Medical Device Manufacturer · US , Columbia , MD

Nucletron Corp.

27 submissions · 27 cleared · Since 1995
27
Total
27
Cleared
0
Denied

Nucletron Corp. — FDA 510(k) Submissions

Nucletron Corp. has submitted 27 FDA 510(k) premarket notifications since 1995, of which 27 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Applicator, Radionuclide, Remote-controlled, System, Planning, Radiation Therapy Treatment, Accelerator, Linear, Medical, System, Simulation, Radiation Therapy, Source, Brachytherapy, Radionuclide . Use the specialty filter in the sidebar to narrow results.

27 devices
1–25 of 27
MICROSELECTRON HDR V2, MODEL 105.999
K092804 · JAQ System, Applicator,... · Radiology
Oct 2009 27d
LUMENCATH APPLICATOR SET, MODELS 189. 795, 189.796, 189.797, 189.798, LUMENCATH CATHETERS
K091598 · JAQ System, Applicator,... · Radiology
Jun 2009 26d
INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
K072445 · KPQ System, Simulation,... · Radiology
Sep 2007 15d
INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001
K041715 · JAQ System, Applicator,... · Radiology
Mar 2005 274d
MICROSELECTRON PDR
K041933 · JAQ System, Applicator,... · Radiology
Aug 2004 30d
ONCENTRA-VISIR
K041719 · MUJ System, Planning,... · Radiology
Jul 2004 28d
SWIFT 2.0, MODEL 132.001
K031158 · JAQ System, Applicator,... · Radiology
Aug 2003 118d
OTP 1.2
K031349 · MUJ System, Planning,... · Radiology
Aug 2003 100d
MICROSELECTRON HDR- GENIE AFTERLOADING SYSTEM, MODEL 105.989 FOR 115VOLT DEVICES AND 105.988 FOR 230VOLT DEVICES
K021286 · JAQ System, Applicator,... · Radiology
May 2002 30d
IMPLANT GUIDANCE SYSTEM APPLICATOR SET
K020015 · JAQ System, Applicator,... · Radiology
Mar 2002 69d
SEED SELECTRON MODEL V. 1.0
K010032 · JAQ System, Applicator,... · Radiology
Oct 2001 287d
OLDELFT THORASCAN MODEL NUMBER 180T
K012165 · KPR System, X-ray, Stationary · Radiology
Sep 2001 70d
PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1
K010784 · MUJ System, Planning,... · Radiology
Apr 2001 26d
SELECT SEED I-125
K002429 · KXK Source, Brachytherapy,... · Radiology
Feb 2001 178d
PROSTATE STEPPER TEMPLATE SET, MODEL PART NUMBER 189,065,189,066,189,067
K003270 · JAQ System, Applicator,... · Radiology
Dec 2000 65d
SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0
K992303 · MUJ System, Planning,... · Radiology
Mar 2000 263d
ITP, MODEL 1.0
K992434 · MUJ System, Planning,... · Radiology
Jan 2000 176d
CET PROSTATE APPLICATOR SET, PART NUMBER 089.066
K990990 · JAQ System, Applicator,... · Radiology
Oct 1999 197d
FREIBURG FLAP APPLICATOR SET, PART NUMBER 089.095
K983338 · JAQ System, Applicator,... · Radiology
Apr 1999 209d
STANDARD CT/MR APPLICATOR SET,RING CT/MR APPLICATOR SET, VAGINAL CT/MR APPLICATOR SET, FLETCHER WILLIAMSON APPLICATOR SE
K983341 · JAQ System, Applicator,... · Radiology
Apr 1999 204d
TREATMENT CONTROL STATION - MICROSELECTRON-HDR CLASSIC UPGRADE, VERSION 1.20
K983115 · JAQ System, Applicator,... · Radiology
Apr 1999 210d
ROTTERDAM NASOPHAYRNX MOULD SET, PART #089.068
K983337 · JAQ System, Applicator,... · Radiology
Apr 1999 191d
PLATO BRACHYTHERAPHY, MODEL V. 14.0
K983343 · MUJ System, Planning,... · Radiology
Apr 1999 191d
VSS, VIRTUAL SIMULATION SYSTEM
K980629 · IYE Accelerator, Linear, Medical · Radiology
May 1998 77d
IBU, INTEGRATED BRACHY THERAPY UNIT
K973848 · KPQ System, Simulation,... · Radiology
Jan 1998 106d
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