FDA Product Code
FDA Product Code JAA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1650
510(k) Clearances — 300 records · page 3 of 3
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K902535 | SONY WBS-700H VIDEOCASSETTE RECORDER SYSTEM | Sony Medical Electronics Co. | 1990-06-29 | Traditional | PDF ↗ |
| K901405 | DIGIFORMER HR DFP-50A | Toshiba America Medical Systems, In.C | 1990-05-07 | Traditional | PDF ↗ |
| K901323 | HYDRA VIEW IMAGING SYSTEM | Mallinckrodt Group, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K901153 | SONY VO-5800H VIDEOCASSETTE RECORDER | Sony Medical Electronics Co. | 1990-04-19 | Traditional | PDF ↗ |
| K900893 | CARDIOVUE CFS-100 | Bv Medical Equipment Co. | 1990-04-19 | Traditional | PDF ↗ |
| K896331 | V2465P X-RAY IMAGE INTENSIFIER | Hamamatsu Photonics K.K. | 1989-12-22 | Traditional | PDF ↗ |
| K895546 | MODIFIED SPANTRON FRAME FREEZE | Spantron, Inc. | 1989-11-13 | Traditional | PDF ↗ |
| K895394 | MOBILE X-RAY TELEVISION UNIT WHA-10A/B | Shimadzu Corp. | 1989-11-13 | Traditional | PDF ↗ |
| K895730 | X-RAY EQUIPMENT (VARIOUS TYPES) | Continental X-Ray Corp. | 1989-11-06 | Traditional | PDF ↗ |
| K894913 | DA-100HS | Fischer Imaging Corp. | 1989-09-18 | Traditional | PDF ↗ |
| K893475 | UROVIEW II | Oec-Diasonics, Inc. | 1989-08-10 | Traditional | PDF ↗ |
| K893644 | PK2025/PK2045 PROGRAMMABLE VIDEO CONTROLLER | Perkins Mfg. Co. | 1989-08-09 | Traditional | PDF ↗ |
| K893476 | ANGIOTEC SPX SPLIT SCREEN DUAL CHANNEL SCAN CONV. | Andros Analyzers, Inc. | 1989-06-23 | Traditional | PDF ↗ |
| K893131 | DIGITAL SPOT IMAGING (DSI) | Philips Medical Systems, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K884598 | SHIMADZU DIGITAL SUBTRACTION SYSTEM DAR-1200 | Shimadzu Precision Instruments, Inc. | 1989-04-20 | Traditional | PDF ↗ |
| K884028 | MULTI CAMERA CONTROL UNIT (MCCU) | Leybold-Inficon, Inc. | 1989-03-15 | Traditional | PDF ↗ |
| K890878 | PHOTOMULITPLIER TUBE INTERFACE P.C. BOARD | U.S. Imaging, Inc. | 1989-03-14 | Traditional | PDF ↗ |
| K890745 | SC-1000 WITH SUFFIXES (SCAN CONVERTER) | Eigen | 1989-03-14 | Traditional | PDF ↗ |
| K884578 | POLARIX 2 AND POLARIX 2E | Dyna-Med | 1989-02-09 | Traditional | PDF ↗ |
| K883580 | UNIVERSAL ABC CONTROLER | Philips Medical Systems (Cleveland), Inc. | 1989-01-09 | Traditional | PDF ↗ |
| K884317 | MEDRAD FLUOROSCOPIC VIDEO ENHANCEMENT SYSTEM | Medrad, Inc. | 1988-12-20 | Traditional | PDF ↗ |
| K883372 | ALPHA MC-9S MOBIL C-ARM IMAGE INTENSIFIER UNIT | Ausonics Pty , Ltd. | 1988-11-25 | Traditional | PDF ↗ |
| K883985 | CARDIAC CX | Fischer Imaging Corp. | 1988-11-21 | Traditional | PDF ↗ |
| K883161 | HIMOBILIX 2N | Bay X-Ray, Inc. | 1988-10-21 | Traditional | PDF ↗ |
| K882311 | SHIMADZU LATERAL C-ARM MH-31 | Shimadzu Precision Instruments, Inc. | 1988-09-14 | Traditional | PDF ↗ |
| K882175 | HR-2000 W/SUFFIXES B,C,D, CARDIO & DIGI LOOP, DDVP | Eigen | 1988-08-19 | Traditional | PDF ↗ |
| K882176 | VTR-12 | Eigen | 1988-08-11 | Traditional | PDF ↗ |
| K880527 | CEILING MOUNTED FLUOROSCOPIC C-ARM ARIEL C-ARM | Fischer Imaging Corp. | 1988-02-29 | Traditional | PDF ↗ |
| K874905 | P2020 MOBILE C-ARM IMAGE INTENSIFIER | Photo Medic Equipment, Inc. | 1988-02-26 | Traditional | PDF ↗ |
| K874901 | REVELATION, RADIO FLUOROSCOPIC X-RAY EXAM TABLE | Fischer Imaging Corp. | 1988-01-29 | Traditional | PDF ↗ |
| K873985 | FLUORO COVER | Condor Medical | 1988-01-19 | Traditional | PDF ↗ |
| K875157 | SHIMADZU CATHETERIZATION C-ARM STAND MH-50A | Shimadzu Precision Instruments, Inc. | 1988-01-19 | Traditional | PDF ↗ |
| K871743 | VIDEO PLUS MODELS VP500, VP500A AND VP1000 | Camtronics, Ltd. | 1987-06-22 | Traditional | PDF ↗ |
| K872061 | LP LATERAL FLUORO POSITIONER (B5077A) | General Electric Co. | 1987-06-22 | Traditional | PDF ↗ |
| K871911 | THE F SPOON HAND HELD FLUOROSCOPIC COMPRESSION | F. Spoon Co. | 1987-05-29 | Traditional | PDF ↗ |
| K871127 | DTV-4112 FLUOROSCOPIC TELEVISION CAMERA | Adac Laboratories | 1987-05-01 | Traditional | PDF ↗ |
| K870869 | DTV-411OP | Adac Laboratories | 1987-05-01 | Traditional | PDF ↗ |
| K871119 | CANON X-RAY IMAGE DISTRIBUTOR CXI-3-3D | Canon USA, Inc. | 1987-03-31 | Traditional | PDF ↗ |
| K863853 | EAZY COVERS | Superior Medical Products | 1987-03-06 | Traditional | PDF ↗ |
| K870429 | EUSEK-BUSH IN-BATH FILMING DEVICE (#MC-00186) | The Mason Clinic | 1987-02-11 | Traditional | PDF ↗ |
| K864749 | TELAMAT | Comet Ltd. C/O Radiology Resources, Inc. | 1987-02-10 | Traditional | PDF ↗ |
| K864837 | MODIFIED MAINFRAME OF MODEL 902 MOBILE C-ARM | Oec-Diasonics, Inc. | 1987-01-30 | Traditional | PDF ↗ |
| K864584 | FLUOROVISION CONTRAST ENHANCER | Digivision, Inc. | 1986-12-29 | Traditional | PDF ↗ |
| K862120 | SCX SYSTEM | General Electric Co. | 1986-06-16 | Traditional | PDF ↗ |
| K861785 | FLUOROSCOPE BAND BAG | Medi-Plast Intl., Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K854953 | DIAMED MODELS 600, 900, 960, 964 | Diamed Division Ill. Tool Works, Inc. | 1986-04-22 | Traditional | PDF ↗ |
| K852346 | XISCAN MODEL 1000 | Xi Tech | 1986-03-10 | Traditional | PDF ↗ |
| K855213 | PET-SCOPE II IMAGE INTENSIFIER | Philips Medical Systems (Cleveland), Inc. | 1986-01-10 | Traditional | PDF ↗ |
| K853984 | CANON X-RAY IMAGE DISTRIBUTOR | Canon USA, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K851031 | EXPOSCOP MOBILE IMAGING SYSTEM | Euro-Electronics, Inc. | 1985-05-28 | Traditional | PDF ↗ |
| K850959 | EQUIPMENT SNAP KOVERS | Advance Medical Designs, Inc. | 1985-04-09 | Traditional | PDF ↗ |
| K844375 | EIGEN FLORO-STOR FS-100 | Eigen Video | 1985-03-26 | Traditional | PDF ↗ |
| K843920 | FLUOROSCAN/TM BY HEALTHMATE | Healthmate, Inc. | 1985-02-07 | Traditional | PDF ↗ |
| K843972 | ANGIOPLUS-S | Oec-Diasonics, Inc. | 1985-01-03 | Traditional | PDF ↗ |
| K843917 | FLUOROSCOPIC AUTOMATIC BRIGHTNESS CNTL | Afp Imaging Corp. | 1985-01-03 | Traditional | PDF ↗ |
| K843235 | STENOSCOP | Cgr Medical Corp. | 1984-11-08 | Traditional | PDF ↗ |
| K842217 | IDAS DIGITAL FLUOROSCOPIC IMAGINS SYS | Micro Consultants, Inc. | 1984-11-08 | Traditional | PDF ↗ |
| K842191 | DIGISTORE 50 | Vas Corp. | 1984-10-25 | Traditional | PDF ↗ |
| K840621 | FLUOROSCOPIC IMAGE INTENSIFIER | Phoenix Radiology, Ltd. | 1984-06-05 | Traditional | PDF ↗ |
| K840225 | C-ARM CEILING CRANE FT-2 | Medicor USA , Ltd. | 1984-03-22 | Traditional | PDF ↗ |
| K840364 | REGISTREX 1000 PLUS DIGITAL RADIOGRAPHY | Advanced Technology Laboratories, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K840134 | CAMTEX 1000 | Digital Imaging Co. of America | 1984-03-16 | Traditional | PDF ↗ |
| K840191 | DIGITAL FLUOROGRAPHY X-RAY SYSTEM | Adac Laboratories | 1984-03-16 | Traditional | PDF ↗ |
| K840390 | TECHNICARE MODEL 1047 | Technicare Corp. | 1984-02-21 | Traditional | PDF ↗ |
| K834287 | DIGITAL RADIOGRAPHY SYS-DPS7100 | Adac Laboratories | 1984-01-10 | Traditional | PDF ↗ |
| K834286 | BI-PLANE DIGITAL FLUOROGRAPHY DFX7000 | Adac Laboratories | 1984-01-04 | Traditional | PDF ↗ |
| K833641 | IMAGE INTENSIFIER TUBE W/HOUSING & | Varian Assoc., Inc. | 1983-12-30 | Traditional | PDF ↗ |
| K833531 | CT SCANNING ACCESSORIES | Lds Hospital | 1983-12-08 | Traditional | PDF ↗ |
| K833237 | DIGITAL RADIOGRAPHY SYS DUAL GANTRIES | American Science and Engineering, Inc. | 1983-12-08 | Traditional | PDF ↗ |
| K833530 | DIGITAL FLUOROGRAPHIC X-RAY SYSTEM | General Electric Co. | 1983-11-21 | Traditional | PDF ↗ |
| K833230 | REGISTREX 1000 DIGITAL RADIOGRAPHY SYS | Advanced Technology Laboratories, Inc. | 1983-11-21 | Traditional | PDF ↗ |
| K827489 | HYPERLUX 30 IMAGE SYSTEM | Cgr Medical Corp. | 1982-11-04 | Traditional | PDF ↗ |
| K820178 | PI808 MOBILE C-ARM IMAGE INTENSIFIER | Precise Optics | 1982-03-04 | Traditional | PDF ↗ |
| K820184 | LATERAL ANGULATING FLUORO SUSPENSION | General Electric Co. | 1982-02-24 | Traditional | PDF ↗ |
| K813158 | RDP-2000 | Machlett Laboratories, Inc. | 1982-01-19 | Traditional | PDF ↗ |
| K813217 | DIGITAL FLUROGRAPHIC IMAGING SYSTEM | Diasonics, Inc. | 1981-12-29 | Traditional | PDF ↗ |
| K812963 | IBIS II | Cgr Medical Corp. | 1981-11-24 | Traditional | PDF ↗ |
| K812775 | FLUORICON L300 IMAGE INTENSIFIER | General Electric Co. | 1981-11-06 | Traditional | PDF ↗ |
| K812561 | LATERAL ANGULATING FLUORO SUSPENSION SYS | General Electric Co. | 1981-10-13 | Traditional | PDF ↗ |
| K812217 | FLUORO AUTOMATIC BRIGHTNESS SYS | Keystone X-Ray, Inc. | 1981-09-16 | Traditional | PDF ↗ |
| K811094 | CARDIAC 1000 TM | American Edwards Laboratories | 1981-07-28 | Traditional | PDF ↗ |
| K811295 | DIGITAL NOISE REDUCER | Philips Medical Systems (Cleveland), Inc. | 1981-06-23 | Traditional | PDF ↗ |
| K810716 | X-RAY IMAGE INTENSIFIER PRODUCTS | Instrumentation Camera, Inc. | 1981-04-23 | Traditional | PDF ↗ |
| K810364 | DIGITAL RADIOGRAPHY SYSTEM | Adac Laboratories | 1981-03-11 | Traditional | PDF ↗ |
| K810189 | SIRECON COMPACT | Siemens Corp. | 1981-03-02 | Traditional | PDF ↗ |
| K802953 | DIGITAL FLUOROGRAPHIC X-RAY SYSTEM | General Electric Co. | 1981-01-09 | Traditional | PDF ↗ |
| K802150 | DIGITAL RADIOGRAPHY SYSTEM | Adac Laboratories | 1980-10-23 | Traditional | PDF ↗ |
| K801948 | DIGITAL SUBTRACTION RADIOGRAPHY SYSTEM | Technicare Corp. | 1980-09-26 | Traditional | PDF ↗ |
| K801320 | SFX-90 TABLE/SPOTFILMER W/FLUORICON L200 | General Electric Co. | 1980-07-21 | Traditional | PDF ↗ |
| K801166 | PET-SCOPE II MODEL DIS-1611 | Diagnostic Information, Inc. | 1980-06-26 | Traditional | PDF ↗ |
| K800639 | ORBITOR | Philips Medical Systems (Cleveland), Inc. | 1980-05-14 | Traditional | PDF ↗ |
| K792225 | P1806 MOBILE C-ARM IMAGE INTENSIFIER | Precise Optics | 1979-12-20 | Traditional | PDF ↗ |
| K791830 | L/U ARM - NEURO - VASCULAR #B5080B | General Electric Co. | 1979-10-26 | Traditional | PDF ↗ |
| K781711 | EVALUSKOP | Siemens Corp. | 1978-10-24 | Traditional | PDF ↗ |
| K771485 | PET-TV X-RAY IMAGE INTENSIFIER SYSTEM | Diagnostic Information, Inc. | 1977-08-16 | Traditional | PDF ↗ |
| K771298 | 6 L.L. SYSTEM | Toshiba Medical Systems | 1977-08-03 | Traditional | PDF ↗ |
| K771096 | TELHTHERAPY SIMULATOR AECL-CP, G-3200 | Atomic Energy of Canada | 1977-07-01 | Traditional | PDF ↗ |
| K770333 | FLUOROSCOPE, C-ARM | Litton Medical Systems | 1977-03-01 | Traditional | PDF ↗ |
| K770337 | FLUOROSCOPIC ASSEMBLY, IMAGE INTENS. | Litton Medical Systems | 1977-03-01 | Traditional | PDF ↗ |
| K761285 | PET-SCOPE | Diagnostic Information, Inc. | 1976-12-29 | Traditional | PDF ↗ |
Product code JAA · Class II · Radiology. Data: openFDA.