Cleared Traditional

K964124 - PHILIPS COMPUTED RADIOGRAPHY (FDA 510(k) Clearance)

K964124 · Philips Medical Systems, Inc. · Radiology device

Dec 1996

Decision

64d

Days

Class 2

Risk

K964124 is an FDA 510(k) clearance for the PHILIPS COMPUTED RADIOGRAPHY. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on December 18, 1996, 64 days after receiving the submission on October 15, 1996.

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

Submission Details

510(k) Number	K964124 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 15, 1996
Decision Date	December 18, 1996
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF