Cleared Traditional

SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5

K940696 · Philips Medical Systems North America, Inc. · Radiology
Mar 1994
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K940696 is an FDA 510(k) clearance for the SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on March 16, 1994, 28 days after receiving the submission on February 16, 1994. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K940696 FDA.gov
FDA Decision Cleared SESE
Date Received February 16, 1994
Decision Date March 16, 1994
Days to Decision 28 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code KXJ — Table, Radiologic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980