QUANTUM™ CT Overlay RT-4550TAQ2

GUDID 10841962111000

QUANTUM CT Overlay for Canon Aquilion CT for 244cm long cradle

Qfix

Indexed-immobilization patient positioning system

• Primary Device ID: 10841962111000
• NIH Device Record Key: dc30a98b-7420-4a25-a494-2b389d28a890
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: QUANTUM™ CT Overlay
• Version Model Number: RT-4550TAQ2
• Catalog Number: RT-4550TAQ2
• Company DUNS: 808875397
• Company Name: Qfix
• 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: false
• Serial Number: true
• Manufacturing Date: true
• 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(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com
• Phone: +1(610)268-0585
• Email: Compliance@qfix.com

Device Dimensions

• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter
• Length: 244 Centimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	10841962111000 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060671

FDA Product Code

• JAI: Couch, radiation therapy, powered

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: 2019-10-22
• Device Publish Date: 2019-10-14

On-Brand Devices [QUANTUM™ CT Overlay]

• 10841962111000: QUANTUM CT Overlay for Canon Aquilion CT for 244cm long cradle
• 10841962111116: QUANTUM CT Overlay for Fujifilm FCT Embrace
• 10841962111291: GE Gen2 QUANTUM CT Overlay for GE GT 1700 and GE NG2000V CT Scanners
• 10841962109106: 36" Table Extension for the Quantum Couchtop
• 10841962109090: 24" Table Extension for the Quantum Couchtop
• 10841962109076: QUANTUM CT Overlay for Toshiba Aquilion CT For 215cm long cradle
• 10841962109069: Quantum Overlay - Siemens PHS1B
• 10841962109052: Quantum CT - Siemens Somatom Definition 64 (for 240cm long cradle)
• 10841962109045: QUANTUM CT for Somatom Emotion Duo, Esprit +, CT For 217cm long cradle
• 10841962109038: QUANTUM CT Overlay for Somatom Plus 4,Volume Ct For 244cm long cradle
• 10841962109021: QUANTUM CT Overlay for Phillips Brilliance CT For 250cm long cradle
• 10841962108901: QUANTUM CT Overlay for GE Lightspeed RT CT For 207 cm long cradle
• 10841962108895: QUANTUM CT Overlay for GE Lightspeed + HiSpeed CT For 231 cm long cradle
• 10841962108888: QUANTUM CT Overlay for GE HiSpeed CT For 219 cm long cradle
• 10841962108871: QUANTUM CT Overlay for GE Lightspeed VCT CT for 262 cm long cradle