Cleared Traditional

K924593 - DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4
(FDA 510(k) Clearance)

K924593 · Philips Medical Systems, Inc. · Radiology

Nov 1992

Decision

75d

Days

Class 2

Risk

K924593 is an FDA 510(k) clearance for the DIAGNOST 76 FAMILY*R/F SYSTEMS - RELEASE 4.4. This device is classified as a Device, Spot-film (Class II — Special Controls, product code IXL).

Submitted by Philips Medical Systems, Inc. (5680 Da Best, NL). The FDA issued a Cleared decision on November 24, 1992, 75 days after receiving the submission on September 10, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1670.

Submission Details

510(k) Number	K924593 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 10, 1992
Decision Date	November 24, 1992
Days to Decision	75 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF