Cleared Traditional

Myray- HYPERION X5

K152162 · Cefla S.C. · Radiology
Dec 2015
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K152162 is an FDA 510(k) clearance for the Myray- HYPERION X5, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Cefla S.C. (Imola (Bo), IT). The FDA issued a Cleared decision on December 24, 2015, 143 days after receiving the submission on August 3, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K152162 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2015
Decision Date December 24, 2015
Days to Decision 143 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code MUH — System, X-ray, Extraoral Source, Digital
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1800

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