The Samsung HERA W10 Elite is a premium ultrasound system for obstetrics and gynecology, aimed at maternal fetal medicine and complex cases. It adds a 27-inch OLED monitor, Advanced MV-Flow, the EV2-12 volume endocavity transducer and expanded AI tools to the HERA W10, and the FDA clears it under that name in 510(k) K230084. In Samsung's US women's health line it sits beside the Z20, V8, V7, V6, V5 and HS40.
- Released
- 2023launched by Samsung
- Display
- 27-inchOLED main monitor
Compatible probes
Linear
- LA2-14A
Convex & microconvex
- CA1-7A
Phased
- PA1-5A Cardiac
Endocavity
- EA2-11AR
- EV2-12 Volume; introduced with the HERA W10 Elite
Specialty
- CV1-8A Volume
Specifications
Display
- Display
27-inch OLED; display area 57% larger than the HERA W10's27-inch OLED (organic light-emitting diode) main monitor, with a display area 57% larger than the HERA W10's and less brightness variation across viewing angles than conventional LCD monitorsShow allShow less
- Touch screen
- Touchscreen with TouchGesture, which rotates, zooms, crops and moves 3D images
Physical
- Control panel
- Moves sideways and forward (pull and rotate together), with a swivel mechanism
- Controls
Programmable trackball, Contextual Button, QuickPreset, Touch CustomizationProgrammable trackball controls; Contextual Button, which assigns diagnostic functions to control panel buttons; QuickPreset; Touch CustomizationShow allShow less
- Design and accessories
- FreeForm design; endocavity transducer holder, cable management, supporting light
Power & battery
- Boot from sleep
- MobileSleep: booting from sleep saves about 63% of the time of a normal boot-up
Connectivity & options
- Image sharing
SonoSync real-time sharing to PCs and smartphones; Mobile Export; HelloMomSonoSync real-time image sharing to PCs and smartphones, with voice and text chat, real-time marking and MultiVue; Mobile Export QR-code image download to smartphones; HelloMom wireless transfer of fetal images and clips to an external device, which requires the Mobile Export optionShow allShow less
- Optional features
Optional, may need additional purchase: 5D CNS+, 5D Heart Color, MV-Flow, SonoSync…May require additional purchase: 5D CNS+, 5D Heart Color, 5D Follicle, 5D Limb Vol., Uterine Contour, S-Detect for Breast, MPI+, Slice A, RealisticVue, CrystalVue, CrystalVue Flow, MV-Flow, E-Strain, E-Thyroid, E-Cervix, 5D NT, ElastoScan+, S-Detect for Thyroid, IOTA-ADNEX, HyCosy, SonoSync and HelloMom (HelloMom also requires the Mobile Export option)Show allShow less
Imaging & software
- Imaging architecture
Crystal Architecture: CrystalBeam beamforming, CrystalLive processing, S-Vue TransducerCrystal Architecture: CrystalBeam beamforming (Arbitrary Waveform Transmission, Massive Parallel Beamforming, Synthetic Aperture), CrystalLive image processing and S-Vue Transducer technologyShow allShow less
- 2D image processing
- ShadowHDR, ClearVision, HQ-Vision
- Imaging modes
2D; color, power and directional power Doppler (S-Flow); PW Doppler; MV-Flow; 3D/4D2D; color Doppler; power Doppler and directional power Doppler (S-Flow); PW Doppler; MV-Flow microvascular flow in 2D and 3D; 3D/4D volume imaging, including STIC volume data (5D Heart Color) and Slice A (4D A-plane); ElastoScan+ elastography, optional, with the strain value not applicable in the United States and CanadaShow allShow less
- 3D/4D rendering
CrystalVue, CrystalVue Flow, RealisticVue (user-selectable lighting), HDVI; LumiFlowCrystalVue, CrystalVue Flow, RealisticVue (user-selectable lighting) and HDVI volume rendering; LumiFlow, a 3D-like display of color and power DopplerShow allShow less
- AI tools
HeartAssist, ViewAssist, BiometryAssist, UterineAssistHeartAssist, which automates acquisition and labeling of fetal cardiac views; ViewAssist; BiometryAssist, one-click measurement of fetal growth parameters; UterineAssist, automatic measurement of uterine size and shapeShow allShow less
- 5D and measurement tools
5D CNS+, 5D Heart Color, 5D NT, 5D Follicle, 5D Limb Vol., 5D LB, MPI+, Uterine Contour5D CNS+ (nine planes and six biometric measurements), 5D Heart Color (fetal heart assessment), 5D NT (nuchal translucency measurement), 5D Follicle, 5D Limb Vol., 5D LB, MPI+ and Uterine ContourShow allShow less
- Other clinical tools
E-Strain, E-Thyroid, E-Cervix, ElastoScan+, S-Detect, IOTA-ADNEX, HyCosyE-Strain, E-Thyroid, E-Cervix, ElastoScan+, S-Detect for Thyroid, S-Detect for Breast, IOTA-ADNEX and HyCosy; in the United States, S-Detect provides only the shape and orientation items automaticallyShow allShow less
- Processing (vs WS80A)
- x10 data transfer rate, x11 processing power, x3 GPU memory, compared with the WS80A
Compliance
- FDA 510(k)
K230084 (2023-04-21), K242444 (2024-11-27); cleared as the HERA W10, Class IIK230084, decided 2023-04-21: the HERA W10 and HERA W9 Diagnostic Ultrasound Systems, Class II, 21 CFR 892.1550; the Elite's model USS-HW1ER4D/US is listed under it, and it added the EV2-12 transducer and the 27-inch OLED main monitor. K242444, decided 2024-11-27: the HERA W10 and HERA W9. No FDA record uses the Elite name.Show allShow less
What to check when buying a used Samsung HERA W10 Elite
Confirm the software is the US configuration
Some features, options and transducers are not sold in every country, and in the US, S-Detect gives only shape and orientation items with no benign-or-malignant recommendation, while the ElastoScan+ strain value does not apply.
How: Check that each AI feature installed is the FDA-cleared US version; a unit whose S-Detect offers a benign-or-malignant recommendation, or that shows an ElastoScan+ strain value, is not set up as a US system.
Confirm the Elite's 27-inch OLED monitor
Elite is a marketing term rather than a product name, and the hardware that sets the W10 Elite apart from the HERA W10 is its 27-inch OLED monitor.
How: Check that the unit has that monitor, whose display area is larger than the HERA W10's, rather than relying on the name in its listing.
Confirm which optional features are licensed
Several W10 Elite features are options that may need an additional purchase, and HelloMom works only with the Mobile Export option.
How: List every option installed and licensed on the unit, such as 5D CNS+, 5D Heart Color, MV-Flow, SonoSync or HelloMom, and match the list against what was quoted.
Ask for the Samsung service and patch records
Updates and security patches reach Samsung systems through technical service bulletins and field engineers, and Samsung Remote Care tracks run time and component wear, so the records show how the unit was kept.
How: Ask which software updates and security patches were applied, and for any Samsung Remote Care (S-RC) self-diagnostic and component-wear data.
Common questions about the Samsung HERA W10 Elite
Is the Samsung HERA W10 Elite FDA-cleared?
Yes, under the HERA W10 name: no FDA record uses the name Elite. The HERA W10 Diagnostic Ultrasound System was cleared with the HERA W9 under 510(k) K230084 on April 21, 2023, as a Class II device (21 CFR 892.1550), and the Elite's model code, USS-HW1ER4D/US, is listed under that clearance. K230084 added the EV2-12 transducer and the 27-inch OLED main monitor to the HERA W10, and a later HERA W10 clearance, K242444, was decided on November 27, 2024.
It is cleared for fetal/obstetric, abdominal, gynecology, pediatric, small organ, neonatal cephalic, adult cephalic, trans-rectal, trans-vaginal, musculoskeletal (conventional and superficial), urology, adult and pediatric cardiac, and peripheral vessel use.
How does the HERA W10 Elite differ from the HERA W9?
The Elite is cleared as the HERA W10, alongside the HERA W9, under 510(k) K230084. The HERA W10 has four active array probe ports where the HERA W9 has three, with a fourth as an option; 6-inch casters where the W9 has 5-inch; and an internal DVD drive, which the W9 does not include. CrystalVue Flow, MPI+ and HeartAssist are supported on the HERA W10 only.
Is the Z20 the same system as the HERA W10 Elite?
No. Samsung introduced the Z20 on September 15, 2024, as a new premium ultrasound system for obstetrics and gynecology, with Live ViewAssist, Live Q-scan and A-Focus added. Live ViewAssist identifies and captures views in real time during scanning; the W10 Elite has ViewAssist, a separately named feature.
When was the HERA W10 Elite introduced in the US?
Samsung introduced the HERA W10 Elite in the US on February 8, 2023, and showed it at the Society for Maternal Fetal Medicine's 43rd Annual Pregnancy Meeting, held February 8 to 10.