Cleared Special

K212837 - ProxiDiagnost N90
(FDA 510(k) Clearance)

K212837 · Philips Medical Systems Dmc GmbH · Radiology

Sep 2021

Decision

14d

Days

Class 2

Risk

K212837 is an FDA 510(k) clearance for the ProxiDiagnost N90, a System, X-ray, Fluoroscopic, Image-intensified (Class II — Special Controls, product code JAA), submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 21, 2021, 14 days after receiving the submission on September 7, 2021. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1650.

Submission Details

510(k) Number	K212837 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 07, 2021
Decision Date	September 21, 2021
Days to Decision	14 days
Submission Type	Special
Review Panel	Radiology (RA)
Summary	Summary PDF