Cleared Traditional

K940632 - I-125 RAPID STRAND (FDA 510(k) Clearance)

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

K940632 · Medi-Physics Inc. Dba Nycomed Amersham Imaging · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1994
Decision
200d
Days
Class 2
Risk

K940632 is an FDA 510(k) clearance for the I-125 RAPID STRAND. Classified as Source, Isotope, Sealed, Gold, Titanium, Platinum (product code IWI), Class II - Special Controls.

Submitted by Medi-Physics Inc. Dba Nycomed Amersham Imaging (Arlington Heights, US). The FDA issued a Cleared decision on September 2, 1994 after a review of 200 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 Medi-Physics Inc. Dba Nycomed Amersham Imaging devices

Submission Details

510(k) Number K940632 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date September 02, 1994
Days to Decision 200 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
93d slower than avg
Panel avg: 107d · This submission: 200d
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.