. #### 9. INTENDED USE Anatomical regions: Head, body, extremity, spine, neck, TMJ, breast, and heart Nuclei excited: Hydrogen Diagnostic use: Diagnostic imaging of the human body (including head, abdomen, breast, heart, pelvis, spine, blood vessels, limbs, and extremities), fluid visualization, 2D and 3D imaging, MR angiography and MR fluoroscopy. {1}------------------------------------------------ ### EQUIVALENCY INFORMATION: 10. : Toshiba America MRI, Inc., believes that the Versions 2 (V2) software upgrade for OPART™ system is substantially equivalent to the software which was cleared with the initial OPART™ system (K962933). The modifications added to the Versions 2 (V2) software do not raise new questions of safety or efficacy. This software does not introduce any new indications for use from those cleared in the Premarket Notification for OPART™ diagnostic resonance system 510(k) number K962933. {2}------------------------------------------------ Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 JUI 1 1998 Bruce Clark Toshiba America MRI, Inc. 280 Utah Avenue South San Francisco. CA 94080 Re: K981475 Version 2 Software Upgrade for OPART™ MRI System Dated: April 23, 1998 Received: April 24, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH Dear Mr. Clark: We have reviewed your Section 510%) 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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendoments, or to devices that have been reclassified in accordance with the provisions of the Federal. Food, Drug, and Cosmenc 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 proctice, labeling, 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 requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (2) CFR Part 820) and that, through periodic OS 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 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 S10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed prodicate 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html". Sincerely yours, Kilian Yin Lillian Yin, Ph.D. Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ Page __ 1___ of ______________________________________________________________________________________________________________________________________________________________ | 510(k) Number (if known): | R98 1475 | |---------------------------|------------------------------------------------------------| | Device Name: | OPART ^TM (MRT-600) Versions 2 Software Upgrade | | Indications for Use: | (unchaged from initial OPART ^TM system K962933) | | Imaging of: | | The Whole Body (including head, abdomen, pelvis, limbs and extremities, spine, . neck, TMJ, heart, blood vessels). [Application terms include MRCP (MR Cholangiopancreatography), MR Urography, MR Myelography, MR Fluoroscopy, SAS (Surface Anatomy Scan), Dynavic Scan and Cine Imaging.] - -Fluid Visualization - ・ 2D/3D Imaging - MR Angiography/MR Vascular Imaging - (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices | 510(k) Number | K981475 | |---------------|---------| |---------------|---------| | Prescription Use (Per 21 CFR§801.109) | X | OR | Over-The-Counter Use | |---------------------------------------|---|----|----------------------| |---------------------------------------|---|----|----------------------| (Optional Format 1-2-96)CONFIDENTIAL