Cleared Traditional

K993227 - PHILIPS INTURIS DICOM RECORDER
(FDA 510(k) Clearance)

K993227 · Philips Medical Systems North America, Inc. · Radiology device

Dec 1999

Decision

85d

Days

Class 2

Risk

K993227 is an FDA 510(k) clearance for the PHILIPS INTURIS DICOM RECORDER. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on December 21, 1999, 85 days after receiving the submission on September 27, 1999.

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

Submission Details

510(k) Number	K993227 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 27, 1999
Decision Date	December 21, 1999
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF