K240290
- 510(k) number
- K240290
- Device name
- AiMIFY (1.x)
- Applicant
- Subtle Medical, Inc. CA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-08-21
- Date received
- 2024-02-01
- 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: K240290.pdf
Official FDA record: K240290
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.