Identity
- Trade Name
- TrueFit Bolus FDA UDI
- Generic Name
- Radiation therapy bolus, single-use FDA UDI
- Device Name
- 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). FDA UDI
- Model / Reference
- N/A FDA UDI
- Description
- 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). FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860007402388 FDA UDI
- 510(k) Number
- K243057 FDA UDI
- FDA Product Code
- MUJ FDA UDI
- GMDN Term
- Radiation therapy bolus, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.5050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radiation therapy bolus, single-use
TrueFit Bolus by Adaptiiv Medical Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Radiation therapy bolus, single-use.
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- Aquaplast RT™ — Qfix · Class II
- Clearsight Bolus — CLEARSIGHT RT LLC · Class I
- Aquaplast RT™ — Qfix · Class II
Cleared under the same submission
K243057 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Adaptiiv Medical Technologies Inc
Sources (1)
- FDA UDI f06f42bd-1861-46d1-b3de-c85f5c6224b9 35 fields · synced May 29, 2026