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FDA 510(k)

HyperVue™ Imaging System - Integrated

K-Number: K253101 · 2025-12-15

ApplicantSpectrawave, Inc.
Decision Date2025-12-15
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HyperVue™ Imaging System - Integrated is a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-12-15 under approval number K253101. 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 - Integrated?

HyperVue™ Imaging System - Integrated is a medical device that received FDA 510(k) clearance on 2025-12-15. It is manufactured by Spectrawave, Inc.. The 510(k) number is K253101.

When was HyperVue™ Imaging System - Integrated approved by the FDA?

HyperVue™ Imaging System - Integrated received FDA 510(k) clearance on 2025-12-15, under approval number K253101.

What company makes HyperVue™ Imaging System - Integrated?

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

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

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

Related Clinical Trials

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Related PubMed Literature

PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) 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: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Spectrawave, Inc.

K230691HyperVue™ Imaging System K221257SpectraWAVE Imaging System K251355X1-FFR K251198HyperVue™ Software K243016Starlight Imaging Catheter

Related Devices (Code: NQQ)

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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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