AVA (Augmented Vascular Analysis)— 510(k) K201369

Substantially Equivalent

See-Mode Technologies Pte, Ltd.

FDA 510(k) clearance K201369 for AVA (Augmented Vascular Analysis), Substantially Equivalent on 2020-09-16. Applicant: See-Mode Technologies Pte, Ltd..

Clearance details

Applicant: See-Mode Technologies Pte, Ltd.
Product code: Code LLZ
Advisory panel: Radiology
Date received: 2020-05-22
Decision date: 2020-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Singapore, SG

Download summary PDF View on FDA.gov ↗

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.