Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1932738

FEI Number

1000143606

Entity Name

MEDTEC LLC

City/State/Country

Orange City, IA, US

Establishment Address

1401 8TH ST. S.E., Orange City, IA 51041, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Medtec LLC (Owner Number: 9033077)

Owner / Operator Contact Address

1401 8TH ST., S.E., --, Orange City, IA 51041, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K973842

PMA Number

N/A

All Registered Proprietary Names

C-Qual M Breastboard; Monarch Overhead Arm Positioner Qfix Radiotherapy Chair QA TOOL MED-TEC LASER POSITIONER Protura Redi Foam Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt Protura Couch Software 1.3 trUpoint Arch DSA Head Holder Qfix Headholder Neuro Head Holder Nurofit MED-TEC SHOULDER SUPPRESSION SYSTEM MRI Redifoam MRI Headrest MRI Vac-Loc Cushions MRI Loc-bar MRI Thermoplastic MRI Uniframe Baseplate MRI Accuform Cushions AccuTatt; Accu-Tatt; ISO Mark; Opti-Tatt AccuForm Cushion Proton Positioning and Immobilization Solutions Breast Board MR & Radiological Patient Positioning Devices Type-S Extension BioXmark Fiducial Markers Vac-Loc cushions BrachyGel Vaginal Hydrogel Packing System Hipfix Hip & Pelvic fixation system MRI Patient Positioning Devices Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask Carbon Fiber Conformal Couch Top

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	2021-06-03
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2021-06-03
JAI	Couch, Radiation Therapy, Powered	Radiology	Class 2	892.5770	2022-10-28
LHO	Instrument, Quality-Assurance, Radiologic	Radiology	Class 1	892.1940	1994-06-03
JAI	Couch, Radiation Therapy, Powered	Radiology	Class 2	892.5770	2009-12-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-09-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2016-11-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-11-28
JAI	Couch, Radiation Therapy, Powered	Radiology	Class 2	892.5770	2013-12-17
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2015-08-26
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	1994-01-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-02-26
FZZ	Marker, Skin	General, Plastic Surgery	Class 1	878.4660	2001-09-27
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-06-23
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-07-05
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-07-05
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2018-07-05
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2010-12-28
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2013-12-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-12-17
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2008-06-23
QUV	Phase-Changing Fiducial Marker For Radiation Therapy	Radiology	Class 2	892.5727	2023-11-15
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-02-26
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-02-26
QXR	Vaginal Hydrogel Packing System	Radiology	Class 2	892.5735	2024-05-21
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2009-09-09
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2013-12-17
LNH	System, Nuclear Magnetic Resonance Imaging	Radiology	Class 2	892.1000	2018-09-10
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-09-10
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2013-12-17

Official Correspondent

Alena Newgren

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Medtec LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2247992	Anholt Technologies Inc.	Avondale, PA, US

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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1932738. Last updated year: 2026. Please use registration number 1932738 when referencing this establishment in official correspondence.