Spectrawave, Inc.
Medical device manufacturer in Bedford, MA.
6510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | 12/15/2025SE |
| K251355 | X1-FFRQHA · Traditional | 10/17/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | 07/16/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | 03/20/2025SE |
| K230691 | HyperVue Imaging SystemNQQ · Traditional | 06/07/2023SE |
| K221257 | SpectraWAVE Imaging SystemNQQ · Traditional | 02/28/2023SE |