C-beam
FDA 510(k) K252735 · Pulmera, Inc.
510(k) numberK252735
Submission
- Device name
- C-beam
- Applicant
- Pulmera, Inc.
Palo Alto, CA, US - Received
- August 28, 2025
- Decision date
- May 22, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code OWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253726 | uAngio AVIVA CXOWB · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 08/21/2026SE |
| K261413 | Extron 3;EXTRON 6OWB · Traditional | DRTECH Corporation | 08/19/2026SE |
| K254205 | Zenition 30OWB · Traditional | Philips Medical Systems Nederland B.V. | 08/07/2026SE |
| K260607 | Shield System (Siemens 30x40)OWB · Special | Radiaction , Ltd. | 07/31/2026SE |
| K253670 | SmartCT (R3.0 (L10))OWB · Abbreviated | Philips Medical Systems B.V. | 07/10/2026SE |
| K252503 | Intelligent NROWB · Traditional | Canon, Inc. | 04/30/2026SE |
| K254173 | ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/24/2026SE |
| K253752 | ARTIS genio floor; ARTIS icono.explore floorOWB · Traditional | Siemens Medical Solutions USA, Inc. | 04/23/2026SE |
| K252229 | Belliger AceOWB · Traditional | Genoray Co., Ltd. | 04/02/2026SE |
| K252099 | TriniasOWB · Abbreviated | Shimadzu Corporation | 03/24/2026SE |
Questions and answers
When was C-beam cleared by the FDA?
C-beam (K252735) received a 510(k) decision of Substantially Equivalent on May 22, 2026, 267 days after the submission was received.
What is the product code of K252735?
The FDA product code is OWB – Interventional Fluoroscopic X-Ray System, a Class II (moderate risk) device regulated under 21 CFR 892.1650.