Anholt Technologies Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
22479921000208827Anholt Technologies Inc.1Y2026-01-01440 CHURCH ROAD Avondale PA US 19311

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3104051612559066K982624MOLDCARE HEAD & NECK CUSHION, MODEL # MT-ACL-14242IYE1998-10-26
3104051137027588K974703CARBON FIBER BREAST BOARDIYE1998-03-10
3104051928956041K973842CARBON FIBER CONFORMAL COUCH TOPIXQ1997-12-05
3104052012600127K951808MED-TEC REDI-FOAMIYE1995-07-06
3104051687143849K950866HIP FIXATION SYSTEMIYE1995-05-30
3104051251358885K935411MED-TEC, INC. BREAST BOARD, MT-250IYE1994-07-18
3104051474504761K935300VAC-LOK IMMOBILIZATION SYSTEMIYE1994-07-18
3104051599675673K935067AQUAPLASTIYE1994-05-26
3104051228369369K933227UNI-FRAME HEAD IMMOBILIZATION SYSTEMIYE1994-07-18
3104051726366679K230312Iris AirShuttle™IYE2023-03-31
3104051386694145K211001C-Qual M™ Breastboard; Monarch™ Overhead Arm PositionerIYE2021-05-20
3104051458988108K193243Alta Multipurpose DeviceIYE2020-02-28
3104051980957754K182189Encompass SRS Headframe ; Encompass MR SRS HeadframeIYE2018-10-04
3104051193948269K182079Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic MaskIYE2018-09-07
3104051050311580K180021Proton Positioing and Immobilization DevicesIYE2018-06-29
3104051386979093K171133Qfix® Abdominal/Thoracic Motion Control System,Qfix® SBRT Solution and AccessoriesIYE2017-07-11
3104051660412942K160627Symphony Patient Transport System, Symphony Patient Trolley, Symphony Standard Transfer Surface, Symphony Portrait (Head/Neck) Transfer Surface, Symphony Brachytherapy solutionIYE2016-06-14
3104051093112439K153270TruGuard Custom Tongue and Jaw PositionerIYE2016-03-08
3104051936050925K153026Body Pro-Lok Respiratory Plate, Respiratory Plate Cushion, Body Pro-Respiratory Belt, Rail Clamp for Respiratory Belt, Pressure Gauge ReplacementIYE2016-05-25
3104051533617155K152321kVue Encompass SRS Insert (Encompass Insert), Encompass SRS Standalone (Encompass Device), Encompass SRS MRI Immobilization device (Encompass MRI Device, Encompass Intracranial Fibreplast Variable Perf Head Only Open View System, Encompass Intracranial Fibreplast Variable Perf Head Only Open View with 119 mm openingIYE2015-12-04
3104051567145440K132908TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KITIYE2014-03-04
3104051473629053K132084PROTURA COUCH SOFTWAREJAI2013-09-26
3104051175358546K121545BELLYBOARD, SBRT ACCESSORIESLNH2012-06-08
3104051624491895K120916QFIX RADIOTHERAPY CHAIRJAI2012-06-20
3104051879445393K111340HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEMLNH2011-06-28
3104051850417681K093738MRI PATIENT POSITIONING DEVICESLNH2010-05-14
3104052047947770K090349CLEARVUE PRONE BREAST TREATMENT TABLEIYE2009-03-09
3104051340847058K080072MRI PATIENT POSITIONING DEVICESIYE2008-06-04
3104051537938165K060737SINMED POSITIONING DEVICESIYE2006-03-31
3104051565581631K060671KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUSJAI2006-05-04
3104051521280223K032156ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENTIYE2003-09-02
3104051758531436K031866MED-TEC 6 DEGREE AXIS COUCH, MODEL MT-6DACJAI2003-08-14
3104051938207784K023293MED-TEC BELLYBOARD, MODELS MT-BBA-01 & MT-BBA-02IYE2002-12-23
3104051403170131K021124ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDERIYE2002-07-02
3104051160143771
3104051307080701
3104051557791181
3104051612748231
3104051661235646
3104051725465006
3104051961600296
3104052041658076

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
IYE262023-03-31
JAI42013-09-26
LNH32012-06-08
IXQ11997-12-05