Accuro 3S

K243937

Rivanna Medical, Inc. · cleared 2025-05-23 · product code IYO · Radiology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.4)
“The Accuro 3S is a diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals. Accuro 3S is intended to be used in a hospital or medical clinic environment at the point of care. Accuro 3S supports B-mode imaging and a SpineNav-AI™ image processing software.”
Algorithmdeep convolutional neural network approach to segmenting certain anatomical structures
source quote (p.7)
“The machine learning algorithm at the foundation of SpineNav-AI is a deep convolutional neural network approach to segmenting certain anatomical structures in the lumbar spine and conveying them by way of graphics to the user.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: acoustic output; cleaning/disinfection; electrical safety; thermal safety; mechanical safety; EMC safety; biocompatibility

standards: 21 CFR 820, ISO 14971:2019, IEC 60601-1 Edition 3.2 2020-08, IEC 60601-1-2 Edition 4.1 2020-09, IEC 60601-1-6 Edition 3.2 2020-07, IEC 60601-2-37 Edition 2.1 2015, IEC 62304, Edition 1.1 2015-06, IEC 62366-1 Edition 1.1 2020-06, IEC 62359 Edition 2.1 2017-09, ISO 10993-1 Fifth edition 2018, NEMA UD 2-2004 (R2009), NEMA PS 3.1 - 3.20e, AAMI TIR69:2017(R2020)

Retrospective clinical

n=81 patients · 7 site(s)

endpoints: per-frame accuracy; per-sequence detection success rate; DICE scores

standards: ISO 14971

Reported performance (4 observations)

accuracyas written: “Epidural Region Indicator accuracy (lateral dimension)”1.61CI ± 2.57 mm
source quote (p.9)
“The Epidural Region Indicator, derived from SpineNav-AI anatomical segmentations, demonstrated accuracy of 1.61 (± 2.57) mm and 2.42 (± 3.41) mm in the lateral and depth dimensions, respectively, compared to the radiologist panel ground truth.”
accuracyas written: “Epidural Region Indicator accuracy (depth dimension)”2.42CI ± 3.41 mm
source quote (p.9)
“The Epidural Region Indicator, derived from SpineNav-AI anatomical segmentations, demonstrated accuracy of 1.61 (± 2.57) mm and 2.42 (± 3.41) mm in the lateral and depth dimensions, respectively, compared to the radiologist panel ground truth.”
accuracyas written: “Range of per-frame accuracy for all anatomical structures”stated without valueCI 82.1% - 99.3%
source quote (p.8)
“The range of per-frame accuracy for all anatomical structures was 82.1% - 99.3%;”
diceas written: “Range of DICE scores for all anatomical structures”stated without valueCI 0.64 - 0.87
source quote (p.8)
“and the range of DICE scores for all anatomical structures was 0.64 - 0.87.”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

8
recalls in product code, 24mo
344
MAUDE reports in code, 12mo
-40%
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code IYO (Civco Medical Instruments Co. Inc., initiated 2026-03-02): "There was an error in inspection and programming of the eTRAX needle sensor for Aurora trackers. The result is a potential for the needle tip position to be incorrectly identified " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98513

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243937