ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)

K961525 · Mri Devices Corp. · MOS · Sep 5, 1996 · Radiology

Device Facts

• Record ID: K961525
• Device Name: ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)
• Applicant: Mri Devices Corp.
• Product Code: MOS · Radiology
• Decision Date: Sep 5, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Device Story

The Model OBC-63 PA Open Breast Coil is a specialized accessory for magnetic resonance imaging (MRI) systems. It functions as a radiofrequency (RF) coil designed to receive signals from breast tissue during an MRI scan. The device is used in clinical imaging environments by trained MRI technologists or radiologists. By providing localized signal detection, the coil enhances image quality and signal-to-noise ratio for breast examinations, assisting clinicians in visualizing anatomical structures and identifying potential pathologies. The output is a raw signal processed by the host MRI system into diagnostic images, which the physician interprets to inform clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a radiofrequency (RF) coil for MRI systems. It operates as a passive or active signal receiver within the magnetic resonance diagnostic device category (21 CFR 892.1000). It is designed for compatibility with existing MRI scanner hardware. No specific materials or software algorithms are detailed in the provided documentation.

Regulatory Classification

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)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

JUL 2 2009

Mr. Thomas Schubert
President
MRI Devices Corporation
Johnson Drive Corporate Center
N8 W22520-K Johnson Drive
WAUKESHA WI 53186

Re: K961525
Trade/Device Name: Model OBC-63 PA Open Breast Coil
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II
Product Code: MOS
Dated: August 13, 1996
Received: August 14, 1996

Dear Mr. Schubert:

This letter corrects our substantially equivalent letter of September 6, 1996.

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 (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 (PMA), it may be subject to 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

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Page 2 – Mr. Schubert

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health’s (CDRH’s) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH’s Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,


Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure