Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3021907554

FEI Number

3021907554

Entity Name

GLEAMER

City/State/Country

Paris Ile-de-France, FR

Establishment Address

47bis Rue des Vinaigriers, Paris Ile-de-France 75010, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GLEAMER (Owner Number: 10084623)

Owner / Operator Contact Address

47bis Rue des Vinaigriers, Paris, FR-IDF 75010, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K212365

PMA Number

N/A

All Registered Proprietary Names

BoneMetrics US BoneView BoneView

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	2025-03-31
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2023-03-15
QBS	Radiological Computer Assisted Detection/Diagnosis Software For Fracture	Radiology	Class 2	892.2090	2022-03-14

Official Correspondent

Antoine Tournier

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@ul.com Phone: (512) 3279997

Related Public Records

Same Entity

GLEAMER

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

Similar Registrations

Registration Number	Establishment Name	Location
3042928350	Computer Vision AG	Wallisellen Zurich, CH
3021027284	ANGIOWAVE IMAGING, INC.	Concord, MA, US
3030088963	REBRAIN	PESSAC Gironde, FR
3042852277	REMEDY LOGIC	New York, NY, US
3027986210	MRIGUIDANCE B.V.	Utrecht, NL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3021907554. Last updated year: 2026. Please use registration number 3021907554 when referencing this establishment in official correspondence.