K232189
- 510(k) number
- K232189
- Device name
- OrionXR
- Applicant
- Hoth Intelligence, Inc. PA · US
- Product code
- LLZ — System, Image Processing, Radiological
- Decision date
- 2023-09-14
- Date received
- 2023-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232189.pdf
Official FDA record: K232189
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.