Cleared Traditional

K915237 - PHILIPS PCR-ACE SYSTEM (FDA 510(k) Clearance)

K915237 · Philips Medical Systems, Inc. · Radiology device

Jan 1992

Decision

48d

Days

Class 2

Risk

K915237 is an FDA 510(k) clearance for the PHILIPS PCR-ACE SYSTEM. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on January 9, 1992, 48 days after receiving the submission on November 22, 1991.

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

Submission Details

510(k) Number	K915237 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 22, 1991
Decision Date	January 09, 1992
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement