Data / Medical devices / United States / Spectrawave, Inc.

Spectrawave, Inc.: FDA-registered device maker in Bedford, MA, United States, 6 510(k) clearances

Name: Spectrawave, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Spectrawave, Inc. is registered with the FDA (registration 3017654247) in Bedford, MA, United States. It lists 6 device types. The FDA files 6 510(k) clearances under its listings, the newest dated December 15, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3017654247
Address: 12 Oak Park Drive, Bedford, MA, United States, 01730
Owner or operator: Philips Medical Systems International BV (2939520)
Roles: Manufacturer
First device listed: June 16, 2026
Registered through: 2026
Brand names listed: HyperVue Imaging System, HyperVue Software, HyperVue Imaging System - Integrated, Starlight Imaging Catheter, X1-FFR

Devices it lists

Device	Product code	Class	Role	Source
Catheter, Intravascular, Plaque Morphology Evaluation	OGZ	2	Manufacturer	accessdata.fda.gov
Optical Coherence Tomography, Intravascular Catheter	ORD	2	Manufacturer	accessdata.fda.gov
System, Image Processing, Radiological	LLZ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Optical Coherence Tomography (Oct)	NQQ	2	Manufacturer	accessdata.fda.gov
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2	Manufacturer	accessdata.fda.gov
X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device	QHA	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 15, 2025	K253101	HyperVue Imaging System - Integrated	NQQ	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov
October 17, 2025	K251355	X1-FFR	QHA	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov
July 16, 2025	K251198	HyperVue Software	NQQ	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov
March 20, 2025	K243016	Starlight Imaging Catheter	NQQ	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov
June 7, 2023	K230691	HyperVue Imaging System	NQQ	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov
February 28, 2023	K221257	SpectraWAVE Imaging System	NQQ	Substantially Equivalent	Spectrawave, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 15, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.