Critical Care Suite with Enteric Tube Positioning AI Algorithm— 510(k) K253502
Substantially EquivalentGe Medical Systems, LLC
FDA 510(k) clearance K253502 for Critical Care Suite with Enteric Tube Positioning AI Algorithm, Substantially Equivalent on 2026-04-14. Applicant: Ge Medical Systems, LLC. Device class: 2.
Summary
GE Medical Systems' Critical Care Suite with Enteric Tube Positioning AI Algorithm is filed under product code QIH (Automated Radiological Image Processing Software). The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
GE Medical Systems filed from Waukesha, Wisconsin. The decision came 166 calendar days after FDA received it (October 30, 2025 to April 14, 2026).
Clearance details
- Applicant
- Ge Medical Systems, LLC
- Product code
- Product code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Waukesha, WI, US
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