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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 the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-12-15 under 510(k) 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. The listed applicant is Spectrawave, Inc.. The 510(k) number is K253101.

When did HyperVue™ Imaging System - Integrated receive FDA 510(k) clearance?

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

Who is the listed applicant for HyperVue™ Imaging System - Integrated?

The FDA 510(k) record lists Spectrawave, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Spectrawave, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251355X1-FFRK251198HyperVue™ SoftwareK243016Starlight Imaging CatheterK230691HyperVue™ Imaging SystemK221257SpectraWAVE Imaging System

Related Devices (Code: NQQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICALK251730LIA Console (542-7)Leadoptik, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi PlantK242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc.

Official Source

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

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