Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019844073

FEI Number

3019844073

Entity Name

TracInnovations A/S

City/State/Country

Ballerup Hovedstaden, DK

Establishment Address

Brydehusvej 13, Ballerup Hovedstaden 2750, DK

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

TracInnovations A/S (Owner Number: 10082007)

Owner / Operator Contact Address

Brydehusvej 13, Ballerup, DK-84 2750, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221785

PMA Number

N/A

All Registered Proprietary Names

TCL3 Motion Tracking System TCL3 Motion Tracking System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2021-06-07
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2022-11-16

Official Correspondent

Barbara Kovacs

US Agent Details

Michelle L. Stock Email: mls@tracinnovations.com Phone: (734) 4129518

Related Public Records

Same Entity

TracInnovations A/S

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
K033504	General Electric Co.	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	2003-11-25
K013636	GE Medical Systems	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	2002-01-24
K250443	Siemens Healthcare GmbH	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	2025-06-16
K151015	Hitachi Medical Systems America, Inc.	ECHELON Oval V 5.0 MRI System	2015-07-29
K910715	Philips Medical Systems (Cleveland), Inc.	VISTA HPQ SYSTEM	1991-06-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0029-2007	Hitachi Medical Systems America Inc	2	MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J.
Z-0033-2014	Philips Medical Systems (Cleveland) Inc	2	Philips MR Systems: Asset 0.5T, Apollo 0.5T, Infinion 1.5T, Eclipse/Polaris 1.5T, Panorama 0.6T 1.0T, Magnetic Resonance Imaging Systems intended for clinical/radiologic diagnostic imaging applications.
Z-0389-2024	Philips North America Llc	2	Achieva 1.5T
Z-0390-2024	Philips North America Llc	2	Achieva 1.5T Conversion
Z-0391-2024	Philips North America Llc	2	Achieva 1.5T Initial System

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3020162557	SPINTECH, INC.	Bingham Farms, MI, US
3012354318	JIANGSU MAGSPIN INSTRUMENT CO., LTD	Kunshan Jiangsu, CN
3003494057	VASSOL, INC.	River Forest, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019844073. Last updated year: 2026. Please use registration number 3019844073 when referencing this establishment in official correspondence.