Data / Medical devices / France / Block Imaging SAS
Block Imaging SAS: FDA-registered device maker in Weyersheim Bas-Rhin, France, 82 510(k) clearances and 3 PMA approvals
Block Imaging SAS is registered with the FDA (registration 3023003446) in Weyersheim Bas-Rhin, France. It lists 18 device types. The FDA files 82 510(k) clearances and 3 PMA approvals under its listings, the newest dated May 19, 2021. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3023003446
- Address
- 5 rue des Vosges, Weyersheim Bas-Rhin, France, 67720
- Owner or operator
- Block Imaging SAS (10086857)
- Roles
- Exporter to the US, Repackager or relabeler
- First device listed
- January 26, 2023
- Registered through
- 2027
- Brand names listed
- 1.5T Signa HDXT, 3T Signa HDXT, Discovery CT, Discovery CT590 RT, Discovery RT, GE 0.2T Profile HD MRI, GE 750 3T MRI, GE 750W 3T MRI and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 19, 2021 | K210880 | Vereos PET/CT | KPS | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 1, 2020 | K200917 | Azurion R2.1 | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 24, 2020 | K200074 | O-arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| February 12, 2020 | K193178 | Biograph Horizon | KPS | Substantially Equivalent | Siemens Medical Solution USA, Inc. | accessdata.fda.gov |
| November 21, 2019 | K192061 | SOMATOM Go Platform SOMATOM go.Now, go.Up, go.All, go.Top, go.Sim, go.Open Pro, Scan & GO | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 26, 2019 | K191777 | Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 4, 2019 | K190461 | Achieva 1.5T, 3.0T and Intera 1.5T MR Systems | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| April 15, 2019 | K183548 | SOMATOM Perspective, SOMATOM Scope/Scope Power, SOMATOM Emotion 16 | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 15, 2019 | K190138 | MAGNETOM Aera | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 2, 2018 | K181403 | Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| May 23, 2018 | K180811 | Biograph Vision | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 13, 2018 | K173632 | SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 30, 2018 | K173630 | SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 29, 2017 | K173664 | Medtronic O-arm O2 Imaging System | OWB | Substantially Equivalent | Medtronic, Inc. | accessdata.fda.gov |
| October 20, 2017 | K172869 | Discovery XR656 HD | KPR | Substantially Equivalent | Ge Hualun Medical Systems Co. , Ltd. | accessdata.fda.gov |
| May 19, 2017 | K170752 | OEC Elite | OWB | Substantially Equivalent | Oec Medical Systems, Inc. | accessdata.fda.gov |
| March 17, 2017 | K163331 | Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| January 6, 2017 | K163116 | Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 | LNH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| December 16, 2016 | K163213 | Revolution CT | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 2, 2016 | K161682 | GE Lunar DXA Bone Densitometers with enCORE version 17 | KGI | Substantially Equivalent | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC | accessdata.fda.gov |
| November 30, 2016 | K162966 | TxRx Knee 15 Flare MR Coil 1.5T | MOS | Substantially Equivalent | Quality Electrodynamics, LLC | accessdata.fda.gov |
| November 15, 2016 | K162990 | Optima XR240amx | IZL | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| November 3, 2016 | K162268 | Senographe Pristina | MUE | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| August 11, 2016 | K161574 | Discovery MI | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| July 29, 2016 | K161563 | Allura Xper FD series and Allura Xper OR Table series | OWB | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| June 9, 2016 | K160618 | Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 25, 2016 | K151765 | SOMATOM Perspective | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| July 17, 2015 | K151486 | Biograph mCT and mCT Flow PET/CT Scanners | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 4, 2015 | K143251 | SIGNA Creator, SIGNA Explorer | LNH | Substantially Equivalent | Ge Healthcare (Ge Medical Systems, LLC) | accessdata.fda.gov |
| December 5, 2014 | K142361 | Discovery MR750 3.0T | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 18, 2014 | K141477 | DISCOVERY IQ | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 21, 2014 | K142006 | SYMBIA 6.0 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| April 28, 2014 | K133580 | ARTIS ONE | OWB | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 21, 2014 | K133657 | DISCOVERY PET/CT 710 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 20, 2014 | K140253 | MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 22, 2013 | K132119 | MAGNETOM PRISMA, MAGNETOM PRISMA FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131576 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 16, 2013 | K131634 | SYMBIA | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| May 21, 2013 | K130842 | ALLURA XPER FD OR TABLE SERIES; ALLURA XPER FD10 SERIES; ALLURA XPER FD20 SERIES; ALLURA XPER FD BIPLANE SERIES | IZI | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| May 17, 2013 | K130885 | MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| February 8, 2013 | K123596 | OPTIMA CT520 | JAK | Substantially Equivalent | Ge Hangwei Medical Systems Co., Ltd. | accessdata.fda.gov |
| January 2, 2013 | K122457 | GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| September 20, 2012 | K121676 | 1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 16, 2012 | K122234 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Healthcare Surgery GE Oec Medical Systems, Inc. | accessdata.fda.gov |
| June 12, 2012 | K120833 | DISCOVERY CT750 HD | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| April 19, 2012 | K121019 | OPTIMA NM/CT 640 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| December 22, 2011 | K110798 | SENOGRAPHE DS, SENOGRAPHE ESSENTIAL | MUE | Substantially Equivalent | General Electric Company | accessdata.fda.gov |
| July 20, 2011 | K110227 | OPTIMA CT660 | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| June 3, 2011 | K111445 | DISCOVERY NM 630 | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 19, 2011 | K093581 | DISCOVERY MODEL CT590 RT AND OPTIMA MODEL CT580 CT SYSTEMS | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 4, 2011 | K103127 | SOMATOM DEFINITION AS | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| December 10, 2009 | K093514 | DISCOVERY MODEL NM/CT 670 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| August 25, 2009 | K092004 | GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ | OWB | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| June 18, 2009 | K090745 | ARTIS ZEE / ZEEGOS WITH SW VC14 | IZI | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| January 13, 2009 | K083166 | SPECIALTY COILS FOR THE MAGNETOM ESSENZA | MOS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| November 21, 2008 | K082506 | SYMBIA, VERSION 4.0 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 8, 2008 | K082816 | GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| October 8, 2008 | K082761 | GE LIGHTSPEED 7.2 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| September 25, 2008 | K082636 | TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T | MOS | Substantially Equivalent | Quality Electrodynamics | accessdata.fda.gov |
| June 12, 2008 | K081496 | OPTIMA PET/CT 560 | KPS | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| May 2, 2008 | K073543 | OEC 9900 ELITE | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| January 31, 2008 | K080124 | VENTRI 1.1 | KPS | Substantially Equivalent | Ge Medical Systems F.I. Haifa | accessdata.fda.gov |
| October 30, 2007 | K072567 | SYMBIA-E, MODEL 10275879 | KPS | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 10, 2007 | K072237 | MAGNETOM VERIO | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| October 7, 2005 | K052621 | 1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL | MOS | Substantially Equivalent | Usa Instruments, Inc. | accessdata.fda.gov |
| September 21, 2005 | K052293 | GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM | LNH | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| August 9, 2005 | K051967 | REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS | KPR | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| March 11, 2005 | K050489 | INNOVA 2100 | OWB | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| March 1, 2005 | K050297 | SOMATOM EMOTION 16 | JAK | Substantially Equivalent | Siemens Medical Solution, Inc. USA | accessdata.fda.gov |
| September 8, 2004 | K042293 | BRILLIANCE CT, PRIVATE PRACTICE CV CONFIGURATION, CT SCANNER | JAK | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| July 30, 2004 | K041949 | ALLURA XPER FD10 | IZI | Substantially Equivalent | Philips Medical Systems North America Co. | accessdata.fda.gov |
| July 21, 2004 | K041112 | MAGNETOM ESPREE SYSTEM | LNH | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| June 22, 2004 | K041543 | GE DISCOVERY ST | KPS | Substantially Equivalent | GE Healthcare | accessdata.fda.gov |
| April 2, 2004 | K040665 | SOMATOM SENSATION 64 AND SENSATION CARDIAC | JAK | Substantially Equivalent | Siemens Medical Solutions USA, Inc. | accessdata.fda.gov |
| March 1, 2004 | K040372 | LIGHTSPEED 7.0 CT SCANNER SYSTEM | JAK | Substantially Equivalent | Ge Medical Systems, LLC | accessdata.fda.gov |
| December 9, 2003 | K033737 | ALLURA XPER FD20 | OWB | Substantially Equivalent | Philips Medical Systems North America, Inc. | accessdata.fda.gov |
| October 10, 2003 | K033168 | GE 0.2T SIGNA PROFILE/I MR SYSTEM | LNH | Substantially Equivalent | General Electric Co. | accessdata.fda.gov |
| August 22, 2003 | K031637 | INNOVA 3100 | OWB | Substantially Equivalent | GE Medical Systems | accessdata.fda.gov |
| July 25, 2003 | K030962 | DPX SERIES BRAVO DUO BONE DENSITOMETER | KGI | Substantially Equivalent | Ge Lunar Corp. | accessdata.fda.gov |
| November 8, 2002 | K023398 | HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY | KGI | Substantially Equivalent | Hologic, Inc. | accessdata.fda.gov |
| April 17, 2002 | K021049 | OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM | OWB | Substantially Equivalent | Ge Oec Medical Systems | accessdata.fda.gov |
| August 26, 1998 | K982265 | AQUILION CT SCANNER, MODEL TSX-101A | JAK | Substantially Equivalent | Toshiba America Medical Systems, In.C | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 11, 2011 | P080003 | SELENIA DIMENSIONS FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | OTE | 10 | November 24, 2025 | accessdata.fda.gov |
| March 15, 2002 | P010025 | LORAD DIGITAL BREAST IMAGER | MUE | 17 | November 16, 2010 | accessdata.fda.gov |
| January 28, 2000 | P990066 | GE HEALTHCARE SENOGRAPHE FULL FIELD DIGITAL MAMMOGRAPHY SYSTEM | MUE | 36 | November 5, 2010 | accessdata.fda.gov |
Compare with other makers
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- All makers of System, Nuclear Magnetic Resonance Imaging
- All makers of System, X-Ray, Stationary
- All makers of System, X-Ray, Tomographic
- All makers of Coil, Magnetic Resonance, Specialty
Updated November 24, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.