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FDA 510(k)

Starlight Imaging Catheter

K-Number: K243016 · 2025-03-20

ApplicantSpectrawave, Inc.
Decision Date2025-03-20
Product CodeNQQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Starlight Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-03-20 under 510(k) number K243016. 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 Starlight Imaging Catheter?

Starlight Imaging Catheter is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Spectrawave, Inc.. The 510(k) number is K243016.

When did Starlight Imaging Catheter receive FDA 510(k) clearance?

Starlight Imaging Catheter received FDA 510(k) clearance on 2025-03-20, under 510(k) number K243016.

Who is the listed applicant for Starlight Imaging Catheter?

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 Starlight Imaging Catheter?

The FDA product code for Starlight Imaging Catheter 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.

K253101HyperVue™ Imaging System - IntegratedK251355X1-FFRK251198HyperVue™ SoftwareK230691HyperVue™ 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.K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.K252851deepLive (OSP12 + DMS)Damae MedicalK251198HyperVue™ SoftwareSpectrawave, Inc.K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant

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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