K242647
- 510(k) number
- K242647
- Device name
- MySegmenter (v2.0.0)
- Applicant
- Mysegmenter Technologies, Inc. DE · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2025-04-16
- Date received
- 2024-09-03
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K242647.pdf
Official FDA record: K242647
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.