511 KEV COLLIMATOR

{0} DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 MAY 29 1997 Ms. Daphne Reed Manager, Regulatory Affairs TRIONIX Research Laboratory, Inc. 8037 Bavaria Road Twinsburg, OH 44087 Re: K964438 511 keV Collimator for TRIONIX Triad Dated: April 4, 1997 Received: April 8, 1997 Regulatory Class: II 21 CFR 892.1200/Procode: 90 KPS Dear Ms. Reed: We have reviewed your Section 510(k) 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 Amendments, or to 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 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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 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 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. 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/dsmamain.html". Sincerely yours, 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 Enclosure {1} 07/16/96 09:21 301 480 4224 Response to Question 1 ATTACHMENT 1 002 Page 1 of 2 510(k) Number (if known): K964438 Device Name: 511 keV collimator for T88 (K873775/A) ## Nuclear Medicine Device Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). | | YES | NO | Energy Range (keV) | | --- | --- | --- | --- | | A. Planar imaging | ☑ | ☐ | 511 keV | | B. Whole body imaging | ☑ | ☐ | 511 keV | | C. Tomographic imaging (SPECT) for non Positron emitter | ☑ | ☐ | 511 keV | | D. Positron imaging by coincidence | ☐ | ☑ | | | E. Positron imaging without coincidence | ☑ | ☐ | | | F. Other indication(s) in the device label, but not included in above list | Could be used with 511 keV photon imaging and photons of smaller energy simultaneously (e.g. 140 keV and 511 keV) | | | (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 801.109) OR Over-the-Counter Use (Division Sign-Off) Division: Productive, Abdominal, ENT, a Division: General Devices 510(k), Number K964438 (Optional Format 1-2-96) {2} 07/16/96 09:21 301 480 4224 F 002 Response to Question 1 Page 2 of 2 510(k) Number (if known): K964438 Device Name: 511 keV Collimator for cardiac Triad (9" and 20") (K920776) (K923345) # Nuclear Medicine Device Indication For Use: To detect or image the distribution of radionuclides in the body or organ, using the following technique(s). | | YES | NO | Energy Range (keV) | | --- | --- | --- | --- | | A. Planar imaging | ☑ | ☐ | 511 keV | | B. Whole body imaging | ☑ | ☐ | 511 keV | | C. Tomographic imaging (SPECT) for non Positron emitter | ☑ | ☐ | 511 keV | | D. Positron imaging by coincidence | ☐ | ☑ | | | E. Positron imaging without coincidence | ☑ | ☐ | | | F. Other indication(s) in the device label, but not included in above list | Could be used with 511 keV photon imaging and photons of smaller energy simultaneously (e.g 140 keV and 511 keV) | | | (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 801.109) (Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Biological Devices 511 Number K964438 (Optional Format 1-2-96)