System, Planning, Radiation Therapy Treatment

FDA product code MUJ · 235 cleared devices

Class 2 Radiology

Regulation: 21 CFR 892.5050
Review panel: RA
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1995-02-16 – 2026-07-08

MUJ 2001-07-12

VARISEED 7.0

Applicant Varian Medical Systems

K number K012017

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MUJ 2001-06-05

HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM

Applicant Mds Nordion

K number K010682

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MUJ 2001-05-23

DCM 1.0

Applicant Mds Nordion

K number K011246

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MUJ 2001-04-10

PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1

Applicant Nucletron Corp.

K number K010784

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MUJ 2001-02-02

P3IMRT TM

Applicant Adac Laboratories

K number K002237

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MUJ 2000-11-03

NOVALIS (SHAPED BEAM SURGERY SYSTEM)

Applicant Brainlab AG

K number K002509

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MUJ 2000-10-25

PIPER

Applicant Rtek Medical Systems, LLC

K number K001295

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MUJ 2000-10-13

FOCUS

Applicant Computerized Medical Systems, Inc.

K number K002147

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MUJ 2000-09-05

PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM

Applicant Nomos Corp.

K number K993675

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MUJ 2000-08-30

PROTON VISION 7.0

Applicant Varian Medical Systems, Inc.

K number K002312

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MUJ 2000-08-23

RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0

Applicant Precision Therapy Intl., Inc.

K number K002240

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MUJ 2000-07-13

BRAINSCAN

Applicant Brainlab AG

K number K994413

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MUJ 2000-06-28

XPLAN 2.1

Applicant Radionics, Inc.

K number K001700

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MUJ 2000-06-02

OPTIRAD

Applicant Permedics, Inc.

K number K993895

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MUJ 2000-05-24

PROTON VISION

Applicant Varian Assoc., Inc.

K number K000922

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MUJ 2000-04-07

ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM

Applicant Adac Laboratories

K number K993923

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MUJ 2000-03-27

SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0

Applicant Nucletron Corp.

K number K992303

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MUJ 2000-03-09

BRACHYVISION 6.0

Applicant Varian Assoc., Inc.

K number K992762

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MUJ 2000-01-13

ITP, MODEL 1.0

Applicant Nucletron Corp.

K number K992434

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MUJ 1999-12-08

HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM

Applicant Helax AB

K number K993766

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MUJ 1999-11-18

TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5

Applicant Kps & Assoc., Inc.

K number K990475

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MUJ 1999-09-09

RENDER-PLAN 3-D

Applicant Precision Therapy Intl., Inc.

K number K992864

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MUJ 1999-09-03

CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM

Applicant Varian Assoc., Inc.

K number K992753

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MUJ 1999-08-30

XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL

Applicant Radionics, Inc.

K number K991237

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MUJ 1999-08-13

EXPLORER 3D

Applicant Our Scientific Intl., Inc.

K number K991815

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MUJ 1999-08-09

CADPLAN HELIOS OPTION 6.0

Applicant Varian Medical Systems, Inc.

K number K984532

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MUJ 1999-04-02

PLATO BRACHYTHERAPHY, MODEL V. 14.0

Applicant Nucletron Corp.

K number K983343

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MUJ 1999-04-01

INTERPLANT

Applicant Burdette Medical Systems, Inc.

K number K982696

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MUJ 1999-02-08

IMAGEFUSION 2.0

Applicant Radionics, Inc.

K number K990071

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MUJ 1998-12-30

ROCS TPS

Applicant Radiation Oncology Computer Systems

K number K982791

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MUJ 1998-12-11

MODIFICATION TO PROWESS PRO-SIM

Applicant Ssgi Prowess Systems

K number K984196

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MUJ 1998-12-11

STRATA, MODEL V.O.95

Applicant Rosses Medical Systems

K number K981678

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MUJ 1998-11-05

MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7

Applicant Multimedia Medical Systems, Inc.

K number K982821

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MUJ 1998-09-02

ACQPLAN

Applicant Philips Medical Systems (Cleveland), Inc.

K number K974770

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MUJ 1995-02-16

FOCUS RTP

Applicant Computerized Medical Systems, Inc.

K number K915691

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