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FDA 510(k)

HyperVue™ Imaging System

K-Number: K230691 · 2023-06-07

ApplicantSpectrawave, Inc.
Decision Date2023-06-07
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HyperVue™ Imaging System is a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2023-06-07 under approval number K230691. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HyperVue™ Imaging System?

HyperVue™ Imaging System is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Spectrawave, Inc.. The 510(k) number is K230691.

When was HyperVue™ Imaging System approved by the FDA?

HyperVue™ Imaging System received FDA 510(k) clearance on 2023-06-07, under approval number K230691.

What company makes HyperVue™ Imaging System?

HyperVue™ Imaging System is manufactured by Spectrawave, Inc..

What is the FDA product code for HyperVue™ Imaging System?

The FDA product code for HyperVue™ Imaging System is NQQ.

Related Clinical Trials

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 40775988 B-onic Suite: An Integrated Platform for Personalized Medical Devices, Real-Time Surgical Planning, and Enhanced Intraoperative Navigation. Studies in health technology and informatics (2025) PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

Other Devices by Spectrawave, Inc.

K221257SpectraWAVE Imaging System K253101HyperVue™ Imaging System - Integrated K251355X1-FFR K251198HyperVue™ Software K243016Starlight Imaging Catheter

Related Devices (Code: NQQ)

K162466LuminScan (TM) Imaging SystemMicro-Tech (Nanjing) Co., Ltd. K153283VivoSight Dx Topical OCT SystemMichelson Diagnostics, Ltd. K160878OPTIS Metallic Stent Optimization E.4 SWLightlab Imaging, Inc. K160240Perimeter Otis™ 1.0 Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc. K153479NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation SystemNinepoint Medical, Inc. K171560OTIS Optical Coherence Tomography SystemPerimeter Medical Imaging, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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