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Radiology · 510(k) · 2023

Velacur

Sonic Incytes. Cleared by FDA on 20 April 2023 under submission K223287, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.

Device record · K223287

  1. Device. VelacurDEVICE
  2. Company. Sonic Incytes (CA)COMPANY
  3. Decision. 20 April 2023, 510(k), substantially equivalent (traditional review); received 25 October 2022DECISION
  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 (7 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.

Velacur is intended to provide estimates of tissue stiffness generated from shear wave speed measurements (40-70 Hz) and coefficient of attenuation. The device is indicated to non-invasively determine liver tissue stiffness and attenuation. These are meant to be used in conjunction with other clinical indicators in order to assist in clinical management of patients with liver disease.

K223287, 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, from Sonic Incytes, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.

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