510(k) Report

FDA applicant

PanopticAI technologies Limited

Hong Kong, HK2 decisions2024–20260 recalls

FDA records 2 decisions for PanopticAI technologies Limited (Hong Kong, HK) from 2024 to 2026: 2 510(k) clearances. All are in product code QME (Software For Optical Camera-Based Measurement…). Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “PanopticAI Technologies Limited”.

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 PanopticAI technologies Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2024: 12026 (partial year): 1
2024high 1 (2024) · low 0 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2024.

FIG. 1 — PanopticAI technologies Limited by year, 2024–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like PanopticAI technologies Limited’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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