Data / Medical devices / United States / Microstructure Imaging, Inc
Microstructure Imaging, Inc: FDA-registered device maker in Brooklyn, NY, United States, 2 510(k) clearances
Microstructure Imaging, Inc is registered with the FDA (registration 3038191646) in Brooklyn, NY, United States. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 11, 2026. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3038191646
- Address
- 370 Jay St, Brooklyn, NY, United States, 11201
- Owner or operator
- Microstructure Imaging, INC (10093290)
- Roles
- Specification developer
- First device listed
- April 24, 2025
- Registered through
- 2027
- Brand names listed
- MICSI-PET, MICSI-RMT
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Specification developer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 11, 2026 | K261305 | MICSI-PET | KPS | Substantially Equivalent | Microstructure Imaging, Inc. | accessdata.fda.gov |
| July 17, 2024 | K241121 | MICSI-RMT | LLZ | Substantially Equivalent | Microstructure Imaging, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of System, Tomography, Computed, Emission
Updated September 11, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.