Philips CT Big Bore
Philips Medical Systems (Cleveland) Inc.
Philips Medical Systems (Cleveland) Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3015442859 | 3015442859 | Philips Medical Systems (Cleveland) Inc. | 1 | N | 2020-04-25 | 100 Park Avenue Suite 300 Orange Village OH US 44122 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 242674 | 1069807376 | K993946 | PEGASYS ULTRA | LLZ | 2000-03-09 |
| 242674 | 1036697622 | K992335 | BEACON-P, MODEL 211059 | KPS | 1999-10-07 |
| 242674 | 2010696512 | K992317 | AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION | KPS | 1999-10-01 |
| 242674 | 1993655324 | K992078 | VANTAGE EXSPECT II | KPS | 1999-09-01 |
| 242674 | 1961019751 | K991607 | VANTAGE 2.5 | KPS | 1999-07-26 |
| 242674 | 1939847733 | K983948 | BEACON, MODEL 211060 | KPS | 1999-04-16 |
| 242674 | 1944720132 | K982911 | FORTE | KPS | 1998-11-16 |
| 242674 | 1176610904 | K981291 | VANTAGE 3.0 INSYNCH | KPS | 1998-06-29 |
| 242674 | 1459698759 | K980867 | 3D-MSPECT | KPS | 1998-06-04 |
| 242674 | 1287294020 | K980715 | AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS) | KPS | 1998-05-06 |
| 242674 | 1478104657 | K974513 | PINPOINT | JAK | 1998-05-20 |
| 242674 | 1090972624 | K974474 | PEGASYS INTOUCH | LLZ | 1998-02-24 |
| 242674 | 1939434747 | K973396 | QUEST PET IMAGING SYSTEM | KPS | 1998-01-21 |
| 242674 | 1473595918 | K973233 | IMAGE FUSION AND REVIEW SYSTEM | KPS | 1997-11-25 |
| 242674 | 1188155278 | K971980 | MCD-AC | KPS | 1997-10-23 |
| 242674 | 1786917280 | K971878 | VANTAGE 2.1 EXSPECT | KPS | 1997-08-08 |
| 242674 | 1833528571 | K964712 | PRISM XPVT SYSTEM (210823) | KPS | 1997-02-21 |
| 242674 | 1107697713 | K962010 | EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS | LLZ | 1997-03-21 |
| 242674 | 1949209068 | K955268 | PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM | JAK | 1996-01-30 |
| 242674 | 1601624393 | K952684 | VERTEX EPIC MCD | KPS | 1995-11-24 |
| 242674 | 1624597113 | K952564 | INSPECT/PROSPECT | KPS | 1995-11-22 |
| 242674 | 1739141321 | K943623 | PQ5000 CT SYSTEM | JAK | 1995-04-27 |
| 242674 | 1159903406 | K943596 | VANTAGE, FOR ADAC GAMMA CAMERAS | KPS | 1995-04-26 |
| 242674 | 1380726319 | K884268 | VOXELSCOPE(TM) | JAK | 1988-12-20 |
| 242674 | 1406713958 | K873075 | ADAC MODEL ARC-5000, GAMMA CAMERA | JWM | 1987-10-30 |
| 242674 | 1781529071 | K193454 | IQon Spectral CT | JAK | 2020-01-24 |
| 242674 | 1739259078 | K172406 | Ingenuity TF | KPS | 2017-10-06 |
| 242674 | 1091718673 | K171850 | Philips CT Big Bore | JAK | 2017-11-09 |
| 242674 | 1978554078 | K163711 | IQon Spectral CT | JAK | 2017-04-05 |
| 242674 | 2033651223 | K162838 | Philips iCT CT System | JAK | 2017-04-07 |
| 242674 | 1602060175 | K160743 | Philips Ingenuity CT | JAK | 2016-08-08 |
| 242674 | 1556382693 | K123599 | INGENUITY DIGITAL PET/CT | KPS | 2013-07-12 |
| 242674 | 1684737691 | K123576 | IMR SOFTWARE APPLICATION | JAK | 2013-06-07 |
| 242674 | 1814093713 | K111336 | EBW NM 2.0 | LLZ | 2011-05-24 |
| 242674 | 1141957110 | K111024 | JETPACK 2.0 | LLZ | 2011-04-21 |
| 242674 | 1339043874 | K103483 | INGENUITY TF PET/MR | OUO | 2011-11-23 |
| 242674 | 1150003882 | K090462 | BRILLIANCE DUAL ENERGY OPTION | JAK | 2009-06-23 |
| 242674 | 1885086905 | K090403 | AUTOSPECT | KPS | 2009-03-31 |
| 242674 | 1034749335 | K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | KPS | 2008-06-04 |
| 242674 | 1652933811 | K081135 | GEMINI CONDOR | KPS | 2008-04-29 |
| 242674 | 1638164832 | K080961 | NM APPLICATION SUITE | LLZ | 2008-04-18 |
| 242674 | 1762800649 | K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | KPS | 2008-04-11 |
| 242674 | 1285072103 | K062298 | APOLLO GAMMA CAMERA SYSTEM | KPS | 2006-08-23 |
| 242674 | 1713262937 | K061029 | JETSTREAM WORKSPACE | LLZ | 2006-05-01 |
| 242674 | 1241609374 | K060937 | BRILLIANCE VOLUME | JAK | 2006-06-05 |
| 242674 | 1220109297 | K060020 | AUTOQUANT PLUS | KPS | 2006-01-20 |
| 242674 | 1895184673 | K052640 | GEMINI RAPTOR | KPS | 2005-10-07 |
| 242674 | 1434490610 | K051170 | GEMINI GXL | KPS | 2005-05-23 |
| 242674 | 1686442247 | K042935 | GEMINI GXL | KPS | 2004-11-09 |
| 242674 | 1173907839 | K042903 | AUTOSPECS | KPS | 2004-10-29 |
| 242674 | 1073389588 | K042880 | JETSTREAM WORKSPACE | KPS | 2004-11-03 |
| 242674 | 1084936311 | K042839 | C-PET PLUS IMAGING SYSTEM | KPS | 2004-10-29 |
| 242674 | 1370138555 | K042293 | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER | JAK | 2004-09-08 |
| 242674 | 2062609912 | K041955 | GEMINI PET/CT IMAGING SYSTEM | KPS | 2004-07-29 |
| 242674 | 1067622764 | K041218 | GRIFFIN SPECT/CT IMAGING SYSTEM | KPS | 2004-05-24 |
| 242674 | 1614389120 | K041182 | SYNTEGRA | KPS | 2004-05-21 |
| 242674 | 1351423502 | K040326 | AUTOQUANT PLUS | KPS | 2004-02-25 |
| 242674 | 1081861725 | K033782 | ALLEGRO IMAGING SYSTEM | KPS | 2003-12-19 |
| 242674 | 1209396406 | K033735 | VANTAGE PRO ATTENUATION CORRECTION DEVICE | KPS | 2003-12-12 |
| 242674 | 1819657787 | K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 | JAK | 2004-01-09 |
| 242674 | 1669786121 | K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM | JAK | 2003-10-29 |
| 242674 | 2003811864 | K033254 | FORTE GAMMA CAMERA SYSTEM | KPS | 2003-10-22 |
| 242674 | 1428712252 | K032036 | GEMINI 16 | KPS | 2003-07-11 |
| 242674 | 1617280204 | K031872 | ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING] | KPS | 2003-06-20 |
| 242674 | 1197781231 | K031705 | SKYLIGHT IMAGING SYSTEM | KPS | 2003-06-17 |
| 242674 | 1730222866 | K022428 | QUANTITATIVE BLOOD POOL SPECT (QBS) | LLZ | 2002-08-06 |
| 242674 | 1471499785 | K013521 | GEMINI IMAGING SYSTEM | JAK | 2001-11-07 |
| 242674 | 2049660029 | K013496 | MODIFICATION TO SKYLIGHT IMAGING SYSTEM | KPS | 2001-11-06 |
| 242674 | 1317535226 | K012009 | MX8000 IDT CT SYSTEM | JAK | 2001-09-13 |
| 242674 | 1422525748 | K010817 | MX8000 V5.0 CT SYSTEM | JAK | 2001-06-15 |
| 242674 | 1420473324 | K003437 | ODYSSEY LX, MODEL 211320 | LLZ | 2001-02-02 |
| 242674 | 1967209313 | K003434 | ALLEGRO TB, ALLEGRO N | KPS | 2000-11-16 |
| 242674 | 1101783922 | K001088 | ULTRASIM CT SYSTEM | JAK | 2000-06-22 |
| 242674 | 1812292934 | K000908 | SKYLIGHT IMAGING SYSTEM | KPS | 2000-04-05 |
Product Codes Associated With Registrations#
PMN#
Ingenuity TF
Philips Medical Systems (Cleveland) Inc.