Radiology · 510(k) · 2026
LOGIQ Totus
GE Medical Systems Ultrasound and Primary Care Diagnostics. Cleared by FDA on 8 January 2026 under submission K253370, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K253370
- Device. LOGIQ TotusDEVICE
- Company. GE Medical Systems Ultrasound and Primary Care DiagnosticsCOMPANY
- Decision. 8 January 2026, 510(k), substantially equivalent (traditional review); received 30 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 (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.
Please type in the marketing application/submission number, if it is known. This K253370 ? textbox will be left blank for original applications/submissions. Please provide the device trade name(s). ? LOGIQ Totus Please provide your Indications for Use below. ? LOGIQ Totus is intended for use by a qualified physician for ultrasound evaluation of Fetal/Obstetrics ; Abdominal(including Renal, Gynecology/Pelvic), Pediatric; Small organ(Breast, Testes , Thyroid ); Neonatal Cephalic; Adult Cephalic; Cardiac(Adult and Pediatric), Periphera l Vascular , Musculo-skeletal Conventional and Superficial; Urology(including Prostate); Transrectal; Transvaginal; Transesophageal and lntraoperative(Abdominal and Vascular). Modes of operation includes: B, M, PW Doppler , CW Doppler , Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 30/40 Imaging mode, Elastography , Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Colo r, B/PWD, B/Color/PWD, B/Power/ PWD. The LOGIQ Totus is intended to be used in a hospital or medical clinic. Please select the types of uses (select one or both, as [gJ Prescription Use (Part 21 CFR 801 Subpart D) applicable). D Over-The-Counter Use (21 CFR 801 Subpart C) ? GE Healthcare 510(k) Premarket Notification Submission 1 510(k) Summary - K253370 In accordance with 21 CFR 807.92 the following summary of information is provided: Date: January 8, 2026 Submitter: GE Medical Systems Ultrasound and Primary care Diagnostics, […]
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
- Mentionsprescription use
- 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 GE Medical Systems Ultrasound and Primary Care Diagnostics, 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.