FDA applicant

Medimaging Integrated Solution, Inc (Miis)

Hsinchu, TW7 decisions2017–20250 recalls

FDA records 7 decisions for Medimaging Integrated Solution, Inc (Miis) (Hsinchu, TW) from 2017 to 2025: 7 510(k) clearances. Most are in product codes HJO (Biomicroscope, Slit-Lamp, Ac-Powered) and HKX (Tonometer, Ac-Powered). Since 2016 its 510(k)s took a median of 209 days from receipt to decision, against 193 for FDA’s reviews in the same codes and years. Its devices cite 9 predicates, 1 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, ophthalmic panel, where it files most

How often FDA has decided Medimaging Integrated Solution, Inc (Miis)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Medimaging Integrated Solution, Inc (Miis) by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Medimaging”

FDA records each applicant name separately; these may or may not be the same firm.

Medimaging Integrated Solutions, Inc. (Miis) 1 Medimaging Integrated Solution, Inc. 1

Medimaging Integrated Solution, Inc (Miis)

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Medimaging”