GammaPod™ Treatment Control System XMSGP030A09.06-101

GUDID 00850002615012

TCS Software

XCISION MEDICAL SYSTEMS, LLC

Stereotactic system application software

• Primary Device ID: 00850002615012
• NIH Device Record Key: e072fb04-4e99-48cf-9423-a6656fa94095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: GammaPod™ Treatment Control System
• Version Model Number: Model A
• Catalog Number: XMSGP030A09.06-101
• Company DUNS: 788286941
• Company Name: XCISION MEDICAL SYSTEMS, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-924-7466
• Email: service@xcision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850002615012 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180571

FDA Product Code

• IWB: System, Radiation Therapy, Radionuclide

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-11
• Device Publish Date: 2019-03-01

Devices Manufactured by XCISION MEDICAL SYSTEMS, LLC

• 00850002615036 - GammaPod™ Imager Loader and Couch: 2019-04-16 Imager Loader and Couch
• 10850002615378 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Elliptical 100-50-16M
• 10850002615385 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Elliptical 100-50-23M
• 10850002615392 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Elliptical 120-60-20L
• 10850002615408 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Elliptical 120-60-30L
• 10850002615415 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Skew 80-40-17S
• 10850002615422 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Skew 100-50-16M
• 10850002615439 - GammaPod™ Breast Immobilization and Localization System: 2019-04-03 Skew 100-50-23M