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IYE

735 FDA 510(k) clearances · Product code

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RecordFirmDate
EXACTRAC 4.0 AND EXACTRAC X-RAY 6D (K040585)Brainlab AG2004-05-11
PROTOS SOFTWARE (K040709)Aktina Medical Physics Corp.2004-04-28
PELVIS BELLYBOARD PLUS PATIENT POSITIONING SYSTEM (K040773)Bionix Development Corp.2004-04-09
DYNATRAC, COD. 50-1A (K034051)3D Line USA, Inc.2004-04-05
ON-BOARD IMAGER DEVICE (K040192)Varian Medical Systems, Inc.2004-02-27
TRILOGY RADIOTHERAPY DELIVERY SYSTEM (K033343)Varian Medical Systems, Inc.2003-12-23
EXACTRAC GATING (K033287)Brainlab AG2003-12-19
ACCUSOFT (K032171)Direx Systems Corp.2003-12-15
XIO RADIATION TREATMENT PLANNING SYSTEM (K032762)Computerized Medical Systems, Inc.2003-12-02
MODIFICATION TO: HI-ART SYSTEM (K033347)Tomotherapy Incorporated2003-11-12
ELEKTA SYNERGY SYSTEM (K032996)Elekta Oncology Systems, Ltd.2003-10-23
MOSFET AUTOSENSE WIRELESS (K032725)Thomson & Nielsen Electronics, Ltd.2003-10-03
I-BEAM (K032100)Computerized Medical Systems, Inc.2003-10-02
PRECISE CARBON FIBER TABLE TOP, MODEL 11-999 (K032248)Aktina Medical Physics Corp.2003-09-25
ONCOR AVANT-GARDE WITH COHERENCE WORKSPACES (K031764)Siemens Medical Solutions USA, Inc.2003-09-05
ONE DIMENSIONAL WATER PHANTOM, WP 1D (K032594)Wellhofer Dosimetrie2003-09-05
ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT (K032156)Wfr/Aquaplast Corp.2003-09-02
OMNIPRO I'MRT (K031634)Wellhofer Dosimetrie2003-08-29
IMSURE (K031975)Prodigm, Inc.2003-08-29
STEREOTACTIC BODY FRAME, MODEL COD. 70-1A (K031631)3D Line USA, Inc.2003-07-18
HEADFIX (K030439)Medical Intelligence Medizintechnik GmbH2003-05-08
2 BASIC (K030175)Capintec, Inc.2003-04-17
VERSABOARD, MODEL 7040 (K030051)Bionix Development Corp.2003-04-04
VICTOREEN THEBES II, MODEL 7020 (K024284)Syncor Radiation Management2003-03-11
RADIONICS VARILINK 2 (K023519)Radionics, A Division of Tyco Healthcare Group LP2003-01-16
NON-INVASIVE PATIENT FIXATION SYSTEM (K023449)Stryker Leibinger2003-01-13
ACCULEAF (K021338)Direx Systems Corp.2003-01-07
MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02 (K023293)Med-Tec,Inc.2002-12-23
BLOCKING TRAY (K023636)Southeastern Radiation Products, Inc.2002-11-22
KLARITY (K022708)Larson Products, Inc.2002-11-12
RADIOSYSTEM/NT, MODEL 80-13020 (K020320)Styker Instruments2002-08-28
CRANIAL STEREOTACTIC EQUIPMENT (K010065)Arplay Medical S.A.2002-07-02
ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER (K021124)Wfr/Aquaplast Corp.2002-07-02
M3 (MICRO-MULTILEAF COLLIMATOR) (K020860)Brainlab AG2002-06-06
MODEL 1133 IVD PC VERSION (K021463)Sun Nuclear Corp.2002-06-06
MOTION TRACKING (K020294)Accuray, Inc.2002-04-22
M3 (MIRCO-MULTILEAF COLLIMATOR (K004022)Brainlab AG2002-03-26
AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGES (K014081)Aktina Medical Physics Corp.2002-03-05
MRI LINE MARKER (K014022)I.Z.I. Corp.2002-03-04
BODYFIX (K013391)Medical Intelligence Medizintechnik GmbH2002-01-11
MILLCOMP (K011845)Math Resolutions, LLC2001-12-04
MOSFET AUTOSENSE, MODEL TN-RD-60 (K013279)Thomson & Nielsen Electronics, Ltd.2001-10-18
MUCHECK - MONITOR UNIT VALIDATION PROGRAM, MODEL V4.1 (K012227)Oncology Data Systems, Inc.2001-10-01
INTRA OPERATIVE RADIATION THERAPY (K004023)Arplay Medical S.A.2001-09-21
OMNIDOS (K011763)Scanditronix Medical AB2001-09-05
MODIFICATION TO: VIEWGT ELECTRONIC PORTAL IMAGING DEVICE (EPID) (K012289)Elekta Oncology Systems, Ltd.2001-08-14
CYBERKNIFE SYSTEM (K011024)Accuray, Inc.2001-08-10
EXAC TRAC 2.0 (NOVALIS BODY MODULE) (K003285)Brainlab AG2001-07-31
RF-IVD WIRELESS DOSIMETER-MODEL 1133 (K011332)Sun Nuclear Corp.2001-07-26
IMMOBILIZATION SYSTEM FOR ENT (K003779)Arplay Medical S.A.2001-07-12
PTW DOSIMETRY DIODE, T60008 (K010916)Ptw-New York Corp.2001-06-20
BREAST-BOARD (MULTIPLE) (K003778)Arplay Medical S.A.2001-06-08
RADCALC, MODEL V.4.0 (K010464)Lifeline Software, Inc.2001-05-17
PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 (K010472)Thomson & Nielsen Electronics, Ltd.2001-05-08
IVD (IN VIVO DOSIMETER), MODEL 1131 (K010449)Sun Nuclear Corp.2001-05-04
ECLIPSE 6.5 (K010975)Varian Medical Systems, Inc.2001-05-02
DOSIMETRY CHECK (K010225)Math Resolutions, LLC2001-04-24
TRAY ADAPTERS, MULTIPLE (K010174)Arplay Medical S.A.2001-04-18
COUCH FOR TOTAL BODY RADIATION (K010063)Arplay Medical S.A.2001-04-02
STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM (K010062)Arplay Medical S.A.2001-03-13
BEAM BLOCK TRAYS (K004015)Arplay Medical S.A.2001-03-13
PORTALVISION (K003636)Varian Medical Systems, Inc.2001-02-02
AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) (K003330)Aktina Medical Physics Corp.2001-01-04
INVAC (K002608)Duncan Hynd Associates, Ltd.2000-11-16
RADIOCAMERAS EXTRACRANIAL SYSTEM (K000246)Surgical Navigation Technologies, Inc.2000-10-20
PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 (K002444)Sun Nuclear Corp.2000-10-18
PREFERENCE TREATMENT SYSTEM (K001833)Northwest Medical Physics Equipment, Inc.2000-09-28
INVIDOS (K002051)Scanditronix Medical AB2000-09-05
MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX (K001052)Med-Tec,Inc.2000-08-30
DOSE 1 (K000209)Scanditronix Wellhofer North America2000-08-18
VARIS 1.4G (K001643)Varian Medical Systems, Inc.2000-06-23
NOVAC7 (K990209)Hitesys S.P.A.2000-06-22
MLC FIT (K991133)Impac Medical Systems, Inc.2000-03-27
RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION (K994355)Surgical Navigation Technologies, Inc.2000-03-22
ISOCENTRIC BEAM CHECKER (K993959)Mick Radio-Nuclear Instruments, Inc.2000-02-14
PERMA-DOC PHANTOM (K993960)Mick Radio-Nuclear Instruments, Inc.2000-02-14
MU PLUS (K992689)Rad Therapy Solutions, Inc.2000-02-10
SUPER TISSUE (K993742)I.Z.I. Corp.2000-02-02
RAPTOR TREATMENT PLANNING SYSTEM (K993359)Nomos Corp.1999-12-21
CONFORMAX MMLC VR1 (K993594)Radionics, Inc.1999-12-15
PRIMUS (K993425)Siemens Medical Solutions USA, Inc.1999-11-26
RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS (K991319)Orfit Industries1999-09-21
THE NOMOS CHANE II (K991966)Nomos Corp.1999-09-03
AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD (K991546)Aktina Medical Physics Corp.1999-07-30
TLC PEDIATRIC FRAME, MODEL TLC-SYS (K991523)Radionics, Inc.1999-07-30
BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY (K991336)Medical Instrumentation & Diagnostics Corp.(Midco)1999-07-12
SHADOW TRAYS (K991107)Mick Radio-Nuclear Instruments, Inc.1999-06-29
AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER (K990997)Aktina Medical Physics Corp.1999-06-22
DOSE CALC, MODEL VS. 1.02 (K990833)Integrity Medical Software, Inc.1999-06-08
DPD-12PCC (K990734)Scanditronix Medical AB1999-05-28
ROCS ULTRASEED (K984241)Radiation Oncology Computer Systems1999-05-12
APOLLO 5, APOLLO 10 (K990383)Precitron A.B.1999-05-05
FOCUS PILOT CONTOURING WORKSTATION (K981535)Computerized Medical Systems, Inc.1999-04-02
OSIRIS (K981153)Huestis Medical1999-03-17
MILLENNIUM MLC -120 (K990085)Varian Assoc., Inc.1999-02-08
RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC (K982549)Radionics, Inc.1998-12-30
PROFA (K981911)Duncan Hynd Associates, Ltd.1998-11-12
RT DESKTOP (K982713)Elekta Oncology Systems, Ltd.1998-11-02
MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 (K982624)Med-Tec,Inc.1998-10-26
RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY (K981597)Radionics, Inc.1998-10-09
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