FDA.reportPublic FDA data

GammaPod™

Primary DI
00850002615005
Brand
GammaPod™
Company
XCISION MEDICAL SYSTEMS, LLC
Model
Model A
Catalog number
XMSGP030A00-0.02
Device description
Stereotactic Radiotherapy System
Published
2019-03-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IWBSystem, Radiation Therapy, Radionuclide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWBSystem, Radiation Therapy, RadionuclideRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K180571000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180571000GammaPodXcision Medical Systems, LLC2018-04-04IWB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002615005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002615005008500026150058500026150050850002615005

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgical systemAn assembly of devices designed to deliver a therapeutic radiation dose to an anatomical region from external beams produced from multiple radionuclide sources arranged in a fixed focal point collimated array; typically used to treat brain, neck, breast and spinal tumours. It typically consists of: 1) a stereotactic positioning device attached to the patient to define the three-dimensional (3-D) co-ordinates of the treatment site; 2) fixed diameter collimators; 3) high-density beam blockers; 4) a shielded housing to hold the sources, reducing room radiation; 5) a precision aligned array to cause the source beams to intersect at a single point; and 6) a moveable patient table.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-855-924-7466service@xcision.com

Regulatory Flags#

DUNS number
788286941
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850002615361GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0012019-03-22
10850002615378GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0022019-03-22
10850002615385GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0032019-03-22
10850002615392GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0042019-03-22
10850002615408GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0052019-03-22
10850002615415GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0062019-03-22
10850002615422GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0072019-03-22
10850002615439GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0082019-03-22
10850002615446GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0092019-03-22
10850002615453GammaPod™ Breast Immobilization and Localization System BolusXMSGP030A10.08-0102019-03-22
10850002615088GammaPod™ Breast Immobilization and Localization System Breast Cup FlangeXMSGP030A10.05-0012019-03-21
10850002615095GammaPod™ Breast Immobilization and Localization System Breast Cup FlangeXMSGP030A10.05-0022019-03-21
10850002615101GammaPod™ Breast Immobilization and Localization System Breast Cup FlangeXMSGP030A10.05-0032019-03-21
10850002615118GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0012019-03-21
10850002615125GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0022019-03-21
10850002615132GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0032019-03-21
10850002615149GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0042019-03-21
10850002615156GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0052019-03-21
10850002615163GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0062019-03-21
10850002615170GammaPod™ Breast Immobilization and Localization System Inner Breast CupXMSGP030A10.02-0072019-03-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860014221910Galaxy RTiAkesis Inc.IWB2026-05-11
06973682570151CybeRayOur United CorporationIWB2026-04-24
07340201503898Leksell GammaPlanElekta Solutions ABIWB2026-02-04
06974783050023SMD-XGD/AR GalaxyOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-30
06974783050009SMD Galaxy RTxOur Smd Medical (Wuhan) Co., Ltd.IWB2025-05-26
07340201502136Leksell GammaPlanElekta Solutions ABIWB2024-02-14
07340201501139Leksell Gamma Knife EspritElekta Solutions ABIWB2023-03-27
07340048311786Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07340048311700Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311731Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311755Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311762Leksell Gamma Knife Perfexion/IconElekta Solutions ABIWB2021-03-28
07340048311779Leksell Gamma Knife IconElekta Instrument ABIWB2021-03-28
07540180000238Clarity®Elekta Solutions ABIWB2020-06-19
07340048311878Leksell GammaPlanElekta Instrument ABIWB2020-06-13
07540180000221Clarity®Elekta Solutions ABIWB2020-05-22
05060608880522ISORAD Detector, 1-4MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880539ISORAD Detector, 1-4MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880546ISORAD Detector, 6-12MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880553ISORAD Detector, 6-12MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880560ISORAD Detector, 6-12MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
05060608880577ISORAD Detector, 15-25MV (-) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880584ISORAD Detector, 15-25MV (+) 3mSUN NUCLEAR CORP.IWB2019-05-21
05060608880591ISORAD Detector, 15-25MV (-) 1.5mSUN NUCLEAR CORP.IWB2019-05-21
07340048306447Leksell Gamma Knife Perfexion/IconElekta Instrument ABIWB2019-04-17
07540180000214Clarity®Elekta Solutions ABIWB2019-03-27
10850002615361GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615378GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615385GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22
10850002615392GammaPod™ Breast Immobilization and Localization System XCISION MEDICAL SYSTEMS, LLCIWB2019-03-22