K253502
- 510(k) number
- K253502
- Device name
- Critical Care Suite with Enteric Tube Positioning AI Algorithm
- Applicant
- Ge Medical Systems, LLC WI · US
- Product code
- QIH — Automated Radiological Image Processing Software
- Decision date
- 2026-04-14
- Date received
- 2025-10-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 1.0 MB · U.S. public domain
Also available from FDA: K253502.pdf
Official FDA record: K253502
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.