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)

VASOVIEW DUPLEX IMAGING SYSTEM

K-Number: K861237 · 1986-07-14

ApplicantSonicaid, Inc.
Decision Date1986-07-14
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent for Some Indications

Device Summary

VASOVIEW DUPLEX IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Sonicaid, Inc.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K861237. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the VASOVIEW DUPLEX IMAGING SYSTEM?

VASOVIEW DUPLEX IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is Sonicaid, Inc.. The 510(k) number is K861237.

When did VASOVIEW DUPLEX IMAGING SYSTEM receive FDA 510(k) clearance?

VASOVIEW DUPLEX IMAGING SYSTEM received FDA 510(k) clearance on 1986-07-14, under 510(k) number K861237.

Who is the listed applicant for VASOVIEW DUPLEX IMAGING SYSTEM?

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

What is the FDA product code for VASOVIEW DUPLEX IMAGING SYSTEM?

The FDA product code for VASOVIEW DUPLEX IMAGING SYSTEM is ITX.

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 Sonicaid, 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.

K873673BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONALK8720745 MHZ TRANSDUCERK863803VASOPULSE(TM)/MODEL 5000K862720VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBESK851102VASOSCREEN IMPEDANCE PLETHYSMOGRAPHK833902VASOSCAN

View all 18 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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.

↑