Cleared Traditional

IMAGING TABLE

K951146 · Septa Corp. · Radiology
May 1995
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K951146 is an FDA 510(k) clearance for the IMAGING TABLE, a Table, Radiologic (Class II — Special Controls, product code KXJ), submitted by Septa Corp. (Mason, US). The FDA issued a Cleared decision on May 4, 1995, 52 days after receiving the submission on March 13, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.

Submission Details

510(k) Number K951146 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 1995
Decision Date May 04, 1995
Days to Decision 52 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