Anholt Technologies Inc.

FDA Device Registration & Listing · Avondale, PA, US · Registration 2247992

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2247992
FEI Number
1000208827
Entity Name
Anholt Technologies Inc.
City/State/Country
Avondale, PA, US
Establishment Address
440 CHURCH ROAD, Avondale, PA 19311, 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
Y
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

, SEQUEL TG-51) MED-TEC PHANTOMS (DISCOVERY Breast Board Body Pro-Lok Respiratory Plate with Cushion, Body Pro-Lok Respiratory Belt Alta Multipurpose Device AccuFix Curve Encompass PentaFix Bellyboard SBRT Accessories Breast Board & Accessories Posifix Head & Neck Posifix head inclination system Posifix pediatric Carbon Fiber Conformal Couch Top trUpoint Arch Protura Couch Software 1.3 QA TOOL MED-TEC LASER POSITIONER Bellyboard Integrity Series Aquaplast Fibreplast IntegraBite VariablePerf Assure AccuFix Tilting Radiotranslucent Headholder Tilt-Pro SRS Adapter Pediatric Table, OPERON D 750-D 850 X-Trans Armboards Armboard Quest FlexLock Portrait Stradivarius QUANTUM kVue Pro Access DoseMax BoS Armshuttle Cosmas kVue IGRT Couchtop and accessories SofTouch Vac-Q-Fix TruGuard Fiducial Markers ZiFix™ Abdominal/Thoracic Motion Control System Qfix SBRT Solution and Accessories ZiFix™ Qfix Abdominal/Thoracic Motion Control System Redi Foam MRI Redifoam MRI Headrest MRI Vac-Loc Cushions MRI Loc-bar MRI Thermoplastic MRI Uniframe Baseplate MRI Accuform Cushions Proton Positioning and Immobilization Solutions AirDrive Caddie ClearVue Protura MRI Patient Positioning Devices DSA Head Holder Qfix Headholder Neuro Head Holder Nurofit MED-TEC SHOULDER SUPPRESSION SYSTEM

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IXG Phantom, Anthropomorphic, Radiographic Radiology Class 1 892.1950 1999-10-15
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2010-12-28
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
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-10-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-10-28
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2022-10-28
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2022-10-28
FRZ Device, Patient Transfer, Powered General Hospital Class 2 880.6775 2022-10-28
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2022-10-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
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 2008-06-13
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-09-09
IXQ Table, Radiographic, Stationary Top Radiology Class 2 892.1980 2013-12-17
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2015-08-26
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2013-12-17
LHO Instrument, Quality-Assurance, Radiologic Radiology Class 1 892.1940 1994-06-03
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-09-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-10-28
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2022-10-28
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2022-10-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-10-28
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2022-10-28
GDC Table, Operating-Room, Electrical General, Plastic Surgery Class 1 878.4960 2022-10-28
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2026-03-23
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-02-26
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2022-10-28
OUO Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance Radiology Class 2 892.1200 2022-10-28
KPS System, Tomography, Computed, Emission Radiology Class 2 892.1200 2022-10-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2022-10-28
LHN System, Radiation Therapy, Charged-Particle, Medical Radiology Class 2 892.5050 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-09-09
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2009-02-26
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
FSA Lift, Patient, Non-Ac-Powered General Hospital Class 1 880.5510 2022-10-28
IYE Accelerator, Linear, Medical Radiology Class 2 892.5050 2022-10-28
JAI Couch, Radiation Therapy, Powered Radiology Class 2 892.5770 2009-12-28
LNH System, Nuclear Magnetic Resonance Imaging Radiology Class 2 892.1000 2013-12-17
IWY Holder, Head, Radiographic Radiology Class 1 892.1920 1994-01-28

Official Correspondent

No official correspondent registered.

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
1932738 MEDTEC LLC Orange City, IA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071992 Varian Medical Systems HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC) 2007-08-15
K253962 Radformation, Inc. ClearCheck (RADCC V2.7) 2026-04-03
K003779 Arplay Medical S.A. IMMOBILIZATION SYSTEM FOR ENT 2001-07-12
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0004-2019 Varian Medical Systems 2
TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019 Varian Medical Systems 2
VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015 N/A 2
Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012 Accuray Incorporated 2
CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

Registration Number Establishment Name Location
3031218453 GUANGDONG MEICEN MEDICAL EQUIPMENT CO., LTD. foshan Guangdong, CN
3007366790 Smith & Nephew, Inc. Memphis, TN, US
3003094912 Varian Medical Systems Imaging Laboratory GmbH Daettwil, Argovia Aargau, CH
3008706707 CORTEX MANUFACTURING, LLC Byhalia, MS, US
3008744062 Smith & Nephew, Inc. Cordova, TN, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2247992. Last updated year: 2026. Please use registration number 2247992 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.