Cleared Traditional

CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT

K926082 · Biodan Medical Systems, Ltd. · Radiology
Dec 1992
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K926082 is an FDA 510(k) clearance for the CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT, a System, X-ray, Angiographic (Class II — Special Controls, product code IZI), submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on December 30, 1992, 29 days after receiving the submission on December 1, 1992. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1600.

Submission Details

510(k) Number K926082 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 1992
Decision Date December 30, 1992
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code IZI — System, X-ray, Angiographic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1600

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