Cleared Traditional

exoplan

K213302 · Exocad GmbH · Radiology
May 2022
Decision
211d
Days
Class 2
Risk

About This 510(k) Submission

K213302 is an FDA 510(k) clearance for the exoplan, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Exocad GmbH (Darmstadt, DE). The FDA issued a Cleared decision on May 3, 2022, 211 days after receiving the submission on October 4, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K213302 FDA.gov
FDA Decision Cleared SESE
Date Received October 04, 2021
Decision Date May 03, 2022
Days to Decision 211 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