Radiology · 510(k) · 2021
Kosmos
EchoNous, Inc.. Cleared by FDA on 6 August 2021 under submission K212100, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K212100
- Device. KosmosDEVICE
- Company. EchoNous, Inc.COMPANY
- Decision. 6 August 2021, 510(k), substantially equivalent (traditional review); received 6 July 2021DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (14 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.
Kosmos is intended to be used by qualified and trained healthcare professionals in the clinical assessment for the following clinical applications by acquiring, processing, displaying, measuring, and storing ultrasound images, or synchronized ultrasound images, electrocardiogram (ECG) rhythms, and digital auscultation (DA) sounds and waveforms. With respect to its ultrasound imaging capabilities, Kosmos is a general purpose diagnostic ultrasound system used in the following clinical applications and modes of operation: • Clinical Applications: Cardiac, Thoracic/Lung, Abdominal, Vascular/Peripheral Vascular, Musculoskeletal, and interventional guidance (includes needle/catheter placement, fluid drainage, and nerve block) • Modes of Operation: B-mode, M-mode, Color Doppler, Pulsed-Wave (PW) Doppler, Continuous-Wave (CW) Doppler, Combined Modes of B+M, and B+CD, B+PW, B+CW, and Harmonic Imaging Kosmos is intended to be used in clinical care and medical education settings on adult and pediatric patient populations. The device is non-invasive, reusable, and intended to be used on one patient at a time.
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, ECG
- 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 EchoNous, Inc., or cleared in 2021. 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.