GammaPod™ Imager Loader and Couch

Basic Information

• Brand Name: GammaPod™ Imager Loader and Couch
• Primary DI: 00850002615036
• Version / Model: Model B
• Catalog Number: XMSGP030A08.00-0.00
• Company Name: XCISION MEDICAL SYSTEMS, LLC
• Labeler DUNS: 788286941
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-03-01
• Public Version: 2
• Public Version Date: 2019-04-16
• Public Version Status: Update
• Public Device Record Key: 373dd31d-f262-4d84-bc27-6428e6ea6f93

Device Description

Imager Loader and Couch

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IWB	System, Radiation Therapy, Radionuclide	Radiology	892.5750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40680	Multi-purpose diagnostic imaging table	An electrically-powered multi-purpose device intended to support and position a patient in conjunction with multiple diagnostic imaging procedures (e.g., x-ray, nuclear medicine or ultrasound). It may contain a variable number of articulated joints to facilitate patient positioning and incorporates electronic or software controls for table height, motion, and/or table top position.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850002615036	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K180571	000