Sonoscape Medical Corp. · Class II · Cleared Dec 5, 2025
| K-number | K252498 |
| Device name | Digital Color Doppler Ultrasound System (X11 Exp/X11 Elite/X11 Pro/X11 Plus/X11 Super/X11 Senior/X11/E11/E11 Pro/E11 Plus/E11 Elite/X11T/X11U/X11R/X11i/X11s/E11T/E11i/E11s/XR1/XR2/ XR3/ER1/ER2/ER3/X10 Exp/X10 Elite/X10 Pro/X10 Plus/X10 Super/X10 Senior/X10/X10T/X10U/ X10R/X10i/X10s/E10/E10 Pro/E10 Plus/E10T/E10i/E10s/SU11A EXP/SU11A PRO/SU11A AD/ SU11A CU/SU11B EXP/SU11B PRO/SU11B AD/SU11B CU/SU11C EXP/SU11C PRO/SU11C AD/ SU11C CU) |
| Applicant | Sonoscape Medical Corp. |
| Product code | IYN |
| Device class | Class II |
| Decision date | Dec 5, 2025 |
| Decision | Substantially Equivalent |
| Regulation | 892.1550 |
The Digital Color Doppler Ultrasound System (X11 Exp Series and related models) is a general-purpose diagnostic ultrasound system intended for use by trained healthcare professionals in hospitals and clinics. It performs ultrasound imaging, measurement, and analysis of the human body across multiple clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging, operating in modes such as B-Mode, M-Mode, Doppler, Color Flow, Tissue Harmonic Imaging, and 3D/4D imaging.
The X11 Exp Series maintains the same intended use and imaging modes as its primary predicate (S90 Exp Series K222596), with probes and biopsy brackets mostly migrated from prior predicates. New features include SR Flow, Micro F, FHR, FreeVue, S-Live variants, auto measurements (Auto CV, Auto IVC, Auto VTI), ATI (equivalent to Attenuation Imaging in Canon's Aplio system), SonoFast workflow presets, and Auto hyd. & asc. measurement. Two new probes (22L-A and P4-12) are acoustically equivalent to previously cleared probes (18L-A and 8P1).
AAMI/ANSI ES 60601-1 (medical electrical equipment general safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-2-37 (ultrasonic diagnostic equipment safety), ISO 10993-1 (biocompatibility evaluation), and AIUM/NEMA UD 2 (acoustic output measurement). Non-clinical testing evaluated acoustic output, biocompatibility, electrical, mechanical, thermal, and electromagnetic compatibility safety.
The subject device is substantially equivalent because it has identical intended use and imaging modes as the S90 Exp Series predicate, complies with the same FDA-recognized electrical and physical safety standards, maintains acoustic output levels below FDA limits, and migrates proven probes and features from legally marketed predicates. New features are either migrated from or equivalent to features already cleared in predicate devices.
View the full FDA submission: accessdata.fda.gov