Cleared Traditional

SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD

K141346 · Sony Electronics, Inc. · Radiology
Jun 2014
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K141346 is an FDA 510(k) clearance for the SONY HYBIRD GRAPHIC UP-971AD, SONY HYBIRD GRAPHIC PRINTER UP-991AD, a Camera, Multi Format, Radiological (Class II — Special Controls, product code LMC), submitted by Sony Electronics, Inc. (Marlborough, US). The FDA issued a Cleared decision on June 26, 2014, 35 days after receiving the submission on May 22, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K141346 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 2014
Decision Date June 26, 2014
Days to Decision 35 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LMC — Camera, Multi Format, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2040

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