510(k) Report

FDA applicant

Medimaging Integrated Solutions, Inc. (Miis)

Hsinchu, CN1 decision2012–20120 recalls

FDA records 1 decision for Medimaging Integrated Solutions, Inc. (Miis) (Hsinchu, CN) in 2012: 1 510(k) clearance. All are in product code HKI (Camera, Ophthalmic, Ac-Powered). Its devices cite 1 predicate, 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, ophthalmic panel, where it files most

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

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Medimaging Integrated Solutions, Inc. (Miis) by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • HKICamera, Ophthalmic, Ac-Powered1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 3 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K120982Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 20123cite it

What has FDA decided for it lately?

  • K120982Digital Eye-Fundus CameraMedimaging Integrated Solutions, Inc. (Miis) · 2012

The one decision as Medimaging Integrated Solutions, Inc. (Miis) →

Other applicant names beginning “Medimaging”

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

Medimaging Integrated Solution, Inc (Miis) 7Medimaging Integrated Solution, Inc. 1