Cleared Traditional

UNiD Spine Analyzer

K170172 · Medicrea International · Radiology
May 2017
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K170172 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 May 24, 2017, 125 days after receiving the submission on January 19, 2017. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number K170172 FDA.gov
FDA Decision Cleared SESE
Date Received January 19, 2017
Decision Date May 24, 2017
Days to Decision 125 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