Cleared Traditional

IPS CaseDesigner

K200810 · Nobel Biocare AB · Radiology
Oct 2020
Decision
195d
Days
Class 2
Risk

About This 510(k) Submission

K200810 is an FDA 510(k) clearance for the IPS CaseDesigner, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Nobel Biocare AB (Goteborg, SE). The FDA issued a Cleared decision on October 8, 2020, 195 days after receiving the submission on March 27, 2020. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K200810 FDA.gov
FDA Decision Cleared SESE
Date Received March 27, 2020
Decision Date October 08, 2020
Days to Decision 195 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