Siemens Corp.
Mavern, PA, US
Siemens Corp. appears in FDA device records in Mavern, PA. FDA records list 82 510(k) clearances between and , 61 PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 82
- PMA records
- 61
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 82FDA records hold 82 510(k) clearances for Siemens Corp. between 1978 and 2015. The busiest year on record is 1981, with 16. The most recent is 2015, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 15 |
| 1979 | 12 |
| 1980 | 8 |
| 1981 | 16 |
| 1982 | 4 |
| 1994 | 2 |
| 1995 | 1 |
| 1997 | 5 |
| 1998 | 1 |
| 1999 | 6 |
| 2003 | 1 |
| 2005 | 3 |
| 2006 | 2 |
| 2007 | 1 |
| 2008 | 1 |
| 2010 | 1 |
| 2011 | 1 |
| 2012 | 1 |
| 2015 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K150843 | syngo®.via (version VB10A) | LLZ | Substantially Equivalent | |
| K123375 | SYNGO.VIA | LLZ | Substantially Equivalent | |
| K110366 | SYNGO.CT CARDIAC FUNCTION | JAK | Substantially Equivalent | |
| K103360 | DIMENSION VISTA DIGITOXIN CALIBRATOR - DGTX CAL | JIT | Substantially Equivalent | |
| K081182 | MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS NEW ANTIMICROBIAL TEST - INDUCIBLE CLINDAMYCIN | JWY | Substantially Equivalent | |
| K071310 | SYNGO CT ONCOLOGY SOFTWARE PACKAGE | JAK | Substantially Equivalent | |
| K063507 | SYNGO NEURO PBV CT | JAK | Substantially Equivalent | |
| K063373 | FLEX LOOP COIL SET 3T | MOS | Substantially Equivalent | |
| K053024 | SYNGO NEURO DSA CT | JAK | Substantially Equivalent | |
| K050867 | SYNGO BODY PERFUSION-CT | JAK | Substantially Equivalent | |
| K043122 | SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY | LLZ | Substantially Equivalent | |
| K032280 | SIREMOBIL ISO-C 3D | IZL | Substantially Equivalent | |
| K993947 | KOORDINANT ANGIOGRAPHIC AND OPERATING ROOM MODEL X-RAY TABLE FAMILY | IZI | Substantially Equivalent | |
| K992925 | AX WORKSTATION DR-VIEWER SOFTWARE OPTION | LLZ | Substantially Equivalent | |
| K991652 | HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM | LNH | Substantially Equivalent | |
| K991600 | SOMATOM PLUS 4 WITH SLIDING GANTRY OPTION | JAK | Substantially Equivalent | |
| K984221 | FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR | LNH | Substantially Equivalent | |
| K984224 | PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS | LNH | Substantially Equivalent | |
| K982536 | PERFUSION CT (COMPUTED TOMOGRAPHY) SOFTWARE PACKAGE | JAK | Substantially Equivalent | |
| K972436 | T1 LINE DENTAL HANDPIECES | EFB | Substantially Equivalent | |
| K972312 | SIEMENS ORTHOPHOS DS/DS CEPH | EHD | Substantially Equivalent | |
| K972276 | CEREC 2 CROWN SOFTWARE | ELW | Substantially Equivalent | |
| K963983 | E. CAM PROFILE ATTENUATION CORRECTION | KPS | Substantially Equivalent | |
| K965238 | T1 CONTROL HIGH SPEED DENTAL HANDPIECE | EFA | Substantially Equivalent | |
| K952533 | SIENET DICOM GATEWAY | LMD | Substantially Equivalent | |
| K941546 | SOMATOM PROJECT 059 | JAK | Substantially Equivalent | |
| K942116 | SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER) | KPS | Substantially Equivalent | |
| K822978 | MINGOGRAF 4, MINGO CARD 4 & MINOCARD 3 | DSF | Substantially Equivalent | |
| K822983 | MINGOCARD 7 & MINGOPHONE 7 | DSF | Substantially Equivalent | |
| K820112 | SIEMENS POLYDOROS 800 | IZO | Substantially Equivalent | |
| K820111 | SIEMENS SIRESKOP 4 | KXJ | Substantially Equivalent | |
| K812610 | SIEMENS-ELEMA PULSE GENERATOR 668 B | DXY | Substantially Equivalent | |
| K812104 | SIEMENS-ELEMA PSA 376 | DTA | Substantially Equivalent | |
| K812721 | DIGITRON | IZI | Substantially Equivalent | |
| K812616 | POLYPHOS 500 | IZO | Substantially Equivalent | |
| K811807 | UROSKOP C | KPR | Substantially Equivalent | |
| K811587 | SIEMENS ANGIOTRON | IXO | Substantially Equivalent | |
| K811302 | SOMATOM 2N | IZF | Substantially Equivalent | |
| K811149 | PANDOROS 1200A | IZI | Substantially Equivalent | |
| K803208 | SIRECUST 358 | DSI | Substantially Equivalent | |
| K810858 | XIMATRON V | KPQ | Substantially Equivalent | |
| K810307 | ZONOGRAPH 6 | IZF | Substantially Equivalent | |
| K810190 | OPTI 110/12/50HSG | ITY | Substantially Equivalent | |
| K810189 | SIRECON COMPACT | JAA | Substantially Equivalent | |
| K810191 | SIRCAM 103 | IZJ | Substantially Equivalent | |
| K803130 | MULTIX U. BUCKY TABLE X-RAY UNIT | KPR | Substantially Equivalent | |
| K803124 | SIDOS U. | KPQ | Substantially Equivalent | |
| K802200 | VERTIX 3D-U | KPR | Substantially Equivalent | |
| K802296 | MINGOGRAF EEG10 | GWQ | Substantially Equivalent | |
| K802292 | MINGOGRAF EEG21 | GWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- ITYAssembly, Tube Housing, X-Ray, Diagnostic
- JITCalibrator, Secondary
- IZJCamera, X-Ray, Fluorographic, Cine Or Spot
- EAGCephalometer
- KLCChair, Dental, With Operative Unit
- MOSCoil, Magnetic Resonance, Specialty
- BYDCondenser, Heat And Moisture (Artificial Nose)
- DSIDetector And Alarm, Arrhythmia
- KPWDevice, Beam Limiting, X-Ray, Diagnostic
- DPSElectrocardiograph
- GWQFull-Montage Standard Electroencephalograph
- IZOGenerator, High-Voltage, X-Ray, Diagnostic
- EFBHandpiece, Air-Powered, Dental
- EFAHandpiece, Belt And/Or Gear Driven, Dental
- DXYImplantable Pacemaker Pulse-Generator
- LNSLithotriptor, Extracorporeal Shock-Wave, Urological
- JWYManual Antimicrobial Susceptibility Test Systems
- ELWMaterial, Impression
- DSFRecorder, Paper Chart
- IXOSynchronizer, Ecg / Respirator, Radiographic
- LMDSystem, Digital Image Communications, Radiological
- LLZSystem, Image Processing, Radiological
- LNHSystem, Nuclear Magnetic Resonance Imaging
- KPQSystem, Simulation, Radiation Therapy
- KPSSystem, Tomography, Computed, Emission
- IZISystem, X-Ray, Angiographic
- JAASystem, X-Ray, Fluoroscopic, Image-Intensified
- IZLSystem, X-Ray, Mobile
- KPRSystem, X-Ray, Stationary
- IZFSystem, X-Ray, Tomographic
- JAKSystem, X-Ray, Tomography, Computed
- KQSTable, Cystometric, Non-Electric And Accessories
- IXRTable, Radiographic, Tilting
- KXJTable, Radiologic
- LOMTest, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen)
- DTATester, Pacemaker Electrode Function
- EHDUnit, X-Ray, Extraoral With Timer
- EAPUnit, X-Ray, Intraoral
- CADVaporizer, Anesthesia, Non-Heated
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain