Sonasource

FOCUS SURGERY INC · Model 102-17000-0009 · UDI-DI 00868108000212

PLP Prescription

510(k) clearances

Adverse events (1 deaths)

Recalls

Facilities

Description

Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions.

Recalls

Date	Firm	Reason
2017-08-14	Edap Technomed Inc.	The US FDA has requested the optional energy treatment settings, "medium" and "low" (Software Protocols 02-Medium and 03-Low) be removed from all Ablatherm Integrated Imagining dev

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.