(60 days)
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Not Found
No
The summary describes a physical accessory for MRI, not a software or algorithm-based device. There is no mention of AI, ML, or image processing that would suggest the use of such technology.
No
The device is described as an "MRI accessory" that improves image homogeneity and serves as a "stabilizing device" to reduce pulsation artifacts. These functions are aimed at improving image quality for diagnostic purposes rather than directly treating a medical condition or restoring function.
No
The device aids in improving MRI image quality and stabilizing the patient during an MRI scan, but it does not directly diagnose conditions or provide diagnostic information. It is an accessory to the MRI process.
No
The description of the device as an "MRI accessory" designed to "improve image homogeneity by reducing skin-air interfaces" and serving as a "stabilizing device" strongly suggests a physical component, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The description of the MR Enhancer clearly states its intended use is as an MRI accessory to improve image quality and reduce artifacts during the MRI scan itself. It interacts with the patient's body externally during the imaging process, not by analyzing a biological sample taken from the body.
The function of the MR Enhancer is to improve the quality of the imaging process, not to analyze a biological sample for diagnostic purposes.
N/A
Intended Use / Indications for Use
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo.
MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Product codes
90 LNH
Device Description
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo.
MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle with three wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB | 4 2000
I.Z.I. Corporation E.J. Smith C/O Smith Associates P.O. Box 4341 Crofton, MD 21114
Re:
K994117 MR Enchancer Dated: November 23, 1999 Received: December 6, 1999 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Smith:
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 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). 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 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 requirements, as set forth in the Quality System Regulation (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 the Electronic Product 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 predication for vour 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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(K) Number (if known): = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = =
Product Name: MR Enhancer
Indications for Use.
MR Enhancer is designed for use as a MRI accessory to improve image homogeneity by reducing skin-air interfaces, thereby images from such pulsing parameters as chemical shift fat saturation and gradient echo.
MR Enhancer also serves as a stabilizing device to reduce vascular and tissue pulsation artifacts.
Federal (U.S.A.) law restricts this device to sale by, or on the order of a physician.
Target Population: Adult
David h. Sezmore
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological De 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
Over the Counter Use _________________________________________________________________________________________________________________________________________________________