FDA applicant

Soma Access Systems, LLC

Greenville, SC1 decision2011–20111 recall

FDA records 1 decision for Soma Access Systems, LLC (Greenville, SC) in 2011: 1 510(k) clearance. All are in product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Soma Access Systems, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2011high 1 (2011) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

1in 2014

2011high 1 (2014) · low 0 (2011)2026

Class I Class II/III not classified

FIG. 1 — Soma Access Systems, LLC by year, 2011–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Soma”

FDA records each applicant name separately; these may or may not be the same firm.

Soma Blue, Inc. 2 Soma Intl., Inc. 1 Soma International, Ltd. 1

Soma Access Systems, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Soma”