Cleared Traditional

TECHFIT Diagnostic Models

K222577 · Techfit Digital Surgery, Inc. · Radiology

Jan 2023

Decision

134d

Days

Class 2

Risk

About This 510(k) Submission

K222577 is an FDA 510(k) clearance for the TECHFIT Diagnostic Models, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Techfit Digital Surgery, Inc. (Daytona Beach, US). The FDA issued a Cleared decision on January 6, 2023, 134 days after receiving the submission on August 25, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K222577 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 25, 2022
Decision Date	January 06, 2023
Days to Decision	134 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF