FDA Registration
Active
🇺🇸 United States
RADIATION PRODUCTS DESIGN, INC.
Reg #: 2182762
·
FEI: 2182762
·
Expires 2026
Products
22
Proprietary Names
167
Establishment Types
3
Classifications
22
Registration Details
- Registration Name
- RADIATION PRODUCTS DESIGN, INC.
- Registration Number
- 2182762
- FEI Number
- 2182762
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5218 Barthel Industrial Dr Ne
- City
- ALBERTVILLE
- State
- MN
- ZIP
- 55301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150382
Owner / Operator
- Firm Name
- RADIATION PRODUCTS DESIGN, INC.
- Operator Number
- 2182762
- Address
- 5218 BARTHEL INDUSTRIAL DR., --
- City
- Albertville
- State
- MN
- Postal Code
- 55301
- Country
- US
- Correspondent
- HOWARD D LARSON
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bed, Manual | FNJ | Class 1 | General Hospital | No | 2018-10-25 |
| Accelerator, Linear, Medical | IYE | Class 2 | Radiology | No | 2018-10-25 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 1998-11-10 |
| Shield, Eye, Radiological | IWS | Class 1 | Radiology | No | 1998-11-10 |
| Table, Powered | INQ | Class 1 | Physical Medicine | No | 2021-08-30 |
| Shield, Gonadal | IWT | Class 1 | Radiology | No | 1998-11-10 |
| Lift, Patient, Non-Ac-Powered | FSA | Class 1 | General Hospital | No | 1980-04-01 |
| Support, Patient Position | CCX | Class 1 | Anesthesiology | No | 1980-04-01 |
| Holder, Head, Radiographic | IWY | Class 1 | Radiology | No | 2001-12-31 |
| System, Applicator, Radionuclide, Manual | IWJ | Class 1 | Radiology | No | 2001-12-31 |
| Stains, Dye Solution | LEE | Class 1 | Hematology | No | 1998-11-10 |
| Device, Transfer, Patient, Manual | FMR | Class 1 | General Hospital | No | 2018-11-14 |
| Holder, Syringe, Lead | IWR | Class 1 | Radiology | No | 1998-11-10 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 1979-04-04 |
| System, X-Ray, Film Marking, Radiographic | JAC | Class 1 | Radiology | No | 2001-12-31 |
| Table, Radiographic, Stationary Top | IXQ | Class 2 | Radiology | No | 2001-12-31 |
| Test-Pattern, Radiographic | IXF | Class 1 | Radiology | No | 1998-11-10 |
| Instrument, Quality-Assurance, Radiologic | LHO | Class 1 | Radiology | No | 2002-01-02 |
| Dispenser, Mercury And/Or Alloy | EHE | Class 1 | Dental | No | 1998-11-10 |
| Stand, Infusion | FOX | Class 1 | General Hospital | No | 1998-11-10 |
| Phantom, Anthropomorphic, Nuclear | IYP | Class 1 | Radiology | No | 2019-09-09 |
| Protractor | HTH | Class 1 | Orthopedic | No | 2001-12-31 |
Proprietary Names
MR, TBI, HDR MANUAL BED WITH FOWLER POSITIONING
RADIO THERAPY TREATMENT CHAIR
Body Caliper
Head-Neck Caliper
Silver-Plated Lead Eye Shield
Lead Eye Shield
TUNGSTEN ELECTRON EYESHIELD
Powered Treatment Tables
Testicle Shield Stand
Testicle Shield
Adjustable Shielding Table w/ Wheels
Anterior/Posterior Treatment Table Shield
Elevating Back Support with Adj. Arm Positioner
ELEVATING BACK SUPPORT WIT
Head Support w/Adjustable Pads
Adjustable Point-to-Point Level
Adult Chin Support w/Angle Indicator
Bite Block System
Chin Support Set (Adult & Child)
Child Chin Support w/Angle Indicator
Fixed Point-to-Point Level
Allen Wrench
Cap (Stainless Steel)
Combination Round Ovoid & Mini-Ovoid Applicator Set
6cm Afterloading Barrel (S.S.) w/ Cap
3M Delclos Uterine/Vaginal Applicator W/O Tandems
Flagged Cervical Stop
Cylinder Stop
Acrylic Cylinder w/ Suture Ring
Vaginal Afterloading Acrylic Cylinder Set
Mini Ovoid HTP Cap with Tungsten Shield
Mini Tandem
Delclos Mini-Ovoid Applicator Set
Cervical Stop
Cylinder Extractor
FSD Long Handle S.S. Applicator Set
Tandem, Stainless Steel
Nylon Cylinder
Right/Left CT Imaging Bucket Carrier-Titanium / Delrin
Delclos Mini-Ovoid Long Handle,Bracket S.S.Set&Ste
UHMW Low Density Cylinderw/ Suture Ring
Acrylic Cylinder w/ Suture Ring - 19mm Dia. X 120mm
Lead/ Nylon Cylinder w/Suture Ring
Dummy Source
Nylon Ovoid Cap
Heyman Dummy Source
Burnett Afterloading Vaginal Applicator
Tandem, Titanium
Bucket Carrier
Clamps, Ring CT / MR SAFE
Clamps, Titanium, With Custom Holes CT / MR CONDITIONAL
Clamps, Collar CT / MR SAFE
CARFUSION DYE
CASTELLANIS PAINT
CT/MR Slessinger Board V2
PET Stainless Steel Syringe Carrier
Stainless Steel Syringe Carrier
Lead Shielded Syringe Holder/Pig
Rolling Radiation Shield
Cesium Storage Safe
L-Block Shield
Transport Cart
HDR Emergency Container
PET Workstation
Over & Under Bed Radiation Shield
DOT Radiation Source Transporter
Matrix Thermo-Shield
BOLUS MATERIAL
Rectal Marker
CT Vaginal Depth Scale, 1.6cm Dia. x 26cm L
Introitus Marke
SS Markers, 0.8mm Dia. x 3mm
CT Rectal Marker
Titanium Markers, 0.8mm Dia. x 5mm Long
Vaginal Depth Scale
SS Markers, 0.8mm Dia. x 5mm
Titanium Markers, 0.8mm Dia. x 3mm Long
Cervix 3/16" Delrin Ball Markers w/Suture Hole
Cervix 3/16" S.S. Ball Markers w/Suture Hole
FIXED HEIGHT TREATMENT TABLE
Graticule,Varian III Wedge Upper,MLC-Opt Coding 5.728
Graticule, Siemens, Tray Slot, Screw Code, Acrylic
Graticule, AECL Therac 6
Graticule, Mitsubishi EXL-22DP Pin - 4.9922mm
Graticule, Varian IIl Xima. Sim. w/Frame, 110cm
Graticule, Varian IIl Xima. Sim. w/Frame,140cm
Graticule, Elekta SL15,18,20,25 f/Block Tray Slot
Graticule, Oldelft Simulator
Graticule,Siemens MLC,W.Slot, Sng.Dig.Co,Acry,4.15mm
Graticule, Elekta SL-20,75, L5- Mounted to Head, 54.2
Graticule, Haynes Simulator, 80cm
Graticule, Varian IIl Xima. Sim. w/Frame, 90cm
Graticule, Varian II Xima. Sim. w/ Frame, 80cm
Graticule, Tray Slot, SL75-5 Asymmetric Diaphragms
Graticule,Siemens Mevasim S Sim., 100cm SSD
Graticule, Siemens Simulator, 100cm SSD
Graticule, GE Saturne S4 Pin - Tray Slot
Replacement Oldelft Simulator Line Reticule ONLY
Oldelft Simulator Reticule 80cm w/Frame
Graticule, Philips 1976 Simulator, 3.2698mm
Graticule,Siemens Replacement Photon, Dig. Coding
Graticule, Kermath Simulator, 80,100cm
Graticule, CGR Simulator, 80, 100cm,
Graticule, ATC/EMI - Pin
Graticule,TEM(Siemens)Sim, 80,100cm,
Graticule, Siemens Mevasim S Sim., 120cm SSD
Graticule,Tray Slot,SL Series & SL75-5 Symmetric Diap
Graticule,Varian II Xima. Sim. w/ Frame, 100cm
Graticule, Elekta Synergy, Mounted to Head
Varian Acrylic Grat. Lower, MLC w/Opt Coding
Graticule, Siemens,W.Slot,Screw Code,Acry,4.15mm
Graticule, Varian IIl Xima. Sim. w/Frame, 120cm
Graticule, Siemens Mevatron 6, W. Slot, 35cm
Graticule,Toshiba LX-8 Sim,80,100cm,
Graticule, GE Saturne 3 Pin
Graticule, Siemens Simulator, 120cm SSD
Graticule, Siemens Mevasim S Sim., 140cm SSD
Oldelft Simulator Reticule 100cm w/Frame
Graticule, Mitsubishi - Pin
Graticule, Replacement Varian Simulator
Graticule, Picker Simulator, 80, 100cm
Graticule, Philips Super M80 Simulator
Tungsten Rotating Alignment Pattern Device for Film
Graticule, Elekta SL75-5 f/Block Tray Slot
Graticule,Varian II Xima. Sim. w/ Frame, 120cm
Graticule, GE 41 - Pin - Block Tray Slot
Graticule, Varian IIl Xima. Sim. wFrame, 100cm
Graticule, Mitsubishi ECL-22DP Pin - 4.8997mm
Graticule, Varian IIl Xima. Sim. w/ Frame, 80cm
Graticule, Siemens, Tray Slot, Digital Code, Acrylic
Graticule,Toshiba LX-30A Sim., 100cm
Graticule, GE Saturne 20 Pin
Graticule, Varian Type III Acrylic w/Opt Coding
Graticule, Philips
Graticule,TEM Simulator, 80, 100cm,
Graticule, AECL Sim, 80, 100cm,
Graticule Frame, Varian III Ximatron Sim, Opt. Coded
Graticule, GE Saturne 43 - Pin, 5.481 mm
Graticule, Varian Type Il, Coding By-Pass
Graticule, Siemens Mevatron 12, W.Slot,
Graticule, Varian II Xima. Sim. w/ Frame, 130cm
Graticule, Philips Loc-Sim Model SLS-9
Graticule,Toshiba LX-30A Sim.,80cm
Graticule, Varian IIl Xima. Sim. w/Frame, 130cm
Graticule, Mitsubishi Sim,80, 100cm,
Graticule, Siemens Simulator, 80cm SSD
Graticule,Siemens Mevasim S Sim. 80cm SSD
Graticule, GE Saturne 43 MLC Pin, Acrylic on Metal
Graticule, Varian II Xima. Sim. w/Frame, 140cm
Graticule, Philips Simulator, 80, 100cm,
Graticule, Siemens Replacement Photon, Screw Coding
Graticule, Mitsubishi EXL-4 Pin
Graticule, Siemens Simulator, 140cm SSD
Tungsten Rotating Alignment Pattern Device for Cassette
Tungsten Alignment Pattern Plate for Accelerators & Sims
Graticule, AECL T750 Therasim 750 Simulator
Optical Distance Verification Tool for Gantry Rotation
Gantry Holder
GARD
Magnetic Front Pointer
Film Cassette for GARD
Digital Alloy Dispenser
LOW AND HIGH ALLOY
IV POLE
Brass Mesh Bolus
Breast Bridge Compressor
Breast Bridge
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)