Cleared Traditional

K993552 - ISOSEED PD-103

K993552 is an FDA 510(k) clearance for ISOSEED PD-103, manufactured by Bebig Isotopentechnik GmbH. The device is a Class 2 Radiology device with product code KXK cleared through the Traditional 510(k) pathway after a 163-day FDA review.

K993552 · Bebig Isotopentechnik GmbH · Radiology device
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Optimized for regulatory review, auditing and printing
Mar 2000
Decision
163d
Days
Class 2
Risk

K993552 is an FDA 510(k) clearance for the ISOSEED PD-103. Classified as Source, Brachytherapy, Radionuclide (product code KXK), Class II - Special Controls.

Submitted by Bebig Isotopentechnik GmbH (Berlin, DE). The FDA issued a Cleared decision on March 31, 2000 after a review of 163 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 Bebig Isotopentechnik GmbH devices

FDA 510(k) Submission Details - K993552

510(k) Number K993552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1999
Decision Date March 31, 2000
Days to Decision 163 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
56d slower than avg
Panel avg: 107d · This submission: 163d
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 78
Devices cleared under the same product code (KXK) and FDA review panel - the closest regulatory comparables to K993552.
PHARMASEED, MODEL BT-103-3
K994016 · Syncor Pharmaceuticals, Inc. · Jul 2000
PHARMASEED, MODEL BT-125-2
K993701 · Syncor International, Inc. · Jun 2000
PHARMASEED, MODEL BT-103-2
K993700 · Syncor International, Inc. · Jun 2000
I-PLANT, MODEL 3500
K994317 · Implant Sciences Corp. · Mar 2000
125-IMPLANT SEEDS, MODEL STM1250
K991881 · Sourcetech Medical, LLC · Mar 2000
PROSTEC 125I BRACHYTHERAPY SEEDS
K993280 · Prostec, LLC · Mar 2000