Chabner XRT Garments
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- Chabner XRT EUDAMEDFDA UDI
- Generic Name
- Radiological breast positioner, wearable FDA UDI
- Device Name
- Chabner XRT Radiation Bra EUDAMEDThe 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
- CRTBRA05 EUDAMEDFDA UDICRTBRA EUDAMED
- 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
- CRTBRA05 FDA UDI
- Primary DI / UDI-DI
- 00860011280149 EUDAMEDFDA UDI
- Basic UDI-DI
- 08600112801CRTBRANS EUDAMED
- Direct Marketing DI
- 00860011280149 EUDAMED
- 510(k) Number
- FDA Product Code
- IYE FDA 510(k)FDA UDI
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
- GMDN Term
- Radiological breast positioner, wearable FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)FDA UDI
- Market of Registration
- Italy EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
These garments are designed as protective and immobilization devices for use during radiation therapy. They are specifically engineered to ensure precise patient positioning and stability, particularly for breast and thoracic treatments, while maintaining radiolucency to allow accurate imaging and treatment delivery.
The Chabner XRT Garments are supplied as single-use, non-sterile items intended for clinical use in radiation oncology settings. They are classified as Class II medical devices under FDA regulations and comply with the requirements of 21 CFR 892.5050. The garments are manufactured to support repeatable and consistent treatment outcomes, with no specific MRI safety considerations noted.
Frequently asked questions
What is the primary purpose of the Chabner XRT Garments in a radiation therapy setting?
The Chabner XRT Garments are designed as protective and immobilization devices to ensure precise patient positioning and stability during radiation therapy, particularly for breast and thoracic treatments. Their radiolucent properties allow for accurate imaging and uninterrupted treatment delivery, helping maintain consistent and repeatable outcomes.
Are these garments reusable or intended for single-use, and what does that mean for clinical workflow?
The Chabner XRT Garments are explicitly supplied as single-use items, meaning each garment is intended for one patient treatment session only. This design choice simplifies clinical workflow by eliminating the need for cleaning, sterilization, or reprocessing between uses, reducing the risk of cross-contamination and ensuring hygiene standards are met.
Do these garments require sterilization before use, and if not, what does that imply for their handling?
The Chabner XRT Garments are non-sterile and intended for clinical use as-is, without requiring sterilization. This means they should be handled with standard infection control practices (e.g., wearing gloves) to minimize exposure risk, but they do not need to undergo additional sterilization procedures like autoclaving or ethylene oxide treatment before use.
What regulatory pathway was followed for the approval of these garments, and how does that affect their use?
The Chabner XRT Garments were cleared through the FDA’s 510(k) pathway, specifically under the Radiology advisory committee (RA) and classified as Substantially Equivalent (SESE) to a predicate device. This means their safety and effectiveness were compared to an existing approved device, and they comply with 21 CFR 892.5050 for protective and immobilization garments. Clinically, this implies they meet established standards for use in radiation therapy settings.
Are there specific storage requirements for these garments, and how should they be stored to maintain integrity?
While the data does not specify exact storage conditions, as single-use, non-sterile items, the garments should be stored in a clean, dry environment protected from direct sunlight, moisture, and physical damage. Proper packaging should remain intact until use to preserve sterility (if applicable to the packaging) and functionality. Always follow manufacturer guidelines for optimal shelf life.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Chabner XRT, Chabner XRT, LLC — MedIndexer | MedIndexer, Chabner XRT - Overview, News & Similar companies | ZoomInfo.com
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K121284 | Class II | Active |
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Manufacturer
- Manufacturer
- Chabner Xrt, LLC
Sources (3)
- FDA 510(k) K121284 24 fields · synced Sep 18, 2026
- FDA UDI 7bd3b691-a225-4446-a579-2c439ffc14b8 36 fields · synced May 30, 2026
- EUDAMED effedf02-b207-4cce-ba42-66b04dec3978 61 fields · synced Aug 2, 2026