# K252735: C-beam

- Pathway: 510(k) (Traditional)
- Applicant: Pulmera, Inc.
- Decided: May 22, 2026 after 267 days
- Product code: OWB (Interventional Fluoroscopic X-Ray System)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K003266 (2000). 17 ancestors in all.
No later device cites it as a predicate yet.
3 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243303: Ziehm Vision RFD 3D, Ziehm Imaging GmbH (2025) Summary page 5.

## Indications for use
The C-Beam device is intended to provide 3D medical imaging of patients during orthopedic, neurological, intra-operative surgical procedures and where the clinician benefits from 3D visualization of complex anatomical structures, such as but not limited to those of high contrast objects, bones, joints, maxillofacial, cervical, thoracic, and lumbar regions of the spine, pelvis, acetabulum and joint fractures of the upper and lower extremities, and where digital image and C-arm positioning data is required for Computer-Assisted Surgery procedures. The visualization of such anatomical structures assists the clinician in the clinical outcome.

Source page: https://510kreport.com/device/K252735
Methodology: https://510kreport.com/methodology