Cleared Traditional

K904587 - DENSICOMP 250

K904587 is an FDA 510(k) clearance for DENSICOMP 250, manufactured by L. Keroack Co.. The device is a Class 2 Radiology device with product code KPW cleared through the Traditional 510(k) pathway after a 107-day FDA review.

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

K904587 is an FDA 510(k) clearance for the DENSICOMP 250. Classified as Device, Beam Limiting, X-ray, Diagnostic (product code KPW), Class II - Special Controls.

Submitted by L. Keroack Co. (Canada H3x 3p3, CA). The FDA issued a Cleared decision on January 24, 1991 after a review of 107 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1610 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all L. Keroack Co. devices

FDA 510(k) Submission Details - K904587

510(k) Number K904587 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 09, 1990
Decision Date January 24, 1991
Days to Decision 107 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 107d · This submission: 107d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPW Device Classification - Class 2, Special Controls

Product Code KPW Device, Beam Limiting, X-ray, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1610
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - KPW Device, Beam Limiting, X-ray, Diagnostic

All 7
Devices cleared under the same product code (KPW) and FDA review panel - the closest regulatory comparables to K904587.
LUMOS, MODEL R 72B
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TF-63SA
K904044 · Toshiba America Medical Systems, In.C · Nov 1990
RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC
K820306 · Tecnomed, Inc. · Mar 1982
RALCO COLLIMATORS, MANUAL RADIOGRAPHIC
K820305 · Tecnomed, Inc. · Mar 1982