Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2182762

FEI Number

2182762

Entity Name

RADIATION PRODUCTS DESIGN, INC.

City/State/Country

ALBERTVILLE, MN, US

Establishment Address

5218 Barthel Industrial Dr Ne, ALBERTVILLE, MN 55301, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

RADIATION PRODUCTS DESIGN, INC. (Owner Number: 2182762)

Owner / Operator Contact Address

5218 BARTHEL INDUSTRIAL DR., --, Albertville, MN 55301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FNJ	Bed, Manual	General Hospital	Class 1	880.5120	2018-10-25
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-10-25
KTZ	Caliper	Orthopedic	Class 1	888.4150	1998-11-10
IWS	Shield, Eye, Radiological	Radiology	Class 1	892.6500	1998-11-10
INQ	Table, Powered	Physical Medicine	Class 1	890.3760	2021-08-30
IWT	Shield, Gonadal	Radiology	Class 1	892.6500	1998-11-10
FSA	Lift, Patient, Non-Ac-Powered	General Hospital	Class 1	880.5510	1980-04-01
CCX	Support, Patient Position	Anesthesiology	Class 1	868.6820	1980-04-01
IWY	Holder, Head, Radiographic	Radiology	Class 1	892.1920	2001-12-31
IWJ	System, Applicator, Radionuclide, Manual	Radiology	Class 1	892.5650	2001-12-31
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	1998-11-10
FMR	Device, Transfer, Patient, Manual	General Hospital	Class 1	880.6785	2018-11-14
IWR	Holder, Syringe, Lead	Radiology	Class 1	892.6500	1998-11-10
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	1979-04-04
JAC	System, X-Ray, Film Marking, Radiographic	Radiology	Class 1	892.1640	2001-12-31
IXQ	Table, Radiographic, Stationary Top	Radiology	Class 2	892.1980	2001-12-31
IXF	Test-Pattern, Radiographic	Radiology	Class 1	892.1940	1998-11-10

Official Correspondent

HOWARD LARSON

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RADIATION PRODUCTS DESIGN, INC.

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

View Entity Profile →

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
K973037	Avid N.I.T., Inc.	N.I.T., INC. RADIONUCLIDE SEED APPLICATOR, MODEL SA-1000	1998-01-27
K865100	Computerized Imaging Reference Systems, Inc.	TISSUE-EQUIVALENT BREAST SIMULATOR	1987-01-12

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2182762. Last updated year: 2026. Please use registration number 2182762 when referencing this establishment in official correspondence.