Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013695852

FEI Number

3013695852

Entity Name

RESOUNDANT, INC.

City/State/Country

Rochester, MN, US

Establishment Address

421 1st Ave SW STE 204W, Rochester, MN 55902, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Resoundant, Inc. (Owner Number: 10054926)

Owner / Operator Contact Address

421 1st Ave SW STE 204W, Rochester, MN 55902, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183193

PMA Number

N/A

All Registered Proprietary Names

Resoundant Hepatogram Plus

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
IXF	Test-Pattern, Radiographic	Radiology	Class 1	892.1940	2017-05-14
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2019-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Resoundant, Inc.

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
K865100	Computerized Imaging Reference Systems, Inc.	TISSUE-EQUIVALENT BREAST SIMULATOR	1987-01-12
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30
K092915	Cedara Software Corp.	CEDARA WEBACCESS, MODEL: 2.4	2010-06-23
K961871	Siemens Medical Solutions USA, Inc.	FLOUROSPOT T.O.P.	1996-07-31

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

Similar Registrations

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3009607881	QUALIFORMED SAS	La Roche Sur Yon Pays de la Loire, FR
3012889794	LEEDS TEST OBJECTS LTD	BOROUGHBRIDGE, YORK North Yorkshire, GB
3011168908	PRO-PROJECT	Okszow Lubuskie, PL
1529041	GE Healthcare Coils	AURORA, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013695852. Last updated year: 2026. Please use registration number 3013695852 when referencing this establishment in official correspondence.