Cleared Traditional

K961637 - PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL) (FDA 510(k) Clearance)

K961637 · Philips Medical Systems (Cleveland), Inc. · Radiology device

Jul 1996

Decision

65d

Days

Class 2

Risk

K961637 is an FDA 510(k) clearance for the PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL). This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on July 3, 1996, 65 days after receiving the submission on April 29, 1996.

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

Submission Details

510(k) Number	K961637 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 29, 1996
Decision Date	July 03, 1996
Days to Decision	65 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF