Product Code: IWB
FDA class 2
21 CFR 892.5750
System, Radiation Therapy, Radionuclide
Radiology
A radionuclide radiation therapy system is a complete device system used to deliver therapeutic doses of radiation from radioactive isotopes to treat malignant and other conditions, encompassing the source handling, positioning, and delivery mechanisms. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification. The product code is IWB, regulated under 21 CFR 892.5750, within the Radiology medical specialty.
510(k)s
48
FEI Numbers
10
Registration Numbers
10
Unique Applicants
27
Years Active
47
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Basic Information
- Product Code
- IWB
- Device Class
- FDA class 2
- Regulation Number
- 892.5750
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 48 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon); Leksell Gamma Knife® (Perfexion) | Jul 02, 2025 | Substantially Equivalent | Elekta Solutions AB |
| K232854 | Leksell GammaPlan (LGP) | Feb 08, 2024 | Substantially Equivalent | Elekta Solutions AB |
| K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta Esprit (New model variant) | Oct 26, 2022 | Substantially Equivalent | Elekta Solutions AB |
| K203250 | TaiChiC | Mar 12, 2021 | Substantially Equivalent | Our United Corporation |
| K203146 | Akesis Galaxy RTi | Mar 05, 2021 | Substantially Equivalent | Akesis, Inc. |
| K200050 | Akesis Galaxy RTx | Feb 04, 2020 | Substantially Equivalent | Akesis, Inc. |
| K190844 | Akesis Galaxy | Sep 04, 2019 | Substantially Equivalent | Akesis, Inc. |
| K180571 | GammaPod | Apr 04, 2018 | Substantially Equivalent | Xcision Medical Systems, LLC |
| K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Mar 30, 2018 | Substantially Equivalent | Elekta Instrument AB |
| K173791 | Leksell GammaPlan | Feb 09, 2018 | Substantially Equivalent | Elekta Instrument AB |
| K172706 | GammaPod - Model A | Dec 22, 2017 | Substantially Equivalent | Xcision Medical Systems, LLC |
| K160440 | Leksell Gamma Knife Icon | Apr 20, 2016 | Substantially Equivalent | Elekta Instrument AB |
| K151159 | Leksell Gamma Knife Perfexion | Oct 29, 2015 | Substantially Equivalent | Elekta Instrument AB |
| K151561 | Leksell Gamma Knife Icon | Aug 04, 2015 | Substantially Equivalent | Elekta Instrument AB |
| K150191 | GammaBeam 500 | Apr 17, 2015 | Substantially Equivalent | Best Theratronics Limited |
| K142219 | GammaBeam 100 | Nov 13, 2014 | Substantially Equivalent | Best Theratronics Limited |
| K133565 | LEKSELL GAMMA KNIFE PERFEXION | May 09, 2014 | Substantially Equivalent | Elekta Instrument AB |
| K131777 | HYPER SOURCE-UNIT ROTATING GAMMA SYSTEM | Feb 28, 2014 | Substantially Equivalent | Hyper Technology, Inc. |
| K120811 | LEKSELL GAMMA KNIFE PERFEXION | May 24, 2012 | Substantially Equivalent | Elekta Instrument AB |
| K102533 | ROTATING GAMMA SYSTEM INFINI (INFINI) | Mar 22, 2011 | Substantially Equivalent | Masep Medical Science & Tech.Development (Shenzhen |
| K092083 | EXTEND FRAME SYSTEM, MODEL 1009633 | Sep 22, 2009 | Substantially Equivalent | Elekta Instrument AB |
| K063512 | LEKSELL GAMMA KNIFE PERFEXION | Mar 05, 2007 | Substantially Equivalent | Elekta Instrument AB |
| K061941 | LEKSELL GAMMA KNIFE PERFEXION, MODEL 715000 | Aug 21, 2006 | Substantially Equivalent | Elekta Instrument AB |
| K061540 | LEKSELL GAMMAPLAN | Jul 05, 2006 | Substantially Equivalent | Elekta Instrument AB |
| K060314 | ROTATING GAMMA SYSTEM. GAMMA ART-6000 | Apr 06, 2006 | Substantially Equivalent | American Radiosurgery, Inc. |
| K053485 | THERATRON EQUINOX, MODELS 80 CM AND 100 CM | Mar 09, 2006 | Substantially Equivalent | Mds Nordion, Inc. |
| K051022 | GAMMAPLAN | Jun 01, 2005 | Substantially Equivalent | Elekta Instrument AB |
| K041125 | MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) | Dec 30, 2004 | Substantially Equivalent | Masep Med Science & Tech. Development (Shenzhen) C |
| K001006 | THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE | Apr 27, 2000 | Substantially Equivalent | Mds Nordion |
| K000478 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/ RADIOTHERAPY V2.1 | Apr 19, 2000 | Substantially Equivalent | Accuray, Inc. |
| K984563 | THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY | Jul 14, 1999 | Substantially Equivalent | Accuray, Inc. |
| K984328 | LEKSELL GAMMA KNIFE TARGET SYSTEM, MODEL 24001 | May 21, 1999 | Substantially Equivalent | Elekta Instrument AB |
| K983917 | THERATRON ELITE | Dec 04, 1998 | Substantially Equivalent | Theratronics, Inc. |
| K973441 | LEKSELL GAMMAPLAN | Apr 01, 1998 | Substantially Equivalent | Patterson Consulting Group, Inc. |
| K964606 | THERATRON 780E | Jun 26, 1997 | Substantially Equivalent | Theratronics, Inc. |
| K970647 | OUR ROTATING GAMMA SYSTEM | May 20, 1997 | Substantially Equivalent | Our Scientific Intl., Inc. |
| K960892 | THE COBALT SCALPEL | Jun 03, 1996 | Substantially Equivalent | Nova Therapeutic System |
| K924849 | LEKSELL GAMMA UNIT MODEL 23004,TYPE B. | Nov 20, 1995 | Substantially Equivalent | Elekta Radiosurgery, Inc. |
| K925133 | DPD-510 THERAPEUTIC RADIATION DOSIMETER | Jan 04, 1993 | Substantially Equivalent | Scanditronix, Inc. |
| K914808 | LEKSELL GAMMAPLAN (LGP) | Jan 23, 1992 | Substantially Equivalent | Elekta Instruments, Inc. |
| K912250 | ISORAD(TM) INTEGRAL BUILDUP PHOTON DIODES | Nov 05, 1991 | Substantially Equivalent | Theta Systems, Inc. |
| K894165 | THERATRON 1000 | Feb 01, 1990 | Substantially Equivalent | Theratronics, Inc. |
| K871215 | DISPOSABLE SHADOW TRAY INSERTS | Apr 06, 1987 | Substantially Equivalent | Mick Radio-Nuclear Instruments, Inc. |
| K863180 | THERATRON-PHOENIX | Oct 27, 1986 | Substantially Equivalent | Aecl Medical |
| K860849 | MARX PLAN, RADIATION THERAPY TREATMENT PLAN SYSTEM | Apr 08, 1986 | Substantially Equivalent | Marx Pland |
| K850543 | THERATRON 780C A RADIONUCLIDE RADIATION THERAPY SY | May 10, 1985 | Substantially Equivalent | Atomic Energy of Canada |
| K827583 | STEREOTACTIC 60 COBALT GAMMA SYSTEM--GAMMAKNIFE | Sep 29, 1982 | Substantially Equivalent | Nucletronix, Inc. |
| K780948 | SYSTEM, PLANNING, TREATMENT | Jun 22, 1978 | Substantially Equivalent | Emi Therapy Systems, Inc. |
FEI Numbers
This FDA classification entry is associated with 10 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 10 registration numbers. Click on an entry to view related FDA registrations.