Cleared Traditional

exoplan 2.3

K183458 · Exocad GmbH · Radiology

Aug 2019

Decision

236d

Days

Class 2

Risk

About This 510(k) Submission

K183458 is an FDA 510(k) clearance for the exoplan 2.3, 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 August 6, 2019, 236 days after receiving the submission on December 13, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K183458 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 2018
Decision Date	August 06, 2019
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF