Voluson S8/ Voluson S10/ Voluson S10 Expert

• K Number: K180374
• Device Name: Voluson S8/ Voluson S10/ Voluson S10 Expert
• Manufacturer: GE Healthcare
• Date Cleared: 2018-03-13 ( 29 days)
• Product Code: IYN ITX IYO
• Regulation Number: 892.1550

Intended Use

The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV). Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal (including renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (includes urology/prostate); Transvaginal (includes infertility monitoring of follicle development).

Device Description

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Predicate Devices

K160184

Reference Devices

K172342 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound System, K162269 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound System

AI/ML (Artificial Intelligence / Machine Learning)

No
The document does not mention AI, ML, or related terms, and the device description focuses on standard ultrasound technology and features.

Therapeutic

No
The device is described as a "general-purpose ultrasound system" used for "Diagnostic ultrasound imaging or fluid flow analysis," indicating its role in diagnosis rather than treatment.

Diagnostic

Yes

The "Intended Use" section explicitly states, "Diagnostic ultrasound imaging or fluid flow analysis of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a mobile console with keyboard control panel, color LCD/TFT touch panel, color video display, optional image storage and printing devices, and utilizes a variety of transducers. These are all hardware components, indicating it is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
• Device Function: The description clearly states the device is a "general-purpose ultrasound system" used for "Diagnostic ultrasound imaging or fluid flow analysis of the human body." This involves using sound waves to create images of internal structures, which is an in vivo (within the living body) diagnostic method, not in vitro.
• Intended Use/Indications: The listed applications are all related to imaging various parts of the body directly, not analyzing samples taken from the body.

Therefore, the device's function and intended use fall outside the scope of an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV).

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

For Voluson S8 / Voluson S10 / Voluson S10 Expert Ultrasound System:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Abdominal[1]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Pediatric: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Small Organ[2]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Neonatal Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5]
Adult Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Cardiac[3]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5]
Peripheral Vascular: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Musculo-skeletal Conventional: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Musculo-skeletal Superficial: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Exam Type, Means of Access:
Transrectal[8]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Transvaginal: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S10 Expert with C2-9-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Abdominal[1]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Pediatric: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with IC9-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Exam Type, Means of Access:
Transrectal[8]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Transvaginal[10]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric
[5] 3D/4D Imaging Mode
[6] Includes imaging of guidance of biopsy (2D/3D/4D)
[7] Includes infertility monitoring of follicle development
[8] Includes urology/prostate
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 4C-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with C1-5-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 8C-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Abdominal[1]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Pediatric: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Small Organ[2]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Neonatal Cephalic: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Cardiac[3]: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 12L-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Small Organ[2]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elastictity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 9L-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Small Organ[2]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 3Sc-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Abdominal[1]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Pediatric: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Adult Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Cardiac[3]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with RIC5-9A-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Exam Type, Means of Access:
Transrectal[8]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Transvaginal: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6,9]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elastictity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with RAB6-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Fetal / Obstetrics[7]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6]
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6]
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [5,6]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elastictity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with ML6-15-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Abdominal[1]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Pediatric: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Small Organ[2]: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Peripheral Vascular: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Musculo-skeletal Conventional: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Musculo-skeletal Superficial: B, M, PW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse, Other [Notes] [6,9]
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elastictity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

For Voluson S8 / Voluson S10 / Voluson S10 Expert with 12S-RS Transducer:
Clinical Application / Anatomy/Region of Interest, Mode of Operation:
Pediatric: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Small Organ[2]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Neonatal Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Adult Cephalic: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Cardiac[3]: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes*, Harmonic Imaging, Coded Pulse
Notes:
[1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
[3] Cardiac is Adult and Pediatric.
[5] 3D/4D Imaging Mode.
[6] Includes imaging of guidance of biopsy (2D/3D/4D).
[7] Includes infertility monitoring of follicle development.
[8] Includes urology/prostate.
[9] Elastography imaging- Elasticity
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

Product codes (comma separated list FDA assigned to the subject device)

IYN, IYO and ITX

Device Description

The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide accurate real-time three-dimensional imaging supporting all standard acquisition modes.

Mentions image processing

Yes, "real-time three-dimensional imaging supporting all standard acquisition modes", "capturing digital images".

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal; Transvaginal.

Indicated Patient Age Range

Pediatric, Neonatal, Adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The subject of this premarket submission, Voluson S8 / Voluson S10 / Voluson S10 Expert, did not require clinical studies to support substantial equivalence.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K160184 Voluson S Series, Voluson S6/S8/S10 Diagnostic Ultrasound System

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K172342 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound System, K162269 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound System

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle. To the right of that is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 13, 2018

GE Healthcare % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive. RP2130 WAUWATOSA WI 53226

Re: K180374

Trade/Device Name: Voluson S8/ Voluson S10/ Voluson S10 Expert Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO and ITX Dated: February 8, 2018 Received: February 12, 2018

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative swirls, also in blue, giving the logo a classic and recognizable appearance.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K180374

Device Name Voluson S8/ Voluson S10/ Voluson S10 Expert

Indications for Use (Describe)

The device is a general-purpose ultrasound system. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TV).

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services [phone] EF

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by a decorative pattern of swirling lines, also in blue. The logo is simple, yet recognizable.

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson S8, Voluson S10 and Voluson S10 Expert systems. Combinations identified "P" for the system represents those previously cleared in K160184. Combinations identified "N" for the transducers represents those not previously cleared any GE Ultrasound system. This modification does not add to indications to the previously cleared system level.

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Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" written in a stylized script in the center. The letters are white, and the circle is surrounded by a thin white border. The logo is simple and recognizable, and it is often used to represent the company.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert Ultrasound System

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

[1] Abdominal includes renal, GYN/Pelvic Notes:

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric

[5] 3D/4D Imaging Mode

[6] Includes imaging of guidance of biopsy (2D/3D/4D)

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

5

Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The logo is colored in a light blue hue. The GE logo is a well-known symbol representing the multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form

Voluson S10 Expert with C2-9-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N	[6]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	[6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6]
Small Organ [2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal [8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

[1] Abdominal includes renal, GYN/Pelvic Notes:

• [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
• [3] Cardiac is Adult and Pediatric.
• [5] 3D/4D Imaging Mode.
• [6] Includes imaging of guidance of biopsy (2D/3D/4D).
• [7] Includes infertility monitoring of follicle development.
• [8] Includes urology/prostate.
• [9] Elastography imaging- Elasticity
• [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

6

Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are curved lines emanating from the top and bottom of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with IC9-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[ 6,9]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transvaginal[10]	P	P	P		P	P	P	P	P	P	[ 6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

[1] Abdominal includes renal, GYN/Pelvic Notes:

• [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
• [3] Cardiac is Adult and Pediatric
• [5] 3D/4D Imaging Mode
• [6] Includes imaging of guidance of biopsy (2D/3D/4D)
• [7] Includes infertility monitoring of follicle development
• [8] Includes urology/prostate
• [9] Elastography imaging- Elasticity
• [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

7

Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are curved lines around the letters, and the circle is outlined in blue. The logo is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 4C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[6]
Pediatric	P	P	P		P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

8

Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are curved lines emanating from the top and bottom of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with C1-5-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[6]
Pediatric	P	P	P		P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

9

Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are curved lines around the letters, and the circle is outlined in blue. The logo is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 8C-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P		P	P	P	P
Abdominal[1]	P	P	P		P		P	P	P	P
Pediatric	P	P	P		P		P	P	P	P
Small Organ[2]	P	P	P		P		P	P	P	P
Neonatal Cephalic	P	P	P		P		P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P		P		P	P	P	P
Peripheral Vascular	P	P	P		P		P	P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P	P
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

10

Image /page/10/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are curved lines emanating from the top and bottom of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 12L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[6,9]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[6,9]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[6,9]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6,9]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[6,9]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

11

Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are curved lines emanating from the top and bottom of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 9L-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[6]
Pediatric	P	P	P		P	P	P	P	P	P	[6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[6]
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

12

Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are curved lines emanating from the top and bottom of the circle, giving the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's brand.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 3Sc-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P	P	P	P	P	P	P	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P	[6]
Cardiac[3]	P	P	P	P	P	P	P	P	P	P	P	[6]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

13

Image /page/13/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circle. The circle is surrounded by a series of curved lines, resembling water droplets or stylized flames. The logo is colored in a light blue hue.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with RIC5-9A-RS Transducer Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Transvaginal	P	P	P		P	P	P	P	P	P	[ 5,6,9]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/14/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are curved lines around the letters, and the circle is outlined in blue. The logo is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with RAB6-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW
Doppler	CW
Doppler	Color
Doppler	Color M
Doppler	Power
Doppler	Combined
Modes*	Harmonic
Imaging	Coded
Pulse	Other
[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5,6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5,6]
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

[1] Abdominal includes renal, GYN/Pelvic Notes:

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has wave-like designs around the letters.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with ML6-15-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [6,9] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [6,9] |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [6,9] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [6,9] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [6,9] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [6,9] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

[2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients

[3] Cardiac is Adult and Pediatric.

[5] 3D/4D Imaging Mode.

[6] Includes imaging of guidance of biopsy (2D/3D/4D).

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/16/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in white inside. There are curved lines around the letters, and the circle is outlined in blue. The logo is simple and recognizable.

Diagnostic Ultrasound Indications for Use Form

Voluson S8 / Voluson S10 / Voluson S10 Expert with 12S-RS Transducer

Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

	Mode of Operation
Clinical Application
Anatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined
Modes*	Harmonic Imaging	Coded Pulse	Other [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P	P	P	P	P	P	P	P
Small Organ[2]	P	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

N = new indication; P = previously cleared by FDA

Notes: [1] Abdominal includes renal, GYN/Pelvic

• [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients
• [3] Cardiac is Adult and Pediatric.
• [5] 3D/4D Imaging Mode.
• [6] Includes imaging of guidance of biopsy (2D/3D/4D).
• [7] Includes infertility monitoring of follicle development.
• [8] Includes urology/prostate.
• [9] Elastography imaging- Elasticity
• [*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/PWD

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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

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Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has a decorative border with wave-like patterns, giving it a distinctive and recognizable appearance.

Voluson S Series (Voluson S8 / Voluson S10 / Voluson S10 Expert)

Section 5: 510(k) Summary

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Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a decorative border that resembles a series of waves or flourishes.

510(k) Summary

	In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:	February 8, 2018
Submitter:	GE Healthcare
9900 Innovation Dr
Wauwatosa, WI 53226
Primary Contact Person:	Bryan Behn
Regulatory Affairs Director
GE Healthcare
T:[phone]
F:[phone]
Secondary Contact Person:	Jiyeon Park
Regulatory Affairs Leader
GE Ultrasound Korea, Ltd.
T: [phone]
F: [phone]
Device: Trade Name:	Voluson S8 / Voluson S10 / Voluson S10 Expert
Common/Usual Name:	Ultrasound system
Classification Names:
Product Code:	Class II
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN
Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Main Predicate Device(s):	K160184 Voluson S Series, Voluson S6/S8/S10 Diagnostic
Ultrasound System
Reference Predicates:	K172342 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound
System
	K162269 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound
System
Device Description:	The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide

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Image /page/19/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are swirling designs around the letters, giving the logo a classic and recognizable appearance. The blue color is consistent throughout the logo.

accurate real-time three-dimensional imaging supporting all standard acquisition modes.

The device is a general-purpose ultrasound system. Specific Intended Use: clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

The Voluson S8 / Voluson S10 / Voluson S10 Expert employs the Technology: same fundamental scientific technology as its predicate devices.

Determination of Comparison to Predicates

Substantial Equivalence: The Voluson S8 / Voluson S10 / Voluson S10 Expert is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.

• . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
• . The proposed Voluson S Series and predicate Voluson S series systems have the same clinical intended use.
• . The proposed Voluson S Series and predicate Voluson S series systems have the same imaging modes.
• . The proposed Voluson S Series and predicate Voluson S series transducers are identical except for the removal of a transducer (E8C-RS); the addition of a new transducer C2-9-RS (similar to C2-9-D on predicate Voluson E Series K162269).
• The proposed Voluson S Series and predicate Voluson S series systems have the same indications for use.
• The systems are manufactured with materials which have ● been evaluated and found to be safe for the intended use of the device.
• The systems have acoustic power levels which are below ●

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510(k) Premarket Notification Submission

the applicable FDA limits.

• . The proposed Voluson S Series and predicate Voluson S series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
• The proposed Voluson S Series and predicate Voluson S . series systems have been designed in compliance with approved electrical and physical safety standards.
• The proposed Voluson S Series adds an improved version ● of existing software feature IOTA LR2 model called IOTA Simple Rules (previously cleared with K172342).
• The proposed Voluson S Series adds a 3D Analysis ● feature of the endometrial cavity called SonoMetrium. (previously cleared with K172342).
• The proposed Voluson S Series adds an enhanced feature of existing software feature HDlive called HDlive Silhouette (previously cleared with K172342).
• The proposed Voluson S Series adds an enhanced feature of existing software feature SRI called VSRI (previously cleared with K172342).
• The proposed Voluson S Series adds a software feature Radiantflow (previously cleared with K172342).

Summary of Non-Clinical Tests:

The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The Voluson S8/S10/S10 Expert systems and its applications comply with voluntary standards:

• . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012 (Consolidated Text)
• IEC60601-1-2, Medical Electrical Equipment – Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007

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GE Healthcare

510(k) Premarket Notification Submission

• . IEC60601-2-37, Medical Electrical Equipment - Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2015
• ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing- Third Edition, 2009/(R)2013
• NEMA UD 2, Acoustic Output Measurement Standard for ● Diagnostic Ultrasound Equipment:2004 (R2009)
• . ISO14971, Application of risk management to medical devices: Second edition 2007
• . NEMA PS 3.1 - 3.20 (2011). Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

The following quality assurance measures were applied to the development of the system:

• Risk Analysis
• Requirements Reviews
• Design Reviews ●
• Testing on unit level (Module verification)
• Integration testing (System verification) ●
• Performance testing (Verification) ●
• Safety testing (Verification) ●

Transducer materials and other patient contact materials are biocompatible.

Summary of Clinical Tests:

The subject of this premarket submission, Voluson S8 / Voluson S10 / Voluson S10 Expert, did not require clinical studies to support substantial equivalence.

• Conclusion: GE Healthcare considers the Voluson S8 / Voluson S10 / Voluson S10 Expert to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).