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Radiology · 510(k) · 2020

KOSMOS

EchoNous, Inc.. Cleared by FDA on 26 March 2020 under submission K193518, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.

Device record · K193518

  1. Device. KOSMOSDEVICE
  2. Company. EchoNous, Inc.COMPANY
  3. Decision. 26 March 2020, 510(k), substantially equivalent (traditional review); received 19 December 2019DECISION
  4. Panel. RadiologyPANEL
  5. Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
  6. Regulation. 21 CFR 892.1550, 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.

KOSMOS is intended to be used by qualified and trained healthcare professionals in the clinical assessment of the cardiac and pulmonary systems and the abdomen by acquiring, processing, displaying, measuring, and storing 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, Peripheral Vascular, and Image Guidance for Needle/Catheter Placement • Modes of Operation: B-mode, M-mode, Color Doppler, Combined Modes of B+M and B+CD, 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. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed […]

K193518, 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 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 2020. The whole record is at FDA AI-enabled medical devices.

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