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FDA 510(k)

AVA (Augmented Vascular Analysis)

K-Number: K201369 · 2020-09-16

ApplicantSee-Mode Technologies Pte, Ltd.
Decision Date2020-09-16
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AVA (Augmented Vascular Analysis) is a medical device manufactured by See-Mode Technologies Pte, Ltd.. It received FDA 510(k) clearance on 2020-09-16 under approval number K201369. 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 AVA (Augmented Vascular Analysis)?

AVA (Augmented Vascular Analysis) is a medical device that received FDA 510(k) clearance on 2020-09-16. It is manufactured by See-Mode Technologies Pte, Ltd.. The 510(k) number is K201369.

When was AVA (Augmented Vascular Analysis) approved by the FDA?

AVA (Augmented Vascular Analysis) received FDA 510(k) clearance on 2020-09-16, under approval number K201369.

What company makes AVA (Augmented Vascular Analysis)?

AVA (Augmented Vascular Analysis) is manufactured by See-Mode Technologies Pte, Ltd..

What is the FDA product code for AVA (Augmented Vascular Analysis)?

The FDA product code for AVA (Augmented Vascular Analysis) is LLZ.

Related Clinical Trials

NCT04772911 Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography ACTIVE_NOT_RECRUITING NCT07586683 OCTA Evaluation of Retinal Vascularization in Preterm Infants With or Without Bronchopulmonary Dysplasia NOT_YET_RECRUITING NCT05650411 Ultrathin-strut Biodegradable Polymer Sirolimus-eluting Stents With P2Y12 Inhibitor-based Single Antiplatelet Therapy vs. Conventional DAPT for Unprotected Left Main Coronary Artery Disease (ULTIMATE-LM) RECRUITING NCT07384741 Using Virtual Reality During PICC and PICC-PORT Placement in Cancer Patients ACTIVE_NOT_RECRUITING NCT07539714 Development of an Active Heat Dissipation Device Based on Thermoelectric Cooling Technology: Aiming to Improve Endurance Sports Performance ACTIVE_NOT_RECRUITING NCT03945058 Neuromodulation of Inflammation and Vascular Function in Systolic Heart Failure TERMINATED

Related PubMed Literature

PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025)

Other Devices by See-Mode Technologies Pte, Ltd.

K240697See-Mode Augmented Reporting Tool, Thyroid (SMART-T)

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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.

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