Cleared Traditional

K212040 - RI.HIP MODELER (FDA 510(k) Clearance)

K212040 · Blue Belt Technologies, Inc. · Radiology device

Mar 2022

Decision

254d

Days

Class 2

Risk

K212040 is an FDA 510(k) clearance for the RI.HIP MODELER. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Blue Belt Technologies, Inc. (Plymouth, US). The FDA issued a Cleared decision on March 11, 2022, 254 days after receiving the submission on June 30, 2021.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K212040 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 30, 2021
Decision Date	March 11, 2022
Days to Decision	254 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF