Cleared Traditional

K973328 - INTERSOURCE

K973328 is an FDA 510(k) clearance for INTERSOURCE, manufactured by International Brachytherapy S.A.. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 462-day FDA review.

K973328 · International Brachytherapy S.A. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1998
Decision
462d
Days
Class 2
Risk

K973328 is an FDA 510(k) clearance for the INTERSOURCE. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by International Brachytherapy S.A. (7180 Seneffe, BE). The FDA issued a Cleared decision on December 10, 1998 after a review of 462 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Radiology submissions.

View all International Brachytherapy S.A. devices

FDA 510(k) Submission Details - K973328

510(k) Number K973328 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1997
Decision Date December 10, 1998
Days to Decision 462 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
355d slower than avg
Panel avg: 107d · This submission: 462d
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 35
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K973328.
ACCU-SPACE ABSORBABLE SEEDING SPACERS
K010621 · Cp Medical · Sep 2001
SELECT SEED I-125
K002429 · Nucletron Corp. · Feb 2001
LOOK COLLAGEN SPACERS, MODEL 1514B
K001765 · Surgical Specialties Corp · Sep 2000
NORTH AMERICAN SCIENTIFIC (NASI) I-125 RADIONUCLIDE BRACHYTHERAPY SOURCE- MODEL MED 3631-A
K972271 · Ml Strategies, Inc. · Oct 1997
NORTH AMERICAN SCIENTIFIC (NASI) 1-125 RADIONUCLIDE BRACHYTHERAPY SOURCE
K964647 · North American Scientific, Inc. · Feb 1997
RADIONUCLIDE CATHETERS, RNC-A, RNC-G, RNC-U
K923697 · Radionics, Inc. · Dec 1993