Cleared Abbreviated

MYRAY SKYVIEW

K081088 · Cefla S.C. · Radiology
Nov 2008
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K081088 is an FDA 510(k) clearance for the MYRAY SKYVIEW, a System, X-ray, Extraoral Source, Digital (Class II — Special Controls, product code MUH), submitted by Cefla S.C. (Ormond Beach, US). The FDA issued a Cleared decision on November 6, 2008, 204 days after receiving the submission on April 16, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number K081088 FDA.gov
FDA Decision Cleared SESE
Date Received April 16, 2008
Decision Date November 06, 2008
Days to Decision 204 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Statement

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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