Cleared Traditional

K111336 - EBW NM 2.0
(FDA 510(k) Clearance)

K111336 · Philips Medical Systems (Cleveland), Inc. · Radiology device

May 2011

Decision

12d

Days

Class 2

Risk

K111336 is an FDA 510(k) clearance for the EBW NM 2.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems (Cleveland), Inc. (San Jose, US). The FDA issued a Cleared decision on May 24, 2011, 12 days after receiving the submission on May 12, 2011.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K111336 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 12, 2011
Decision Date	May 24, 2011
Days to Decision	12 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF