Radiology · 510(k) · 2021
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co.,LTD. Cleared by FDA on 16 November 2021 under submission K212265, product code IYN (system, imaging, pulsed doppler, ultrasonic). What FDA's record says, in FDA's words.
Device record · K212265
- Device. TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite Diagnostic Ultrasound System, TEX10/ TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound SystemDEVICE
- Company. Shenzhen Mindray Bio-Medical Electronics Co.,LTD (CN)COMPANY
- Decision. 16 November 2021, 510(k), substantially equivalent (traditional review); received 20 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 (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.
TEX20/TEX20 Pro/TEX20S/TEX20T/TEX20 Exp/TEX20 Elite/TEX10/TEX10 Pro/TEX10S/TEX10T/TEX10 Exp/ TEX10 Elite/TE X/TE X Lite Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates. It is intended for use in Ophthalmic, fetal, abdominal,Intra-operative(abdominal, thoracic, and vascular), Laparoscopic, pediatric, small organ(breast, thyroid, testes), neonatal and adult cephalic, trans-rectal, trans-vaginal, musculo-skeletal(conventional, superficial), Thoracic/Pleural (For detection of fluid and pleural motion/sliding.), adult and pediatric cardiac, trans-esoph. (Cardiac), peripheral vessel, and urology exams. Modes of operation include: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined mode(B+M, PW+B, Color+B, Power+B, PW+Color+B, Power+PW+B), Tissue Harmonic Imaging, Smart3D, iScape View, TDI, Color M, Strain Elastography, Contrast imaging (Contrast agent for LVO), and Contrast imaging (Contrast agent for Liver).
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
- 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, 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.