News | Magnetic Resonance Imaging (MRI) | December 09, 2019

Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway

Guidance for Industry and Food and Drug Administration staff

Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway

December 9, 2019 — The U.S. Food and Drug Administration (FDA) has issued a guidance for industry and FDA administration staff for Magnetic Resonance (MR) Coil —Performance Criteria for Safety and Performance Based Pathway. The draft is being distributed for comment purposes only.

This draft guidance provides performance criteria for magnetic resonance (MR) coils in support of the Safety and Performance Based Pathway.  Under this framework, submitters planning to submit a 510(k) using the Safety and Performance Based Pathway for MR coils will have the option to use the performance criteria proposed in this draft guidance to support substantial equivalence, rather than a direct comparison of the performance of the subject device to that of a predicate device.

For the current edition of the FDA-recognized standard(s) referenced in this document, see the FDA Recognized Consensus Standards Database.  For more information regarding use of consensus standards in regulatory submissions, please refer to the FDA guidance titled Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices.  

Docket Number:

FDA-2019-D-1650

Issued by:

Center for Devices and Radiological Health

 

You can download the PDF here.

 

Related content:

Magnetic Resonance Coil-Performance Criteria for Safety and Performance Based Pathway; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

Framework for the Safety and Performance Based Pathway

Related Content

According to the CDC, if you are fully vaccinated you can start doing many things that you had stopped doing because of the pandemic. Infographic courtesy of the CDC.

According to the CDC, if you are fully vaccinated you can start doing many things that you had stopped doing because of the pandemic. Infographic courtesy of the CDC.

News | Coronavirus (COVID-19) | May 13, 2021
May 13, 2021 — The Centers for Disease Control and Prevention (CDC) just
National Imaging Solutions, a recognized leader in medical imaging and radiology solutions, announced it has acquired DynaRad — the oldest manufacturer of portable X-ray systems in the US. This new investment will allow National Imaging Solutions to support its customers by supplying them with DynaRad portable X-ray machines, including a mobile field X-ray device using nanotube technology.
News | Radiology Business | May 11, 2021
May 11, 2021 — ...
New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

New Module Creates a Warped MRI Scan that Matches Real-Time Ultrasound Results (Graphic: Business Wire)

News | Artificial Intelligence | May 07, 2021
3D aMRI not only provides a stunning look inside the "beating brain", but it can also measure this physiological motion in all directions. Here, the amplitude of brain motion is overlayed for each brain slice and orientation in 3D. Image credit: 3D aMRI method outlined in Abderezaei et al. Brain Multiphysics (2021); Terem et al. Magnetic Resonance in Medicine (2021).

3D aMRI not only provides a stunning look inside the "beating brain", but it can also measure this physiological motion in all directions. Here, the amplitude of brain motion is overlayed for each brain slice and orientation in 3D. Image credit: 3D aMRI method outlined in Abderezaei et al. Brain Multiphysics (2021); Terem et al. Magnetic Resonance in Medicine (2021).

News | Magnetic Resonance Imaging (MRI) | May 06, 2021
May 6, 2021 — Magnetic Resonance Imaging
After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by

After radiosurgery concurrent with nivolumab in 59-year-old patient with melanoma BM (patient 1; Supplemental Tables 3 and 5), F-18 FET PET at follow-up 12 weeks after treatment initiation (bottom row) shows significant decrease of metabolic activity (TBRmean, ?28%) compared with baseline (top row), although MRI changes were consistent with progression according to iRANO criteria. Reduction of metabolic activity was associated with stable clinical course over 10 mo. CE = contrast-enhanced. Image created by N. Galldiks et al., Research Center Juelich, Juelich, Germany.

News | PET Imaging | May 05, 2021
May 5, 2021 — For patients with brain metastases, amino acid ...
News | Artificial Intelligence | April 30, 2021
April 30, 2021 — Canon Medical is bringing the power of accessible...
The Women’s Heart Attack Research Program (HARP) study shows combining OCT and cardiac MRI can help detect the underlying cause of heart attacks in women who did not have blocked arteries.

The Women’s Heart Attack Research Program (HARP) study shows combining OCT and cardiac MRI can help detect the underlying cause of heart attacks in women who did not have blocked arteries.

News | Cardiac Imaging | April 30, 2021
April 30, 2021 — In almost 10 percent of...
Using ultra-high field magnetic resonance imaging (MRI) to map the brains of people with #Down_syndrome (#DS), #researchers from #CaseWesternReserveUniversity, #ClevelandClinic, University Hospitals and other institutions detected subtle differences in the structure and function of the #hippocampus—a region of the #brain tied to memory and learning.

Using ultra-high field magnetic resonance imaging (MRI) to map the brains of people with Down syndrome (DS), researchers from Case Western Reserve University, Cleveland Clinic, University Hospitals and other institutions detected subtle differences in the structure and function of the hippocampus—a region of the brain tied to memory and learning.

News | Magnetic Resonance Imaging (MRI) | April 29, 2021
April 29, 2021 — Using...