Accelerator, Linear, Medical
Regulation 892.5050
15510(k)s in 12 months (738 all time)
8recalls in 12 months (563 all time)
542recalls that name a 510(k)
Top companies in IYE
| Company | 510(k)s | Recalls |
|---|---|---|
| Siemens Medical Solutions USA, Inc. | 18 | 206 |
| Varian Medical Systems | 83 | 27 |
| Elekta , Ltd. | 19 | 77 |
| Varian Medical Systems, Oncology Systems | 2 | 68 |
| Accuray Incorporated | 19 | 32 |
| Landauer | 1 | 39 |
| Brainlab | 22 | 17 |
| Varian Assoc., Inc. | 27 | 0 |
| Medtec, Inc. | 20 | 0 |
| Sun Nuclear Corp. | 19 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 31, 2001 | K003285 | EXAC TRAC 2.0 (NOVALIS BODY MODULE) Brainlab AG, DE | IYE |
| Jul 26, 2001 | K011332 | RF-IVD WIRELESS DOSIMETER-MODEL 1133 Sun Nuclear Corp. | IYE |
| Jul 12, 2001 | K003779 | IMMOBILIZATION SYSTEM FOR ENT Arplay Medical S.A., FR | IYE |
| Jun 20, 2001 | K010916 | PTW DOSIMETRY DIODE, T60008 Ptw-New York Corp. | IYE |
| Jun 8, 2001 | K003778 | BREAST-BOARD (MULTIPLE) Arplay Medical S.A., FR | IYE |
| May 17, 2001 | K010464 | RADCALC, MODEL V.4.0 Lifeline Software, Inc. | IYE |
| May 8, 2001 | K010472 | PATIENT DOSE VERIFICATION SYSTEM, MODEL TN-RD-50 Thomson & Nielsen Electronics, Ltd., CA | IYE |
| May 4, 2001 | K010449 | IVD (IN VIVO DOSIMETER), MODEL 1131 Sun Nuclear Corp. | IYE |
| May 2, 2001 | K010975 | ECLIPSE 6.5 Varian Medical Systems, Inc. | IYE |
| Apr 24, 2001 | K010225 | DOSIMETRY CHECK Math Resolutions, LLC | IYE |
| Apr 18, 2001 | K010174 | TRAY ADAPTERS, MULTIPLE Arplay Medical S.A., FR | IYE |
| Apr 2, 2001 | K010063 | COUCH FOR TOTAL BODY RADIATION Arplay Medical S.A., FR | IYE |
| Mar 13, 2001 | K010062 | STYROFOAM CUTTERS FOR BLOCK CASTING SYSTEM Arplay Medical S.A., FR | IYE |
| Mar 13, 2001 | K004015 | BEAM BLOCK TRAYS Arplay Medical S.A., FR | IYE |
| Feb 2, 2001 | K003636 | PORTALVISION Varian Medical Systems, Inc. | IYE |
| Jan 4, 2001 | K003330 | AKTINA MEDICAL PHYSICS CORPORATION ACTIVE BREATHING COORDINATOR (ABC) Aktina Medical Physics Corp. | IYE |
| Nov 16, 2000 | K002608 | INVAC Duncan Hynd Associates, Ltd. | IYE |
| Oct 20, 2000 | K000246 | RADIOCAMERAS EXTRACRANIAL SYSTEM Surgical Navigation Technologies, Inc. | IYE |
| Oct 18, 2000 | K002444 | PRECISION DOSIMETRY ELECTROMETER, MODEL 1010 OR 206 Sun Nuclear Corp. | IYE |
| Sep 28, 2000 | K001833 | PREFERENCE TREATMENT SYSTEM Northwest Medical Physics Equipment, Inc. | IYE |
| Sep 5, 2000 | K002051 | INVIDOS Scanditronix Medical AB, SE | IYE |
| Aug 30, 2000 | K001052 | MED-TEC (MEDICAL INTELLIGENCE) BODYFIX SYSTEM, MODEL MT-BFX Med-Tec,Inc. | IYE |
| Aug 18, 2000 | K000209 | DOSE 1 Scanditronix Wellhofer North America | IYE |
| Jun 23, 2000 | K001643 | VARIS 1.4G Varian Medical Systems, Inc. | IYE |
| Jun 22, 2000 | K990209 | NOVAC7 Hitesys S.P.A. | IYE |
| Mar 27, 2000 | K991133 | MLC FIT Impac Medical Systems, Inc. | IYE |
| Mar 22, 2000 | K994355 | RADIOCAMERAS SYSTEM HEAD/NECK APPLICATION Surgical Navigation Technologies, Inc. | IYE |
| Feb 14, 2000 | K993960 | PERMA-DOC PHANTOM Mick Radio-Nuclear Instruments, Inc. | IYE |
| Feb 14, 2000 | K993959 | ISOCENTRIC BEAM CHECKER Mick Radio-Nuclear Instruments, Inc. | IYE |
| Feb 10, 2000 | K992689 | MU PLUS Rad Therapy Solutions, Inc. | IYE |
| Feb 2, 2000 | K993742 | SUPER TISSUE I.Z.I. Corp. | IYE |
| Dec 21, 1999 | K993359 | RAPTOR TREATMENT PLANNING SYSTEM Nomos Corp. | IYE |
| Dec 15, 1999 | K993594 | CONFORMAX MMLC VR1 Radionics, Inc. | IYE |
| Nov 26, 1999 | K993425 | PRIMUS Siemens Medical Solutions USA, Inc. | IYE |
| Sep 21, 1999 | K991319 | RAYCAST IMMOBILIZATION SYSTEMS HARDWARE AND THERMOPLASTIC MATERIALS Orfit Industries | IYE |
| Sep 3, 1999 | K991966 | THE NOMOS CHANE II Nomos Corp. | IYE |
| Jul 30, 1999 | K991546 | AKTINA MEDICAL PHYSICS CORPORATION TILT BOARD Aktina Medical Physics Corp. | IYE |
| Jul 30, 1999 | K991523 | TLC PEDIATRIC FRAME, MODEL TLC-SYS Radionics, Inc. | IYE |
| Jul 12, 1999 | K991336 | BODYLOC WHOLE BODY STEREOTACTIC LOCALIZER SYSTEM FOR RADIOTHERAPY Medical Instrumentation & Diagnostics Corp.(Midco) | IYE |
| Jun 29, 1999 | K991107 | SHADOW TRAYS Mick Radio-Nuclear Instruments, Inc. | IYE |
| Jun 22, 1999 | K990997 | AKTINA MEDICALPHYSICS CORPORATION MECHANICAL FRONTPOINTER Aktina Medical Physics Corp. | IYE |
| Jun 8, 1999 | K990833 | DOSE CALC, MODEL VS. 1.02 Integrity Medical Software, Inc. | IYE |
| May 28, 1999 | K990734 | DPD-12PCC Scanditronix Medical AB, SE | IYE |
| May 12, 1999 | K984241 | ROCS ULTRASEED Radiation Oncology Computer Systems | IYE |
| May 5, 1999 | K990383 | APOLLO 5, APOLLO 10 Precitron A.B., SE | IYE |
| Apr 2, 1999 | K981535 | FOCUS PILOT CONTOURING WORKSTATION Computerized Medical Systems, Inc. | IYE |
| Mar 17, 1999 | K981153 | OSIRIS Huestis Medical | IYE |
| Feb 8, 1999 | K990085 | MILLENNIUM MLC -120 Varian Assoc., Inc. | IYE |
| Dec 30, 1998 | K982549 | RADIONICS MINI MULTI-LEAF COLLIMATOR, MODEL RADIONICS MMLC Radionics, Inc. | IYE |
| Nov 12, 1998 | K981911 | PROFA Duncan Hynd Associates, Ltd. | IYE |
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