NEMA MRI 510(k) templates
In 1995, the NEMA MR Section Regulatory and Legislative Subcommittee developed two templates to standardize the format and content of common MRI 510(k) premarket notification submissions:
- Standardized 510(k) pre-market notification submission template for RF coil accessories intended for use with magnetic
resonance diagnostic imaging devices >>>
- Standardized 510(k) pre-market notification submission template for software intended for use with magnetic resonance
diagnostic imaging devices >>>
While nearly 10 years old, these documents remain relevant and are in active use today. Unfortunately, they are not available either through the NEMA or FDA websites. They are, however, available free via download.
MRI case study
COASTAL recently participated in end-stage product development for an MRI-compatible accessory, and performing comprehensive product management activities...
- MRI safety testing at 1.5T and 3.0T
- MRI compatibility testing at 3.0T
- Develop on-device labeling
- Risk assessment compliant with ISO 14971
- Develop prodcut specifications
- Develop materials analysis report
- Revisions to product brochures
- RSNA'03 Hot Topics presentation
- Pre-clinical testing presentation to Harvard Medical School Clinical Advisory Board
- Develop white paper describing testing and results in support of marketing and sales activities
- Develop manuscript detailing testing and results submitted to peer-reviewed journals for publication
- Develop and submit 510(k) premarket notification to FDA
