K231955
- 510(k) number
- K231955
- Device name
- aprevo® Digital Segmentation
- Applicant
- Carlsmed, Inc. CA · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2023-11-03
- Date received
- 2023-07-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K231955.pdf
Official FDA record: K231955
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.