Cleared Traditional

K922604 - DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE
(FDA 510(k) Clearance)

K922604 · Biodan Medical Systems, Ltd. · Radiology

Oct 1992

Decision

140d

Days

Class 2

Risk

K922604 is an FDA 510(k) clearance for the DELUXE ADJUSTABLE HEIGHT ULTRASOUND TABLE. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II — Special Controls, product code IYO).

Submitted by Biodan Medical Systems, Ltd. (Shirley, US). The FDA issued a Cleared decision on October 20, 1992, 140 days after receiving the submission on June 2, 1992.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.

Submission Details

510(k) Number	K922604 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1992
Decision Date	October 20, 1992
Days to Decision	140 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement