Cleared Traditional

SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD

K141454 · Sony Electronics, Inc. · Radiology
Jun 2014
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K141454 is an FDA 510(k) clearance for the SONY DIGITAL PRINTER UP-D898MD/SONY HYBRID PRINTER UP-X898MD, 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, 24 days after receiving the submission on June 2, 2014. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2040.

Submission Details

510(k) Number K141454 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2014
Decision Date June 26, 2014
Days to Decision 24 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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