Cleared Traditional

e-Ortho Shoulder Software v1.1

K220758 · FH Industrie · Radiology
Sep 2022
Decision
199d
Days
Class 2
Risk

About This 510(k) Submission

K220758 is an FDA 510(k) clearance for the e-Ortho Shoulder Software v1.1, 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, 2022, 199 days after receiving the submission on March 15, 2022. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K220758 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2022
Decision Date September 30, 2022
Days to Decision 199 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