Cleared Traditional

K972271 - NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A

K972271 is an FDA 510(k) clearance for NORTH AMERICAN SCIENTIFIC (NASI) I-125 ..., manufactured by Ml Strategies, Inc.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K972271 · Ml Strategies, Inc. · Radiology device
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Oct 1997
Decision
132d
Days
Class 2
Risk

K972271 is an FDA 510(k) clearance for the NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MOD.... Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Ml Strategies, Inc. (Boston, US). The FDA issued a Cleared decision on October 28, 1997 after a review of 132 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K972271

510(k) Number K972271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1997
Decision Date October 28, 1997
Days to Decision 132 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d slower than avg
Panel avg: 107d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KXK Device Classification - Class 2, Special Controls

Product Code KXK Source, Brachytherapy, Radionuclide
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.

Regulatory Peers - KXK Source, Brachytherapy, Radionuclide

All 145
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K972271.
UROMED BRACHYTHERAPHY IODINE-125 SOURCES
K982226 · Uromed Corp. · May 1999
`BI I-125 BRACHYTHERAPHY SEED, MODEL 125SL & 125SH
K984446 · Urocor, Inc. · Apr 1999
INTERSOURCE
K973328 · International Brachytherapy S.A. · Dec 1998
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · North American Scientific, Inc. · Feb 1997
BEBIG INACTIVE OPHTHALMIC APPLICATORS FOR IODINE 125 SEEDS
K945983 · Bebig Trade, Inc. · Oct 1995
STERILE VIDEO CAMERA COVER AND DRAPE
K936086 · Micromedical Devices, Inc. · Mar 1994
K972271 · NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
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