K242810
- 510(k) number
- K242810
- Device name
- RadUnity (Version 1.0.0)
- Applicant
- Radunity Corp. WI · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2024-11-26
- Date received
- 2024-09-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K242810.pdf
Official FDA record: K242810
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.