Voluson P6, Voluson P8

K160162 · GE Healthcare · IYN · Apr 26, 2016 · Radiology

Device Facts

• Record ID: K160162
• Device Name: Voluson P6, Voluson P8
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Apr 26, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Indications for Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal (Obstetrics); Abdominal (including renal and GYN/pelvic); Pediatric; Small Organ (breast, testes, thyroid, salivary gland, lymph nodes, pediatric and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

Device Story

Mobile ultrasound console with keyboard, color LCD, and DICOM networking; utilizes linear, curved linear, and matrix phased array transducers for real-time 2D/3D/4D imaging. Operates by emitting ultrasonic pulses and processing echoes to visualize anatomy and blood flow. Used by clinicians in clinical settings for general radiology and OB/GYN exams. Includes IOTA LR2 model for GYN measurements and SIM card for wireless image/text transmission. Output displayed on screen for diagnostic assessment and biopsy guidance; aids clinical decision-making by providing real-time anatomical visualization and quantitative measurements.

Clinical Evidence

No clinical studies required; substantial equivalence supported by bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal/electrical/electromagnetic safety verification.

Technological Characteristics

Mobile console with color LCD; uses linear, curved linear, and matrix phased array transducers. Features STB MLA4 beamformer. Connectivity via DICOM and wireless SIM (MMS/SMS). Complies with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, NEMA UD 2/3, and ISO 10993-1. Biocompatible patient-contact materials.

Indications for Use

Indicated for diagnostic ultrasound imaging and fluid flow analysis in fetal/OB, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, transrectal, and transvaginal applications. Includes biopsy guidance.

Regulatory Classification

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.

Predicate Devices

• Voluson P Series (K141675)
• Voluson E Series; E6/E8/E10 (K152567)
• Voluson E Series; E6/E8/E10 (K142472)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing to the right, arranged in a cascading manner. The profiles are depicted in a dark color, creating a silhouette effect. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 26, 2016

GE Healthcare % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226

Re: K160162

Trade/Device Name: Voluson P6 / Voluson P8 Ultrasound Systems Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: March 31, 2016 Received: April 1, 2016

Dear Ms. Ortiz:

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D'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 'GE' intertwined within a circular frame. The logo is colored in a light blue hue, which gives it a clean and modern appearance.

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) 6016

Device Name Voluson P6 / Voluson P8

Indications for Use (Describe)

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obsternes); Abdominal (including renal and GYN/pelvic); Pediatic; Small Organ (breast, testes, thyroid, salivary gland, Jymph nodes, pediatic and neonatal patients); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-sketal Conventional and Superficial; Transrectal (Including Urology and Prostate) (TR); Transvaginal (TV).

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

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

FORM FDA 3881 (1/14)

PSC Publishing Services [phone]

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Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. There are also some swirl-like designs around the circle.

## Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 Ultrasound System

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

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

[*] 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/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.

### Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 with IC9-RS Transducer

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

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|-----------------|------------------|-------------|---------------|--|
| Clinical Application<br>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 | [ 6] | |
| Abdominal[1] | N | N | N | | N | N | N | N | N | N | [ 6] | |
| 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] | N | N | N | | N | N | N | N | N | N | [ 6] | |
| Transvaginal[10] | N | N | N | | N | N | N | N | N | N | [ 6] | |
| 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

[*] 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' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.

#### Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 with 4C-RS Transducer

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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.

[*] 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 script inside. There are decorative swirls around the letters, and the blue color is a medium shade. The logo is simple and recognizable, representing the well-known multinational corporation.

### Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 with E8C-RS Transducer

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

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | [6] | |
| 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] | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [6] | |
| 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

[*] 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 General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a circular frame. The color of the logo is blue, and the background is white.

### Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 with 12L-RS Transducer

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

| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| 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.

[*] 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 General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. There are three stylized swirls around the circle.

### Diagnostic Ultrasound Indications for Use Form

Voluson P6 / Voluson P8 with 3Sc-RS Transducer

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

| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | [6] |
| Cardiac[3] | 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.

[*] 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 General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.

#### Diagnostic Ultrasound Indications for Use Form

#### Voluson P6 / Voluson P8 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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | [5,6] |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [5,6] |
| 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] | N | N | N | N | N | N | N | N | N | N | [5,6] |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | [5,6] |
| 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.

[*] 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/10/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 circular border. The logo is colored in a light blue hue, and the background is white.

### Diagnostic Ultrasound Indications for Use Form

#### Voluson P6 / Voluson P8 with RAB2-6-RS Transducer

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

| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | | | | | | | | | | | |
| 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

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.

[*] 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/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 script inside. There are swirling lines around the letters, and the circle is outlined in white. The logo is simple and recognizable, and it is associated with a well-known company.

## 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

| Date: | January 26, 2016 |
|----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:[phone]<br>F:[phone] |
| Secondary Contact Person: | Chan Sook Kim<br>Regulatory Affairs Leader<br>GE Healthcare<br>T: [phone]<br>F: [phone] |
| Device:<br>Trade Name: | Voluson P6 / Voluson P8 Ultrasound Systems |
| Common/Usual Name: | Ultrasound system |
| Classification Names:<br>Product Code: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K141675 Voluson P Series; Voluson P6/P8 Diagnostic<br>Ultrasound System |
| | K152567 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound<br>System |
| | K142472 Voluson E Series; E6/E8/E10 Diagnostic Ultrasound<br>System |
| Device Description: | The systems are full-featured Track 3 ultrasound systems,<br>primarily for general radiology use and specialized for OB/GYN<br>with particular features for realtime 3D/4D acquisition. They<br>consist of a mobile console with keyboard control panel; color<br>LCD display, color video display and optional image storage and<br>printing devices. They provide high performance ultrasound<br>imaging and analysis and have comprehensive networking and<br>DICOM capability. They utilize a variety of linear, curved linear.<br>matrix phased array transducers including mechanical and |

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Image /page/12/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 frame has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The color of the logo is blue.

electronic scanning transducers, which provide accurate realtime three dimensional imaging supporting all standard acquisition modes.

The device is a general purpose ultrasound system. Intended Use: 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 (Including Urology and Prostate) (TR); Transvaginal (TV).

The Voluson P6 / Voluson P8 employs the same fundamental Technology: scientific technology as its predicate devices.

#### Determination of Comparison to Predicates

Substantial Equivalence: The Voluson P6 / Voluson P8 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 Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same clinical intended use.
- . The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have the same imaging modes.
- The Voluson P6 / Voluson P8 and predicate Voluson P Series systems transducers are identical except for the removal of two transducers for RIC5-9W-RS and RAB2-5-RS; the addition of two new transducers IC9-RS (similar to IC9-D on predicate Voluson E Series K152567), and RIC5-9A-RS (similar to RIC5-9W-RS on predicate Voluson P Series K141675)
- The Voluson P6 / Voluson P8 and predicate Voluson P 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.

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Image /page/13/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 circular border. The color of the logo is a light blue.

- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The Voluson P6 / Voluson P8 and predicate Voluson P Series systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The Voluson P6 / Voluson P8 and predicate systems have been designed in compliance with approved electrical and physical safety standards.
- The Voluson P6 / Voluson P8 adds a SIM card to the system to allow users to send images and text via MMS SMS wirelessly (previously cleared with K142472).
- The Voluson P6 / Voluson P8 adds a GYN measurement ● tool created by IOTA Group called IOTA LR2 model (previously cleared with K142472).
- The proposed Voluson P6 / Voluson P8 beam former has ● changed to STB MLA4 (previously cleared with K152567 / K142472).

## 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 P6 / Voluson P8 and its applications comply with voluntary standards:

- . AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/C1:2012
- IEC60601-1-2, Medical Electrical Equipment Part 1-. 2:General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests 2007
- . IEC60601-2-37, Medical Electrical Equipment - Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- NEMA UD 3, Standard for Real Time Display of Thermal . and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment:2004
- ISO10993-1, Biological Evaluation of Medical Devices-●

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Image /page/14/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 has a few white swirls around the letters.

Part 1: Evaluation and Testing- Third Edition, 2009

- . NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
- . 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 P6 / Voluson P8, did not require clinical studies to support substantial equivalence.

- GE Healthcare considers the Voluson P6 / Voluson P8 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).