FDA Registration
Active
🇺🇸 United States
Anholt Technologies Inc.
Reg #: 2247992
·
FEI: 1000208827
·
Expires 2026
Products
19
Proprietary Names
94
Establishment Types
3
Classifications
19
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Registration Details
- Registration Name
- Anholt Technologies Inc.
- Registration Number
- 2247992
- FEI Number
- 1000208827
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 440 CHURCH ROAD
- City
- Avondale
- State
- PA
- ZIP
- 19311
- Country
- US
Regulatory Submissions
- 510(k) Number
- K935411
Owner / Operator
- Firm Name
- Medtec LLC
- Operator Number
- 9033077
- Address
- 1401 8TH ST., S.E., --
- City
- Orange City
- State
- IA
- Postal Code
- 51041
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Phantom, Anthropomorphic, Radiographic | IXG | Class 1 | Radiology | No | 1999-10-15 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2010-12-28 |
| System, Nuclear Magnetic Resonance Imaging | LNH | Class 2 | Radiology | No | 2016-11-28 |
| System, X-Ray, Tomography, Computed | JAK | Class 2 | Radiology | No | 2022-10-28 |
| Tomographic Imager Combining Emission Computed Tomography With Nuclear Magnetic Resonance | OUO | Class 2 | Radiology | No | 2022-10-28 |
| Couch, Radiation Therapy, Powered | JAI | Class 2 | Radiology | No | 2022-10-28 |
| Device, Patient Transfer, Powered | FRZ | Class 2 | General Hospital | No | 2022-10-28 |
| System, Radiation Therapy, Charged-Particle, Medical | LHN | Class 2 | Radiology | No | 2022-10-28 |
| System, Tomography, Computed, Emission | KPS | Class 2 | Radiology | No | 2022-10-28 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2013-12-17 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 1994-06-03 |
| Table, Operating-Room, Electrical | GDC | Class 1 | General, Plastic Surgery | No | 2022-10-28 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 2022-10-28 |
| Holder, Head, Radiographic | IWY | Class 1 | Radiology | No | 1994-01-28 |
| Marker, Skin | FZZ | Class 1 | General, Plastic Surgery | No | 2001-09-27 |
| System, X-Ray, Angiographic | IZI | Class 2 | Radiology | No | 2023-04-05 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2023-04-05 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2005-06-28 |
| Table, Radiologic | KXJ | Class 2 | Radiology | No | 1995-01-30 |
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
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
Solstice SRS Immobilization System; Solstat Immobilization System; Solstice Thermoplastic Mask
Hipfix
Hip & Pelvic fixation system
Encompass SRS Immobilization System
AccuTatt; Accu-Tatt; ISO Mark; Opti-Tatt
AccuForm Cushion
Iris AirShuttle (TM)
C-Qual M Breastboard; Monarch Overhead Arm Positioner
Qfix Radiotherapy Chair
Vac-Loc cushions
MED-TEC THERMOPLASTIC SHIELD
MEDTEC FLAT-FOAM
MEDTEC SHIELDING ALLOY
Symphony Patient Transport System; AirDrive Trolley; AirShuttle
Imaging Extension, Long, OPERON D 750-D
Insight MRI Head Coil Holder
Insight MRI Overlay
MED-TEC DUAL LEG POSITIONER
Imaging Extension, Short, OPERON D 750-D
Insight MRI Bridge with Body Coil Holder
Type-S Extension
MR & Radiological Patient Positioning Devices
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility