Cleared Traditional

RADIOGRAPHIC ITT TABLE

K963905 · X-Ray Technologies, Inc. · Radiology
Nov 1996
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K963905 is an FDA 510(k) clearance for the RADIOGRAPHIC ITT TABLE, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by X-Ray Technologies, Inc. (Skokie, US). The FDA issued a Cleared decision on November 12, 1996, 43 days after receiving the submission on September 30, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K963905 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 1996
Decision Date November 12, 1996
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

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