K232344
- 510(k) number
- K232344
- Device name
- Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR
- Applicant
- GE Medical Systems SCS FR
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2023-10-11
- Date received
- 2023-08-04
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K232344.pdf
Official FDA record: K232344
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.