K240786
- 510(k) number
- K240786
- Device name
- AutoChamber
- Applicant
- HeartLung Corporation TX · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2024-10-10
- Date received
- 2024-03-22
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K240786.pdf
Official FDA record: K240786
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.