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.

AI/ML Overview

This document describes the GE Healthcare Voluson S8/S10/S10 Expert ultrasound system and its equivalence to predicate devices, but it does not provide acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined for AI/ML performance evaluation.

Instead, this is a 510(k) premarket notification summary from the FDA, focusing on:

Substantial Equivalence: Comparing the new device to existing legally marketed devices (predicates).
Safety and Effectiveness: Ensuring the device meets recognized safety standards and performs as intended.

Here's an analysis based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not contain a table of numerical acceptance criteria or reported specific device performance metrics for AI/ML algorithms as typically seen in studies evaluating diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, it asserts "substantial equivalence" to predicate devices, meaning its performance characteristics are deemed similar enough that it doesn't raise new questions of safety or effectiveness. The "performance" discussed is related to its ability to perform diagnostic ultrasound imaging and fluid flow analysis, offering various imaging modes, and complying with safety standards.

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

Sample Size for Test Set: Not applicable / Not provided. This document specifies that "The subject of this premarket submission... did not require clinical studies to support substantial equivalence." Therefore, no specific test set of patient data was used for performance evaluation of new AI/ML features in what would typically be considered an AI/ML clinical study.
Data Provenance (country of origin, retrospective/prospective): Not applicable / Not provided.

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

Number of Experts: Not applicable / Not provided. Since clinical studies for substantial equivalence were not required, there was no separate ground truth establishment process involving external experts for performance evaluation. The ground truth for general ultrasound imaging is established through standard medical practice and expert interpretation.
Qualifications of Experts: Not applicable / Not provided specifically for this submission.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable / Not provided. No specific test set performance evaluation was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

MRMC Study Done: No. The document explicitly states: "The subject of this premarket submission... did not require clinical studies to support substantial equivalence."
Effect Size of Human Readers with vs. without AI Assistance: Not applicable / Not provided.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study Done: No. The document states that clinical studies were not required. The "improved version of existing software feature IOTA LR2 model called IOTA Simple Rules," "3D Analysis feature of the endometrial cavity called SonoMetrium," "enhanced feature of existing software feature HDlive called HDlive Silhouette," and "enhanced feature of existing software feature SRI called VSRI" are mentioned as being "previously cleared with K172342" or are enhancements of existing features. This indicates that these features were likely evaluated in the context of substantial equivalence to previous versions or predicate devices, rather than as new standalone AI detections requiring their own independent performance studies for this specific submission.

7. Type of Ground Truth Used:

Type of Ground Truth: Not explicitly stated or required for this type of submission. For ultrasound imaging systems, ground truth is typically established by medical professionals through established diagnostic protocols, expert interpretation, and potentially correlation with other diagnostic modalities or pathology where applicable. However, no specific ground truth was established for a new clinical performance study for this submission.

8. Sample Size for the Training Set:

Sample Size for Training Set: Not applicable / Not provided. As this submission focuses on substantial equivalence of an ultrasound system and enhancements to existing software features, specific AI model training data sizes are not detailed in this regulatory document.

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

How Ground Truth Was Established: Not applicable / Not provided.

Summary of AI/ML Specifics from the Document:

The document mentions several "improved" or "enhanced" software features that could potentially involve AI/ML components (e.g., IOTA Simple Rules, SonoMetrium, HDlive Silhouette, VSRI, Radiantflow). However, for this specific 510(k) submission (K180374), these features are explicitly stated to be either:

"previously cleared with K172342" (a reference predicate).
"an improved version of existing software feature" or "an enhanced feature of existing software feature."

This implies that the novelty of these features for this particular submission was not in their initial safety and effectiveness evaluation as new AI/ML tools, but rather in their inclusion or minor enhancement within the Voluson S8/S10/S10 Expert system, aligning with existing predicate clearances. Therefore, detailed performance studies for these specific AI/ML components are not provided within this document, as they were likely addressed in previous clearances (like K172342 for the Voluson E Series).

Conclusion: This document is a 510(k) premarket notification for an ultrasound system, demonstrating substantial equivalence to predicate devices and adherence to general safety and performance standards. It does not contain the detailed AI/ML specific acceptance criteria or performance study data that you requested, as the submission strategy relied on substantial equivalence rather than novel clinical performance data for new AI/ML features.

Summary

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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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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 PRAStaff@fda.hhs.gov

"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 (301) 443-6740 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 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	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)

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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 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	[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)

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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 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	[ 6,9]
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)

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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 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
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 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

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

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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 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 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]	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)

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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 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	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)

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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 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	[ 5,6,9]
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

(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/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 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
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 ApplicationAnatomy/Region of Interest	B	M	PWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes*	HarmonicImaging	CodedPulse	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 ApplicationAnatomy/Region of Interest	B	M	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	CombinedModes*	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

(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/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 Healthcare9900 Innovation DrWauwatosa, WI 53226
Primary Contact Person:	Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(262)247-5502F:(414)918-8275
Secondary Contact Person:	Jiyeon ParkRegulatory Affairs LeaderGE Ultrasound Korea, Ltd.T: +82 31 740 6307F: +82 31 740 6431
Device: Trade Name:	Voluson S8 / Voluson S10 / Voluson S10 Expert
Common/Usual Name:	Ultrasound system
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
Main Predicate Device(s):	K160184 Voluson S Series, Voluson S6/S8/S10 DiagnosticUltrasound System
Reference Predicates:	K172342 Voluson E Series; E6/E8/E10 Diagnostic UltrasoundSystem
	K162269 Voluson E Series; E6/E8/E10 Diagnostic UltrasoundSystem
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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Image /page/20/Picture/0 description: The image is a blank white square. There are no objects or figures in the image. The background is also white. There is nothing to describe in the image.

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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Image /page/21/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. There are four water droplet-like shapes surrounding the circle, positioned at the cardinal directions.

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).

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.