Fibroid Mapping Reviewer Application (FMRA)

FDA 510(k) K222683 · Nesa Medtech Private Limited

Substantially Equivalent

510(k) numberK222683

Submission

Device name
Fibroid Mapping Reviewer Application (FMRA)
Applicant
Nesa Medtech Private Limited
Bengaluru, IN
Received
September 6, 2022
Decision date
July 17, 2023
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 Fibroid Mapping Reviewer Application (FMRA) cleared by the FDA?

Fibroid Mapping Reviewer Application (FMRA) (K222683) received a 510(k) decision of Substantially Equivalent on July 17, 2023, 314 days after the submission was received.

What is the product code of K222683?

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