Cleared Traditional

e-Ortho Shoulder Software

K201928 · FH Industrie · Radiology
Sep 2020
Decision
82d
Days
Class 2
Risk

About This 510(k) Submission

K201928 is an FDA 510(k) clearance for the e-Ortho Shoulder Software, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by FH Industrie (Quimper Finistere, FR). The FDA issued a Cleared decision on September 30, 2020, 82 days after receiving the submission on July 10, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K201928 FDA.gov
FDA Decision Cleared SESE
Date Received July 10, 2020
Decision Date September 30, 2020
Days to Decision 82 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050