Source, Brachytherapy, Radionuclide

Device Code: 5379

Product Code(s): KXK

Device Classification Information

Device Type ID5379
Device NameSource, Brachytherapy, Radionuclide
Regulation DescriptionRadionuclide Brachytherapy Source.
Regulation Medical SpecialtyRadiology
Review PanelRadiology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number892.5730 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKXK
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5379
DeviceSource, Brachytherapy, Radionuclide
Product CodeKXK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionRadionuclide Brachytherapy Source.
CFR Regulation Number892.5730 [🔎]
Premarket Reviews
ManufacturerDecision
ADVANCED NUCLIDE TECHNOLOGIES, LLC
 
SUBSTANTIALLY EQUIVALENT
1
C.R. BARD, INC.
 
SUBSTANTIALLY EQUIVALENT
1
CIVATECH ONCOLOGY, INC.
 
SUBSTANTIALLY EQUIVALENT
1
ECKERT & ZIEGLER BEBIG GMBH
 
SUBSTANTIALLY EQUIVALENT
1
ISOAID, L.L.C.
 
SUBSTANTIALLY EQUIVALENT
1
SALUTARIS MEDICAL DEVICES, INC.
 
SUBSTANTIALLY EQUIVALENT
2
SOURCE PRODUCTION & EQUIPMENT CO., INC.
 
SUBSTANTIALLY EQUIVALENT
1
VARIAN
 
SUBSTANTIALLY EQUIVALENT
1
VARIAN MEDICAL SYSTEMS, INC
 
SUBSTANTIALLY EQUIVALENT
1
Device Problems
Inadequate Instructions For Healthcare Professional
6
Sticking
4
Positioning Failure
1
Incorrect Measurement
1
Use Of Device Problem
1
Activation, Positioning Or Separation Problem
1
No Apparent Adverse Event
1
Adverse Event Without Identified Device Or Use Problem
1
Device Inoperable
1
Device Operates Differently Than Expected
1
Total Device Problems 18
Recalls
Manufacturer Recall Class Date Posted
1
Bard Brachytherapy, Inc.
II Apr-27-2018
2
C.R. Bard, Inc.
II Dec-20-2017
3
Source Production & Equipment Inc
II Jun-25-2015
TPLC Last Update: 2019-04-02 21:05:12

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