Identity
- Trade Name
- Chabner XRT FDA UDI
- Generic Name
- Radiological breast positioner, wearable FDA UDI
- Device Name
- The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and radiation treatment, including proton therapy. The bra can also be used for breast support during other radiologic procedures such as CT, MRI and diagnostic X-rays. The bra, customizable for a wide variety of body types, is made of lightweight, advanced materials providing enhanced support ideal for positioning the breast and ensuring patient comfort without irritation or sensitization. FDA UDI
- Model / Reference
- CRTBRA04 FDA UDI
- Description
- The Chabner XRT Radiation Bra provides optimal breast support during simulation, planning and radiation treatment, including proton therapy. The bra can also be used for breast support during other radiologic procedures such as CT, MRI and diagnostic X-rays. The bra, customizable for a wide variety of body types, is made of lightweight, advanced materials providing enhanced support ideal for positioning the breast and ensuring patient comfort without irritation or sensitization. FDA UDI
Identifiers
- Catalog Number
- CRTBRA04 FDA UDI
- Primary DI / UDI-DI
- 00860011280132 FDA UDI
- 510(k) Number
- K121284 FDA UDI
- FDA Product Code
- IYE FDA UDI
- GMDN Term
- Radiological breast positioner, wearable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Radiological breast positioner, wearable
Chabner XRT by Chabner Xrt, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Radiological breast positioner, wearable.
- Chabner XRT — Chabner Xrt, LLC · Class II
- Chabner XRT — Chabner Xrt, LLC · Class II
Cleared under the same submission
K121284 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
- Chabner Xrt, LLC
Sources (1)
- FDA UDI 4c4e344a-f06d-4f19-8824-f45bc067a5ab 36 fields · synced May 30, 2026