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 |
|---|---|---|---|
| Aug 14, 2015 | K151372 | Low Dose CT Lung Cancer Screening Option for Qualified GE Systems Ge Medical Systems, LLC | JAK |
| Aug 13, 2015 | K151533 | Respiratory Gating for Scanners Varian Medical Systems, Inc. | JAK |
| Aug 11, 2015 | K150757 | syngo.CT Dual Energy Siemens Medical Solutions USA, Inc. | JAK |
| Aug 11, 2015 | K150745 | syngo.CT Single Source Dual Energy Siemens Medical Solutions USA, Inc. | JAK |
| Aug 7, 2015 | K150665 | Philips Spectral CT Applications Philips Medical Systems Nethrlands BV, NL | JAK |
| May 18, 2015 | K150785 | syngo.CT Dental Siemens Medical Solutions USA, Inc. | JAK |
| May 15, 2015 | K143294 | Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways Toshibamedical Systems Corporation, JP | JAK |
| Apr 17, 2015 | K150104 | Vitrea CT Myocardial Perfusion Vital Images, Inc. | JAK |
| Apr 16, 2015 | K143416 | SOMATOM Definition Flash (VA48) Siemens Medical Solutions USA, Inc. | JAK |
| Apr 8, 2015 | K143400 | SOMATOM Definition AS/AS+ Siemens Medical Solutions USA, Inc. | JAK |
| Apr 6, 2015 | K143401 | SOMATOM Definition Edge Siemens Medical Solutions USA, Inc. | JAK |
| Mar 26, 2015 | K143409 | SOMATOM Definition AS Open (VA48) Siemens Medical Solutions USA, Inc. | JAK |
| Mar 19, 2015 | K150003 | Aquilion LB, TSX-201A/3, V6.0 Toshibamedical Systems Corporation, JP | JAK |
| Mar 10, 2015 | K142465 | Aquilion ONE Vision, v7.0 Toshibamedical Systems Corporation, JP | JAK |
| Jan 26, 2015 | K142222 | NewTom 5G Qr S.R.L., IT | JAK |
| Jan 16, 2015 | K142584 | iMAR Siemens Medical Solutions USA, Inc. | JAK |
| Jan 12, 2015 | K143223 | CGBA-032A, Aquilion PRIME Self-Propelled Scan Base Kit for IVR-CT Toshibamedical Systems Corporation, JP | JAK |
| Dec 23, 2014 | K142697 | NExCT 7 Neurologica Corporation | JAK |
| Dec 3, 2014 | K133373 | CLEARVIEW Neusoft Medical Systems Co., Ltd., CN | JAK |
| Nov 26, 2014 | K141741 | AQUILION PRIME, V6.00 Toshibamedical Systems Corporation | JAK |
| Nov 21, 2014 | K133674 | PHILIPS IQON SPECTRAL CT Philips Healthcare (Cleveland) | JAK |
| Nov 13, 2014 | K133643 | SYNGO, CT LIVER ANALYSIS Siemens Medi Cal Solutions, Inc. | JAK |
| Oct 16, 2014 | K133677 | SYNGO CT SINGLE SOURCE DUAL ENERGY Siemens Medical Solutions USA, Inc. | JAK |
| Sep 25, 2014 | K133603 | PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION Philips Medical Systems | JAK |
| Sep 17, 2014 | K141069 | Lung Density Analysis Imbio, LLC | JAK |
| Sep 15, 2014 | K140912 | SOMATOM SCOPE/SOMATOM SCOPE POWER Siemens Medical Solutions USA, Inc. | JAK |
| Sep 5, 2014 | K134025 | AQUILION ONE VISION SELF-PROPELLED SCAN BASE KIT FOR IVR-CT Toshibamedical Systems Corporation | JAK |
| Sep 5, 2014 | K133324 | SURESUBTRACTION LUNG Toshiba Medical Systems Corporation, Japan | JAK |
| Aug 14, 2014 | K140232 | SYNGO CT 2014A (SOMARIS/5 VB42) FOR SOMATOM EMOTION & SENSATION FAMILY CT Siemens Medical Solutions USA, Inc. | JAK |
| Jul 7, 2014 | K133648 | SYNGO, CT DUAL ENERGY Siemens Medical Solutions USA, Inc. | JAK |
| Jun 27, 2014 | K133901 | PARI-PATH SURGICAL NAVIGATION SYSTEM Paritic, Inc. | JAK |
| Jun 20, 2014 | K133646 | ADMIRE Siemens Medical Systems, Inc. | JAK |
| Jun 13, 2014 | K132524 | CT TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) PLANNING APPLICATION Philips Medical Systems | JAK |
| May 19, 2014 | K132108 | MAXIO Perfint Healthcare Pvt, Ltd. | JAK |
| Apr 30, 2014 | K133590 | SOMATOM PERSPECTIVE Siemens Medical Solutions USA, Inc. | JAK |
| Apr 22, 2014 | K133649 | HEPATIC VCAR GE Medical Systems SCS | JAK |
| Apr 17, 2014 | K133589 | SOMATOM FORCE Siemens Medical Solutions USA, Inc. | JAK |
| Apr 11, 2014 | K133705 | REVOLUTION CT Ge Medical Systems, LLC | JAK |
| Apr 7, 2014 | K132902 | SYNGO DUAL ENERGY SOFTWARE PACKAGE Siemens Medical Solutions USA, Inc. | JAK |
| Mar 25, 2014 | K133640 | ASIR-V Ge Medical Systems, LLC | JAK |
| Mar 11, 2014 | K131433 | ISYS 1 (U.S),ACCESSORY, NON-STERILE Isys Medizintechnik GmbH | JAK |
| Feb 10, 2014 | K133497 | AQUILION ONE VISION Toshibamedical Systems Corporation | JAK |
| Feb 6, 2014 | K132813 | DUAL ENERGY SYSTEM PACKAGE Toshibamedical Systems Corporation | JAK |
| Jan 17, 2014 | K133424 | SOMATOM EMOTION 6 CT SYSTEMS, SOMATOM EMOTION 16 Siemens Medical Solutions USA, Inc. | JAK |
| Jan 17, 2014 | K132410 | DISCOVERY CT 590 RT, OPTIMA CT 580, OPTIMA CT 580 RT, OPTIMA CT 580 W Ge Medical Systems, LLC | JAK |
| Jan 13, 2014 | K130552 | CT PULMONARY ANALYSIS Qi Imaging, LLC | JAK |
| Jan 2, 2014 | K130901 | SOMATOM DEFINITION AS OPEN Siemens Medical Systems, Inc. | JAK |
| Dec 12, 2013 | K132523 | MYOPERFUSION Toshibamedical Systems Corporation | JAK |
| Nov 7, 2013 | K132222 | AQUILION ONE VISION, V6.0 Toshibamedical Systems Corporation | JAK |
| Sep 26, 2013 | K131431 | AIRO CT SYSTEM Mobius Imaging, LLC | JAK |
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