Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017654247

FEI Number

3017654247

Entity Name

SPECTRAWAVE, INC.

City/State/Country

Bedford, MA, US

Establishment Address

12 Oak Park Drive, Bedford, MA 01730, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Philips Medical Systems International BV (Owner Number: 2939520)

Owner / Operator Contact Address

Veenpluis 6, Best, NL-NOTA 5684PC, NL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251355

PMA Number

N/A

All Registered Proprietary Names

HyperVue Imaging System HyperVue Imaging System - Integrated HyperVue Imaging System HyperVue Software X1-FFR

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-16
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	Class 2	870.1200	2026-06-16
ORD	Optical Coherence Tomography, Intravascular Catheter	Cardiovascular	Class 2	870.1200	2026-06-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2026-06-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2026-06-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2026-06-16
ORD	Optical Coherence Tomography, Intravascular Catheter	Cardiovascular	Class 2	870.1200	2026-06-16
OGZ	Catheter, Intravascular, Plaque Morphology Evaluation	Cardiovascular	Class 2	870.1200	2026-06-16
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	Class 2	892.1560	2026-06-16
NQQ	System, Imaging, Optical Coherence Tomography (Oct)	Radiology	Class 2	892.1560	2026-06-16
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2026-06-16
QHA	X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device	Radiology	Class 2	892.1600	2026-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Philips Medical Systems International BV

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3003584029	Braemar Manufacturing, LLC	San Diego, CA, US
3042175841	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.	Best Noord-Brabant, NL
3008514395	Telcare, LLC	Linwood, PA, US
3004961434	RESPIRATORY TECHNOLOGIES, INC.	Plymouth, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K882805	Coopervision-Cilco	CILCO VILLASENOR PACHYMETER	1988-08-12
K791040	Shimadzu Corp.	SECTOR SCANNER, SDU-100, COMPUTERIZED	1979-10-04
K162372	Qt Ultrasound, LLC	QT Ultrasound Breast Scanner-1	2017-06-06
K930964	Acuson Corp.	ACUSON MODEL #29001 (DIAGNOSTIC ULTRASOUND DEVICE)	1994-10-26
K052355	U-Systems, Inc.	AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS	2005-09-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2011	Verathon, Inc.	2	BVI 9600 Bladder Volume Instrument, Aorta Scan Mode The BladderScan BVI 9600 with AortaScan Mode is a user-selectable, dual-function ultrasound device that projects ultrasound energy either into the lower abdomen to obtain an image of the bladder for measuring bladder volume, or into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements.
Z-0004-2011	Verathon, Inc.	2	AortaScan AMI 9700 The AortaScan AMI 9700 is an ultrasound device that projects ultrasound energy into the mid-abdomen to obtain an image of the abdominal aorta for aortic diameter measurements
Z-0005-2011	Verathon, Inc.	2	BladderScan BVM 9500 The BladderScan BVM 9500 is intended to project ultrasound energy through the lower abdomen to obtain an image of the bladder and measure urinary bladder volume and mass noninvasively.
Z-0027-2014	SonoSite, Inc.	2	P21x/5-1 MHz transducer, Part Number P07698-23 Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with SonoMB Multi Beam Technology and Auto Gain capabilities, SonoHD Imaging Technology, Tissue Harmonic Imaging, M-Mode, Velocity Color Flow Doppler, Color Power Doppler (CDP), Pulsed Wave (PW), TDI Pulsed Wave, and Continuous Wave Doppler.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system

Similar Registrations

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3012081348	THE SENTINEL IMAGING GROUP, INC	Clarks Summit, PA, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017654247. Last updated year: 2026. Please use registration number 3017654247 when referencing this establishment in official correspondence.