Cleared Traditional

K852542 - PALLADIUM SEED MODEL 100 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K852542 · Nuclear Medicine, Inc. · Radiology device
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Jan 1986
Decision
214d
Days
Class 2
Risk

K852542 is an FDA 510(k) clearance for the PALLADIUM SEED MODEL 100. Classified as Source, Isotope, Sealed, Gold, Titanium, Platinum (product code IWI), Class II - Special Controls.

Submitted by Nuclear Medicine, Inc. (Atlanta, US). The FDA issued a Cleared decision on January 14, 1986 after a review of 214 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5730 - 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 Nuclear Medicine, Inc. devices

Submission Details

510(k) Number K852542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1985
Decision Date January 14, 1986
Days to Decision 214 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
107d slower than avg
Panel avg: 107d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IWI Source, Isotope, Sealed, Gold, Titanium, Platinum
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5730
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.