510(k) Report

FDA applicant

InVision Medical Technology Corporation

Los Angeles, CA2 decisions2024–20250 recalls

FDA records 2 decisions for InVision Medical Technology Corporation (Los Angeles, CA) from 2024 to 2025: 2 510(k) clearances. Most are in product codes SDJ (Adjunctive Cardiac Amyloidosis Status Indicator) and QIH (Automated Radiological Image Processing Software). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided InVision Medical Technology Corporation’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2024: 12025: 1
2024high 1 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — InVision Medical Technology Corporation by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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