K231995
- 510(k) number
- K231995
- Device name
- AcuityUDR
- Applicant
- Radmedix, LLC OH · US
- Product code
- KPR — System, X-Ray, Stationary
- Decision date
- 2023-10-25
- Date received
- 2023-07-05
- Decision
- Substantially Equivalent
- Clearance type
- Abbreviated
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K231995.pdf
Official FDA record: K231995
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.