Radiology · 510(k) · 2016
Clarius Ultrasound System
Clarius Mobile Health Corp.. Cleared by FDA on 30 November 2016 under submission K163138, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K163138
- Device. Clarius Ultrasound SystemDEVICE
- Company. Clarius Mobile Health Corp. (CA)COMPANY
- Decision. 30 November 2016, 510(k), substantially equivalent (abbreviated review); received 9 November 2016DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (12 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 Clarius Ultrasound System is a software-based ultrasound imaging system and accessories intended for use in Point-of-Care Imaging of Medical Conditions on the general public. Point-of-Care clinical applications include: Emergency triage exam to look at trauma conditions Procedure guidance to guide needles into the body; and Other targeted diagnostic and measurement applications: fetal, fetal echo, abdominal, small organ, musculo-skeletal (conventional), musculo-skeletal (superficial), urology, gynecology, cardiac adult, cardiac pediatric, peripheral vessel, pediatric, carotid The Clarius Ultrasound System is intended for use in environments where healthcare is provided by trained medical professionals. The device is not intended for use in emergency medical service, ambulance, or aircraft. Users will be trained medical professionals (e.g., doctors, nurses, technicians).
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.
- Modalities namedultrasound
- Mentionstriage or notification
- Mentionsmeasurement or quantification
- Mentionsa diagnostic claim
- Mentionsadult patients
- Mentionspediatric patients
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 2,748 reports filed against devices carrying product code IYN. 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 · ACUSON Origin Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00096
30 September 2026 · Malfunction · ACUSON Sequoia Ultrasound System · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00097
30 September 2026 · Malfunction · AFFINITI 30 · Philips Ultrasound, Inc · report 3019216-2026-100325
30 September 2026 · Injury · EPIQ 5G · Philips Ultrasound, Inc · report 3019216-2026-100326
29 September 2026 · Malfunction · ACUSON Juniper · Siemens Medical Solutions USA, Inc. · report 3023245-2026-00091
One of the patient exams performed on the Juniper system displays an "Unarchived" error message and they are unable to send this study to PACS. All other exams performed before are after this one are transferring over to the PACS as expected without any errors. The problem occurred after a Breast study was completed and the user tried to send it over to the network PACS. TSE worked with the customer and she confirmed that the problem cannot be reproduced, as it only is affecting this one exam. […]
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 IYN, in Radiology, from Clarius Mobile Health Corp., or cleared in 2016. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.