K241108
- 510(k) number
- K241108
- Device name
- RemedyLogic AI MRI Lumbar Spine Reader
- Applicant
- Remedy Logic, Inc. NY · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-10-30
- Date received
- 2024-04-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K241108.pdf
Official FDA record: K241108
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.