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)

AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION

K-Number: K093672 · 2009-12-11

ApplicantSentinelle Medical, Inc.
Decision Date2009-12-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION is the device name listed in this FDA 510(k) record. The listed applicant is Sentinelle Medical, Inc.. It received FDA 510(k) clearance on 2009-12-11 under 510(k) number K093672. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION?

AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION is a medical device that received FDA 510(k) clearance on 2009-12-11. The listed applicant is Sentinelle Medical, Inc.. The 510(k) number is K093672.

When did AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION receive FDA 510(k) clearance?

AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION received FDA 510(k) clearance on 2009-12-11, under 510(k) number K093672.

Who is the listed applicant for AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION?

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

What is the FDA product code for AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION?

The FDA product code for AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION is LLZ.

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 Sentinelle Medical, 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.

K103274SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGINGK100113VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51K070244AEGISK060873VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS

Related Devices (Code: LLZ)

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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑