BENELUX IMAGING

FDA Device Registration & Listing · Hilversum Noord-Holland, NL · Registration 3029521953

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
3029521953
FEI Number
3029521953
Entity Name
BENELUX IMAGING
City/State/Country
Hilversum Noord-Holland, NL
Establishment Address
Burgemeester Gulcherlaan 24, Hilversum Noord-Holland 1217PC, NL
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Benelux Imaging (Owner Number: 10088672)
Owner / Operator Contact Address
Burgemeester Gulcherlaan 24, Hilversum, NL-NH 1217PC, NL
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K151486
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-12-17
OTE Digital Breast Tomosynthesis Unknown Class 3 N/A 2024-04-26
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-02-12
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-02-12
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2025-02-12
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2026-03-31
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-12-13
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2023-10-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2026-03-20
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2025-11-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2025-11-21
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2023-12-13
MOS Coil, Magnetic Resonance, Specialty Radiology Class 2 892.1000 2023-12-13
LNI System, Nuclear Magnetic Resonance Spectroscopic Radiology Class 2 892.1000 2023-12-13
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-09-03
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-09-03

Official Correspondent

Nick Vochteloo

US Agent Details

Diana Upton Email: Dupton@Optonline.Net Phone: (201) 4156807

Related Public Records

Same Entity

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

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K243523 Siemens Medical Solutions USA, Inc. NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime 2025-02-12
K781431 General Electric Co. ELECTRIC CT/T OPERATOR DISPLAY CONSOLE 1978-09-07
K231574 FUJIFILM Healthcare Americas Corporation Scenaria View 4.2 2023-10-12
K233583 FUJIFILM Healthcare Americas Corporation FCT iSTREAM Phase 1 2024-04-26
K151376 Covidien, LLC superDimension Navigation System 2015-11-05

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2011 GE Medical Systems, LLC 2
HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017 Philips Medical Systems 2
Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017 Philips Medical Systems 2
Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017 Philips Medical Systems 2
Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017 Philips Medical Systems 2
Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

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2134213 CANON MEDICAL INFORMATICS, INC. MINNETONKA, MN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3029521953. Last updated year: 2026. Please use registration number 3029521953 when referencing this establishment in official correspondence.
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