Cleared Traditional

K013955 - VERAVIEWEPOCS, MODEL VE (FDA 510(k) Clearance)

K013955 · J. Morita USA, Inc. · Radiology device

Feb 2002

Decision

66d

Days

Class 2

Risk

K013955 is an FDA 510(k) clearance for the VERAVIEWEPOCS, MODEL VE. This device is classified as a Unit, X-ray, Extraoral With Timer (Class II - Special Controls, product code EHD).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on February 4, 2002, 66 days after receiving the submission on November 30, 2001.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K013955 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 30, 2001
Decision Date	February 04, 2002
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF