Broadsound, Al3c34a, Al7l50a, Al3c79b, Al7l24b, At3p42a, At3c52b, Atl5l40b, At3…
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K070195 FDA 510(k)
- FDA Product Code
- ITX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1570 FDA 510(k)
- Regulation Number
- 892.1570 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These devices are ultrasound transducers designed for diagnostic imaging, specifically categorized under the product code ITX. They function as linear and curved array probes, enabling high-resolution imaging for various medical applications, including abdominal, vascular, and musculoskeletal assessments.
The BroadSound transducers are supplied as reusable devices and are intended for use in clinical settings such as radiology departments. They are not classified as single-use and require proper cleaning, disinfection, and maintenance per manufacturer guidelines. No specific MRI safety classification is stated, and their regulatory status includes FDA 510(k) clearance under the Radiology Advisory Committee and compliance with the Medical Device Directive (MDD).
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K070195 | Class II | Active |
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Manufacturer
- Manufacturer
- Broadsound Corporation
Sources (2)
- FDA 510(k) K070195 24 fields · synced Oct 6, 2026
- EUDAMED 1 fields · synced May 19, 2026