K241847
- 510(k) number
- K241847
- Device name
- Imbio PHA (4.0.0)
- Applicant
- Imbio, Inc. MN · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-08-30
- Date received
- 2024-06-26
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241847.pdf
Official FDA record: K241847
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.