(28 days)
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic images of the head and neck when interpreted by a trained physician.
Model NVA-127-8-A Neurovascular Array Coil
This document is a 510(k) premarket notification approval letter for a Magnetic Resonance (MR) diagnostic device. It does not contain information about acceptance criteria or a study proving device performance as requested in the prompt. The letter confirms substantial equivalence to a predicate device but does not detail performance data, sample sizes, expert qualifications, or ground truth methodologies.
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Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing or feather shapes.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas Schubert Chief Technology Officer MRI Devices Corporation N27 W23676 Paul Rd PEWAUKEE WI 53072
Re: K050621 Trade/Device Name: Model NVA-127-8-A Neurovascular Array Coil Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: MOS Dated: March 8, 2005 Received: March 10, 2005
Dear Mr. Schubert:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced We have reviewed your Section 510(t) premaint from only alent (for the indications for use stated in
above and have determined the device is substantially equivalent commerce above and nave determined the devices marketed in interstate commerce prior to the enclosure) to legally marketed predical Device Amendments, or to devices that have been May 28, 1976, the enactinent date of the Frederal Food. Drug, and Cosmetic Act (Act) that reclassified in accordance with the provisions of application (PMA). You may, therefore, market the A do not require approval of a premaince approvisions of the Act. The general controls provisions of the Act device, subject to the general controls provisions of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
APR 7
2002
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket If your device is classified (see above) in only of included to the major regulations affecting your Approval), it may be subject to such additions. Title 21, Pars 800 to 898. In addition, FDA device can be found in the code of I concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that Please be advised that FDA s Issualled of a succements of the requirements of the Act or any
FDA has made a determination that your device complies with all the FDA has made a delerinmation mallyout de rice ochip.Federal agencies. You must comply with all the Federal statures and regulations administered of Cater of Chine (2) CFR Part 807); labeling Act 's requirements, including, but not minted to registerials as set forth in the quality systems (QS) (21 CFR Part 801); good manufacturing practice roomic product radiation control provisions
regulation (21 CFR Part 820); and if applica as co (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 alexal This letter will allow you to begin marketing your actives of your device of your device of your device of your device to a legally premarket notification. The FDA finding of substantial equiralent of 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), pleased If you desire specific advice for your device on our labeling regaration (1998).
contact the Office of Compliance at one of the following numbers, based on the regulation num 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 Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general inionnal on your respensioners as its toll-free number (800) DIVISion of Small Manalastics or at its Internet address 058-2041 of (2017) victrh/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
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Special 510(K) Application, Device Modification Special 310(K) Application, Device I Array Coil, March 8, 2005
Section C – Statement of Indications for Use
Applicant: MRI Devices Corporation Applicant: Mer (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ 510(K) number (IF Rilowit). 127-8-A Neurovascular Array Coil
Indications for use:
To be used in conjunction with a Magnetic Resonance Scanner to produce diagnostic I o be used in confulication with a Magnette resered by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over-The-Counter Use or
(Per 21 CFR 801.109) (Optional Format 1-2-96)
Nancy Buxton
Division Sign-Off
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices K0506 5 ! (Xk) Number ______________________________________________________________________________________________________________________________________________________________
Page 3
§ 892.1000 Magnetic resonance diagnostic device.
(a)
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).(b)
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.