← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K061952 # CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16 (K061952) _Invivo · MOS · Jul 28, 2006 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K061952 ## Device Facts - **Applicant:** Invivo - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Jul 28, 2006 - **Decision:** SESE - **Submission Type:** Special - **Regulation:** 21 CFR 892.1000 - **Device Class:** Class 2 - **Review Panel:** Radiology ## Intended Use To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician. ## Device Story Cardiovascular Array Coils (Models CAC-63-16, CAC-63-32, CAC-123-32, CAC-127-16) are accessory devices for Magnetic Resonance (MR) scanners. Coils function as radiofrequency (RF) receivers to detect MR signals from patient anatomy. These signals are transformed by the host MR scanner into diagnostic images of cardiovascular, pulmonary, renal, and abdominal systems. Used in clinical settings by trained medical professionals (radiologists/technicians). Output is viewed on MR scanner workstations to assist in clinical diagnosis. Benefit includes high-quality diagnostic imaging of specified organ systems. ## Clinical Evidence No clinical data provided; bench testing only. ## Technological Characteristics RF receiver coils for Magnetic Resonance Imaging. Device functions as a passive component within an MR system to detect electromagnetic signals. Form factor consists of array coil configurations (16 or 32 channel variants). Connectivity is via direct interface to the MR scanner hardware. Sterilization is not applicable as these are non-invasive diagnostic accessories. ## Regulatory Identification A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information). ## Special Controls *Classification.* Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three curved lines representing its wings or body. The logo is black and white and appears to be a scanned image. Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850 JUL 2 8 2006 Mr. Thomas Schubert Chief Technology Officer Invivo Corporation 3545 SW 47th Ave. GAINESVILLE FL 32608 Re: K061952 Trade/Device Name: Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: June 20, 2006 Received: July 10, 2006 Dear Mr. Schubert: 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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Image /page/0/Picture/11 description: The image is a black and white logo with the text "1906-2006" at the top. Below the text is the abbreviation "PA" in large, bold letters. Underneath the abbreviation is the word "Centennial" in a smaller font. There are three stars below the word "Centennial". The logo is surrounded by a circular border. Protecting and Promoting Public Health {1}------------------------------------------------ Page 2 - 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. This letter will allow you to begin marketing your device as described in your Section 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 contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxx | (Gastroenterology/Renal/Urology | 240-276-0115 | |----------------|---------------------------------|--------------| | 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 894.xxx | (Radiology) | 240-276-0120 | | Other | 240-276-0100 | | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html. Sincerely yours, Nancy C. Hogdon Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Special 510(K) Application, Device Modification Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils June 20, 2006 Page 3 of 35 ## Section C - Statement of Indications for Use Applicant: Device Name: Invivo Corporation 510(k) number (if known): Models CAC-63-16, CAC-63-32, CAC-123-32, & CAC-127-16 Cardiovascular Array Coils Indications for use: To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the cardiovascular, pulmonary, renal, and abdominal systems that can be interpreted by a trained physician. Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) ் ப V David A. Ingram (Division Sign-Off) Division of Reproductive, A and Radiological Device 510(k) Number __ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K061952](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K061952) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com