K242054
- 510(k) number
- K242054
- Device name
- OptimMRI (v2)
- Applicant
- Rebrain, Sas FR
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-08-12
- Date received
- 2024-07-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.3 MB · U.S. public domain
Also available from FDA: K242054.pdf
Official FDA record: K242054
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.