K233699
- 510(k) number
- K233699
- Device name
- SubtleREFORMAT (1.x)
- Applicant
- Subtle Medical, Inc. CA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-04-29
- Date received
- 2023-11-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.0 MB · U.S. public domain
Also available from FDA: K233699.pdf
Official FDA record: K233699
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.