KUEHNE GMBH

FDA Device Registration & Listing · Dortmund North Rhine-Westphalia, DE · Registration 3009963139

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
3009963139
FEI Number
3009963139
Entity Name
KUEHNE GMBH
City/State/Country
Dortmund North Rhine-Westphalia, DE
Establishment Address
Beratgerstr. 19, Dortmund North Rhine-Westphalia 44149, DE
Establishment Type(s)
Export Device to the United States But Perform No Other Operation on Device
Owner / Operator
Kuehne GmbH (Owner Number: 10088909)
Owner / Operator Contact Address
Beratgerstr. 19, Dortmund, DE-NW 44149, DE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K041543
PMA Number
N/A

All Registered Proprietary Names

GE Discovery NM/ CT 670 Philips Gemini PET/CT GE Optima 660 CT GE Discovery 690 PET/CT Philips Allura XPER FD10 BIPS Parts GE Discovery PET/CT

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 2024-12-13
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-12-13
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 2026-03-12
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2025-02-13
IZI System, X-Ray, Angiographic Radiology Class 2 892.1600 2025-01-03
KPR System, X-Ray, Stationary Radiology Class 2 892.1680 2025-11-24
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2025-11-24
IZF System, X-Ray, Tomographic Radiology Class 2 892.1740 2025-11-24
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2024-12-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2024-12-03

Official Correspondent

Gerrit Runte

US Agent Details

Mackenzie Dryer Business: Block Imaging Email: mackenzie.dryer@blockimaging.com Phone: (517) 9997099

Related Public Records

Same Entity

Kuehne GmbH
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009963139. Last updated year: 2026. Please use registration number 3009963139 when referencing this establishment in official correspondence.
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