System, X-Ray, Tomography, Computed
Regulation 892.1750
22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Top companies in JAK
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 12, 2000 | K000819 | PHILIPS CT SECURA MV Philips Medical Systems North America, Inc. | JAK |
| Mar 23, 2000 | K994431 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES Shimadzu Medical Systems | JAK |
| Mar 17, 2000 | K000359 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150. C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRO Imatron, Inc. | JAK |
| Feb 15, 2000 | K000300 | LIGHTSPEED 2.0CT SCANNER SYSTEM Ge Medical Systems, Inc. | JAK |
| Dec 21, 1999 | K993645 | CT/E COMPUTED TOMOGRAPHY SCANNNER SYSTEM Ge Medical Systems, Inc. | JAK |
| Nov 24, 1999 | K993792 | SMART VESSEL ANALYSIS (SMART VA) OPTION Ge Medical Systems, Inc. | JAK |
| Nov 24, 1999 | K993791 | CT PERFUSION OPTION Ge Medical Systems, Inc. | JAK |
| Nov 9, 1999 | K992740 | EBT ULTRAFAST CT SCANNER SYSTEM; ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS Imatron, Inc. | JAK |
| Aug 17, 1999 | K991764 | SOMATOM PROJECT 10-CT SCANNERS Siemens Medical Solutions USA, Inc. | JAK |
| Aug 10, 1999 | K991766 | ECG-GATING SYSTEM FOR AQUILION CT SCANNER, TSX-101A Toshiba America Medical Systems, In.C | JAK |
| Jun 18, 1999 | K991716 | HISPEED NX/I CT SCANNER SYSTEM Ge Medical Systems, Inc. | JAK |
| Jun 9, 1999 | K991600 | SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION Siemens Corp. | JAK |
| Jun 8, 1999 | K991553 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS W/FLUORO OPTION Shimadzu Corp. | JAK |
| May 13, 1999 | K991278 | PHILIPS TOMOSCAN AV-NT Philips Medical Systems North America, Inc. | JAK |
| May 12, 1999 | K990426 | CALCIUM SCORING Siemens Medical Solutions USA, Inc. | JAK |
| Apr 21, 1999 | K984156 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TX W/FLURO OPTION Shimadzu Medical Systems | JAK |
| Mar 19, 1999 | K990134 | MULTISLICE UPGRADE KIT FOR AQUILION CT SCANNER, TSX-101A (AQUILION,MULTI) Toshiba America Medical Systems, In.C | JAK |
| Mar 12, 1999 | K984634 | 3D-ANGIO Siemens Medical Corp. | JAK |
| Nov 24, 1998 | K982536 | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE Siemens Corp. | JAK |
| Nov 19, 1998 | K982010 | FACTS Philips Medical Systems (Cleveland), Inc. | JAK |
| Nov 4, 1998 | K983140 | CT BIOPSYVIEW Philips Medical Systems North America, Inc. | JAK |
| Oct 21, 1998 | K982787 | ASTEION CT SCANNER, TSX-021A Toshiba America Medical Systems, In.C | JAK |
| Oct 6, 1998 | K982631 | PHILIPS TOMOSCAN CS Philips Medical Systems, Inc. | JAK |
| Oct 5, 1998 | K982583 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TXL Shimadzu Corp. | JAK |
| Sep 30, 1998 | K982349 | SOMATOM PLUS 4WITH VOLUME ZOOM CT SCANNERS Siemens Medical Solutions USA, Inc. | JAK |
| Sep 2, 1998 | K982060 | VOLUMAX CT IMAGING SYSTEM Elscint, Inc. | JAK |
| Aug 26, 1998 | K982265 | AQUILION CT SCANNER, MODEL TSX-101A Toshiba America Medical Systems, In.C | JAK |
| Aug 18, 1998 | K982004 | CT CORONARY ARTERY CALCIFICATION SCORING (CACS) OPTION FOR ADVANTAGE WINDOWS General Electric Co. | JAK |
| Jul 6, 1998 | K974715 | ADVANTAGE 3D XR GE Medical Systems | JAK |
| Jun 3, 1998 | K974344 | CT SCOPE Elscint, Inc. | JAK |
| May 20, 1998 | K980837 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7000TS Shimadzu Medical Systems | JAK |
| May 20, 1998 | K974513 | PINPOINT Philips Medical Systems (Cleveland), Inc. | JAK |
| Apr 13, 1998 | K980176 | HISPEED QX/I CT SCANNER SYSTEM General Electric Co. | JAK |
| Apr 13, 1998 | K980169 | HISPEED LX//I, HISPEED FX/I, AND HISPEED DX/I FAMILY OF SYSTEMS General Electric Co. | JAK |
| Feb 20, 1998 | K974455 | ANATOM 1000 (A MINUS, A-) Analogic Corp. | JAK |
| Feb 13, 1998 | K974307 | RTR-2000/RTR-4000 Terarecon,Inc. | JAK |
| Dec 22, 1997 | K973908 | AUKLET CT SCANNER, TSX-003A Toshiba America Medical Systems, In.C | JAK |
| Nov 21, 1997 | K973168 | SMARTVIEW OPTIONS FOR HISPEED CT/I GE Medical Systems | JAK |
| Nov 4, 1997 | K972903 | IMATRON ULTRA ACCESS WORKSTATION WITH CARDIAC SOFTWARE EXTENSIONS Imatron, Inc. | JAK |
| Oct 15, 1997 | K972879 | ULTRAFAST CT SCANNER; EBT CT SCANNER, EVOLUTION Imatron, Inc. | JAK |
| Oct 8, 1997 | K973329 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TX Shimadzu Medical Systems | JAK |
| Oct 8, 1997 | K973327 | SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-6800TH Shimadzu Medical Systems | JAK |
| Sep 23, 1997 | K972399 | ADVANTAGE WINDOWS VOLUME RENDERING OPTION Ge Medical Systems, Inc. | JAK |
| Sep 3, 1997 | K971717 | FLY THROUGH Siemens Medical Solutions USA, Inc. | JAK |
| Jul 14, 1997 | K970819 | TARGOBEAM Ferguson Medical | JAK |
| Jun 13, 1997 | K971054 | OSTEO CT FOR THE SOMATOM AR FAMILY AND PLUS 4 CT SYSTEMS Siemens Medical Solutions USA, Inc. | JAK |
| May 29, 1997 | K970980 | CARDIAC SCORING FOR CT SCANNERS Elscint, Inc. | JAK |
| May 20, 1997 | K970999 | SONY PGM-100P1MD TRINITRON COLOR GRAPHIC MONITOR Sony Medical Systems | JAK |
| Apr 4, 1997 | K970606 | COMPUTED TOMOGRAPHY X-RAY SYSTEM GE Medical Systems | JAK |
| Mar 11, 1997 | K965004 | C.A.R.E. VISION FOR THE SOMATOM PLUS 4 CT SCANNER Siemens Medical Solutions USA, Inc. | JAK |
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