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 7 of 8
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K951142 | PULSE KLYSTRON AMPLIFIER (L-5822-00) | Litton Systems, Inc. | 1995-06-16 | Traditional | PDF ↗ |
| K935615 | MEDICAL LINEAR ACCELERATOR | Accelerator Systems Intl., Inc. | 1995-06-09 | Traditional | PDF ↗ |
| K945903 | BRAINLAB MASK SYSTEM | Brainlab Med. Computersysteme GmbH | 1995-06-05 | Traditional | PDF ↗ |
| K950866 | HIP FIXATION SYSTEM | Medtec, Inc. | 1995-05-30 | Traditional | PDF ↗ |
| K942346 | IMAGERT | Impac Medical Systems, Inc. | 1995-05-15 | Traditional | PDF ↗ |
| K943714 | MICRO MULTILEAF COLLIMATOR | Leibinger F.L. Fischer | 1995-05-12 | Traditional | PDF ↗ |
| K926449 | VARIAN MULTILEAF COLLIMATOR, RELEASE 4.0 | Varian Assoc., Inc. | 1995-05-05 | Traditional | PDF ↗ |
| K933117 | IORT SYSTEM | Northwest Medical Physics Center | 1995-02-16 | Traditional | PDF ↗ |
| K934523 | GILL-THOMAS-COSMAN (GTC) RELOCATABLE HEAD HOLDER SYSTEM WITH DEPTH CONFIRMATION HELMET(DH-1) | Radionics, Inc. | 1995-02-08 | Traditional | PDF ↗ |
| K943464 | PHILIPS IMPROVED CHECK RADIOGRAPH OPTION | Philips Medical Systems North America, Inc. | 1995-02-01 | Traditional | PDF ↗ |
| K940145 | COMPU-CUTTER THERAPEUTIC SHIELDING CUTTING DEVICE | Huestis Machine Corp. | 1995-01-24 | Traditional | PDF ↗ |
| K943406 | RF DRIVER, RADIO FREQUENCY DRIVER | Pro-Comm, Inc. | 1994-12-15 | Traditional | PDF ↗ |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | Victoreen, Inc. | 1994-12-09 | Traditional | PDF ↗ |
| K943199 | MOTORIZED DEPTH DOSE APPARATUS | Medtec, Inc. | 1994-12-07 | Traditional | PDF ↗ |
| K944315 | BLOCKING TRAY | Medtec, Inc. | 1994-11-22 | Traditional | PDF ↗ |
| K926008 | PINNACLE 3 | Adac Laboratories | 1994-10-04 | Traditional | PDF ↗ |
| K930513 | VARIAN RMS-2000, RELEASE 2.5 | Varian Assoc., Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K932501 | VARIAN ORIGAMI, VERSION 1.0 | Varian Assoc., Inc. | 1994-09-23 | Traditional | PDF ↗ |
| K924685 | STP COMPLETE MODULE SET AND MASK FIXATION SYSTEM | Leibinger GmbH | 1994-09-16 | Traditional | PDF ↗ |
| K942083 | ADVANCED THERAPY DOSIMETER | Keithley Instruments, Inc. | 1994-09-02 | Traditional | PDF ↗ |
| K930506 | THERPAC RADIOTHERAPY TREATMENT PLANNING SYSTEM | Pinecliff Assoc. | 1994-08-29 | Traditional | PDF ↗ |
| K926321 | VARIAN C/D-SERIES CLINACS (CLINAC 600 C/D) | Varian Assoc., Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K934303 | RFA A-300 | Scanditronix, Inc. | 1994-08-09 | Traditional | PDF ↗ |
| K942092 | DPD-3 | Scanditronix, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | Victoreen, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K935928 | RIT 113 FILM ANALYSIS SYSTEM | Radiological Imaging Technology, Inc. | 1994-07-29 | Traditional | PDF ↗ |
| K940237 | THERAPLAN V05B/ TP-11 V09B | Theratronics, Inc. | 1994-07-26 | Traditional | PDF ↗ |
| K934657 | BRAINLAB LINAC HARDWARE | Brainlab Med. Computersysteme GmbH | 1994-07-22 | Traditional | PDF ↗ |
| K935411 | MED-TEC, INC. BREAST BOARD, MT-250 | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K935300 | VAC-LOK IMMOBILIZATION SYSTEM | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K942282 | MED-TEC BREAST SUPPORT SYSTEM | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K935412 | MED-TEC, INC. BREAST BOARD, MT-200 | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K933227 | UNI-FRAME HEAD IMMOBILIZATION SYSTEM | Medtec, Inc. | 1994-07-18 | Traditional | PDF ↗ |
| K932598 | TN-RD-50 | Keithley Instruments, Inc. | 1994-06-03 | Traditional | PDF ↗ |
| K935067 | AQUAPLAST | Wfr/Aquaplast Corp. | 1994-05-26 | Traditional | PDF ↗ |
| K922276 | THERAC 25 | Theratronics, Inc. | 1994-05-25 | Traditional | PDF ↗ |
| K926187 | POSICAST IMMOBILIZATION SYSTEM | Huestis Machine Corp. | 1994-04-15 | Traditional | PDF ↗ |
| K935021 | HANDI-FOAM | Medtec, Inc. | 1994-04-07 | Traditional | PDF ↗ |
| K933558 | ARM RADIATION BEAM SCANNER | Advanced Radiation Measurements, Inc. | 1994-03-16 | Traditional | PDF ↗ |
| K930182 | RADIATION TREATMENT FOR CANCER PATIENTS | Northwest Medical Physics Center | 1994-01-05 | Traditional | PDF ↗ |
| K931927 | VICTOREEN MODEL 530 | Victoreen, Inc. | 1993-11-15 | Traditional | PDF ↗ |
| K933493 | RAM-PACS | Medical Knowledge Systems, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K934566 | RADASSIST | Diacor, Inc. | 1993-11-03 | Traditional | PDF ↗ |
| K933613 | 3-WAY HEAD IMMOBILIZER; 3WAY DELUXE REUSABLE FRAME HEAD IMMOBILIZER | Bionix Development Corp. | 1993-10-07 | Traditional | PDF ↗ |
| K933614 | PITUITARY BOARD | Bionix Development Corp. | 1993-10-07 | Traditional | PDF ↗ |
| K923522 | LINAC-BASED STEROTACTIC RADIOSURGERY | Radionics Software Applications, Inc. | 1993-08-18 | Traditional | PDF ↗ |
| K930279 | REFIX(TM) SYSTEM | Nomos Corp. | 1993-07-27 | Traditional | PDF ↗ |
| K930246 | MAMMORX | Diacor, Inc. | 1993-07-26 | Traditional | PDF ↗ |
| K924495 | PHILIPS RTNET RADIOTHERAPY NETWORKING SYSTEM | Philips Medical Systems, Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K925714 | BREAST SIMULATION SYSTEM | Severn Research, Inc. | 1993-06-08 | Traditional | PDF ↗ |
| K924240 | PROWESS 2000 | Small Systems Group, Inc. | 1993-05-17 | Traditional | PDF ↗ |
| K921740 | COMPUTER ASSISTED STEREOTACTIC SURGERY -- MODIFIED | Medical Instrumentation & Diagnostics Corp.(Midco) | 1993-04-07 | Traditional | PDF ↗ |
| K924632 | LCM-2-LINAC COUCH-MOUNT SYSTEM | Radionics, Inc. | 1993-04-07 | Traditional | PDF ↗ |
| K920879 | BRAINSCAN RADIOSURGERY MODULE | Brainlab | 1992-12-29 | Traditional | PDF ↗ |
| K921991 | PLATO RADIATION THERAPY PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1992-11-27 | Traditional | PDF ↗ |
| K911973 | LINEAR ACCELERATOR COLLIMATOR | Medical Equipment Development Co., Inc. | 1992-10-15 | Traditional | PDF ↗ |
| K914698 | SETUP COMPUTER WITH SOFTWARE V-1261,62 AND 63 | K.S., Inc. | 1992-06-05 | Traditional | PDF ↗ |
| K920455 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER (MOD.) | S & S Inficon, Inc. | 1992-03-31 | Traditional | PDF ↗ |
| K920041 | ADAC XL-PLAN-PC | Adac Laboratories | 1992-03-30 | Traditional | PDF ↗ |
| K913612 | SEQUENCER | Impac Medical Systems, Inc. | 1991-12-19 | Traditional | PDF ↗ |
| K913674 | RECORD AND VERIFY MEVATRON ADAPTER | Computerized Medical Systems, Inc. | 1991-11-22 | Traditional | PDF ↗ |
| K913119 | VARIAN C-SERIES CLINACS (CLINAC 2300C/D) | Varian Assoc., Inc. | 1991-11-07 | Traditional | PDF ↗ |
| K913174 | VARIAN CLINAC 600SR | Varian Assoc., Inc. | 1991-11-05 | Traditional | PDF ↗ |
| K912630 | XKNIFE RADIOSURGERY SYSTEM | Rsa, Inc. | 1991-11-04 | Traditional | PDF ↗ |
| K911750 | COMPUTER ASSIST STEREOTACTIC SURG SYST, MODIFIED | Medical Instrumentation & Diagnostics Corp.(Midco) | 1991-10-15 | Traditional | PDF ↗ |
| K911612 | NUCLETRON PLANNING SYSTEM | Nucletron-Oldelft Corp. | 1991-06-13 | Traditional | PDF ↗ |
| K904908 | STEREOTACTIC IRRADIATION SYSTEM | Northwest Medical Physics Center | 1991-06-06 | Traditional | PDF ↗ |
| K901932 | VARIAN ELECTRONIC PORTAL IMAGING SYSTEM | Varian Assoc., Inc. | 1991-05-03 | Traditional | PDF ↗ |
| K904364 | VARIAN C-SERIES CLINACS CLINAC 600C,2100C,2500C | Varian Assoc., Inc. | 1991-02-27 | Traditional | PDF ↗ |
| K905007 | STANDARD BREAST BOARDS; DELUXE BREAST BOARD | Bionix Development Corp. | 1991-02-12 | Traditional | PDF ↗ |
| K903139 | BEAMVIEW & BEAMVIEW PLUS (AKA PROJECT 743) | Siemens Medical Laboratories, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K900434 | MM-22 MICROTRON, MM50 MICROTRON | Scanditronix, Inc. | 1990-10-23 | Traditional | PDF ↗ |
| K902339 | THERAVIEW DIGITAL PORTAL IMAGING COMPUTER | S & S Inficon, Inc. | 1990-08-23 | Traditional | PDF ↗ |
| K902849 | PHILIPS VERIFLEX | Philips Medical Systems, Inc. | 1990-08-03 | Traditional | PDF ↗ |
| K892425 | STP COMPLETE MODULE SET | Leibinger & Fischer , Ltd. | 1990-03-23 | Traditional | PDF ↗ |
| K895697 | VAC FIX(R) SYSTEM | S&S Par Scientific | 1990-01-12 | Traditional | PDF ↗ |
| K894722 | RENNER-PLAN | W.D. Renner Consulting Co. | 1990-01-03 | Traditional | PDF ↗ |
| K895733 | FIBERVISION(TM) | Fiber Imaging, Inc. | 1989-11-21 | Traditional | PDF ↗ |
| K895500 | PATIENT POSITIONING ACCESSORIES | Perkins Mfg. Co. | 1989-11-06 | Traditional | PDF ↗ |
| K894912 | SRI 100 RADIOTHERAPY IMAGING SYSTEM | Philips Medical Systems, Inc. | 1989-10-13 | Traditional | PDF ↗ |
| K894706 | HT-RES RTP SYSTEM | Adac Laboratories | 1989-10-11 | Traditional | PDF ↗ |
| K891292 | SRS-200 RADIOSURGERY SYSTEM | Philips Medical Systems North America, Inc. | 1989-09-18 | Traditional | PDF ↗ |
| K893978 | MEDISYS RECORD AND VERIFY SYSTEM | Medisys, Inc. | 1989-09-01 | Traditional | PDF ↗ |
| K894123 | VERICORD S3 | Philips Medical Systems, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K894230 | PATIENT DATA MANAGEMENT SYSTEM (PROJECT 735) | Siemens Medical Laboratories, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K892845 | SOFTWARE RELEASE 1.3 FOR THE SL SERIES LINEAR ACCE | Philips Medical Systems, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K892860 | SATURNE 41 | General Electric Co. | 1989-06-23 | Traditional | PDF ↗ |
| K883019 | SATURNE 42 AND 43 | General Electric Co. | 1988-11-10 | Traditional | PDF ↗ |
| K883264 | SL SERIES ACCELERATORS SL15, SL18, SL20 & SL25 | Philips Medical Systems, Inc. | 1988-10-11 | Traditional | PDF ↗ |
| K883101 | DVS (OPTION 01) | O.M.I. Oncology Microsystems, Inc. | 1988-10-07 | Traditional | PDF ↗ |
| K883067 | MODIFIED SL-SERIES LINEAR ACCELERATORS | Philips Medical Systems, Inc. | 1988-09-30 | Traditional | PDF ↗ |
| K882231 | SL SERIES, SL 15, 18, 20 & 25 (MODIFICATION) | Philips Medical Systems, Inc. | 1988-09-22 | Traditional | PDF ↗ |
| K882729 | MEVATRON, M 2 CLASS | Siemens Medical Laboratories, Inc. | 1988-09-19 | Traditional | PDF ↗ |
| K882326 | VARIAN CLINAC 1800S | Varian Assoc., Inc. | 1988-09-19 | Traditional | PDF ↗ |
| K880200 | EXL-14 MEDICAL LINEAR ACCELERATOR | Mitsubishi Intl. Corp. | 1988-08-04 | Traditional | PDF ↗ |
| K874558 | SL SERIES, SL 15, 18, 20 & 25 | Philips Medical Systems, Inc. | 1988-05-02 | Traditional | PDF ↗ |
| K873398 | EXL-22DP X-RAY RADIATION THERAPY SYSTEM | Mitsubishi Intl. Corp. | 1988-04-29 | Traditional | PDF ↗ |
| K874893 | MODEL 35300 TRACKER(TM) THERAPY BEAM EVALUATOR | Keithley Instruments, Inc. | 1988-02-17 | Traditional | PDF ↗ |
| K871214 | GRATICULE | Mick Radio-Nuclear Instruments, Inc. | 1987-05-08 | Traditional | PDF ↗ |
| K870525 | PHILIPS MODEL SL75-10 LINEAR ACCELERATOR | Industrial Accelerator Co. | 1987-04-01 | Traditional | PDF ↗ |
Product code IYE · Class II · Radiology. Data: openFDA.