Cleared Traditional

K220758 - e-Ortho Shoulder Software v1.1 (FDA 510(k) Clearance)

K220758 · FH Industrie · Radiology device

Sep 2022

Decision

199d

Days

Class 2

Risk

K220758 is an FDA 510(k) clearance for the e-Ortho Shoulder Software v1.1. This device is classified as 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 FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K220758 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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