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AVA (Augmented Vascular Analysis)

K201369 Class II Traditional
Decision Date
2020-09-16
Sponsor / Applicant
See-Mode Technologies Pte, Ltd.

Technical Specification

510(k) Submission ID K201369
Product Code LLZ
Medical Specialty / Panel Radiology
Regulation Citation 21 CFR 892.2050
Decision Date 2020-09-16
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

AVA (Augmented Vascular Analysis) received FDA 510(k) clearance under submission number K201369, sponsored by See-Mode Technologies Pte, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-09-16.

Classification & Regulation

This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.