Cleared Traditional

LEGACY/LEGACY-D TABLE

K973039 · GE Medical Systems · Radiology
Oct 1997
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K973039 is an FDA 510(k) clearance for the LEGACY/LEGACY-D TABLE, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by GE Medical Systems (Milwaukee, US). The FDA issued a Cleared decision on October 16, 1997, 63 days after receiving the submission on August 14, 1997. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K973039 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 1997
Decision Date October 16, 1997
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IXR — Table, Radiographic, Tilting
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1980

Similar Devices — IXR Table, Radiographic, Tilting

All 76
VISION R/F TILTING TABLE
K000412 · Villa Sistemi Medicali S.P.A. · Apr 2000
CAP-35B III/CINE 275
K971128 · Jamieson Film Co. · Apr 1997
PHILIPS EASY DIAGNOST
K970640 · Philips Medical Systems North America, Inc. · Mar 1997
ELECTROPHYSIOLOGY TILT TABLE MODEL #9660
K965105 · U.S. Imaging Tables, Inc. · Jan 1997
FLUOROVIEW SERIES FLUOROSCOPIC TABLES
K965096 · U.S. Imaging Tables, Inc. · Jan 1997
TILTING RADIOGRAPHIC TABLE (REMOTE)
K963851 · Acoma Medical Imaging, Inc. · Jan 1997