Med-Tec Bellyboard, Models MT-BBA-01 & MT-BBA-02
FDA 510(k)Class II (US FDA 510(k))
by Medtec LLC
Identifiers
- 510(k) Number
- K023293 FDA 510(k)
- FDA Product Code
- IYE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.5050 FDA 510(k)
- Regulation Number
- 892.5050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Med-Tec Bellyboard, Models MT-BBA-01 & MT-BBA-02 is a patient positioning accessory for radiation therapy. It is designed to be placed on a treatment table and features a cutout to facilitate displacement of the small bowel from the radiation treatment field.
It is used in clinical radiation oncology settings and operated by radiation therapists. The device can be used standalone or integrated with the MED-TEC HipFix system. It is supplied as a reusable device and has received FDA 510(k) clearance under K023293 with product code IYE.
Frequently asked questions
What is the Med-Tec Bellyboard used for?
The Med-Tec Bellyboard is a patient positioning accessory for radiation therapy designed to be placed on a treatment table and features a cutout to facilitate displacement of the small bowel from the radiation treatment field. It is used in clinical radiation oncology settings and operated by radiation therapists.
Is the Med-Tec Bellyboard reusable or single-use?
The Med-Tec Bellyboard is supplied as a reusable device, meaning it can be cleaned and used multiple times in clinical radiation oncology settings after proper reprocessing between uses.
What regulatory pathway was used for the Med-Tec Bellyboard?
The Med-Tec Bellyboard received FDA 510(k) clearance under K023293 with product code IYE, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.
Can the Med-Tec Bellyboard be used with other systems?
Yes, the Med-Tec Bellyboard can be used standalone or integrated with the MED-TEC HipFix system, allowing flexibility in clinical setup depending on the treatment requirements and existing equipment in the radiation oncology department.
What models of the Med-Tec Bellyboard are available?
The Med-Tec Bellyboard is available in two models: MT-BBA-01 and MT-BBA-02, both designed as patient positioning accessories for radiation therapy with a cutout to displace the small bowel from the treatment field.
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: Med-tec Bellyboard, Models Mt-bba-01 & Mt-bba-02, fda.innolitics.com, BELLYBOARD, SBRT ACCESSORIES by MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS ..., Med-Tec,Inc. — 8 FDA 510 (k)s · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K023293 | Class II | Active |
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Manufacturer
- Manufacturer
- Medtec LLC
- FDA Applicant
- Med-Tec,Inc.
Sources (1)
- FDA 510(k) K023293 24 fields · synced Sep 19, 2026