Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follice development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal (Conventional and Superficial); Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).

Device Description

The Voluson i is a compact, general purpose diagnostic ultrasound system which consists of a portable console, approximately 313 mm wide, 313 mm deep and 59 mm high when closed. It has an integrated acquisition, processing and display unit and a notebook-like user interface consisting of a keyboard and trackball. This configuration will provide users with enhanced convenience and portability.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the GE Voluson i Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing new performance criteria through clinical trials. Therefore, the information typically found in an AI/ML device's acceptance criteria and study section (like specific metrics, sample sizes for test/training sets, expert qualifications, and detailed ground truth establishment) is not present.

Based on the provided text, here’s a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) are described for the Voluson i ultrasound system beyond general safety and effectiveness. The document states that "The device has been evaluated for acoustic output, biocompatibility, beaming and electrical safety, and has been found to conform with applicable medical device safety standards." No specific performance metrics or their values are reported for the Voluson i in comparison to a predicate device in the context of quantitative acceptance criteria. Instead, the "performance" is implicitly demonstrated through the claim of "substantially equivalent" to predicate devices.

The "Indications for Use" forms for each transducer (12L-RS, PA2-5-RS, E8C-RS, RAB2-5-RS, RSP6-16-RS, RIC5-9-RS, 4C-RS) describe the modes of operation and clinical applications for which the device is intended. These are not performance metrics but rather definitions of intended use. The "P" (previously cleared by FDA) and "N" (new indication) markers indicate the scope of the device's capabilities relative to prior clearances but do not provide quantitative performance data.

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

The document explicitly states: "2. Clinical Tests: None required." This indicates that no clinical tests were performed or deemed necessary to demonstrate the safety and effectiveness of the Voluson i system for this 510(k) submission. Therefore, there is no test set sample size or data provenance to report from this document. The assessment was based on non-clinical tests and comparison to predicate devices already on the market.

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

Since no clinical tests were performed, there was no "ground truth" to establish for a test set in the context of this submission. The determination of substantial equivalence relies on the known safety and effectiveness of predicate devices, which would have undergone their own validation processes.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical tests were performed and thus no test set with ground truth requiring adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: None required." The submission focuses on demonstrating substantial equivalence to predicate devices, not on comparing the effectiveness of human readers with and without AI assistance (as this is an ultrasound system, not an AI diagnostic tool).

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

Not applicable for this type of device. The Voluson i is a diagnostic ultrasound system, an imaging modality operated by a human, not a standalone AI algorithm. Its performance is intrinsically tied to human operation and interpretation.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Not applicable, as no clinical tests requiring the establishment of a novel ground truth were performed for this submission. The ground truth for the predicate devices would have been established through their own clearance processes, but this is not detailed here.

8. The Sample Size for the Training Set:

Not applicable. The Voluson i is a diagnostic ultrasound system. The document does not describe any machine learning components that would require a "training set" in the context of AI/ML.

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

Not applicable, for the same reason as above.

Summary of the Study and Device Assessment (based on the provided text):

The GE Voluson i Diagnostic Ultrasound System's acceptance was based on a 510(k) premarket notification process, which aims to demonstrate substantial equivalence to legally marketed predicate devices.

The study that "proves" the device meets acceptance criteria is primarily non-clinical testing and a comparison to predicate devices:

Non-clinical Tests: The device underwent evaluations for "acoustic output, biocompatibility, beaming and electrical safety" and was found to conform with applicable medical device safety standards.
Comparison with Predicate Devices: The Voluson i is described as being "of a comparable type and substantially equivalent... to the unmodified Voluson 730 Pro/Expert and also to the comparable type and substantially equivalent... The same technological characteristics, key safety and effectiveness features, and similar physical design, construction, and materials." (K003525, K032620, K041688 were the predicate devices).
Clinical Tests: The document explicitly states "None required."
Conclusion: GE Healthcare's opinion is that the Voluson i Diagnostic Ultrasound System is "substantially equivalent to devices currently cleared for market," based on its conformance to safety standards, quality systems, and the established safe and effective performance history of GE Healthcare products.

In essence, for this 510(k) clearance, the "acceptance criteria" were met by demonstrating that the new device is as safe and effective as existing legally marketed devices, primarily through non-clinical testing and technological comparison, without requiring new clinical trials to establish novel performance metrics or ground truth.

Summary

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DEC 16 2005
ko 53435

Attachment B:

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a circular border, creating a recognizable emblem for the company.

GE Healthcare

General Electric Company P.O. Box 414, Milwaukee, WI 53201

Section a):

1. Submitter:	GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLCPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	December 8, 2005
2. Device Name:	Voluson i Diagnostic Ultrasound SystemUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYNDiagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX

Marketed Device: Voluson 730 Pro/Expert Diagnostic Ultrasound - K003525, K032620, K041688 A device currently in commercial distribution.
Device Description: The Voluson i is a compact, general purpose diagnostic ultrasound system which 4. Device Describited. The Voluson is a sense , goride, 313 mm deep and 59 mm high when closed. consists of a portable consolitically oo min the your a notebook-like user interface consisting of It has agailal acquisition, processing and display ou a notification will provide users with enhanced convenience and portability.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follice development); Pediatric of Feial/OB, Abdominal (Including OTN, pervice and Internation (adult and pediatio);
Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; (TV); Transport Strail Organ (preast, testes, thyrou ctc.), reonatur and Paul. So, Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal, PV and neurological).
Comparison with Predicate Devices: With respect to features and applications, the Voluson is of a o. Quilibalison will i redicate Dovisor white the unmodified Voluson 730 Pro/Expert and also to the comparable type and substantially oqurtail.com the same technological characteristics, key safety and effectiveness features, and similar physical design, construction, and materials.

Section b):

Non-dinical Tests: The device has been evaluated for acoustic output, biocompatibility, beaning and 1. Northallincal rests. The dovice has book of accommission safety, and has been found to conform with applicable medical device safety standards.

1. Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditor. I reactive, FDA 5. Outligusion. Thich could one ney to reasonation. The design and development process of the davine sesferms gudelines, and established include of pation one in 14485 quality systems. The device conforms manufacturer conforms with 21 OF C 88, 100 connent is verified through independent evaluations of esfa and to applicable inedical device sales and compulated a long history of safe and with origoing factory survellance. "Diagnoons and of GE Healthcare that the GE Volusor i Diagnostic effective performatice. Therefore, it is the opinion of O2 readined in the evices currently cleared for market.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement. The seal is black and white.

DEC 16 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager, GE Ultrasound Product Safety and Regulatory Engineering General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue WEST MILWAUKEE WI 53219

Re: K053435

Trade Name: GE Voluson i Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: December 8, 2005 Received: December 9, 2005

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section 310(x) premaintentially equivelent (for the referenced above and we have determined the device marketed predicate devices marketed in
indications for use stated in the enclosure) to legally marketed predicel Davice interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate collineree prof to May 20, 1978, the case with the provisions of the provisions of the subject to Amendments, or to devices market Act (Act). You may, therefore, market the device, subject to Federal Food, Drug, and Cosment Processor (Free). Founday someral controls provisions of the Actinclude the general controls provisions of the Feir - No Fees, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intential I his determination of substantar equirated upposes in the many of emarket notification:

Transducer Model Number

12L-RS PA2-5-RS

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

E8C-RS

RAB2-5-RS

RSP6-16-RS

RIC5-9-RS

4C-RS

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), If your device is classified (Sce above) into e. Existing major regulations affecting your device. FDA it may be subject to such addinonal controls: "Existing highert good to 898. In addition, FDA
can be found in the Code of Federal Regulations, Title 21, Parts 800 to Associa can be found in the Code of I cucial Regulations, Fried in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA $ Issualles of a sudomatic equirements of the Act
that FDA has made a determination that your device only addres accepains. You must that FDA has made a decermination and your and your her Federal agencies. You must or any Federal statures and regulations administered of registration and listing (21
comply with all the Act's requirements, including, but not was requirements as set comply with all the Act S requirements, monation ing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing the electronic CFR Part 807); labeling (21 CFR Fart 800); good manaxt 820); and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR 1000 1050 forth in the quality systems (QS) regulation (21-51-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This determination of substantial equivalence is granted on the condition that print online in This determination of Substantial equivalence special report should contain complete the first device, you submit a postcreatine special reported on production line devices, requested
information, including acoustic output measurements based on production for information, including acousus output measurements 30, 1997 "Information for Manufacturers" in Appendix G, (enclosed) of the Center S September 30, 1977 - and Transducers." If the special Seeking Marketing Clearance of Diagnostic United Co., acoustic output greater than approved report is incomplete of contails unaccepable varies (orgi, doction in the which as a result may be considered adulterated or misbranded.

The special report should reference the manufacturer's 510(k) number. It should be clearly and The special report should reference the manufactures in duplicate to:

Food and Drug Administration i Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850

This letter will allow you to begin marketing your device as described in your premarket I his letter will anow you to begin marketing your device of your device to a legally marketed notification. The PDA imania of succeantal required and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (1 CFR Part 801), please If you desire specific advice for your ac not on one on one one the regulation entitled, contact the Office of Comphance at (210) 275 -ation" (21CFR Part 807.97). You may obtain " Misbranding by reference to premarket notification - (2) OF C S C from the Division of Small

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

Page 3 – Mr. Schuh

Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or Manufacturers, International and Collisuner Assistance at to ter levels.
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

If you have any questions regarding the content of this letter, please contact REVIEWER at (301) 594-1212.

Sincerely yours,

Nancy C Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Diagnostic Ultrasound Indications for Use Form

GE Voluson i 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	[5,6]
Abdominal[1]	P	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]	P	P	P		P	P	P	P	P	P	[5,6]
Neonatal Cephalic	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	[5,6]
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	[5,6]
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	P	P	P		P	P	P	P	P	P
Intraoperative Neurological	P	P	P		P	P	P	P	P	P
Intravascular

| Labarsopic
N = new indication: P = previously cleared by FDA; E = added under Appendix E

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

[1] Abdonimal includes renar, OTNF owle
[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

[8] Includes urologyprostate
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(Please Do not WRITE BELOW THIS LINE - Continue on another Page if NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon
(Division Sign-Off)

Pivision of Reproductive, Abdominal ୍ୟ Radiological Devices 5 ! O(k) Number _

E-2

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

..............................................................................................................................................................................

Diagnostic Ultrasound Indications for Use Form

GE Voluson i with 12L-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]				N	N	N	N	N	N	[6]
Pediatric	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]	N	N	N	N	N	N	N	N	N	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Conventional	N	N	N	N	N	N	N	N	N	[6]
Musculo-skeletal Superficial	N	N	N	N	N	N	N	N	N	[6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	N	N	N	N	N	N	N	N	N
Intraoperative Neurological	N	N	N	N	N	N	N	N	N
Intravascular

Laparoscopic ــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــــ

N = new indication; P = previously deared by FDA; E = added under Appellux E
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediatric

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

[6] Includes imaging of guidance of blopsy (2D)
{"] Combined modes are B/M, B/Color M, B/PWD or CWD, B/ColoriPWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) SEDONOTWRITEDECOM Office of Device Evaluation (ODE)

Daney C. Brogdon
(Division Sign-Off)

Division of Reproductive, Abdominal ano Radiological Devices 5 ! (k) Number ______________

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i with PA2-5-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	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P
Pediatric
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P	P
Cardiac [3]	P	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

Labalosopio
N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[3] Cardiac is Adult and Pediatric.

[3] Cardiac is Adult and Pealativ.
[1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Eva!nation (ODE)

Nancy C. Hogdon
(Division Sign-Off)

arren at Rearchin and Carrological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i 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]	N	N	N		N	N	N	N	N	N	[6]
Abdominal[1]
Pediatric
Small Organ[2]
Neonatal Cephalic	N	N	N		N	N	N	N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N		N	N	N	N	N	N	[6]
Transvaginal	N	N	N		N	N	N	N	N	N	[6]
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular
Laparoscopic

Notes: [6] Includes imaging of guidance of biopsy (2D)

[7] Includes infertility monitoring of follicle development

[/ Includes internity montoning of follolo dovelopment
["] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Brogdon

โ

(Division Sig Division of Reproduc ive Abdo and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i 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
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

Labaroscopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

[5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

[1] Includes imerally monitoring or relations of tellists of the Province or CWD, B/Power/PWD.

(PLEASE DO NOT WRITE BELOW THIS LINE · CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nency C. Brogdon

of Reproci VA. Ab and Particlogical Devices (k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i with RSP6-16-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	E	E	E		E	E	E	E	E	E	[5,6]
Small Organ[2]	E	E	E		E	E	E	E	E	E	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	E	E	E		E	E	E	E	E	E	[5,6]
Musculo-skeletal Conventional	E	E	E		E	E	E	E	E	E	[5,6]
Musculo-skeletal Superficial	E	E	E		E	E	E	E	E	E	[5,6]
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	E	E	E		E	E	E	E	E	E
Intraoperative Neurological	E	E	E		E	E	E	E	E	E
Intravascular

| Capansopic
N = newindication; P = previously cleared by FDA; E = added under Appendix E

N = new indication; P = previously dealed by PDA, E = added ander Apportan =
Notes: [2] Small organ includes breast, testes, thyroid, salivary gland, lymph nodes, pediati [5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

[ ] Includes internity monioning of folliele Gevelopment
[ ] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon
(Division Sign-Off)

Division of Reproductive, and Radiological Devices 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i with RIC5-9-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]	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
Laparoscopic

Expares --------------------------------------------------------------------------------------------------------------------------------------------------------------------

Notes: [5] 3D/4D Imaging Mode

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

[7] Includes infertility monitoring of follicle development

[8] Includes urology/prostate

[6] Includes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

(Division Division of Reproductive, Ab forninal, and Radiological Devices - Number _

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

Diagnostic Ultrasound Indications for Use Form

GE Voluson i 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	P	[6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[6]
Pediatric	N	N	N	N	N	N	N	N	N	N	[6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative
Intraoperative Neurological
Intravascular

Labarssopic
N = new indication; P = previously cleared by FDA; E = added under Appendix E

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

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

[7] Includes infertility monitoring of follicle development

[1] Includes intertify montaining er comise B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

(Please do not write below this line - continue on another Page if needed) Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Boydon

(Division Sign-Off) Division of Reproductive, Abdo and Radiological Devices 5 : (k) Number _

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.