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 |
|---|---|---|---|
| Mar 6, 1997 | K964890 | ANATOM 2000 Analogic Corp. | JAK |
| Feb 10, 1997 | K964747 | SOMATOM PLUS 4 CT SCANNER Siemens Medical Solutions USA, Inc. | JAK |
| Jan 24, 1997 | K964746 | HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION GE Medical Systems | JAK |
| Jan 17, 1997 | K964583 | XRT-7.0 Elscint, Inc. | JAK |
| Jan 10, 1997 | K964318 | PHILIPS TOMOSCAN AV EXPANDER UPGRADE Philips Medical Systems North America, Inc. | JAK |
| Dec 18, 1996 | K963896 | MOBILE CT PROSPEED FAMILY GE Medical Systems | JAK |
| Oct 25, 1996 | K960985 | SLS-CT Bio-Imaging Research, Inc. | JAK |
| Jul 3, 1996 | K961464 | SELECT/SP Elscint, Inc. | JAK |
| Jun 17, 1996 | K961055 | CT PROSPEED CT/I GE Medical Systems | JAK |
| May 14, 1996 | K955583 | VIFS Konica Medical Corp. | JAK |
| Apr 15, 1996 | K950972 | REAL-TIME RECONSTRUCTION SYSTEM MODEL TSXF-001A Toshiba America Medical Systems, In.C | JAK |
| Apr 3, 1996 | K960635 | PULMO CT WITH REFERENCE DATABASE FOR THE SOMATOM PLUS AND PLUS 4 COMPUTED TOMOGRAPHY SYSTEMS Siemens Medical Solutions USA, Inc. | JAK |
| Feb 9, 1996 | K955255 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TX Shimadzu Medical Systems | JAK |
| Jan 30, 1996 | K955268 | PQ-2000+ COMPUTED TOMOGRAPHY X-RAY SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| Jan 26, 1996 | K955254 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-7000TC Shimadzu Medical Systems | JAK |
| Jan 26, 1996 | K955253 | SHIMADZU WHOLE BODY X-RAY SCANNER SCT-7000TH Shimadzu Medical Systems | JAK |
| Oct 19, 1995 | K935454 | DPX TISSUE QUANTIFICATION OUTPUT Lunar Corp. | JAK |
| Oct 7, 1995 | K954255 | PHILIPS TOMOSCAN SR 8000 Philips Medical Systems North America, Inc. | JAK |
| Apr 27, 1995 | K943623 | PQ5000 CT SYSTEM Philips Medical Systems (Cleveland), Inc. | JAK |
| Mar 14, 1995 | K945512 | HRSW OPTION FOR CT TWIN FLASH Elscint, Inc. | JAK |
| Feb 7, 1995 | K944013 | CT PROSPEED FAMILY GE Medical Systems | JAK |
| Jan 25, 1995 | K944131 | ANATOM 2000 Analogic Corp. | JAK |
| Nov 29, 1994 | K944983 | MEDRAD COUNTERPOISE SYSTEM Medrad, Inc. | JAK |
| Oct 21, 1994 | K944326 | PHILIPS TOMOSCAN SR5000 Philips Medical Systems North America, Inc. | JAK |
| Oct 11, 1994 | K936272 | PHILIPS TOMOSCAN SR 4000 Philips Medical Systems North America, Inc. | JAK |
| Sep 20, 1994 | K941546 | SOMATOM PROJECT 059 Siemens Corp. | JAK |
| Aug 23, 1994 | K940606 | HISPEED ADVANTAGE II GE Medical Systems | JAK |
| Jul 29, 1994 | K941745 | TSX-002A (XVISION) CT SCANNER Toshiba America Medical Systems, In.C | JAK |
| Jul 29, 1994 | K932508 | ANGIOCT OPTION FOR CT-TWIN, HELICAT & OMNIVIEW Elscint, Inc. | JAK |
| Jul 5, 1994 | K942040 | MRX-280 Mrx Corp. | JAK |
| Jul 5, 1994 | K935487 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4800TF Shimadzu Corp. | JAK |
| May 17, 1994 | K923524 | VOLUMETRIC RENDERING TECHNIQUE OPTION Siemens Medical Solutions USA, Inc. | JAK |
| Apr 7, 1994 | K924985 | COMPUTERIZED TOMOGRAPHY X-RAY SYSTEM OPTION Siemens Medical Solutions USA, Inc. | JAK |
| Mar 22, 1994 | K932848 | SIMULIX-MC CT EXTENSION Oldelft Corp. of America | JAK |
| Dec 14, 1993 | K934832 | IMPAX 3000 Heraeus Kulzer, Inc. | JAK |
| Sep 13, 1993 | K930765 | ULTRA COMPACT VIDEO IMAGER International Imaging Electronics | JAK |
| Mar 19, 1993 | K930090 | HELICAT Elscint, Inc. | JAK |
| Mar 10, 1993 | K924082 | PHILIPS TOMOSCAN SR7000 CT SYSTEMS Philips Medical Systems, Inc., NL | JAK |
| Feb 2, 1993 | K923077 | ADVANTAGE WINDOWS 3D OPTION AND DENTASCAN OPTION GE Medical Systems | JAK |
| Jan 15, 1993 | K924810 | SIM/PLANT Columbia Scientific, Inc. | JAK |
| Oct 20, 1992 | K921192 | CT SYTEC 6000 COMPUTED TOMOGRAPHY SYSTEM GE Medical Systems | JAK |
| Sep 23, 1992 | K923114 | HEAD RESTRAINT FOR CT TABLES Cook, Inc., CA | JAK |
| Sep 23, 1992 | K923111 | ARM EXTENDER FOR CT TABLES Cook, Inc., CA | JAK |
| Sep 23, 1992 | K923110 | SCAN BAND Cook, Inc., CA | JAK |
| Sep 23, 1992 | K923109 | ADULT CHIN STRAP FOR CT TABLES Cook, Inc., CA | JAK |
| Sep 23, 1992 | K923108 | WRIST RESTRAINT FOR GE9800 C.T. TABLES Cook, Inc., CA | JAK |
| Sep 11, 1992 | K923106 | SCAN BAND Cook, Inc., CA | JAK |
| Jul 21, 1992 | K915738 | EXCEL CT TWIN Elscint, Inc. | JAK |
| May 28, 1992 | K921432 | SHIMADZU WHOLE BODY X-RAY CT SCANNER SCT-4500TF Shimadzu Medical Systems | JAK |
| Feb 27, 1992 | K914305 | SYTEC DENTASCAN General Electric Co. | JAK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.