QUANTUM™ CT Overlay RT-4550FE
GUDID 10841962111116
QUANTUM CT Overlay for Fujifilm FCT Embrace
Qfix
Indexed-immobilization patient positioning system| Primary Device ID | 10841962111116 |
| NIH Device Record Key | fd307a58-1203-42d6-8e17-8f85321675f7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | QUANTUM™ CT Overlay |
| Version Model Number | RT-4550FE |
| Catalog Number | RT-4550FE |
| 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 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com | |
| Phone | +1(610)268-0585 |
| Compliance@qfix.com |
Device Dimensions
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
| Length | 242 Centimeter |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10841962111116 [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 | 2021-01-29 |
| Device Publish Date | 2021-01-21 |
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 |
Trademark Results [QUANTUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 QUANTUM 98867628 not registered Live/Pending |
Xplorian LLC 2024-11-22 |
 QUANTUM 98807712 not registered Live/Pending |
Into-Me-Sea LLC 2024-10-17 |
 QUANTUM 98804816 not registered Live/Pending |
QuantumADR LLC 2024-10-16 |
 QUANTUM 98719255 not registered Live/Pending |
Evolve Biologix Inc. 2024-08-27 |
 QUANTUM 98705080 not registered Live/Pending |
Intervet Inc. 2024-08-19 |
 QUANTUM 98650676 not registered Live/Pending |
Raynor Marketing Ltd. 2024-07-16 |
 QUANTUM 98424129 not registered Live/Pending |
HOUSE X AMERICA LLC 2024-02-27 |
 QUANTUM 98417725 not registered Live/Pending |
Meta Materials Inc. 2024-02-23 |
 QUANTUM 98388177 not registered Live/Pending |
Thomas P. Dakich 2024-02-02 |
 QUANTUM 98386723 not registered Live/Pending |
Kuku, Jalil 2024-02-01 |
 QUANTUM 98384415 not registered Live/Pending |
Starkey Laboratories, Inc. 2024-01-31 |
 QUANTUM 98362353 not registered Live/Pending |
The Upper Deck Company 2024-01-17 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.