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Radiology · 510(k) · 2018

Uscan

EchoNous, Inc.. Cleared by FDA on 10 July 2018 under submission K181574, product code IYO (system, imaging, pulsed echo, ultrasonic). What FDA's record says, in FDA's words.

Device record · K181574

  1. Device. UscanDEVICE
  2. Company. EchoNous, Inc.COMPANY
  3. Decision. 10 July 2018, 510(k), substantially equivalent (traditional review); received 15 June 2018DECISION
  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 (10 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.

Abdominal Pediatric Small Organ (prostate) Musculo-skeletal (Conventional) Peripheral Vessel Needle guidance Abdominal Pediatric Small Organ (prostate) Musculo-skeletal (Conventional) Opthalmic Fetal – OB/GYN Abdominal Pediatric Small Organ (breast, thyroid, testicle, prostate) Neonatal Cephalic Adult Cephalic Trans-Rectal Trans-Vaginal Musculo-skeletal (Conventional) Musculo-skeletal (Superficial) Cardiac Adult Cardiac Pediatric Peripheral Vessel Needle guidance Transducer Types Linear Array Annular Array Annular Array Linear Array Curved Linear Array Intracavitary Phased Array Transducer Frequency 3.0 – 14.0 MHz 3.0 – 7.0 MHz 1.0 – 15.0 MHz Modes of Operation 2D / B-mode 2D / B-mode 2D / B-mode Tissue Harmonic Imaging M-mode Color M-mode Color Power Doppler Combination Modes Velocity Color Doppler PW Doppler Not available Not available Not available CW Doppler Not available Not available Not available Feature Uscan Ultrasound System (This submission) Uscan Ultrasound System (K160420) SonoSite SII Ultrasound System (K162045) Patient Contact Materials Transducers: ABS+PC (acrylonitrile butadiene styrene + polycarbonate) Cycoloy Polymethyl Pentene based Olefin Copolymer Silicone Rubber RTV Thermoplastic polyurethane Transducers: Cycoloy Polymethyl Pentene based Olefin Copolymer Thermoplastic polyurethane Transducers: Acrylonitrile-butadiene- styrene (ABS) Cycoloy Polycarbonate (PC) Polysulfone Poly-Vinyl-Chloride (PVC) Silicone Rubber Silicone Rubber RTV […]

K181574, 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 EchoNous, Inc., or cleared in 2018. The whole record is at FDA AI-enabled medical devices.

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