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 |
|---|---|---|---|
| Sep 21, 2005 | K052447 | SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 Analogic Corp. | JAK |
| Sep 8, 2005 | K052260 | SUPERDIMENSION/BRONCHUS 4.1 Superdimension, Ltd. | JAK |
| Sep 8, 2005 | K052216 | SOMATOM DEFINITION Siemens Medical Systems, Inc. | JAK |
| Aug 25, 2005 | K052157 | INNOVA CT OPTION FOR DIGITAL FLUOROSCOPIC IMAGING SYSTEMS INNOVA MODELS 4100, 4100IQ, 3100, 3100IQ & 2100IQ Ge Medical Systems, LLC | JAK |
| Aug 19, 2005 | K051980 | DVT SCANNER Imaging Sciences Intl., Inc. | JAK |
| Aug 9, 2005 | K052029 | SYNGO CIRCULATION Siemens AG Medical Solutions, DE | JAK |
| Jul 15, 2005 | K051833 | TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER Toshiba America Medical Systems, In.C | JAK |
| Jul 14, 2005 | K051765 | CERETOM, MODEL NL3000 Neurologica Corporation | JAK |
| Apr 14, 2005 | K050867 | SYNGO BODY PERFUSION-CT Siemens AG, DE | JAK |
| Mar 10, 2005 | K050458 | TSX-201A AQUILION LB CT SCANNER Toshiba America Medical Systems, In.C | JAK |
| Mar 1, 2005 | K050297 | SOMATOM EMOTION 16 Siemens Medical Solution, Inc. USA | JAK |
| Feb 3, 2005 | K043469 | SYNGO INSPACE 4D Siemens AG Medical Solutions, DE | JAK |
| Dec 23, 2004 | K043086 | SOMATOM RESPIRATORY GATING Siemens Medical Solutions USA, Inc. | JAK |
| Dec 15, 2004 | K043087 | SOMATOM CARE CONTRAST CT Siemens Medical Solutions USA, Inc. | JAK |
| Nov 18, 2004 | K043111 | PLAQUEVIEW SOFTWARE, MODEL CSPV-0001A Toshiba America Medical Systems, In.C | JAK |
| Nov 8, 2004 | K042438 | SUPERDIMENSION/BRONCHUS Superdimension, Ltd. | JAK |
| Sep 14, 2004 | K042328 | SOMATOM SPIRIT Siemens Medical Systems, Inc. | JAK |
| Sep 8, 2004 | K042293 | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER Philips Medical Systems (Cleveland), Inc. | JAK |
| Sep 1, 2004 | K042229 | SOMATOM RADIATION TREATMENT PLANNING (RTP) PACKAGE Siemens Medical Solution, Inc. USA | JAK |
| Jul 13, 2004 | K040782 | N-VIVO CALCIUM SCORE ON IA CHASSIS RELEASE, MODEL RELEASE X.XX Image Analysis, Inc. | JAK |
| Jun 22, 2004 | K041521 | VOLUME VIEWER PLUS General Electric Medical Systems | JAK |
| Jun 17, 2004 | K041542 | CT-C3000DUAL AND CT-C2800DUAL FAMILY OF DUAL-SLICE CT SCANNER SYSTEMS Neusoft Digital Medical Systems Co., Ltd., CN | JAK |
| May 27, 2004 | K041267 | CARDIQ ANALYSIS III General Electric Medical Systems | JAK |
| Apr 21, 2004 | K040902 | HITACHI PRESTO Hitachi Medical Systems America, Inc. | JAK |
| Apr 6, 2004 | K040224 | CADIMPLANT Praxim, Inc. | JAK |
| Apr 2, 2004 | K040665 | SOMATOM SENSATION 64 AND SENSATION CARDIAC Siemens Medical Solutions USA, Inc. | JAK |
| Mar 22, 2004 | K040577 | SOMATOM PROJECT P30L Siemens Medical Systems, Inc. | JAK |
| Mar 2, 2004 | K033774 | CT-MASS Medis Medical Imaging Systems BV, NL | JAK |
| Mar 1, 2004 | K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Feb 20, 2004 | K033677 | BRAIN PERFUSION OPTION Philips Medical Systems (Cleveland), Inc. | JAK |
| Jan 9, 2004 | K033357 | ACQSIM-MULTISLICE-CT, MODEL 453567042271 Philips Medical Systems (Cleveland), Inc. | JAK |
| Dec 23, 2003 | K033832 | SYNGO PERFUSION-CT Siemens AG Medical Solutions, DE | JAK |
| Nov 20, 2003 | K033502 | LIGHTSPEED 6.0 CT SCANNER SYSTEM Ge Medical Systems, LLC | JAK |
| Nov 10, 2003 | K033418 | TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS Toshiba America Medical Systems, In.C | JAK |
| Nov 10, 2003 | K032823 | MEDICHEART, MODEL RELEASE 1 Medicsight, GB | JAK |
| Nov 10, 2003 | K032536 | SOMATOM EXTENDED FIELD OF VIEW SOFTWARE OPTION Siemens Medical Solutions USA, Inc. | JAK |
| Nov 10, 2003 | K032475 | SOMATON COMPUTED TOMOGRAPHY X-RAY SYSTEMS SLIDING GANTRY OPTION Siemens Medical Solutions USA, Inc. | JAK |
| Nov 5, 2003 | K033102 | MEDIC COLON MODEL, RELEASE 1 Medicsight, GB | JAK |
| Oct 30, 2003 | K032915 | ADVANTAGE 4D OPTION Ge Medical Systems, LLC | JAK |
| Oct 29, 2003 | K033326 | PHILIPS PLUS COMPUTED TOMOGRAPHY SYSTEM Philips Medical Systems, Inc. | JAK |
| Oct 2, 2003 | K032243 | MINICAT DENTOCAT Xoran Technologies, Inc. | JAK |
| Jun 20, 2003 | K031871 | AUTOBONE Ge Medical Systems Europe, FR | JAK |
| May 22, 2003 | K031469 | AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 Toshiba America Medical Systems, In.C | JAK |
| May 21, 2003 | K031206 | RADIOMED SOFT TISSUE MARKER Radiomed Corp. | JAK |
| May 6, 2003 | K031261 | CARD EP GE Medical Systems | JAK |
| May 6, 2003 | K030450 | 3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH J. Morita USA, Inc. | JAK |
| May 6, 2003 | K023943 | CT COLONOGRAPHY Ge Medical Systems, Inc. | JAK |
| Mar 10, 2003 | K030420 | LIGHTSPEED 5.0 COMPUTED TOMOGRAPHY SYSTEM GE Medical Systems | JAK |
| Mar 4, 2003 | K024171 | VIDAR BONE TRACK SYSTEM SOFTWARE Vidar Systems Corp. | JAK |
| Feb 21, 2003 | K024149 | PRIMELUNG Accuimage Diagnostics Corp. | JAK |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.