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 6 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K982713 | RT DESKTOP | Elekta Oncology Systems, Ltd. | 1998-11-02 | Traditional | PDF ↗ |
| K982624 | MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242 | Med-Tec,Inc. | 1998-10-26 | Traditional | PDF ↗ |
| K981597 | RADIONICS SLICE EDITOR IMAGING SOFTWARE UTILITY | Radionics, Inc. | 1998-10-09 | Traditional | PDF ↗ |
| K982463 | EXTRACRANIAL RADIOTHERAPY SYSTEM | Howmedica, Inc. | 1998-09-30 | Traditional | PDF ↗ |
| K981055 | XKNIFE-4 | Radionics, Inc. | 1998-09-29 | Traditional | PDF ↗ |
| K981790 | IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW | Elekta Oncology Systems, Ltd. | 1998-08-07 | Traditional | PDF ↗ |
| K982513 | MX MEVATRON | Siemens Medical Solutions USA, Inc. | 1998-07-31 | Special | PDF ↗ |
| K982502 | GENESIS IMRT LINEAR ACCELERATOR | Siemens Medical Solutions USA, Inc. | 1998-07-31 | Special | PDF ↗ |
| K981424 | NOMOS BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM | Nomos Corp. | 1998-07-17 | Traditional | PDF ↗ |
| K981346 | RADIOCAMERAS BITEBLOCK LOCALIZATION AND POSITIONING SYSTEM | Surgical Navigation Technologies, Inc. | 1998-07-10 | Traditional | PDF ↗ |
| K981313 | SEQUENCER | Impac Medical Systems, Inc. | 1998-07-09 | Traditional | PDF ↗ |
| K980904 | MUCHECK MONITOR UNIT VALIDATION PROGRAM | Medical Dosimetry Services, Inc. | 1998-06-08 | Traditional | PDF ↗ |
| K973936 | FOCUS RTP SYSTEM | Computerized Medical Systems, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K980826 | EQUIDOSE SOLID STATE DIODE DETECTORS | Cii Mastek, Inc. | 1998-06-01 | Traditional | PDF ↗ |
| K980750 | RADIOCAMERAS PATIENT POSITIONING SYSTEM | Surgical Navigation Technologies, Inc. | 1998-05-20 | Traditional | PDF ↗ |
| K980379 | PROWESS PRO-SIM | Ssgi Prowess Systems | 1998-05-18 | Traditional | PDF ↗ |
| K980629 | VSS, VIRTUAL SIMULATION SYSTEM | Nucletron Corp. | 1998-05-06 | Traditional | PDF ↗ |
| K980402 | CAPINTEC MODEL 292 ELECTROMETER | Capintec, Inc. | 1998-04-24 | Traditional | PDF ↗ |
| K974703 | CARBON FIBER BREAST BOARD | Medtec, Inc. | 1998-03-10 | Traditional | PDF ↗ |
| K974700 | MATRIX MT-MX3 | Medtec, Inc. | 1998-03-04 | Traditional | PDF ↗ |
| K974310 | NOMOS SLIT COLLIMATOR (BEAK) | Nomos Corp. | 1998-02-06 | Traditional | PDF ↗ |
| K972816 | ADVANCED TREATMENT PLANNING SYSTEM | Advanced Radiation Therapy Systems, Inc. | 1998-01-23 | Traditional | PDF ↗ |
| K972451 | COREGISTRATION FUNCTION | Nomos Corp. | 1998-01-22 | Traditional | PDF ↗ |
| K973963 | 120 LEAF MULTILEAF COLLIMATOR | Mitsubishi Electronics America, Inc. | 1998-01-14 | Traditional | PDF ↗ |
| K973540 | ELEKTA ONCOLOGY SYSTEMS ICOM/QUICKMODE SOFTWARE OPTIONS | Elekta Oncology Systems, Inc. | 1997-12-17 | Traditional | PDF ↗ |
| K973889 | VARIAN MULTILEAF COLLIMATOR WITH DYNAMIC ARC THERAPY FEATURE | Varian Medical Systems, Inc. | 1997-11-21 | Traditional | PDF ↗ |
| K971893 | SNT LINAC ACCESSORIES | Surgical Navigation Technologies, Inc. | 1997-11-13 | Traditional | PDF ↗ |
| K972905 | XPLAN-1 | Radionics Software Applications, Inc. | 1997-10-28 | Traditional | PDF ↗ |
| K971367 | BRAINSCAN CONFORMAL RT MODULE | Brainlab AG | 1997-10-27 | Traditional | PDF ↗ |
| K972804 | BANG POLYMER GEL DOSIMETER, BANG 533 | Mgs Research, Inc. | 1997-10-23 | Traditional | PDF ↗ |
| K972709 | TBI STAND | Mick Radio-Nuclear Instruments, Inc. | 1997-10-16 | Traditional | PDF ↗ |
| K972617 | HELAX-VISIR | Helax AB | 1997-10-01 | Traditional | PDF ↗ |
| K972275 | LANTIS TREATSTATION | Siemens Medical Solutions USA, Inc. | 1997-09-08 | Traditional | PDF ↗ |
| K970464 | P REFERENCE TPS (TREATMENT PLANNING SOFTWARE) 1.1 | Northwest Medical Physics Equipment, Inc. | 1997-09-05 | Traditional | PDF ↗ |
| K963451 | ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING | Topslane | 1997-08-05 | Traditional | PDF ↗ |
| K970384 | VELOS CONSTANCY CHECK DEVICE, MODEL 55-145 | Aktina Medical Physics Corp. | 1997-07-29 | Traditional | PDF ↗ |
| K965010 | TARGET 2 VERSION 1.1 | GE Medical Systems | 1997-07-23 | Traditional | PDF ↗ |
| K962950 | CADPLAN, VERSION 2.62. RADIATION THERAPY TREATMENT PLANNING SYSTEM | Varian Medical Systems, Inc. | 1997-07-22 | Traditional | PDF ↗ |
| K970236 | THERAPLAN PLUS VERSION 1.2 | Theratronics, Inc. | 1997-07-09 | Traditional | PDF ↗ |
| K964206 | NUCLETRON PLATO EXTERNAL BEAM PLANNING RTS V2 AND RTS 3D V2 | Nucletron Corp. | 1997-06-20 | Traditional | PDF ↗ |
| K964785 | VERIDOSE DIODES | Victoreen, Inc. | 1997-06-13 | Traditional | PDF ↗ |
| K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 | Victoreen, Inc. | 1997-06-06 | Traditional | PDF ↗ |
| K970586 | BRAINLAB MICRO MULTI-LEAF COLLIMATOR | Brainlab Med. Computersysteme GmbH | 1997-05-12 | Traditional | PDF ↗ |
| K970564 | DYNAMIC WEDGE | Mitsubishi Electronics America, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K970291 | ACCESSORIES TO THE STEREOTACTIC BODY FRAM | Elekta Instrument AB | 1997-04-24 | Traditional | PDF ↗ |
| K970137 | EXL-12SP,12DP,15DP,20DP LINAC | Mitsubishi Electronics America, Inc. | 1997-04-15 | Traditional | PDF ↗ |
| K964517 | LINAC SCALPEL FLOORSTAND | Surgical Navigation Technologies, Inc. | 1997-04-01 | Traditional | PDF ↗ |
| K964167 | DECISION SUPPORT SYSTEM (FOR RADIATION ONCOLOGY) | Multidata Systems International Corp. | 1997-03-21 | Traditional | PDF ↗ |
| K964840 | BEAM BLOCK TRAYS | Aktina Medical Physics Corp. | 1997-02-11 | Traditional | PDF ↗ |
| K962335 | MLC FIT | Impac Medical Systems, Inc. | 1997-02-06 | Traditional | PDF ↗ |
| K964485 | PORTPRO ELECTRONIC PORTAL IMAGING SYSTEM | Eliav , Ltd. | 1997-02-04 | Traditional | PDF ↗ |
| K961400 | RFA-300, LDA UTILITY | Scanditronix Medical AB | 1997-01-03 | Traditional | PDF ↗ |
| K963860 | THE NOMOS TALON POSITIONING AND IMMOBILIZATION SYSTEM | Nomos Corp. | 1996-12-23 | Traditional | PDF ↗ |
| K963624 | PHILIPS SLI SERIES LINEAR ACCELERATOR | Philips Medical Systems, Inc. | 1996-12-06 | Traditional | PDF ↗ |
| K963258 | PEACOCK SYSTEM | Nomos Corp. | 1996-11-18 | Traditional | PDF ↗ |
| K962792 | LINAC SCALPEL TREATMENT PLANNING SYSTEM | Surgical Navigation Technologies, Inc. | 1996-11-12 | Traditional | PDF ↗ |
| K954679 | THERAPLAN PLUS | Theratronics, Inc. | 1996-11-08 | Traditional | PDF ↗ |
| K961484 | CASS SYSTEM (MODIFICATION) | Medical Instrumentation & Diagnostics Corp.(Midco) | 1996-11-07 | Traditional | PDF ↗ |
| K962487 | BREAST TREATMENT AID M200 | S. and H. Engineering, Inc. | 1996-09-09 | Traditional | PDF ↗ |
| K962080 | RPS-50 BEAM SCANNER | Sofield Science Services, Inc. | 1996-08-23 | Traditional | PDF ↗ |
| K962155 | GILL-THOMAS-COSMAN(GTC) DENTAL TRAY | Radionics Software Applications, Inc. | 1996-08-22 | Traditional | PDF ↗ |
| K961467 | HEAD RETAINING DEVICE | S. and H. Engineering, Inc. | 1996-08-09 | Traditional | PDF ↗ |
| K961214 | MULTI LEAF COLLIMATOR | Mitsubishi Intl. Corp. | 1996-08-06 | Traditional | PDF ↗ |
| K954861 | BRAINLAB CT/X-RAY LOCALIZER | Brainlab Med. Computersysteme GmbH | 1996-08-05 | Traditional | PDF ↗ |
| K960293 | MRTOFLM COMPUTER PROGRAM | Northwest Medical Physics Equipment, Inc. | 1996-08-01 | Traditional | PDF ↗ |
| K961170 | BREAST TREATMENT AID | S. and H. Engineering, Inc. | 1996-06-19 | Traditional | PDF ↗ |
| K961208 | 0.6CC IONIZATION CHAMBER - WATERPROOF 0.6CC IONIZATION CHAMBER | Ptw-New York Corp. | 1996-06-17 | Traditional | PDF ↗ |
| K960834 | KODAK EC-L CASSETTE | Eastman Kodak Company | 1996-05-28 | Traditional | PDF ↗ |
| K960338 | STEREOTACTIC BODY FRAME | Elekta Instrument AB | 1996-04-23 | Traditional | PDF ↗ |
| K954564 | PID-1 PRECISION INTELLIGENT DOSIMETER | Gammex, Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K960510 | THERAVIEW | Infimed, Inc. | 1996-04-22 | Traditional | PDF ↗ |
| K940663 | PEACOCK PLAN | Nomos Corp. | 1996-04-09 | Traditional | PDF ↗ |
| K951581 | PINNACLE3 APEX | Adac Laboratories | 1996-04-08 | Traditional | PDF ↗ |
| K955774 | VARIS PORTALVISION | Varian Assoc., Inc. | 1996-03-15 | Traditional | PDF ↗ |
| K953508 | COMPUTE-RX PLAN PC3D | Medicalibration Physics Consultant Services, Inc. | 1996-02-26 | Traditional | PDF ↗ |
| K943224 | VARIAN MULTILEAF COLLIMATOR | Varian Assoc., Inc. | 1996-02-02 | Traditional | PDF ↗ |
| K952314 | EXL-12SP & 12DP LINAC | Mitsubishi Intl. Corp. | 1996-01-17 | Traditional | PDF ↗ |
| K954705 | ACRYSTEEL BLOCKING TRAY | Medtec, Inc. | 1996-01-05 | Traditional | PDF ↗ |
| K954634 | RADIOSURGERY VERIFICATION PHANTOM | The Phantom Laboratory, Inc. | 1995-12-22 | Traditional | PDF ↗ |
| K952108 | EXL-15DP & 20-DP LINAC | Mitsubishi Intl. Corp. | 1995-12-21 | Traditional | PDF ↗ |
| K946074 | ALDERSON BREST DOSIMETRY SYSTEM | Radiology Support Devices, Inc. | 1995-12-21 | Traditional | PDF ↗ |
| K954165 | PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM | Ptw-New York Corp. | 1995-12-05 | Traditional | PDF ↗ |
| K940001 | PLATO-SRS(STEREO RADIOSURGERY TREATMENT PLANNING SYS) | Nucletron Corp. | 1995-11-14 | Traditional | PDF ↗ |
| K953570 | PHILIPS MULTI LEAF PRESCRIPTION ENTRY SYSTEM (MLP) | Philips Medical Systems, Inc. | 1995-10-25 | Traditional | PDF ↗ |
| K953482 | XKNIFE-3 | Radionics Software Applications, Inc. | 1995-10-25 | Traditional | PDF ↗ |
| K951764 | UNIDOS UNIVERSAL DOSIMETER MODEL 10002-WITH TNC CONNECTOR, 10005-WITH BNT CONNECTOR | Ptw-New York Corp. | 1995-10-07 | Traditional | PDF ↗ |
| K953046 | PERI-PUSHER | Diacor, Inc. | 1995-09-22 | Traditional | PDF ↗ |
| K952729 | PAINTED WEDGE & ROD BREAST BOARD | Medtec, Inc. | 1995-09-15 | Traditional | PDF ↗ |
| K941118 | HEAD IMMOBILIZATION APPARATUS | Northwest Medical Physics Center | 1995-08-25 | Traditional | PDF ↗ |
| K952457 | RAPID-FOAM | The Soule Co., Inc. | 1995-08-23 | Traditional | PDF ↗ |
| K950061 | HERCULES RADIATION THERAPY COUCH | Precision Therapy Intl., Inc. | 1995-08-16 | Traditional | PDF ↗ |
| K952189 | MED-TEC REDISET | Medtec, Inc. | 1995-08-09 | Traditional | PDF ↗ |
| K944040 | PLANET THERMOPLASTIC IMMOBILIZATION SYSTEM | S & S X-Ray Products, Inc. | 1995-07-21 | Traditional | PDF ↗ |
| K950075 | MED-TEC TRAY ADAPTER | Medtec, Inc. | 1995-07-13 | Traditional | PDF ↗ |
| K945321 | WELLHOFER WP700 V. 3.2 | Medical Physics Instrumentation, Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K951679 | MED-TEC TESTICULAR SEPARATOR | Medtec, Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K951947 | MED-TEC RADIO THERAPY TREATMENT CHAIR | Medtec, Inc. | 1995-07-12 | Traditional | PDF ↗ |
| K951808 | MED-TEC REDI-FOAM | Medtec, Inc. | 1995-07-06 | Traditional | PDF ↗ |
| K951717 | MED-TEC KNEE CRUTCH | Medtec, Inc. | 1995-06-28 | Traditional | PDF ↗ |
| K951143 | PULSE KLYSTRON AMPLIFIFER (L-5822-90) | Litton Systems, Inc. | 1995-06-19 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.