Micsi-Rmt

FDA 510(k) K241121 · Microstructure Imaging, Inc.

Substantially Equivalent

510(k) numberK241121

Submission

Device name
Micsi-Rmt
Applicant
Microstructure Imaging, Inc.
Brooklyn, NY, US
Received
April 23, 2024
Decision date
July 17, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was Micsi-Rmt cleared by the FDA?

Micsi-Rmt (K241121) received a 510(k) decision of Substantially Equivalent on July 17, 2024, 85 days after the submission was received.

What is the product code of K241121?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.