K252735
- 510(k) number
- K252735
- Device name
- C-beam
- Applicant
- Pulmera, Inc. CA · US
- Product code
- OWB — Interventional Fluoroscopic X-Ray System
- Decision date
- 2026-05-22
- Date received
- 2025-08-28
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K252735.pdf
Official FDA record: K252735
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.