# Microstructure Imaging, Inc (specification developer, Brooklyn, NY): 2 new FDA device listings, incl. system, image processing, radiological

**Score:** 80/100

| Field | Value |
|---|---|
| Establishment | Microstructure Imaging, Inc |
| Owner / operator | Microstructure Imaging, INC |
| Role | Specification developer (outsources manufacturing) |
| Establishment types | Develop Specifications But Do Not Manufacture At This Facility |
| Location | Brooklyn, NY, US |
| New listings | 2 |
| Devices | System, Image Processing, Radiological; System, Tomography, Computed, Emission |
| Product codes | LLZ, KPS |
| Device classes | Class II |
| Medical specialties | Radiology |
| Brand names | MICSI-PET |
| First new listing | 2026-10-06 |
| Latest new listing | 2026-10-06 |
| FDA registration number | 3038191646 |
| Registration expires | 2027-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
- Listed in the last 45 days.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-11-04T21:52:36.524Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.