Cleared Traditional

MAMMI

K140996 · General Equipment For Medical Imaging (Oncovision- · Radiology
Jun 2014
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K140996 is an FDA 510(k) clearance for the MAMMI, a System, Tomography, Computed, Emission (Class II — Special Controls, product code KPS), submitted by General Equipment For Medical Imaging (Oncovision- (Valencia, ES). The FDA issued a Cleared decision on June 11, 2014, 55 days after receiving the submission on April 17, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1200.

Submission Details

510(k) Number K140996 FDA.gov
FDA Decision Cleared SESE
Date Received April 17, 2014
Decision Date June 11, 2014
Days to Decision 55 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code KPS — System, Tomography, Computed, Emission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1200

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