Cleared Traditional

K812235 - GOLD(AU 195) SPOT MARKER SOURCES (FDA 510(k) Clearance)

Class I Radiology device.

K812235 · Amersham Corp. · Radiology device
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Sep 1981
Decision
29d
Days
Class 1
Risk

K812235 is an FDA 510(k) clearance for the GOLD(AU 195) SPOT MARKER SOURCES. Classified as Source, Calibration, Sealed, Nuclear (product code IXD), Class I - General Controls.

Submitted by Amersham Corp. (Mchenry, US). The FDA issued a Cleared decision on September 9, 1981 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1400 - 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 Amersham Corp. devices

Submission Details

510(k) Number K812235 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 1981
Decision Date September 09, 1981
Days to Decision 29 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code IXD Source, Calibration, Sealed, Nuclear
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.1400
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.