Radiology · 510(k) · 2025
FETOLY
Diagnoly. Cleared by FDA on 12 September 2025 under submission K251368, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K251368
- Device. FETOLYDEVICE
- Company. Diagnoly (FR)COMPANY
- Decision. 12 September 2025, 510(k), substantially equivalent (traditional review); received 1 May 2025DECISION
- Panel. RadiologyPANEL
- Product code. IYN, System, Imaging, Pulsed Doppler, UltrasonicCODE
- Regulation. 21 CFR 892.1550, Class IIREG
- Source. FDA database entry · decision document (23 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.
FETOLY is intended to analyze fetal ultrasound image sequences using machine learning techniques to automatically: • detect brain and heart views and quality criteria within the views; • detect images suitable for measuring biometric parameters of the fetal heart and brain and provide quantitative measurements of these parameters. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images. FETOLY is indicated for use during routine fetal heart and brain examination of 2 nd and 3 rd trimester pregnancy (gestational age: from 17 to 40 weeks). 6 Summary of the technological characteristics of FETOLY compared to the predicate device K251368 510(k) Summary Document number: 300-TEMP-17 version 02 Application date: 2024-10-23 Page 7 / 19 Aspect Predicate device: FETOLY-HEART K241380 Reference device: Voluson Expert 18/20/22 (FETAL HS Feature) K220358 Proposed device: FETOLY Comparison between Proposed and
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
- Mentionsdetection or identification of findings
- Mentionsmeasurement or quantification
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 Diagnoly, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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