Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020928588

FEI Number

3020928588

Entity Name

PIUR IMAGING GMBH

City/State/Country

Vienna Wien, AT

Establishment Address

Kaiserstrasse 8/1/11, Vienna Wien 1070, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

PIUR IMAGING GmbH (Owner Number: 10091767)

Owner / Operator Contact Address

Kaiserstrasse 8/1/11, Vienna, AT-9 1070, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K250484

PMA Number

N/A

All Registered Proprietary Names

PIUR tUS Infinity PIUR tUS inside

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	2024-10-31
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2026-05-05

Official Correspondent

Frederik Bender

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: customerservices@dawamedical.com Phone: (305) 5999373

Related Public Records

Same Entity

PIUR IMAGING 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
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 3020928588. Last updated year: 2026. Please use registration number 3020928588 when referencing this establishment in official correspondence.