Chrysalis Intelligence · Sponsors · Spectrawave, Inc.

Spectrawave, Inc.

Bedford, MA, US · 6 510(k) clearances

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Total clearances

6

2023-02-28 → 2025-12-15

Last 12 months

2

Product codes

2

Most recent

2025-12-15

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Class II	Radiology	5	2025-12-15
QHA	X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device	Class II	Radiology	1	2025-10-17

Filings

All 510(k) clearances (6)

Date	K-number	Device	Code	Class	Specialty
2025-12-15	K253101	HyperVue Imaging System - Integrated	NQQ	Class II	Radiology
2025-10-17	K251355	X1-FFR	QHA	Class II	Radiology
2025-07-16	K251198	HyperVue Software	NQQ	Class II	Radiology
2025-03-20	K243016	Starlight Imaging Catheter	NQQ	Class II	Radiology
2023-06-07	K230691	HyperVue Imaging System	NQQ	Class II	Radiology
2023-02-28	K221257	SpectraWAVE Imaging System	NQQ	Class II	Radiology