Cleared Traditional

K904587 - DENSICOMP 250
(FDA 510(k) Clearance)

K904587 · L. Keroack Co. · Radiology
Jan 1991
Decision
107d
Days
Class 2
Risk

K904587 is an FDA 510(k) clearance for the DENSICOMP 250, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by L. Keroack Co. (Canada H3x 3p3, CA). The FDA issued a Cleared decision on January 24, 1991, 107 days after receiving the submission on October 9, 1990. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number K904587 FDA.gov
FDA Decision Cleared SESE
Date Received October 09, 1990
Decision Date January 24, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary —

Device Classification

Product Code KPW — Device, Beam Limiting, X-ray, Diagnostic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1610