← Product Code [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS) · K050299 # HRK-123 KNEE ARRAY COIL (K050299) _Mri Devices Corporation · MOS · Feb 24, 2005 · Radiology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K050299 ## Device Facts - **Applicant:** Mri Devices Corporation - **Product Code:** [MOS](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS.md) - **Decision Date:** Feb 24, 2005 - **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 images of the knee that can be interpreted by a trained physician. ## Device Story HRK-123 Knee Array Coil is an accessory for Magnetic Resonance (MR) scanners; functions as a radiofrequency (RF) receiver coil to capture MR signals from the knee anatomy. Device transforms received RF signals into image data for display on MR scanner console. Used in clinical radiology settings by trained technologists/radiologists. Output provides diagnostic images for physician interpretation to assist in clinical decision-making regarding knee pathology. Benefits include high-resolution imaging of knee structures. ## Clinical Evidence Bench testing only. ## Technological Characteristics RF receiver coil for MR imaging; form factor specific to knee anatomy; connects to MR scanner system; passive device component; non-invasive. ## 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 seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes forming its body, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle. Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Mr. Thomas Schubert Chief Technology Officer MRI Devices Corporation N27W23676 Paul Rd. PEWAUKEE WI 53072 Re: K050299 FEB 2 4 2005 Trade/Device Name: HRK-123 Knee Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 MOS Dated: February 7, 2005 Received: February 7, 2005 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. 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. {1}------------------------------------------------ This letter will allow you to begin marketing your device as described in your Section 510(k) I mb lotter with acation. The FDA finding of substantial equivalence of your device to a legally prematice notification: "The starsification 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 rryou desire specific at neve of the following numbers, based on the regulation number at the top of this letter: | 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 | |-----------------|----------------------------------|--------------| | 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 | | 21 CFR 892.xxxx | (Radiology) | 240-276-0120 | | Other | | 240-276-0100 | Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Allot, prease note the regulation on your responsibilities under the Act from the 007. 77. Tou may obtain burers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Nancy C. hogdon Nancy C. Brogdon 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 Model HRK-123 Knee Array Coil, February 7, 2005 ## Section C - Statement of Indications for Use Applicant: MRI Devices Corporation S10(k) number (if known): A 1050 2 99 510(K) Hamber (II hal HRK-123 Knee Array Coil Indications for use: To be used in conjunction with a Magnetic Resonance Scanner to produce To be used in conjuntion wee that can be interpreted by a trained physician. Concurrence of CDRH, Office of Device Evaluation (ODE) or Prescription ીકભ Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96) David le heppner ar: (){{} ** eproductive, Ab ancal Devices mher _________________________________________________________________________________________________________________________________________________________________________ --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K050299](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/MOS/K050299) **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