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

FDA 510(k)

VOLCANO S51 FAMILY OF IMAGING SYSTEMS

K-Number: K061215 · 2006-08-10

ApplicantVolcano Corporation
Decision Date2006-08-10
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VOLCANO S51 FAMILY OF IMAGING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2006-08-10 under 510(k) number K061215. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VOLCANO S51 FAMILY OF IMAGING SYSTEMS?

VOLCANO S51 FAMILY OF IMAGING SYSTEMS is a medical device that received FDA 510(k) clearance on 2006-08-10. The listed applicant is Volcano Corporation. The 510(k) number is K061215.

When did VOLCANO S51 FAMILY OF IMAGING SYSTEMS receive FDA 510(k) clearance?

VOLCANO S51 FAMILY OF IMAGING SYSTEMS received FDA 510(k) clearance on 2006-08-10, under 510(k) number K061215.

Who is the listed applicant for VOLCANO S51 FAMILY OF IMAGING SYSTEMS?

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

What is the FDA product code for VOLCANO S51 FAMILY OF IMAGING SYSTEMS?

The FDA product code for VOLCANO S51 FAMILY OF IMAGING SYSTEMS is IYO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Volcano Corporation 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.

K210235Verrata PLUS Pressure Guide WireK203719IntraSight MobileK202543OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipK192886OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-TipK190626SyncVision SystemK190078IntraSight

View all 42 devices →

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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.

↑