Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Spectrawave, Inc.. It received FDA 510(k) clearance on 2025-03-20 under approval 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. It is manufactured by Spectrawave, Inc.. The 510(k) number is K243016.

When was Starlight Imaging Catheter approved by the FDA?

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

What company makes Starlight Imaging Catheter?

Starlight Imaging Catheter is manufactured by Spectrawave, Inc..

What is the FDA product code for Starlight Imaging Catheter?

The FDA product code for Starlight Imaging Catheter is NQQ.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT05225935 Computed Tomography-Guided Catheter Ablation for Ventricular Tachycardia COMPLETED NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT07595666 Comparison of NeuroEXPLORER PET/CT Versus Standard-of-care PET/CT of the Head and Neck Region. ENROLLING_BY_INVITATION NCT06795763 Acolyte CTO-PCI Study: Imaging and Catheter System to Treat Patients With Coronary Chronic Total Occlusion, Who Have Persistent Symptoms Following Medical Therapy and Are Undergoing Percutaneous Coronary Interventional Procedures ENROLLING_BY_INVITATION NCT02761889 Hypofractionated Image-Guided Radiotherapy (IGRT) With Organ Motion Mitigation and Urethral Sparing for Prostate Cancer COMPLETED

Other Devices by Spectrawave, Inc.

K230691HyperVue™ Imaging System K221257SpectraWAVE Imaging System K253101HyperVue™ Imaging System - Integrated K251355X1-FFR K251198HyperVue™ Software

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.

↑