The Samsung HERA W10 is a cart-based obstetrics and gynecology ultrasound system, introduced in October 2018 as the HERA platform's principal model. Its FDA clearance spans obstetrics, gynecology, abdominal, urology, musculoskeletal and cardiac exams. It differs from the HERA W9 in its CrystalVue Flow, MPI+ and swivel panel, shares its platform with the chair-type HERA I10, and preceded the 2023 HERA W10 Elite.
- Released
- 2018launched by Samsung
- Probe ports
- 4active array probe ports
- Display
- 21.5 inLED, 1920 × 1080
- Weight
- 153 kgon 6-inch casters
Compatible probes
Linear
- L3-12A
- LA2-9A
- LA2-14A Added in 2021 (K211824)
- LA4-18B
Convex & microconvex
- CA1-7A
- CA2-9A
- CA3-10A
- CF4-9
- CV1-8A
Phased
- PA1-5A Added in 2021 (K211824)
- PA3-8B
- PA4-12B
- PM1-6A
Endocavity
- E3-12A
- EA2-11AR Ergonomic; added in 2019 (K192319)
- EA2-11AV Ergonomic; added in 2019 (K192319)
- EA2-11B
- EV2-10A Added in 2019 (K192319)
- EV3-10B
Specifications
Display
- Main monitor
21.5-in LED widescreen, 256 gray shades; 23-in and 23.8-in options21.5-inch wide-screen monitor (LCD with LED backlight), 256 gray shades, as standard; 23-inch and 23.8-inch options in the 2019 configurationShow allShow less
- Main monitor resolution
- 1920 × 1080 pixels
- Monitor arm
- Articulating
- Touch screen
- 13.3-in, tilting; 14-in option added in 2022
Physical
- Weight
- 153 kg
- Height
- 1340–1695 mm
- Width
- 598 mm
- Depth
- 955–1265 mm
- Casters
- 6-inch
- Control panel
Swiveling; travels 550 mm left to right and 219 mm top to bottomWide Control Panel on a swivel mechanism, with a moving range of 550 mm left to right and 219 mm top to bottom; it can be pulled out and rotated at the same timeShow allShow less
- Probe ports
- 4 active array probe ports
- Ergonomic fittings
- FreeForm design, Mood Light, endocavity transducer holder, cable management
Power & battery
- Power supply
- 100–240 V AC, 50/60 Hz
- Power rating
- 1400 VA
Connectivity & options
- DICOM
- Ultrasound Image Storage and Modality Worklist (system version 1.00.06)
- Network
- Ethernet 100baseT or 10baseT, depending on installed hardware
- Internal storage
- 128 GB SSD plus 1 TB HDD
- Internal DVD drive
- Included (not on the HERA W9)
- Backup media
- DVD, USB
- Export formats
- BMP, JPEG, TIFF, DICOM, AVI, MP4
- Image sharing
SonoSync live sharing to PC, tablet or phone; HelloMom QR-code sharingSonoSync: real-time image sharing over a network to a PC, tablet or smartphone, with voice chat, marking and a MultiVue multi-image view; first cleared in 2018 as not intended for diagnosis, and indicated for diagnostic image viewing and review in 2024. HelloMom: shares selected fetal images through a QR codeShow allShow less
- Optional features
HeartAssist, Slice A, 5D CNS+, ViewAssist, 5D Limb Vol., MPI+, SonoSync, HelloMomOptional features that may need an additional purchase: HeartAssist, Slice A, 5D CNS+, ViewAssist, 5D Limb Vol., MPI+, SonoSync and HelloMomShow allShow less
- Cybersecurity
Antivirus and firewall, secure OS, account management, audit trail, encryptionSecurity tools (antivirus and firewall), a secure operating system, account management, an audit trail, data encryption and transmission securityShow allShow less
Imaging & software
- Imaging architecture
Crystal Architecture: S-Vue single-crystal transducers, CrystalBeam, CrystalLiveCrystal Architecture: S-Vue single-crystal transducer technology, CrystalBeam beamforming (arbitrary-wave transmission, massive parallel beamforming, synthetic aperture) and the CrystalLive image-processing engine (2D, 3D rendering and color Doppler processing)Show allShow less
- Beamformer
- 192
- HERA platform processing
- 11-fold processing power and 10 times the data transfer speed of the WS80A
- Imaging modes
B, M, PW, CW, color and power Doppler, S-Flow, TDI, TDW, 3D/4D, ElastoScan+, MV-FlowB-mode, M-mode, pulsed wave (PW) Doppler, continuous wave (CW) Doppler, color Doppler, Tissue Doppler Imaging (TDI), Tissue Doppler Wave (TDW), power amplitude Doppler, pulse inversion harmonic imaging (S-Harmonic), directional power Doppler (S-Flow), color M-mode, 3D and 4D imaging modes, ElastoScan+ mode, tissue harmonic imaging, MV-Flow mode, combined modes; multi-image modes (Dual, Quad)Show allShow less
- 2D image enhancement
- ShadowHDR, HQ-Vision, S-Harmonic, ClearVision (CrystalLive 2D)
- Flow imaging
MV-Flow, S-Flow, LumiFlow, CrystalLive ColorMV-Flow (slow, microvascular flow), S-Flow (directional power Doppler), LumiFlow (3D-appearing visualization of blood flow) and CrystalLive ColorShow allShow less
- 3D/4D rendering and volume tools
CrystalVue, CrystalVue Flow, RealisticVue, AmbientLight, HDVI, Slice A and moreCrystalVue, CrystalVue Flow (not on the HERA W9), RealisticVue, AmbientLight, HDVI, Slice A, 3D MagiCut, VOCAL, XI VOCAL and XI STICShow allShow less
- 5D automated OB tools
- 5D Heart Color, 5D CNS+, 5D Limb Vol., 5D Follicle, 5D NT, 5D LB; 2D NT
- AI-assisted measurement
BiometryAssist, HeartAssist (not on the HERA W9), ViewAssistBiometryAssist (fetal biometry), HeartAssist (fetal heart views and measurements; not on the HERA W9) and ViewAssist (view classification and annotation); HeartAssist and ViewAssist added in 2021Show allShow less
- Breast and thyroid tools
S-Detect for breast and thyroid, E-Breast, E-Strain, E-ThyroidS-Detect for breast and thyroid; E-Breast and E-Strain (breast elastography with strain ratio); E-Thyroid (thyroid elastography with ECI)Show allShow less
- Gynecology and fetal cardiac analysis
IOTA-ADNEX, E-Cervix, MPI+ (MPI+ not on the HERA W9)IOTA-ADNEX (ovarian lesion classification), E-Cervix (cervical elastography) and MPI+ (semi-automated left and right ventricular myocardial performance index; not on the HERA W9)Show allShow less
- Other tools
ADVR, AutoIMT+, CEUS+, NeedleMate+, PanoramicADVR, AutoIMT+, CEUS+, NeedleMate+ and Panoramic, named as HERA W10 features in the April 2023 clearanceShow allShow less
- Workflow tools
QuickPreset, EzExam+, QuickScan, MobileSleep, QuickPrep (not on the HERA W9)QuickPreset, EzExam+, QuickScan, MobileSleep (starting from sleep mode saves about 63% of the time of a normal start-up) and QuickPrep (transducer recognition, not on the HERA W9); version 1.00 also has a Q Scan controlShow allShow less
- Image management
- SonoView
- Touch-screen controls
Touch Customization, Touch Gesture (rotate, zoom, move 3D images), contextual buttonsTouch Customization (move touch-screen buttons for each mode and feature, and bring frequently used functions to the first page), Touch Gesture (rotate, zoom and move a 3D image from the touch screen) and contextual buttons (diagnostic functions assigned to control-panel buttons)Show allShow less
- Acoustic output display
- MI and TI shown automatically in real time
- Transducer frequency range
- 1.0 to 20.0 MHz
- Revision and software
Versions 1.00, 1.00.06, V1.02 (US model USS-HRW1Q4C/US) and V1.03Version 1.00; system version 1.00.06; V1.02, the label of the US model USS-HRW1Q4C/US; and V1.03Show allShow less
Compliance
- FDA 510(k)
K182595 (Dec 18, 2018); later K192319, K211824, K220043, K230084, K242444K182595 (December 18, 2018); with the HERA W9: K192319 (December 10, 2019), K211824 (September 9, 2021), K220043 (April 5, 2022), K230084 (April 21, 2023) and K242444 (November 27, 2024)Show allShow less
- Classification
- 21 CFR 892.1550, Class II; product codes IYN, IYO, ITX
What to check when buying a used Samsung HERA W10
Confirm both acoustic output indices display live
The HERA W10 is built to show the mechanical index and thermal index automatically in real time, so a unit that does not show both is not working as designed.
How: During live imaging, confirm that both the MI and TI readouts appear on screen and update as you scan.
Confirm which optional features are licensed
Tools such as HeartAssist, ViewAssist, MPI+, SonoSync and HelloMom are optional features that can need an additional purchase, and features, options and transducers are not sold in every country.
How: On the unit itself, confirm that each optional feature you need is installed and licensed, and get that list in writing before purchase.
Confirm administrator access and patient data handling
The system runs account management, an audit trail and data encryption, so a new owner needs administrator access to manage its users and the patient data stored on it.
How: At handover, sign in with the administrator account and agree in writing how the patient data stored on the unit is handled.
Test DICOM connectivity with your receiving systems
The HERA W10 sends images and takes its worklist over DICOM, and a unit that will not connect to the systems it has to feed leaves integration work after purchase.
How: Send a test image to each system that must receive the unit's studies, query the modality worklist from the unit, and confirm both work.
Common questions about the Samsung HERA W10
Is the Samsung HERA W10 FDA-cleared?
Yes. It was cleared under 510(k) K182595 on December 18, 2018, as the HERA W10 Diagnostic Ultrasound System, a Class II ultrasonic pulsed Doppler imaging system under 21 CFR 892.1550.
Its cleared applications are fetal and obstetric, abdominal, gynecology, pediatric, small organ, neonatal and adult cephalic, transrectal, transvaginal, musculoskeletal, urology, adult and pediatric cardiac, and peripheral vessel imaging.
Later clearances name the HERA W9 and HERA W10 together: K192319 (December 10, 2019), K211824 (September 9, 2021), K220043 (April 5, 2022), K230084 (April 21, 2023) and K242444 (November 27, 2024).
What is the difference between the HERA W10 and the HERA W9?
The HERA W10 has four active probe ports, where the HERA W9 has three as standard and a fourth as an option. It sits on 6-inch casters where the HERA W9 has 5-inch ones, its control panel swivels where the HERA W9's rotates, and it offers a 23-inch main monitor option the HERA W9 does not.
CrystalVue Flow, MPI+, HeartAssist and the QuickPrep transducer recognition tool run on the HERA W10 and not on the HERA W9, and the HERA W10 has an internal DVD drive the HERA W9 lacks.
How does the HERA W10 Elite differ from the HERA W10?
Elite is Samsung's marketing term, not a separate product name, and the 510(k) clearances name the device HERA W10.
Announced in February 2023, the HERA W10 Elite adds Advanced MV-Flow for 2D and 3D views of microcirculation and slow blood flow, a 27-inch OLED monitor whose display area is 57% larger than the HERA W10's, the EV2-12 transducer, and updates to HeartAssist, ViewAssist (with 16 new views) and BiometryAssist.
Clearance K230084 (April 21, 2023) added the 27-inch OLED monitor and the EV2-12 transducer to the HERA W9 and HERA W10.
What is the difference between the HERA W10 and the HERA I10?
Samsung introduced the HERA I10 alongside the HERA W10 in 2018 as a chair-type ultrasound system built on the HERA W10's platform, with a different ergonomic design.