510(k) Report

FDA applicant

Riverain Technologies, Inc.

Miamisburg, OH5 decisions2012–20240 recalls

FDA records 5 decisions for Riverain Technologies, Inc. (Miamisburg, OH) from 2012 to 2024: 5 510(k) clearances. Most are in product codes OEB (Lung Computed Tomography System…) and QFM (Radiological Computer-Assisted Prioritization…). Its devices cite 9 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Riverain Technologies, LLC”, “Riverain Technologies”.

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 Riverain Technologies, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2012: 12016: 12022: 22024: 1
2012high 2 (2022) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Riverain Technologies, Inc. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Riverain Technologies, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Riverain”

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