PreciseRT ART-PA-MSPRT

GUDID 00850306007605

DM Magnification Stand Assembly PreciseRT

ADVANCED RADIATION THERAPY, LLC

General-purpose brachytherapy system applicator, manual

• Primary Device ID: 00850306007605
• NIH Device Record Key: 70c05522-885d-4cad-b592-5e638311d97e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PreciseRT
• Version Model Number: 450729
• Catalog Number: ART-PA-MSPRT
• Company DUNS: 193415051
• Company Name: ADVANCED RADIATION THERAPY, 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: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com
• Phone: (978)649-0007
• Email: info@accuboost.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850306007605 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K863890

FDA Product Code

• KXH: Cradle, Patient, Radiologic

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: 2021-10-05
• Device Publish Date: 2021-09-27

Devices Manufactured by ADVANCED RADIATION THERAPY, LLC

• 00850306007605 - PreciseRT: 2021-10-05DM Magnification Stand Assembly PreciseRT
• 00850306007605 - PreciseRT: 2021-10-05 DM Magnification Stand Assembly PreciseRT
• 00850306007513 - AccuBoost: 2019-12-11 Positioning Accessory - Top
• 00850306007520 - AccuBoost: 2019-12-11 DV Low Profile Bottom Positioning Tray
• 00850306007537 - AccuBoost: 2019-12-11 GE - Paddle Assembly
• 00850306007544 - AccuBoost: 2019-12-11 Planmed Sophie - Paddle Assembly
• 00850306007551 - AccuBoost: 2019-12-11 Digital Mammo - Paddle Assembly
• 00850306007568 - AccuBoost: 2019-12-11 DM Positioning Tray
• 00850306007575 - AccuBoost: 2019-12-11 DM Magnification Stand Assembly