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Radiology · 510(k) · 2025

Accuro 3S

Rivanna Medical, Inc.. Cleared by FDA on 23 May 2025 under submission K243937, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.

Device record · K243937

  1. Device. Accuro 3SDEVICE
  2. Company. Rivanna Medical, Inc.COMPANY
  3. Decision. 23 May 2025, 510(k), substantially equivalent (traditional review); received 20 December 2024DECISION
  4. Panel. RadiologyPANEL
  5. Product code. IYO, System, Imaging, Pulsed Echo, UltrasonicCODE
  6. Regulation. 21 CFR 892.1560, Class IIREG
  7. Source. FDA database entry · decision document (9 pages)SOURCE

Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.

What FDA cleared it for

The Indications for Use statement, verbatim, from the decision document.

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 hospita l or medical clinic environment at the point of care. Accuro 3S supports B-mode imaging and a SpineNav-AI image processing software. Accuro 3S

K243937, FDA decision document · source

What the statement says

Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.

Adverse-event reports in MAUDE, by product code

As of , MAUDE held 6,627 reports filed against devices carrying product code IYO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:

30 September 2026 · Malfunction · MEDLINE · Medline Industries, LP · report 1417592-2026-53998

It was reported that PRODUCT SCREEN COMES UP WITH ERROR CODE E005 BATTERY ERROR.

30 September 2026 · Injury · ViewFlex¿ICE Catheter · Abbott Medical · report 2030404-2026-00047

The following was published in the JACC: CASE REPORTS, "AIatrogenic VSD, Closure Attempt With Complications, and Ultimate Success", Jakob Schroder, MD, PHD, Niels Vejlstrup, MD, PHD, Laurence Campens, MD, PHD, Michael Rahbek Schmidt, MD, PHD, DMSC. VOL. 31, NO. 7, 202 6BACKGROUND Iatrogenic postsurgical ventricular septal defect (VSD) is a rare complication of surgical aortic valve replacement (SAVR). CASE SUMMARY A patient presented with left-sided heart failure due to an initially missed […]

30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-54811

30 September 2026 · Malfunction · MEDLINE CO-LABEL · Medline Industries, LP · report 1417592-2026-55041

30 September 2026 · Malfunction · Site~Rite 8 Scanner · C.R. Bard, Inc. (BASD) -3006260740 · report 3006260740-2026-07105

Where this fits

This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.

More devices under product code IYO, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.

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