BLOCK IMAGING SAS

FDA Device Registration & Listing · Weyersheim Bas-Rhin, FR · Registration 3023003446

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3023003446
FEI Number
3023003446
Entity Name
BLOCK IMAGING SAS
City/State/Country
Weyersheim Bas-Rhin, FR
Establishment Address
5 rue des Vosges, Weyersheim Bas-Rhin 67720, FR
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Block Imaging SAS (Owner Number: 10086857)
Owner / Operator Contact Address
1845 Cedar Street, Holt, MI 48842, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
PMA Number
N/A

All Registered Proprietary Names

Hologic Selenia 2D Mammography Philips XPER FD10 Cath and Angio GE Head Neck and Spine Array Coil GE BrightSpeed Elite GE BrightSpeed Elite Select GE BrightSpeed Excel Select GE Brightspeed Elite 16 Slice CT GE BrightSpeed Edge Select GE Optima CT540 GE 750 3T MRI GE Performix tube Hologic 113T tube GE Discovery 690 PET/CT GE Discovery 600 PET/CT GE Discovery PET/CT GE Innova IGS 530 Cath Angio GE Innova 3131 Cath Siemens Biograph mCT PET/CT Siemens Somatom Perspective CT TxRx 15Ch Knee Coil Siemens SOMATOM go.All Siemens SOMATOM go.Top Siemens SOMATOM go.Up Siemens SOMATOM go.Now GE Optima XR240 Portable X-ray 3T Signa HDXT 1.5T Signa HDXT Signa Vibrant GE Discovery NM 530c (Ventri 1.1) GE Optima 660 CT GE Revolution EVO CT GE Innova 3100-IQ GE Innova 4100-IQ GE Innova 2100-IQ Siemens Somatom Definition AS CT Philips Achieva 3T MRI Philips Achieva 1.5T MRI OEC 9800 C-Arm GE Lunar Prodigy Advance GE Lunar Prodigy Primo GE Lunar Prodigy Siemens Somatom Scope CT Siemens Somatom Perspective CT Siemens Somatom Emotion CT Siemens MRI head coil GE LightSpeed VCT GE Senographe Pristina 3D Mammography Symbia Intevo Symbia T Symbia T16 Symbia T6 Symbia E Symbia T2 Symbia Intevo 6 Symbia Intevo Excel Symbia S Symbia Intevo 2 Symbia Intevo 16 GE 750W 3T MRI OEC 9900 Elite C-Arm GE Explorer 1.5T MRI Magnetom Avanto FIT Magnetom Skyra FIT Magnetom Prisma Fit GE Optima NM/CT 640 Philips Vereos PET/CT GE Discovery MI PET/CT Revolution HD CT GE Discovery 750HD CT Revolution Discovery CT Discovery CT GE LightSpeed VCT 64 Slice CT GE Discovery XR656 Rad Room Philips Allura Xper FD10 Philips Allura FD20/20 GE Essential Siemens Biograph Horizon - 4R Siemens Biograph Horizon Siemens Biograph Horizon - 3R GE Senographe Essential Mammography Philips FD 20/10 Hologic Dimensions 3D Mammo Medtronic O-Arm O2 Imaging System Siemens Skyra 3T MRI GE Optima 660 CT GE IGS 530 Cath GE Innova 3100 Cath GE Revolution CT GE Optima 450W 1.5T MRI GE DPX Bravo Bone Densitometer Philips Allura FD20 GE HDXT 1.5T MRI Siemens Artis Zee Cath Philips Ingenia 1.5T and 3T Siemens Biograph MCT 128 PET/CT Siemens Symbia T6 SPECT/CT Toshiba Aquilion 16 Slice CT GE Optima NM/CT 630 GE Optima NM/CT 640 Hologic Discover DEXA Siemens Espree 1.5T MRI Siemens Somatom Sensation CT GE 0.2T Profile HD MRI OEC 9900 C-Arm SOMATOM Definition Flash SOMATOM Definition AS Open SOMATOM Force SOMATOM Definition Edge SOMATOM Definition AS/AS+ SOMATOM Definition Confidence SOMATOM Drive Siemens Aera 1.5T MRI Philips Azurion 3 M15 Cath Angio Siemens Symbia E Nuclear Camera GE Discovery 710 PET/CT Siemens Emotion 16 CT GE Optima 520 CT

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2024-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2023-01-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-06-18
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
ITY Assembly, Tube Housing, X-Ray, Diagnostic Radiology Class 1 892.1760 2025-02-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-05-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-05-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-27
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2026-05-01
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-12-10
IZL System, X-Ray, Mobile Radiology Class 2 892.1720 2024-04-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-07-09
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-07-09
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-07-09
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-01-29
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-01-26
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-05-27
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-05-27
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-05-27
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-06-26
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-04-30
KGI Densitometer, Bone Radiology Class 2 892.1170 2025-01-15
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-01-15
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-01-15
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-07-16
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-11
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-08-26
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-08-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-03-05
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-03-05
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2025-03-05
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-10-11
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-09-04
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-05-20
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-05-20
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-01-14
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-01-14
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-11-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-11-24
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2024-04-30
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2024-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-04-30
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2024-03-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-09-16
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-09-16
MUE Full Field Digital, System, X-Ray, Mammographic Radiology Class 2 892.1715 2025-04-15
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-05-27
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-05-27
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2025-05-27
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-16
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-06-16
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
KGI Densitometer, Bone Radiology Class 2 892.1170 2024-09-04
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2024-04-30
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-03-19
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-03-19
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-04-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-04-30
KGI Densitometer, Bone Radiology Class 2 892.1170 2024-04-30
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-04-11
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2024-04-30
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2024-04-30
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile Radiology Class 2 892.1650 2024-04-30
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-10-07
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2024-04-30
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2024-04-30
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2024-04-30
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2026-05-20
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2026-05-20
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-04-30
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-01-26
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-03-21
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-06-26

Official Correspondent

Grace Lyon

US Agent Details

Grace Lyon Business: BLOCK IMAGING Email: grace.lyon@blockimaging.com Phone: (517) 6688800

Related Public Records

Same Entity

Block Imaging SAS
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3023003446. Last updated year: 2026. Please use registration number 3023003446 when referencing this establishment in official correspondence.
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