MEDRAD 1.5T EXTREMITY ARRAY

K973787 · Medrad, Inc. · MOS · Dec 30, 1997 · Radiology

Device Facts

• Record ID: K973787
• Device Name: MEDRAD 1.5T EXTREMITY ARRAY
• Applicant: Medrad, Inc.
• Product Code: MOS · Radiology
• Decision Date: Dec 30, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.

Device Story

The MEDRAD 1.5T Extremity Array is a four-coil phased array MRI accessory; operates in transmit-receive mode. Device excites and receives signals from hydrogen protons; facilitates diagnostic quality radiographic imaging of extremities. Used in healthcare facilities; operated by trained MRI technologists or radiologists. Output is raw signal data processed by compatible GE 1.5T Signa Advantage, Horizon, or Horizon LX MRI scanners to generate clinical images. Enhances image quality for extremity examinations; aids physicians in diagnostic decision-making.

Clinical Evidence

Bench testing only; no clinical data provided.

Technological Characteristics

Four-coil phased array design; operates in transmit-receive mode. Designed for 1.5T magnetic resonance imaging systems. Compatible with GE Signa Advantage, Horizon, and Horizon LX platforms. Passive hardware accessory; no software or active electronic processing components.

Indications for Use

Indicated for use in patients undergoing MR imaging of the extremities to obtain diagnostic quality radiographic images when used with compatible GE 1.5T Signa Advantage, Horizon, and Horizon LX scanner systems.

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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Public Health Service

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DEC 30

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Mary Ann Greenawalt Senior Regulatory Affairs Associate MEDRAD, Inc. One Medrad Drive Indianola, PA 15051

Re: K973787

MEDRAD 1.5T Extremity Array (MRI accessory) Dated: October 3, 1997 Received: October 6, 1997 Regulatory Class: II 21 CFR 892.1000/Procode: 90 MOS

Dear Ms. Greenawalt:

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 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 and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either 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 Current Good Manufacturing Practice requirement, as set forth in the Qualion (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

H. William Yu

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

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Image /page/1/Picture/1 description: The image shows the word "MEDRAD" in a stylized, bold, black font. The letters are slightly slanted to the right, giving the word a dynamic appearance. A small "R" in a circle, indicating a registered trademark, is positioned to the upper right of the letter "D". Above the word "MEDRAD" is the text "P.2".

## MEDRAD 1.5T EXTREMITY ARRAY INTENDED USE

510(k) Number: K973787 Medrad 1.5T Extremity Array Device Name: Intended Use: The 1.5T Extremity Array is a four-coil phased array device which operates in the transmit-receive mode. The device is

intended to excite and receive signal from hydrogen protons for diagnostic quelity radiographic images when used with GE 1.5T Signa Advantage, Horizon and Horizon LX scanner(s) during MR imaging.

Environment of Use: Health Care Facilities Signa Advantage, Horizon and Horizon LX Magnetic Equipment of Use: Resonance Systems

Medrad, inc

One Medrad Drive Indianola, PA 15051-07B0 [phone]

hiliaufr

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number

**Prescription Use**
(Per 21 CFR 801.109)