Cleared Traditional

K063267 - ISITE PACS, V 4. X (FDA 510(k) Clearance)

K063267 · Stentor Inc., A Philips Medical Systems Co. · Radiology device

Nov 2006

Decision

10d

Days

Class 2

Risk

K063267 is an FDA 510(k) clearance for the ISITE PACS, V 4. X. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Stentor Inc., A Philips Medical Systems Co. (Brisbane, US). The FDA issued a Cleared decision on November 9, 2006, 10 days after receiving the submission on October 30, 2006.

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

Submission Details

510(k) Number	K063267 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 2006
Decision Date	November 09, 2006
Days to Decision	10 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF