Cleared Traditional

K896588 - ONCOPROBE II SYSTEM (FDA 510(k) Clearance)

Class I Radiology device.

K896588 · Care Wise Medical Products Corp. · Radiology device
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Mar 1990
Decision
113d
Days
Class 1
Risk

K896588 is an FDA 510(k) clearance for the ONCOPROBE II SYSTEM. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Care Wise Medical Products Corp. (Morgan Hill, US). The FDA issued a Cleared decision on March 14, 1990 after a review of 113 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1320 - 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 Care Wise Medical Products Corp. devices

Submission Details

510(k) Number K896588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1989
Decision Date March 14, 1990
Days to Decision 113 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
6d slower than avg
Panel avg: 107d · This submission: 113d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IZD Probe, Uptake, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1320
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.