Cleared Traditional

K053220 - VERAVIEW IC 5, MODEL XDP1 (FDA 510(k) Clearance)

K053220 · J. Morita USA, Inc. · Radiology device

Jan 2006

Decision

50d

Days

Class 2

Risk

K053220 is an FDA 510(k) clearance for the VERAVIEW IC 5, MODEL XDP1. This device is classified as a System, X-ray, Extraoral Source, Digital (Class II - Special Controls, product code MUH).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on January 6, 2006, 50 days after receiving the submission on November 17, 2005.

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

Submission Details

510(k) Number	K053220 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 17, 2005
Decision Date	January 06, 2006
Days to Decision	50 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF