Cleared Special

UNiD Spine Analyzer

K180091 · Medicrea International · Radiology
Feb 2018
Decision
27d
Days
Class 2
Risk

About This 510(k) Submission

K180091 is an FDA 510(k) clearance for the UNiD Spine Analyzer, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Medicrea International (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on February 8, 2018, 27 days after receiving the submission on January 12, 2018. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K180091 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 2018
Decision Date February 08, 2018
Days to Decision 27 days
Submission Type Special
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