RELU BV

FDA Device Registration & Listing · Leuven Antwerpen, BE · Registration 3031915908

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
3031915908
FEI Number
3031915908
Entity Name
RELU BV
City/State/Country
Leuven Antwerpen, BE
Establishment Address
Kolonel Begaultlaan 1A/51, Leuven Antwerpen 3012, BE
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Relu BV (Owner Number: 10091216)
Owner / Operator Contact Address
Kolonel Begaultlaan 1A/51, Leuven, BE-WBR 3012, BE
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K252708
PMA Number
N/A

All Registered Proprietary Names

Relu Cloud

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2026-06-19

Official Correspondent

No official correspondent registered.

US Agent Details

Bill Jacqmein Email: bjacqmein@primepathmedtech.com Phone: (404) 2166190

Related Public Records

Same Entity

Relu BV
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
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3031915908. Last updated year: 2026. Please use registration number 3031915908 when referencing this establishment in official correspondence.
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