FDA Product Code
FDA Product Code IYE — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.5050
510(k) Clearances — 738 records · page 5 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K041557 | MOBILEMOSFET WIRELESS DOSIMETRY SYSTEM, MODEL TN-RD-70-W | Thomson & Nielsen Electronics, Ltd. | 2004-06-25 | Special | PDF ↗ |
| K040687 | ONEDOSE PATIENT DOSIMETRY SYSTEM | Sicel Technologies, Inc. | 2004-06-25 | Traditional | PDF ↗ |
| K041315 | CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Accuray, Inc. | 2004-06-10 | Special | PDF ↗ |
| K040585 | EXACTRAC 4.0 AND EXACTRAC X-RAY 6D | Brainlab AG | 2004-05-11 | Traditional | PDF ↗ |
| K040709 | PROTOS SOFTWARE | Aktina Medical Physics Corp. | 2004-04-28 | Traditional | PDF ↗ |
| K040773 | PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM | Bionix Development Corp. | 2004-04-09 | Traditional | PDF ↗ |
| K034051 | DYNATRAC, COD. 50-1A | 3D Line USA, Inc. | 2004-04-05 | Traditional | PDF ↗ |
| K040192 | ON-BOARD IMAGER DEVICE | Varian Medical Systems, Inc. | 2004-02-27 | Special | PDF ↗ |
| K033343 | TRILOGY RADIOTHERAPY DELIVERY SYSTEM | Varian Medical Systems, Inc. | 2003-12-23 | Traditional | PDF ↗ |
| K033287 | EXACTRAC GATING | Brainlab AG | 2003-12-19 | Traditional | PDF ↗ |
| K032171 | ACCUSOFT | Direx Systems Corp. | 2003-12-15 | Traditional | PDF ↗ |
| K032762 | XIO RADIATION TREATMENT PLANNING SYSTEM | Computerized Medical Systems, Inc. | 2003-12-02 | Traditional | PDF ↗ |
| K033347 | MODIFICATION TO: HI-ART SYSTEM | Tomotherapy Incorporated | 2003-11-12 | Special | PDF ↗ |
| K032996 | ELEKTA SYNERGY SYSTEM | Elekta Oncology Systems, Ltd. | 2003-10-23 | Special | PDF ↗ |
| K032725 | MOSFET AUTOSENSE WIRELESS | Thomson & Nielsen Electronics, Ltd. | 2003-10-03 | Special | PDF ↗ |
| K032100 | I-BEAM | Computerized Medical Systems, Inc. | 2003-10-02 | Traditional | PDF ↗ |
| K032248 | PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 | Aktina Medical Physics Corp. | 2003-09-25 | Traditional | PDF ↗ |
| K031764 | ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES | Siemens Medical Solutions USA, Inc. | 2003-09-05 | Traditional | PDF ↗ |
| K032594 | ONE DIMENSIONAL WATER PHANTOM, WP 1D | Wellhofer Dosimetrie | 2003-09-05 | Traditional | PDF ↗ |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT | Wfr/Aquaplast Corp. | 2003-09-02 | Traditional | PDF ↗ |
| K031975 | IMSURE | Prodigm, Inc. | 2003-08-29 | Traditional | PDF ↗ |
| K031634 | OMNIPRO I'MRT | Wellhofer Dosimetrie | 2003-08-29 | Traditional | PDF ↗ |
| K031631 | STEREOTACTIC BODY FRAME, MODEL COD. 70-1A | 3D Line USA, Inc. | 2003-07-18 | Traditional | PDF ↗ |
| K030439 | HEADFIX | Medical Intelligence Medizintechnik GmbH | 2003-05-08 | Traditional | PDF ↗ |
| K030175 | 2 BASIC | Capintec, Inc. | 2003-04-17 | Traditional | PDF ↗ |
| K030051 | VERSABOARD, MODEL 7040 | Bionix Development Corp. | 2003-04-04 | Traditional | PDF ↗ |
| K024284 | VICTOREEN THEBES II, MODEL 7020 | Syncor Radiation Management | 2003-03-11 | Traditional | PDF ↗ |
| K023519 | RADIONICS VARILINK 2 | Radionics, A Division of Tyco Healthcare Group LP | 2003-01-16 | Traditional | PDF ↗ |
| K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM | Stryker Leibinger | 2003-01-13 | Traditional | PDF ↗ |
| K021338 | ACCULEAF | Direx Systems Corp. | 2003-01-07 | Traditional | PDF ↗ |
| K023293 | MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 | Med-Tec,Inc. | 2002-12-23 | Traditional | PDF ↗ |
| K023636 | BLOCKING TRAY | Southeastern Radiation Products, Inc. | 2002-11-22 | Traditional | PDF ↗ |
| K022708 | KLARITY | Larson Products, Inc. | 2002-11-12 | Traditional | PDF ↗ |
| K020320 | RADIOSYSTEM/NT, MODEL 80-13020 | Styker Instruments | 2002-08-28 | Traditional | PDF ↗ |
| K010065 | CRANIAL STEREOTACTIC EQUIPMENT | Arplay Medical S.A. | 2002-07-02 | Traditional | PDF ↗ |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | Wfr/Aquaplast Corp. | 2002-07-02 | Traditional | PDF ↗ |
| K021463 | MODEL 1133 IVD PC VERSION | Sun Nuclear Corp. | 2002-06-06 | Special | PDF ↗ |
| K020860 | M3 (MICRO-MULTILEAF COLLIMATOR) | Brainlab AG | 2002-06-06 | Traditional | PDF ↗ |
| K020294 | MOTION TRACKING | Accuray, Inc. | 2002-04-22 | Traditional | PDF ↗ |
| K004022 | M3 (MIRCO-MULTILEAF COLLIMATOR | Brainlab AG | 2002-03-26 | Traditional | PDF ↗ |
| K014081 | AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES | Aktina Medical Physics Corp. | 2002-03-05 | Traditional | PDF ↗ |
| K014022 | MRI LINE MARKER | I.Z.I. Corp. | 2002-03-04 | Traditional | PDF ↗ |
| K013391 | BODYFIX | Medical Intelligence Medizintechnik GmbH | 2002-01-11 | Traditional | PDF ↗ |
| K011845 | MILLCOMP | Math Resolutions, LLC | 2001-12-04 | Traditional | PDF ↗ |
| K013279 | MOSFET AUTOSENSE, MODEL TN-RD-60 | Thomson & Nielsen Electronics, Ltd. | 2001-10-18 | Special | PDF ↗ |
| K012227 | MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 | Oncology Data Systems, Inc. | 2001-10-01 | Traditional | PDF ↗ |
| K004023 | INTRA OPERATIVE RADIATION THERAPY | Arplay Medical S.A. | 2001-09-21 | Traditional | PDF ↗ |
| K011763 | OMNIDOS | Scanditronix Medical AB | 2001-09-05 | Traditional | PDF ↗ |
| K012289 | MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) | Elekta Oncology Systems, Ltd. | 2001-08-14 | Special | PDF ↗ |
| K011024 | CYBERKNIFE SYSTEM | Accuray, Inc. | 2001-08-10 | Traditional | PDF ↗ |
| K003285 | EXAC TRAC 2.0 (NOVALIS BODY MODULE) | Brainlab AG | 2001-07-31 | Traditional | PDF ↗ |
| K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 | Sun Nuclear Corp. | 2001-07-26 | Traditional | PDF ↗ |
| K003779 | IMMOBILIZATION SYSTEM FOR ENT | Arplay Medical S.A. | 2001-07-12 | Traditional | PDF ↗ |
| K010916 | PTW DOSIMETRY DIODE, T60008 | Ptw-New York Corp. | 2001-06-20 | Traditional | PDF ↗ |
| K003778 | BREAST-BOARD (MULTIPLE) | Arplay Medical S.A. | 2001-06-08 | Traditional | PDF ↗ |
| K010464 | RADCALC, MODEL V.4.0 | Lifeline Software, Inc. | 2001-05-17 | Traditional | PDF ↗ |
| K010472 | PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 | Thomson & Nielsen Electronics, Ltd. | 2001-05-08 | Traditional | PDF ↗ |
| K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 | Sun Nuclear Corp. | 2001-05-04 | Traditional | PDF ↗ |
| K010975 | ECLIPSE 6.5 | Varian Medical Systems, Inc. | 2001-05-02 | Special | PDF ↗ |
| K010225 | DOSIMETRY CHECK | Math Resolutions, LLC | 2001-04-24 | Traditional | PDF ↗ |
| K010174 | TRAY ADAPTERS, MULTIPLE | Arplay Medical S.A. | 2001-04-18 | Traditional | PDF ↗ |
| K010063 | COUCH FOR TOTAL BODY RADIATION | Arplay Medical S.A. | 2001-04-02 | Traditional | PDF ↗ |
| K004015 | BEAM BLOCK TRAYS | Arplay Medical S.A. | 2001-03-13 | Traditional | PDF ↗ |
| K010062 | STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM | Arplay Medical S.A. | 2001-03-13 | Traditional | PDF ↗ |
| K003636 | PORTALVISION | Varian Medical Systems, Inc. | 2001-02-02 | Traditional | PDF ↗ |
| K003330 | AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) | Aktina Medical Physics Corp. | 2001-01-04 | Traditional | PDF ↗ |
| K002608 | INVAC | Duncan Hynd Associates, Ltd. | 2000-11-16 | Traditional | PDF ↗ |
| K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM | Surgical Navigation Technologies, Inc. | 2000-10-20 | Traditional | PDF ↗ |
| K002444 | PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 | Sun Nuclear Corp. | 2000-10-18 | Traditional | PDF ↗ |
| K001833 | PREFERENCE TREATMENT SYSTEM | Northwest Medical Physics Equipment, Inc. | 2000-09-28 | Special | PDF ↗ |
| K002051 | INVIDOS | Scanditronix Medical AB | 2000-09-05 | Traditional | PDF ↗ |
| K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX | Med-Tec,Inc. | 2000-08-30 | Traditional | PDF ↗ |
| K000209 | DOSE 1 | Scanditronix Wellhofer North America | 2000-08-18 | Traditional | PDF ↗ |
| K001643 | VARIS 1.4G | Varian Medical Systems, Inc. | 2000-06-23 | Special | PDF ↗ |
| K990209 | NOVAC7 | Hitesys S.P.A. | 2000-06-22 | Traditional | PDF ↗ |
| K991133 | MLC FIT | Impac Medical Systems, Inc. | 2000-03-27 | Traditional | PDF ↗ |
| K994355 | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION | Surgical Navigation Technologies, Inc. | 2000-03-22 | Traditional | PDF ↗ |
| K993960 | PERMA-DOC PHANTOM | Mick Radio-Nuclear Instruments, Inc. | 2000-02-14 | Traditional | PDF ↗ |
| K993959 | ISOCENTRIC BEAM CHECKER | Mick Radio-Nuclear Instruments, Inc. | 2000-02-14 | Traditional | PDF ↗ |
| K992689 | MU PLUS | Rad Therapy Solutions, Inc. | 2000-02-10 | Traditional | PDF ↗ |
| K993742 | SUPER TISSUE | I.Z.I. Corp. | 2000-02-02 | Traditional | PDF ↗ |
| K993359 | RAPTOR TREATMENT PLANNING SYSTEM | Nomos Corp. | 1999-12-21 | Traditional | PDF ↗ |
| K993594 | CONFORMAX MMLC VR1 | Radionics, Inc. | 1999-12-15 | Special | PDF ↗ |
| K993425 | PRIMUS | Siemens Medical Solutions USA, Inc. | 1999-11-26 | Special | PDF ↗ |
| K991319 | RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS | Orfit Industries | 1999-09-21 | Traditional | PDF ↗ |
| K991966 | THE NOMOS CHANE II | Nomos Corp. | 1999-09-03 | Traditional | PDF ↗ |
| K991523 | TLC PEDIATRIC FRAME, MODEL TLC-SYS | Radionics, Inc. | 1999-07-30 | Traditional | PDF ↗ |
| K991546 | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD | Aktina Medical Physics Corp. | 1999-07-30 | Traditional | PDF ↗ |
| K991336 | BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY | Medical Instrumentation & Diagnostics Corp.(Midco) | 1999-07-12 | Traditional | PDF ↗ |
| K991107 | SHADOW TRAYS | Mick Radio-Nuclear Instruments, Inc. | 1999-06-29 | Traditional | PDF ↗ |
| K990997 | AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER | Aktina Medical Physics Corp. | 1999-06-22 | Traditional | PDF ↗ |
| K990833 | DOSE CALC, MODEL VS. 1.02 | Integrity Medical Software, Inc. | 1999-06-08 | Traditional | PDF ↗ |
| K990734 | DPD-12PCC | Scanditronix Medical AB | 1999-05-28 | Special | PDF ↗ |
| K984241 | ROCS ULTRASEED | Radiation Oncology Computer Systems | 1999-05-12 | Traditional | PDF ↗ |
| K990383 | APOLLO 5, APOLLO 10 | Precitron A.B. | 1999-05-05 | Traditional | PDF ↗ |
| K981535 | FOCUS PILOT CONTOURING WORKSTATION | Computerized Medical Systems, Inc. | 1999-04-02 | Traditional | PDF ↗ |
| K981153 | OSIRIS | Huestis Medical | 1999-03-17 | Traditional | PDF ↗ |
| K990085 | MILLENNIUM MLC -120 | Varian Assoc., Inc. | 1999-02-08 | Special | PDF ↗ |
| K982549 | RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC | Radionics, Inc. | 1998-12-30 | Traditional | PDF ↗ |
| K981911 | PROFA | Duncan Hynd Associates, Ltd. | 1998-11-12 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.