The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and 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 (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Device Description

The subject device consists of a mobile console with keyboard, specialized controls, a color video LCD display with electronicarray transducers. It has the same general appearance, dimensions and weight as the unmodified device, it is a Track 3 generalpurpose imaging and analysis system providing real-time digital acquisition, processing and display capability intended for general radiology imaging and evaluation with some cardiology and vascular applications.

AI/ML Overview

The GE Voluson S6/S8 Ultrasound System is a general-purpose imaging and analysis system. The provided document is a 510(k) Premarket Notification Summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical study results for novel acceptance criteria.

Therefore, this document does not contain explicit acceptance criteria tables with reported device performance metrics like sensitivity or specificity, nor does it detail a clinical study designed to "prove the device meets acceptance criteria" in terms of algorithm performance for specific medical tasks. Instead, it describes non-clinical tests and affirms the device's technical equivalence and safety to its predicates.

Based on the provided text, here's a breakdown of what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Not applicable. The document focuses on demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not on setting and meeting specific performance acceptance criteria from a clinical study. The device is a diagnostic ultrasound system, whose performance is generally assessed through imaging quality, safety, and functionality, rather than specific diagnostic accuracy metrics, which would typically be evaluated in a clinical study if new diagnostic indications or automated analysis features were being introduced.

2. Sample Size Used for the Test Set and Data Provenance:

Not applicable to a clinical study demonstrating performance against acceptance criteria. The document explicitly states: "The subject of this premarket submission, Voluson S6, Voluson S8, did not require clinical studies to support substantial equivalence." (Page 1)

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts:

Not applicable. No clinical study data for ground truth establishment is presented.

4. Adjudication Method for the Test Set:

Not applicable. No clinical study data for ground truth establishment is presented.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a general diagnostic ultrasound system, not explicitly an AI-assisted diagnostic tool. No MRMC study is mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done:

Not applicable. The device is a diagnostic ultrasound system that requires a human operator for image acquisition and interpretation. It is not an algorithm-only device.

7. The Type of Ground Truth Used:

Not applicable, as no dedicated clinical study assessing diagnostic performance against a ground truth is described. The "ground truth" for this type of submission relies on the established safety and performance of its predicate devices and compliance with regulatory standards.

8. The Sample Size for the Training Set:

Not applicable. As this device is not an AI/algorithm-based diagnostic product with a training set in the conventional sense, no training data or sample size is relevant for this submission.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. See point 8.

Summary of Device Evaluation (from the provided text):

The GE Voluson S6, Voluson S8 Ultrasound System underwent non-clinical tests to demonstrate substantial equivalence to its predicate devices, covering:

Acoustic output
Biocompatibility
Cleaning and disinfection effectiveness
Thermal, electrical, electromagnetic, and mechanical safety

The development process also included standard quality assurance measures such as:

Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Final Acceptance Testing (Validation)
Performance testing (Verification)
Safety testing (Verification)

The conclusion states that GE Healthcare considers the Voluson S6, Voluson S8 to be as safe, as effective, and its performance substantially equivalent to the predicate device(s). The FDA concurred with this finding of substantial equivalence based on the provided information, without requiring clinical studies.

The tables in pages 6-19 list the various clinical applications and modes of operation for the Voluson S6/S8 system with different transducers. "P" indicates applications and modes previously cleared by FDA, while "N" indicates new indications. These tables specify the intended uses and capabilities of the device and its transducers, rather than presenting acceptance criteria for a performance study.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows a logo of the General Electric (GE) company. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The design has a vintage or slightly distressed appearance, with rough edges and a textured look, suggesting it might be an older version of the logo.

APR 2 7 2012

GE Healthcare

510(k) Premarket Notification Submission

510(k) Summary

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

Date:	March 7, 2012
Submitter:	GE Healthcare9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:	Bryan BehnRegulatory Affairs ManagerGE HealthcareT:(414)721-4214F:(414)918-8275
Trade Name:Device:	Voluson S6, Voluson S8 Ultrasound System
Common/Usual Name:	Voluson S6, Voluson S8
Classification Names:Product Code:	Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX

K103649 Voluson S6, Voluson S8 Diagnostic Ultrasound System Predicate Device(s):

K113758, K112213 Voluson E6E8E8ExpertE10

K053435 Voluson i

K113690 LOGIQ e

Device Description:

The device is a general-purpose ultrasound system. Specific Intended Use: clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and 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 (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows a circular logo with the letters 'GE' intertwined in the center. The letters are stylized with curved lines and a swirling design. The logo is surrounded by a decorative border with a repeating pattern. The image is in black and white.

510(k) Premarket Notification Submission

Technology:

Determination of Substantial Equivalence:

The Voluson S6, Voluson S8 employs the same fundamental scientific technology as its predicate devices

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. Voluson S6, Voluson S8 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. 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)
Final Acceptance Testing (Validation)
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 S6, Voluson S8, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the Voluson S6, Voluson S8 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

APR 2 7 2012

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care, LLC 9900 Innovation Drive WAUWATOSA WI 53226

Re: K120741

Trade/Device Name: Voluson S6. Voluson S8 Regulation Number: 21 CFR 892-1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: March 7, 2012 Received: March 12, 2012

Dear Mr. Behn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). 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.

This determination of substantial equivalence applies to the following transducers intended for use with the Voluson S6, Voluson S8, as described in your premarket notification:

Transducer Model Number

RAB4-8-RS	AB2-7-RS	3Sc-RS
4C-RS	RIC5-9W-RS	9L-RS
E8C-RS	RAB2-5-RS	P2D
C1-5-RS	8C-RS
12L-RS	ML6-15-RS

{3}------------------------------------------------

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. 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); 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.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.

Sincerely Yours,

Michael O'Keeffe, Jr.

Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

{4}------------------------------------------------

510(k) Number (if known):

Device Name:

Voluson S6, Voluson S8

Indications for Use:

The device is a general-purpose ultrasound system. Specific clinical applications and exam types include: Fetal (Obstetrics); Abdominal (including renal and 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 (PV); Musculo-skeletal Conventional and Superficial; Transrectal (TR); Transvaginal (TV).

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use_NA (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Aunh D. Th

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) Number K120741

{5}------------------------------------------------

Indications for Use Forms

The following forms represent indications with clinical applications and exam types along with the modes of operation for the Voluson S6, Voluson S8 system. Combinations identified "P" for the system represents those previously cleared in K103649. laominod " 101 the of brow" for the system represents those that are new in this release. Combinations identified "P" for the transducers represents those previously cleared with this or another GE Ultrasound system. Combinations identified "N" for the transducers uns of allouise. On the viewiously cleared any GE Ultrasound system. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Devices Evaluation and Safety

510K.K120741

Confidential and Privileged. This document contidential and privileged trade secrets and other Connidential and Priviteged. This document connance connecting connection of thers not employed by General Electric Co. All rights reserved

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The logo is presented in black and white, with the letters and border appearing in black against a white background. The design is simple yet recognizable, representing the well-known multinational conglomerate.

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 Ultrasound System

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined	Harmonic	Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse	[Notes]
Ophthalmic
Fetal / Obstetrics 17	P	P	P	N	. P	P	b	P	. P	P	[ 5,6,9]
Abdominal(!)	P	P	P	N	P	P	P	P	P	P	[ 5,6,9]
Pediatric	P	P	P	N	P	P	P	P	P	P	[ 5,6,9]
Small Organ®]	P	P	P	N	P	P	P	P	P	P	[ 2,6,9]
Neonatal Cephalic	P	P	P	N	P	P	P	P	P	P	[ર]
Adult Cephalic	P	P	P	N	P	P	P	P	P	P
Cardiaclil	P	P	P	N	P	P	P	P	P	P	(ર)
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5,6,9]
Musculo-skeletal Superficial	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	[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

[1] I loominal inolodes renar, 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.

on and Selety

[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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR, 801.109)

(Divsion Bigh-Om

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white and appears to be a vintage or classic version of the GE logo.

โ

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with RAB4-8-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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

N = new indication; P = previously cleared by FDA

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

[1] Addoninal includes frenci, OTTC. 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).

Svaluation and Safety

[7] Includes infertility monitoring of follicle development.

[8] Includes urology/prostate.

[9] Elastography imaging- Elasticity

[9] Elastography imagings Elastony
[*] 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)
Division of Radiologicel Devices

Office of In Vitro Di

EIOK

{8}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE Voluson S6/S8 with 4C-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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

N = new indication; P = previously cleared by FDA

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

[1] Adominial indudes rendry of Nr.) of the stires, the mary 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

[5] Clastography Imeging 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

SIOK

{9}------------------------------------------------

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with E8C-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic	P	P	P		P	P	P	P	P	P
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
I anarosconic

N = new indication; P = previously cleared by FDA

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

[1] Addonifial molodou Tonal, D Proid, 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

[0] Clactography ime 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

{10}------------------------------------------------

Diagnostic Ultrasound Indications for Use Form

GE Voluson S6/S8 with C1-5-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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

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

[0] Clastography imbging "Exection")
[*] 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Om
Division of Radiological Devices
Office of In Vitro Diagriostic Device Evaluation and Safety
Deynep Eyelust

510K

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected, creating a distinctive monogram. The logo is presented in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with 12L-RS Transducer

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

	Mode of Operation
Clinical Application	B	M	PW	CW	Color	Color M	Power	Combined Harmonic		Coded	Other
Anatomy/Region of Interest			Doppler	Doppler	Doppler	Doppler	Doppler	Modes	Imaging	Pulse	(Notes)
Ophthalmic
Fetal / Obstetrics 77
Abdomina[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
Cardiaclil
Peripheral Vascular	b	P	P		P	P	P	P	P	P	(୧' à)
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	(୧'୨)
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
7 operaceanie

N = new indication; P = previously cleared by FDA

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

[1] Abdominal includes Terrar, C. Fron Civis
[2] Small organ includes breast, testes, thyroid, saliyary 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

[0] Liactography images 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)
(Division Sign-Off)

Division of Rediological Devices Office of In Vitro Diagnostic Device Evaluation and Satety

510K

{12}------------------------------------------------

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with AB2-7-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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

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

[1] I loonliner malasot renay, 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K. 120741

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines, giving them a flowing appearance. The logo is presented in black and white, with the letters and border appearing in black against a white background.

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with RIC5-9W-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[ 5,6]
Abdominal[1]
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]
Transvaginal	P	P	P		P	P	P	P	P	P	[5,6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

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

[၁] Clastography imaging - Loonshi
[၁] Combined modes are Β/Μ, Β/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 Diagnostic Devices (OIVD)

Prescription User (Per 21-CFR 801.109)

(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K

{14}------------------------------------------------

Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized and connected in a flowing, cursive-like manner. The logo is black and white.

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with RAB2-5-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	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
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

N = new indication; P = previously cleared by FDA (K053435)

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

[1] 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

[5] Clastogruphy Imaging "LiaoRing" LiaoRing", "LiaoRiPWD, 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

on of Radiological Devices Office of In ice Evaluation and Safety

{15}------------------------------------------------

Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is black and white and has a vintage look.

Diagnostic Ultrasound Indications for Use Form

GE Voluson S6/S8 with 8C-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	N	P	P	P	N
Abdominal[1]	P	P	P		P	N	P	P	P	N
Pediatric	P	P	P		P	N	P	P	P	N
Small Organ[2]	P	P	P		P	N	P	P	P	N	(9)
Neonatal Cephalic	P	P	P		P	N	P	P	P	N
Adult Cephalic
Cardiac[3]	P	P	P		P	N	P	P	P	N
Peripheral Vascular	P	P	P		P	N	P	P	P	N
Musculo-skeletal Conventional	P	P	P		P	N	P	P	P	N	(9)
Musculo-skeletal Superficial	P	P	P		P	N	P	P	P	N	(9)
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

N = new indication; P = previously cleared by FDA(K113690)

[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 Diagnostic Devices (OIVD)

ision Sign-On)
Division of Rediological Devices valuation and Safety Office of In, Vitro Diagnostic Dovit し

510K

{16}------------------------------------------------

Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized manner. The letters are enclosed within a circular border that has a decorative, swirling pattern around the edges.

510(k) Premarket Notification Submission

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with ML6-15-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes)
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	N	N	N	N	N	N	N	N	N	N	(6,9)
Pediatric	N	N	N	N	N	N	N	N	N	N	(6,9)
Small Organ[2]	N	N	N	N	N	N	N	N	N	N	(6,9)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	N	(6,9)
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	N	(6,9)
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	N	(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

[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

[3] Clastography Integring "Liaons")
[*] 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 Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices valuation and Safety Office of In Diagnostic Device Et

510K. K120741

{17}------------------------------------------------

Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The intertwined letters are enclosed within a circular border, and there are decorative swirls or flourishes around the letters, adding to the logo's distinctive appearance.

Diagnostic Ultrasound Indications for Use Form

GE Voluson S6/S8 with 3Sc-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other(Notes)
Ophthalmic
Fetal / Obstetrics[7]	N	N	N	N	N	N	N	N	N	N
Abdominal[1]	N	N	N	N	N	N	N	N	N	N
Pediatric	N	N	N	N	N	N	N	N	N	N
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	N	N	N	N	N	N	N	N	N	N
Cardiac[3]	N	N	N	N	N	N	N	N	N	N
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 Diagnostic Devices (OIVD)

Division Sign off

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K. 6128741

{18}------------------------------------------------

Image /page/18/Picture/0 description: The image shows a logo. The logo is circular and contains a stylized monogram in the center. The monogram appears to be the letters 'G' and 'E' intertwined. The background of the circle has a textured or patterned appearance.

Diagnostic Ultrasound Indications for Use Form GE Voluson S6/S8 with 9L-RS Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	N	N	N		N	N	N	N	N	N
Abdominal[1]	P	P	P		P	N	P	P	P	P
Pediatric	P	P	P		P	N	P	P	P	P
Small Organ[2]	P	P	P		P	N	P	P	P	P	(9)
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P		P	N	P	P	P	P
Musculo-skeletal Conventional	P	P	P		P	N	P	P	P	P
Musculo-skeletal Superficial	P	P	P		P	N	P	P	P	P	(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(K113690)

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

[2] Small organ includes breast, 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 Diagnostic Devices (OIVD)

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

BIOK

{19}------------------------------------------------

Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The logo is in black and white and has a vintage look.

Diagnostic Ultrasound Indications for Use Form

GE Voluson S6/S8 with P2D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic				P
Cardiac[3]				P
Peripheral Vascular				P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal[8]
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
I anarosconic

N = new indication; P = previously cleared by FDA(K112213)

[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 Diagnostic Devices (OIVD)

રૂડે

Prescription User (Per 21 CFR 801.109)

(Division Sign-Off)

Division of Radiological Devices Vitro Diagnostic Device Evaluation and Safety Office at In

510K

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.