FDA Product Code
FDA Product Code MUJ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 257 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K031281 | ERGO SRS | 3D Line USA, Inc. | 2003-12-23 | Traditional | PDF ↗ |
| K032456 | PROWESS | Prowess, Inc. | 2003-10-16 | Traditional | PDF ↗ |
| K032724 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2003-10-09 | Traditional | PDF ↗ |
| K030821 | SIMUPLAN TREATMENT PLANNING SYSTEM, MODEL V. 7.5 | Simuplan S.L. | 2003-09-17 | Traditional | PDF ↗ |
| K032345 | CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | 2003-09-03 | Special | PDF ↗ |
| K032209 | NOMOS CORVUS 5.0M | Nomos Corp. | 2003-08-21 | Special | PDF ↗ |
| K031349 | OTP 1.2 | Nucletron Corp. | 2003-08-07 | Special | PDF ↗ |
| K022961 | RTDOSEPLAN | Math Resolutions, LLC | 2003-01-31 | Traditional | PDF ↗ |
| K022036 | SIEMENS VIRTUAL SIMULATION (VSIM) | Siemens Medical Solutions USA, Inc. | 2002-11-05 | Traditional | PDF ↗ |
| K022741 | SPOT PRO (220V), MODEL 131.099 | Nucletron Corporation | 2002-10-24 | Special | PDF ↗ |
| K020027 | FOCUS RADIATION TREATMENT PLANNING SYSTEM | Computerized Medical Systems, Inc. | 2002-10-08 | Traditional | PDF ↗ |
| K022307 | KONRAD, MODEL V.2.0 | Mrc Systems GmbH | 2002-10-08 | Traditional | PDF ↗ |
| K022411 | PRECISEPLAN 2.0 | Precision Therapy Intl., Inc. | 2002-09-20 | Traditional | PDF ↗ |
| K013644 | ACQPLAN 5.0 | Philips Medical Systems, Inc. | 2002-09-12 | Traditional | PDF ↗ |
| K020971 | DCM 2.0 | Mds Nordion AB | 2002-06-06 | Traditional | PDF ↗ |
| K021268 | ECLIPSE, HELIOS OPTION | Varian Medical Systems, Inc. | 2002-05-22 | Special | PDF ↗ |
| K012575 | PREFERNCE IMRT TREATMENT PLANNING MODULE | Northwest Medical Physics Equipment, Inc. | 2002-03-12 | Traditional | PDF ↗ |
| K013673 | HI-ART SYSTEM | Tomo Therapy, Inc. | 2002-01-28 | Traditional | PDF ↗ |
| K013535 | EVTOOL MODEL # V. 1.0 | 3D Line USA, Inc. | 2002-01-18 | Traditional | PDF ↗ |
| K013112 | FOCAL SIM | Computerized Medical Systems, Inc. | 2001-12-05 | Traditional | PDF ↗ |
| K013661 | XPLAN 2.2 WITH THE BODY SYSTEM | Radionics, A Division of Tyco Healthcare Group LP | 2001-12-03 | Special | PDF ↗ |
| K002132 | ASHA TREATMENT PLANNING SYSTEM, MODEL ASHA TPS | Intelligent Instruments Pvt. , Ltd. | 2001-10-18 | Traditional | PDF ↗ |
| K012017 | VARISEED 7.0 | Varian Medical Systems | 2001-07-12 | Special | PDF ↗ |
| K010682 | HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM | Mds Nordion | 2001-06-05 | Traditional | PDF ↗ |
| K011246 | DCM 1.0 | Mds Nordion | 2001-05-23 | Special | PDF ↗ |
| K010784 | PLATO SRS STEREOTACTIC RADIOSURGERY PLANNING SYSTEM,MODEL 2.0, PLATO IFS IMAGE FUSION SOFTWARE, MODEL 2.1 | Nucletron Corp. | 2001-04-10 | Special | PDF ↗ |
| K002237 | P3IMRT TM | Adac Laboratories | 2001-02-02 | Traditional | PDF ↗ |
| K002509 | NOVALIS (SHAPED BEAM SURGERY SYSTEM) | Brainlab AG | 2000-11-03 | Traditional | PDF ↗ |
| K001295 | PIPER | Rtek Medical Systems, LLC | 2000-10-25 | Traditional | PDF ↗ |
| K002147 | FOCUS | Computerized Medical Systems, Inc. | 2000-10-13 | Traditional | PDF ↗ |
| K993675 | PEREGRINE RADIATION THERAPY DOSE CALCULATION SYSTEM | Nomos Corp. | 2000-09-05 | Traditional | PDF ↗ |
| K002312 | PROTON VISION 7.0 | Varian Medical Systems, Inc. | 2000-08-30 | Special | PDF ↗ |
| K002240 | RENDER-PLAN 3-D 4.00 & PRECISE-PLAN 1.0 | Precision Therapy Intl., Inc. | 2000-08-23 | Special | PDF ↗ |
| K994413 | BRAINSCAN | Brainlab AG | 2000-07-13 | Traditional | PDF ↗ |
| K001700 | XPLAN 2.1 | Radionics, Inc. | 2000-06-28 | Special | PDF ↗ |
| K993895 | OPTIRAD | Permedics, Inc. | 2000-06-02 | Traditional | PDF ↗ |
| K000922 | PROTON VISION | Varian Assoc., Inc. | 2000-05-24 | Traditional | PDF ↗ |
| K993923 | ADAC PINNACLE3TM RADIATION THERAPY PLANNING SYSTEM | Adac Laboratories | 2000-04-07 | Traditional | PDF ↗ |
| K992303 | SONOGRAPHIC PLANNING OF ONCOLOGY TREATMENTS (SPOT), MODEL V.. 1.0 | Nucletron Corp. | 2000-03-27 | Traditional | PDF ↗ |
| K992762 | BRACHYVISION 6.0 | Varian Assoc., Inc. | 2000-03-09 | Traditional | PDF ↗ |
| K992434 | ITP, MODEL 1.0 | Nucletron Corp. | 2000-01-13 | Traditional | PDF ↗ |
| K993766 | HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM | Helax AB | 1999-12-08 | Special | PDF ↗ |
| K990475 | TRAPIS (TRANSPERINEAL PROSTATE IMPLANT SIMULATOR), VERSION 1.5 | Kps & Assoc., Inc. | 1999-11-18 | Traditional | PDF ↗ |
| K992864 | RENDER-PLAN 3-D | Precision Therapy Intl., Inc. | 1999-09-09 | Special | PDF ↗ |
| K992753 | CADPLAN PLUS: 3D TREATMENT PLANNING SYSTEM | Varian Assoc., Inc. | 1999-09-03 | Special | PDF ↗ |
| K991237 | XPLAN-2 WITH HEAD AND NECK LOCALIZER, MODEL HNL | Radionics, Inc. | 1999-08-30 | Traditional | PDF ↗ |
| K991815 | EXPLORER 3D | Our Scientific Intl., Inc. | 1999-08-13 | Traditional | PDF ↗ |
| K984532 | CADPLAN HELIOS OPTION 6.0 | Varian Medical Systems, Inc. | 1999-08-09 | Traditional | PDF ↗ |
| K983343 | PLATO BRACHYTHERAPHY, MODEL V. 14.0 | Nucletron Corp. | 1999-04-02 | Traditional | PDF ↗ |
| K982696 | INTERPLANT | Burdette Medical Systems, Inc. | 1999-04-01 | Traditional | PDF ↗ |
| K990071 | IMAGEFUSION 2.0 | Radionics, Inc. | 1999-02-08 | Special | PDF ↗ |
| K982791 | ROCS TPS | Radiation Oncology Computer Systems | 1998-12-30 | Traditional | PDF ↗ |
| K981678 | STRATA, MODEL V.O.95 | Rosses Medical Systems | 1998-12-11 | Traditional | PDF ↗ |
| K984196 | MODIFICATION TO PROWESS PRO-SIM | Ssgi Prowess Systems | 1998-12-11 | Special | PDF ↗ |
| K982821 | MMS THERPACPLUS B3DTUI MODEL NUMBER 6.7 | Multimedia Medical Systems, Inc. | 1998-11-05 | Traditional | PDF ↗ |
| K974770 | ACQPLAN | Philips Medical Systems (Cleveland), Inc. | 1998-09-02 | Traditional | PDF ↗ |
| K915691 | FOCUS RTP | Computerized Medical Systems, Inc. | 1995-02-16 | Traditional | PDF ↗ |
Product code MUJ · Class II · Radiology. Data: openFDA.