Radiology · 510(k) · 2026
6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)
Esaote, S.p.A.. Cleared by FDA on 6 April 2026 under submission K253288, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K253288
- Device. 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)DEVICE
- Company. Esaote, S.p.A. (IT)COMPANY
- Decision. 6 April 2026, 510(k), substantially equivalent (traditional review); received 29 September 2025DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (8 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.
if it is known. This K253288Please type in the marketing application/submission number, textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? 6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85) Please provide your Indications for Use below. The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes. Main application: Districts: Invasive access: Cardiac Cardiac Adult, Cardiac Pediatric Transesophageal Vascular Neonatal, Adult Cephalic, Vascular Not applicable General Imaging Abdominal, Breast, Musculoskeletal, Neonatal, Pediatric, Small Organs (Testicles), Thyroid, Urological Intraoperative (Abdominal), Laparoscopic, Transrectal Women Health OB/Fetal, Gynecology Transrectal, Transvaginal Virtual Navigator option supports a radiological clinical ultrasound examination (first modality) by providing additional image information from a second imaging modality. As second imaging modality it is intended any image coming from CT, MR, US, PET, XA and NM. The second modality provides additional security in assessing the morphology of the real time ultrasound image. The primary modes of operation are: B-Mode, M-Mode, Tissue Enhancement Imaging (TEl), Multi View (MView), Doppler (both Pulsed Wave (PW) and Continuous Wave (CW)), Color Flow Mapping (CFM), Power Doppler, Tissue Velocity Mapping […]
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 namedCT, MRI, ultrasound
- 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 Esaote, S.p.A., or cleared in 2026. 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.