Cleared Traditional

K882449 - CESIUM 137 SOURCE, MODEL CSM-40 (FDA 510(k) Clearance)

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

K882449 · Cis-Us, Inc. · Radiology device
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Apr 1989
Decision
304d
Days
Class 2
Risk

K882449 is an FDA 510(k) clearance for the CESIUM 137 SOURCE, MODEL CSM-40. Classified as Source, Isotope, Sealed, Gold, Titanium, Platinum (product code IWI), Class II - Special Controls.

Submitted by Cis-Us, Inc. (Bedford, US). The FDA issued a Cleared decision on April 14, 1989 after a review of 304 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Cis-Us, Inc. devices

Submission Details

510(k) Number K882449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 1988
Decision Date April 14, 1989
Days to Decision 304 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
197d slower than avg
Panel avg: 107d · This submission: 304d
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.