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)

VISTA AVS

K-Number: K063600 · 2006-12-19

ApplicantSummit Doppler Systems, Inc.
Decision Date2006-12-19
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

VISTA AVS is the device name listed in this FDA 510(k) record. The listed applicant is Summit Doppler Systems, Inc.. It received FDA 510(k) clearance on 2006-12-19 under 510(k) number K063600. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VISTA AVS?

VISTA AVS is a medical device that received FDA 510(k) clearance on 2006-12-19. The listed applicant is Summit Doppler Systems, Inc.. The 510(k) number is K063600.

When did VISTA AVS receive FDA 510(k) clearance?

VISTA AVS received FDA 510(k) clearance on 2006-12-19, under 510(k) number K063600.

Who is the listed applicant for VISTA AVS?

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

What is the FDA product code for VISTA AVS?

The FDA product code for VISTA AVS is JAF.

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 Summit Doppler Systems, 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.

K103693VANTAGE ABIK101816STN PROBEK093393LIFEDOP MODEL 300ABIK090499LIFEDOP MODEL, L350RK060410ECHOHEART TRANSVAGINAL DOPPLER PROBEK024197LIFEDOP DOPPLER

View all 7 devices →

Related Devices (Code: JAF)

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.

K242487Laminar P1 (LDH-HW-001)Laminar Digital Health, Inc.K110628SIMPLEABINewman MedicalK093393LIFEDOP MODEL 300ABISummit Doppler Systems, Inc.K090009THD SLIDE ONEThd SpaK081429THD SLIDEThd SpaK070815THDG.F. S.R.L.

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.

↑