Cleared Traditional

K930962 - CAPTUS 2000 WEL COUNTER (FDA 510(k) Clearance)

Class I Radiology device.

K930962 · Capintec Instruments, Inc. · Radiology device
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May 1993
Decision
83d
Days
Class 1
Risk

K930962 is an FDA 510(k) clearance for the CAPTUS 2000 WEL COUNTER. Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Capintec Instruments, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on May 18, 1993 after a review of 83 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Capintec Instruments, Inc. devices

Submission Details

510(k) Number K930962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1993
Decision Date May 18, 1993
Days to Decision 83 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 107d · This submission: 83d
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.