adaptiiv.comTrueFit Bolus; TrueFlex Bolus
Adaptiiv Medical Technologies, Inc.
Adaptiiv
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014873236 | 3014873236 | ADAPTIIV MEDICAL TECHNOLOGIES, INC. | 1 | N | 2026-01-01 | 1559 Barrington Street Suite 200-D Halifax Nova Scotia CA B3J 1Z8 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00860007402319 | 3D Bolus Application - 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only. | +19024429091 | support@adaptiiv.com |
| 00860007402326 | 3D Brachy Application - 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only. | +19024429091 | support@adaptiiv.com |
| 00860007402333 | Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) - Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder. | +1 (902) 442-9091 | support@adaptiiv.com |
| 00860007402340 | TrueFlex Bolus - TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone. | +1 (902) 442-9091 | suport@adaptiiv.com |
| 00860007402371 | Nova Surface Applicator - Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Rate (HDR) brachytherapy by providing a patient-specific fit and catheter trajectory design. The applicator is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, and radiation therapists. It is only intended to be utilized in radiation therapy, where a patient requires a total prescription dose on or near the skin surface. The device is made of methacrylic resin. | +1 (902) 442-9091 | support@adaptiiv.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 222088 | 1276434936 | K243057 | TrueFit Bolus; TrueFlex Bolus | MUJ | 2024-10-23 |
| 222088 | 1141708221 | K241318 | Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA) | MUJ | 2024-08-30 |
| 222088 | 1070950576 | K213438 | 3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory | MUJ | 2022-01-19 |
| 222088 | 1716258974 | K180289 | 3D Bolus Software | MUJ | 2018-07-10 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| MUJ | 4 | 2024-10-23 |
PMN#
Nova Surface Applicator (ADPT-ONDEM-3DPRT-BRA)
Adaptiiv Medical Technologies, Inc.
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
Adaptiiv
GUDID#
TrueFit Bolus - TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).
2024-12-09
Nova Surface Applicator - Nova Surface Applicator is a 3D printed patient-matched radiation therapy accessory that expands the application of High Dose Rate (HDR) brachytherapy by providing a patient-specific fit and catheter trajectory design. The applicator is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, and radiation therapists. It is only intended to be utilized in radiation therapy, where a patient requires a total prescription dose on or near the skin surface. The device is made of methacrylic resin.
2024-12-09
TrueFlex Bolus - TrueFlex Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit.The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of silicone.
2024-12-09
TrueFit Bolus - TrueFit Bolus is a 3D printed patient-matched radiation therapy accessory that expands the application of external beam radiation therapy by providing a patient-specific fit. The device is only suitable for use by qualified medical professionals such as radiation oncologists, medical physicists, dosimetrists and radiation therapists. The device is used in radiation therapy when a patient requires the total prescription dose to be delivered on or near the skin surface. The device is made of Polyamide (PA12).
2024-12-09
Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) - Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.
2022-08-16
Patient-Matched 3D Printed radiation Therapy Accessory (Ultrasint TPU) - Adaptiiv’s 3D printed patient-matched radiation therapy accessory is a customizable accessory that expands the application of external beam radiation therapy, allowing to overcome the skin-sparing effects inherent to high energy photons and electrons. The desired external beam radiation therapy accessories will be printed using HP Jet Fusion 5200 Series 3D Printing Solution and Ultrasint® Thermoplastic polyurethane (TPU01) powder.
2022-08-16
3D Brachy Application - 3D Brachy Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during surface brachytherapy. The use of 3D Brachy application is by prescription only.
2022-03-28
3D Bolus Application - 3D Bolus Software application is indicated for and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-matched 3D printable accessories intended for use during external beam (photon or electron) radiation therapy. The use of 3D Bolus application is by prescription only.
2022-03-28
3D Bolus Software - 3D Bolus Software is indicated for, and intended for use as an accessory to a radiation therapy treatment planning system (TPS) to design patient-specific 3D-printable objects intended for use during external beam photon or electron radiation therapy, or brachytherapy.
2021-08-09