Company · US
Siemens Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2015. Name variants (Inc, Corp, punctuation) are merged.
82510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | 10 |
| KPR | System, X-Ray, Stationary | 7 |
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 6 |
| IZF | System, X-Ray, Tomographic | 4 |
| IZI | System, X-Ray, Angiographic | 4 |
| LLZ | System, Image Processing, Radiological | 4 |
| EHD | Unit, X-Ray, Extraoral With Timer | 3 |
| KXJ | Table, Radiologic | 3 |
| LNH | System, Nuclear Magnetic Resonance Imaging | 3 |
| DSF | Recorder, Paper Chart | 2 |
| GWQ | Full-Montage Standard Electroencephalograph | 2 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 2 |
| IXR | Table, Radiographic, Tilting | 2 |
| IZJ | Camera, X-Ray, Fluorographic, Cine Or Spot | 2 |
| IZL | System, X-Ray, Mobile | 2 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 2 |
| KPQ | System, Simulation, Radiation Therapy | 2 |
| KPS | System, Tomography, Computed, Emission | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 |
| CAD | Vaporizer, Anesthesia, Non-Heated | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 24, 2015 | K150843 | syngo®.via (version VB10A) Siemens AG, DE | LLZ |
| Nov 20, 2012 | K123375 | SYNGO.VIA Siemens AG, DE | LLZ |
| Apr 12, 2011 | K110366 | SYNGO.CT CARDIAC FUNCTION Siemens AG | JAK |
| Dec 17, 2010 | K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL Siemens Corp. | JIT |
| Aug 8, 2008 | K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN Siemens | JWY |
| Jun 8, 2007 | K071310 | SYNGO CT ONCOLOGY SOFTWARE PACKAGE Siemens AG, DE | JAK |
| Nov 30, 2006 | K063507 | SYNGO NEURO PBV CT Siemens AG, DE | JAK |
| Nov 17, 2006 | K063373 | FLEX LOOP COIL SET 3T Siemens AG, DE | MOS |
| Nov 4, 2005 | K053024 | SYNGO NEURO DSA CT Siemens AG, DE | JAK |
| Apr 14, 2005 | K050867 | SYNGO BODY PERFUSION-CT Siemens AG, DE | JAK |
| Feb 9, 2005 | K043122 | SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY Siemens AG | LLZ |
| Sep 10, 2003 | K032280 | SIREMOBIL ISO-C 3D Siemens AG | IZL |
| Dec 21, 1999 | K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY Siemens Corp. | IZI |
| Nov 23, 1999 | K992925 | AX WORKSTATION DR-VIEWER SOFTWARE OPTION Siemens Corp. | LLZ |
| Aug 3, 1999 | K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM Siemens Corp. | LNH |
| Jun 9, 1999 | K991600 | SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION Siemens Corp. | JAK |
| Feb 12, 1999 | K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR Siemens Corp. | LNH |
| Feb 2, 1999 | K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS Siemens Corp. | LNH |
| Nov 24, 1998 | K982536 | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE Siemens Corp. | JAK |
| Sep 22, 1997 | K972436 | T1 LINE DENTAL HANDPIECES Siemens AG | EFB |
| Sep 15, 1997 | K972312 | SIEMENS ORTHOPHOS DS/DS CEPH Siemens AG | EHD |
| Aug 15, 1997 | K972276 | CEREC 2 CROWN SOFTWARE Siemens AG | ELW |
| Mar 31, 1997 | K963983 | E. CAM PROFILE ATTENUATION CORRECTION Siemens Corp. | KPS |
| Mar 19, 1997 | K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE Siemens AG | EFA |
| Aug 23, 1995 | K952533 | SIENET DICOM GATEWAY Siemens AG | LMD |
| Sep 20, 1994 | K941546 | SOMATOM PROJECT 059 Siemens Corp. | JAK |
| Jul 29, 1994 | K942116 | SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER) Siemens Corp. | KPS |
| Dec 15, 1982 | K822978 | MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 Siemens Corp. | DSF |
| Nov 24, 1982 | K822983 | MINGOCARD 7 & MINGOPHONE 7 Siemens Corp. | DSF |
| Feb 24, 1982 | K820112 | SIEMENS POLYDOROS 800 Siemens Corp. | IZO |
| Feb 18, 1982 | K820111 | SIEMENS SIRESKOP 4 Siemens Corp. | KXJ |
| Dec 10, 1981 | K812610 | SIEMENS-ELEMA PULSE GENERATOR 668 B Siemens Corp. | DXY |
| Dec 2, 1981 | K812104 | SIEMENS-ELEMA PSA 376 Siemens Corp. | DTA |
| Nov 4, 1981 | K812721 | DIGITRON Siemens Corp. | IZI |
| Oct 13, 1981 | K812616 | POLYPHOS 500 Siemens Corp. | IZO |
| Aug 10, 1981 | K811807 | UROSKOP C Siemens Corp. | KPR |
| Jul 10, 1981 | K811587 | SIEMENS ANGIOTRON Siemens Corp. | IXO |
| Jun 23, 1981 | K811302 | SOMATOM 2N Siemens Corp. | IZF |
| Jun 9, 1981 | K811149 | PANDOROS 1200A Siemens Corp. | IZI |
| May 27, 1981 | K803208 | SIRECUST 358 Siemens Corp. | DSI |
| May 13, 1981 | K810858 | XIMATRON V Siemens Corp. | KPQ |
| Mar 11, 1981 | K810307 | ZONOGRAPH 6 Siemens Corp. | IZF |
| Mar 2, 1981 | K810190 | OPTI 110/12/50HSG Siemens Corp. | ITY |
| Mar 2, 1981 | K810189 | SIRECON COMPACT Siemens Corp. | JAA |
| Feb 26, 1981 | K810191 | SIRCAM 103 Siemens Corp. | IZJ |
| Jan 28, 1981 | K803130 | MULTIX U. BUCKY TABLE X-RAY UNIT Siemens Corp. | KPR |
| Jan 22, 1981 | K803124 | SIDOS U. Siemens Corp. | KPQ |
| Oct 23, 1980 | K802200 | VERTIX 3D-U Siemens Corp. | KPR |
| Oct 3, 1980 | K802296 | MINGOGRAF EEG10 Siemens Corp. | GWQ |
| Oct 3, 1980 | K802292 | MINGOGRAF EEG21 Siemens Corp. | GWQ |
Newest 50 of 82.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||