# Spectrawave, Inc.

- Location (FDA's records): Bedford, MA
- FDA decisions: 6 (2023–2025): 6 510(k) clearances
- Product codes: NQQ (5), QHA (1)
- 510(k) review time since 2016: median 90 days, against 146 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 7 (4 its own); citations of its devices by later devices: 4 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Pie Medical Imaging BV: 1 (https://510kreport.com/company/pie-medical-imaging)
- Abbott Medical: 1 (https://510kreport.com/company/abbott-medical)
- Infraredx, Inc.: 1 (https://510kreport.com/company/infraredx)

## Its most-cited devices
- K221257: SpectraWAVE Imaging System (2023), cited by 3
- K230691: HyperVue™ Imaging System (2023), cited by 1

## Recent decisions
- K253101: HyperVue™ Imaging System - Integrated (Dec 15, 2025)
- K251355: X1-FFR (Oct 17, 2025)
- K251198: HyperVue™ Software (Jul 16, 2025)
- K243016: Starlight Imaging Catheter (Mar 20, 2025)
- K230691: HyperVue™ Imaging System (Jun 7, 2023)
- K221257: SpectraWAVE Imaging System (Feb 28, 2023)

Source page: https://510kreport.com/company/spectrawave