Cleared Traditional

K013751 - HANDHELD GAMMA FINDER (HGF) (FDA 510(k) Clearance)

Class I Radiology device.

K013751 · Silicon Instruments Gmhb · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2002
Decision
85d
Days
Class 1
Risk

K013751 is an FDA 510(k) clearance for the HANDHELD GAMMA FINDER (HGF). Classified as Probe, Uptake, Nuclear (product code IZD), Class I - General Controls.

Submitted by Silicon Instruments Gmhb (Berlin, DE). The FDA issued a Cleared decision on February 6, 2002 after a review of 85 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 Silicon Instruments Gmhb devices

Submission Details

510(k) Number K013751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2001
Decision Date February 06, 2002
Days to Decision 85 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
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.