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Microstructure Imaging, Inc.

United StatesFDA applicant, unverified

Microstructure Imaging, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 15 Nov 2026.

Devices
4

Registry facts

Counted by deviCERTS from registry records, 15 Nov 2026

Registries
  • FDA 510(k) 2
  • FDA GUDID 2

A device listed in two registries counts in both.

Device classes
  • FDA Class II 4
Identifiers
  • DUNS 081151542

What Microstructure Imaging, Inc. makes

Microstructure Imaging, Inc. develops radiology DICOM image processing application software designed for medical imaging analysis, specifically the MICSI-RMT system.

The company’s portfolio is regulated under FDA Class II devices and is listed in the FDA’s 510(k) and UDI registries.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue4

Newest first, rows 1-4 of 4

  • Micsi-Pet 1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Micsi-Pet Ref K261305

    Active Regimes: 510(k) Registry: 510(k) Class:II
  • Micsi-Rmt 1

    Active Regimes: 510(k) Registry: GUDID Class:II
  • Micsi-Rmt Ref K241121

    Active Regimes: 510(k) Registry: 510(k) Class:II

Company details

DUNS number
081151542
Phone
7188012324

Frequently asked questions

How many devices does Microstructure Imaging, Inc. have in the registry?

The registry currently lists 4 devices for Microstructure Imaging, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Microstructure Imaging, Inc.'s devices?

Among its 4 most recently registered devices, Microstructure Imaging, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Microstructure Imaging, Inc.'s devices fall under?

Among its 4 most recently registered devices, the classes recorded for Microstructure Imaging, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Microstructure Imaging, Inc. in the registry?

The most recently registered devices listed for Microstructure Imaging, Inc. include MICSI-PET 1, MICSI-PET, MICSI-RMT 1 and MICSI-RMT.

Generated automatically from registry data and not verified by a human reviewer.