FDA applicant

Pronova Solutions, LLC

Maryville, TN2 decisions2016–20260 recalls

FDA records 2 decisions for Pronova Solutions, LLC (Maryville, TN) from 2016 to 2026: 2 510(k) clearances. All are in product code LHN (System, Radiation Therapy, Charged-Particle…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “ProNova Solutions”.

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 Pronova Solutions, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2016high 1 (2016) · low 0 (2017)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Pronova Solutions, LLC by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Pronova”

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

Pronova Laboratories BV 1

Pronova Solutions, LLC

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Pronova”