MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM

{0}------------------------------------------------ K041840 AUG 2 0 2004 ## 510(k) SUMMARY | Submitted by: | MEDX, Incorporated<br>3456 N. Ridge Ave. #100<br>Arlington Height, IL 60004 | |--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Telephone: | (847)-463-2020 | | Fax: | (847)-463-2019 | | Contact Person: | Floyd R. Rowan, Executive<br>Vice President | | Date Summary Prepared: | July 6, 2004 | | Trade Name of Device: | MEDX NuQuest™ - InteCam™<br>SPECT 37-75 System. | | Common Name | Gamma Camera System. | | Classification: | This device is classified as a<br>Class II Device. Radiology Panel<br>Classification Name: System,<br>Tomography, Computed, Emis-<br>sion. Ref. 21CFR892.1200,<br>Product Code: KPS. | | Substantial Equivalence: | The MEDX NuQuest - InteCam<br>SPECT 37-75 is substantially<br>equivalent to the Siemens Inte-<br>grated ORBITER™ Gamma<br>Camera System. | Intended Use: The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals. {1}------------------------------------------------ Description of Device: The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of: - A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software. - NuQuest™ Nuclear Medicine Computer and related . software. The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software. The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software. It should be pointed out that the NuQuest Nuclear Medicine Computer has a cleared 510(k): K953255.The imaging software (under the trade name IM512P) also has a cleared 510(k): K945792. Note: Digitrac and Orbiter are registered trademarks of Siemens Gammasonic, Inc. Scientific Principle: Diagnostic Nuclear Medicine began in early 1950's with the availability of short half-life isotopes. Isotopes such as 1131 were injected into the patient and were selectively taken up by organ systems such as the thyroid. Measurement of the resulting radioactivity in the organ provided information on both the size of the organ and the relative amount of the isotope taken up. Nuclear Medicine cameras work on the principle similar to television cameras. A collimator (lens) "focuses" gamma rays on a scintillation crystal. The scintillation crystal converts gamma rays into light. Photomultiplier tubes are then used to convert the light into electrical signal proportional to the energy of the detected gamma ray. Early instruments used a single hole lead collimator and detector that was moved in a raster pattern forming a 2-D image of the organ of interest. In the late 1950's {2}------------------------------------------------ methods were developed for directly obtaining a 2-D image by using a large crystal with multiple photomultiplier tubes and electronically calculating the position and energy of the gamma event. Two dimensional projections collected position and onergy of be mathematically combined to yield a three dimensional representation of the data. This principle of tomographic reconstruction was roproovered early in this century, but it was not until the advent of high speed computer that the technique could be successfully applied in diagnostic imaging first to CT then to Nuclear Medicine and MRI. Nuclear Medicine is currently of great interest because of its high contrast, and relatively low cost per study. The ability to attach isotopes to substances that are rolarroly taken up by specific tissue types can provide very high contrast by the organ of interest and the surrounding tissue. This has tended to compensate for the relatively poor spatial resolution of Nuclear Medicine compared to other modalities such as MRI. In addition the uptake and clearing of the radioisotopes can be observed temporally, providing an indication of the biological activity of the tissue. This is important when attempting to determine tissue viability, or finding areas of abnormal activity such as cancerous tissue. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows a logo with a circular border containing text. Inside the circle is a stylized image of a bird in flight, represented by three curved lines. The bird is oriented towards the right side of the image. The text around the border is not clear enough to read. Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AUG 2 0 2004 Mr. Floyd R. Rowan Executive Vice President MEDX. Inc. 3456 N. Ridge Ave., #100 ARLINGTON HTS II_ 60004 Re: K041840 K041840 Trade/Device Name: MEDX NuQuest™ – InteCam™ SPECT 37-75 System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: July 7, 2004 Received: July 8, 2004 Dear Mr. Rowan: We have reviewed your Section 510(k) premarket not intent to market the device tion indication We have reviewed your Section 510(x) jirchitet is substantially equivalent (for the indications referenced above and have determined the devices marketed in interstate referenced above and nave decembled the devices marketed pressmanteted in interstate for use stated in the enclosure) to regally interest and calcul Device Americal Device Americal Food Drug commerce prior to May 28, 1976, the enactitions of the Federal Food, Drug, devices that have been reclassified in accordance with use and over oval application (PMA). and Cosmetic Act (Act) that do not required and seasonal sensions of the Act. The and Cosmetic Act (Act) that do not require approvate or a provisions of the Act. The Act. The You may, therefore, market the device, subject to the general concertirent i You may, therefore, market the device, subject of the general vegistration, listing of general controls provisions of the Act include requirements for annual management general controls provisions of the Act mende requirements of the samst misbranding and adulteration. If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), (1 If your device is classified (sec above) in the major regulations affecting your device can be it may be subject to additional controls. Existing major regulations affectiv if may be subject to additions. Title 21, Parts 800 to 898. In addition, FDA may found in the Code of Federal Regulations, Title 21, Farts 800 to 898. In addition, FDA may found in the Code of Federal Regulations, Free Beyeve in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determiration aos not mean Please be advised that TDA s issualice of a subslies with other requirements of the Act that FDA has made a determination that your device addressing - You must that FDA has made a determination that your device or other Federal agencies. You must or any Federal statutes and regulations and to red limited to: registration and listing comply with all the Act s requirements metuding, good manufacturing practice requirements as sch (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice th (2) CFR Part 807); labellig (21 CFR Pair 800); good natif applicable, the electronic forth in the quality systems (QS) regulation (21 CFR Part 21 CFR 1000-1050 forth in the quality systems (Q5) regulation (21 Of the Act); 21 CFR 1000-1050. product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ ## 1",t;"," } This letter will allow you to begin marketing your device as described in your Scetten \$10(k). This letter will allow you to begin national equivalence of your device of your device to alle;ally prematicet notification - The FDA finding of substant the species to this, premarket notification - The FIDA finding of substantial cours and this, permits your devito proceed to the market If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your device on our faction of the regulation of contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter : | 8xx.1xxx | (301) 594-4591 | |----------------------------------|----------------| | 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 | | 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 | | 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 | | Other | (301) 594-4692 | Additionally, for questions on the promotion and advectising of your device, please contact the Additionally, for questions on the promotion and an realled, "Misbranding Office of Compliance at (30) 594-4639. Also, please note the regulation entitled, "Mislor general Office of Compliance at (301) Sylant (2017) Part 807.97 you may obtain. Other general by reference to premarket notification" (21CPR Part he obtained from the Division of Sm by reference to premarket notheration' (21CA Far 801779) your drom the Division of Small information on your responsibilities under the Act may be obtained from the Division information on your responsibilities under the Act they of the number (800) 638-2041 or Manufacturers, International and Consumer Assistance at its toll-fires mann huml. Manufacturers, International and Consumer Assistance at to tor 2011 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html. Sincerely yours, Nancy C. Brogdon Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices ()flice of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ ## Indications for Use 510(k) Number (if known): K 041840 Device Name: MEDX NuQuest™- InteCam™ SPECT 37-75 System Indications For Use: The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals. Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) David R. Harrison (Division Sign-Off) Division of Reproductive, A and Radiological Devices 510(k) Number Page 1 of /