Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).

Device Description

The GE Marlin is a full featured echocardiography system in a highly compact and portable package. It has a full complement of interchangeable electronic array transducers giving it additional capability in general imaging. Although this modificantly changes the size and packaging of the device, it does retain the same intended use and overall imaging capability as the unmodified GE Vivid 3

AI/ML Overview

The GE Marlin Diagnostic Ultrasound System, cleared under K033139, is primarily a re-packaging of an existing device (GE Vivid 3) into a more compact and portable form, while also adding interchangeability with several new transducers. As such, the submission primarily focuses on establishing substantial equivalence based on technical characteristics, safety, and functionality rather than clinical performance metrics in a way that would require specific acceptance criteria and a study to prove they are met.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific quantitative acceptance criteria or reported device performance metrics in the way one might expect for an AI/CADe device (e.g., sensitivity, specificity, AUC). Instead, it establishes substantial equivalence by demonstrating that the GE Marlin system (including its various transducers) performs functions and uses technology comparable to existing cleared devices.

The "performance" is implicitly defined by its "Intended Use" and "Mode of Operation" for various clinical applications, which are identical to or a subset of those already cleared for the predicate devices. The acceptance criteria essentially revolve around meeting established safety standards and maintaining equivalent imaging capabilities to the predicate.

Acceptance Criterion (Implicit)	Reported Device Performance (Implicit/Demonstrated)
Intended Use: Device offers ultrasound evaluation for specified clinical applications (Fetal, Abdominal, Pediatric, Small Organ, etc.)	The GE Marlin Diagnostic Ultrasound System, with its various transducers (3C-RS, 8C-RS, E8C-RS, 8L-RS, i12L-RS, i/t739-RS, 3S-RS, 7S-RS, 10S-RS, 6T-RS, 9T-RS, P2D, P6D), is indicated for all listed diagnostic ultrasound imaging and fluid flow analysis applications (refer to "Indications for Use Forms" for each transducer). These indications are either "P" (previously cleared by FDA) or "N" (new indication, implying similar functionality to an existing predicate).
Mode of Operation: Supports standard ultrasound modes (B, M, PW Doppler, CW Doppler, Color Doppler, etc.) for each application.	All listed transducers support various combinations of B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Combined Modes, and Harmonic Imaging, as indicated by "P" or "N" on the respective tables.
Safety: Conforms to applicable medical device safety standards (acoustic output, biocompatibility, thermal, electrical, mechanical).	"The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards." Additionally, "ongoing production surveillance" verifies compliance.
Substantial Equivalence to Predicate Device (GE Vivid 3): Same intended use and overall imaging capability.	"The GE Marlin is a comparable type and substantially equivalent to the unmodified Vivid 3 in terms of intended use and clinical utility." It shares "the same technological characteristics, overall design, construction methods and materials."
Substantial Equivalence to GE LOGIQ Book: Comparable physical size and portability.	"Additionally, it is comparable to the GE LOGIQ Book with respect to physical size and portability."

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

The document explicitly states: "2. Clinical Tests: None required."
Therefore, there was no separate "test set" in the context of clinical performance evaluation (e.g., for accuracy, sensitivity, specificity). The substantial equivalence justification relies on non-clinical tests and comparison to predicate devices.

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

Since no clinical tests or test sets were explicitly detailed for new performance claims, there were no experts establishing ground truth in this context. The "ground truth" for the device itself is its design and manufacturing adherence to safety standards and its functional equivalence to already cleared devices.

4. Adjudication Method for the Test Set

Not applicable, as no clinical test set was described.

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

Not applicable. This submission is for a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device, and no MRMC study was performed or required.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithmic device requiring standalone performance evaluation. It is an imaging system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the claims in this submission is the established safety and effectiveness of the predicate GE Vivid 3 and GE LOGIQ Book ultrasound systems, and the manufacturer's verification through non-clinical testing (acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, mechanical safety) that the GE Marlin system meets these standards and maintains equivalent functionality. There is no external clinical ground truth established for the Marlin system itself that is presented.

8. The Sample Size for the Training Set

Not applicable, as this is hardware (an ultrasound system), not a software algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable, as no training set was used.

Summary

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K033139

Attachment B

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

Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular shape. The circle has decorative swirls or flourishes around the perimeter, giving it a distinctive and recognizable appearance. The logo is black and white.

GE Ultrasound

GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue Milwaukee, WI 53219

Section a):

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:	September 29, 2003

Device Name: GE Marlin Diagnostic Ultrasound System.
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝ
Marketed Device: GE Vivid 3 Ultrasound System,
510(k) Number K020789, a device currently in commercial distribution.
Device Description: The GE Marlin is a full featured echocardiography system in a highly compact and portable package. It has a full complement of interchangeable electronic array transducers giving it additional capability in general imaging. Although this modificantly changes the size and packaging of the device, it does retain the same intended use and overall imaging capability as the unmodified GE Vivid 3
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, and vascular).
Comparison with Predicate Device: The GE Marlin is a comparable type and substantially equivalent to the unmodified Vivid 3 in terms of intended use and clinical utility. Additionally, it is comparable to the GE LOGIQ Book with respect to physical size and portability. The Marlin shares the same technological characteristics, overall design, construction methods and materials as the predicate devices. Transducers are already cleared for use with the predicate devices and other GE ultrasound systems or utilizes the same materials and construction.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.

2. Clinical Tests: None required.

Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 9001 & 13485 quality system standards for medical device manufacturers. The product is designed to conform with applicable medical device safety standards and compliance is verified through independent evaluation with ongoing production surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE Marlin Ultrasound System is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, with three faces overlapping to suggest a sense of community and support. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 3 2003

Mr. Allen Schuh Manager, GE Ultrasound Product Safety and Regulatory Compliance GE Medical Systems Ultrasound and Primary Care Diagnostic, LLC 4855 West Electric Avenue MILWAUKEE WI 53219

Re: K033139

Trade Name: GE Marlin Diagnostic 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 trasducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 29, 2003 Received: September 30, 2003

Dear Mr. Schuh:

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 GE Marlin Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C-RS 8C-RS

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

E8C-RS
8L-RS
i12L-RS
i/t739-RS
3S-RS
7S-RS
10S-RS
6T-RS
9T-RS
P2D
P6D

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 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); 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 determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units 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 prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:

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

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

Page 3 - Mr. Schuh

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 contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

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

Sincerely yours,

Daniel A. Segner

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

Enclosure(s)

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin Diagnostic 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
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]	P	P	P	P	P	P	P	P	P
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P
Transvaginal	P	P	P	P	P	P	P	P	P
Transuretheral
Intraoperative (specify)[5]	P	P	P	P	P	P	P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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

David A. Lynn

(Division Sign-Off) n of Reproductive, Abdominal, and Radiological Devi

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 3C-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
Ophthalmic
Fetal / Obstetrics	N	N	N		N		N	N	N
Abdominal[1]	N	N	N		N		N	N	N
Pediatric	N	N	N		N		N	N	N
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[4] Other use includes Urology.

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

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

Concurrence of CDRH, Office of Deyice Evaluation (ODE)

David A. Hyman
Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin 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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N
Pediatric	N	N	N		N		N	N	N
Small Organ (specify)[2]	N	N	N		N		N	N	N
Neonatal Cephalic	N	N	N		N		N	N	N
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N		N		N	N	N
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Iaparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[2] Small organ includes breast, testes, thyroid.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Yamil A. Lynn

(Division Sign-Off Division of Reproductive, Abdominal, and Radiological Devices

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin 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
Ophthalmic
Fetal / Obstetrics		N	N		N		N	N	N
Abdominal[1]	N	N	N		N		N	N	N
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	N	N	N		N		N	N	N
Exam Type, Means of Access
Transesophageal
Transrectal	N	N	N		N		N	N	N
Transvaginal	N	N	N		N		N	N	N
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[4] Other use includes Urology.

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

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

Concurrence of CDRH, Office of Dealer Evaluation (ODE)

Daniel A. Lyon

(Division gn-Off Division of Reproductive, Abdominal. and Radiological I 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 8L-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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	N	N	N		N		N	N	N
Pediatric	N	N	N		N		N	N	N
Small Organ (specify)[2]	N	N	N		N		N	N	N
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular	N	N	N		N		N	N	N
Musculo-skeletal Conventional	N	N	N		N		N	N	N
Musculo-skeletal Superficial	N	N	N		N		N	N	N
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Lynn

(Division Sign-Off)

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

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

Diaqnostic Ultrasound Indications for Use Form

GE Marlin with i12L-RS Transducer

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

Clinical ApplicationAnatomy/Region of Interest	Mode of Operation
	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P
Pediatric	P	P	P		P		P	P	P
Small Organ (specify)[2]	P	P	P		P		P	P	P
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P		P		P	P	P
Peripheral Vascular	P	P	P		P		P	P	P
Musculo-skeletal Conventional	P	P	P		P		P	P	P
Musculo-skeletal Superficial	P	P	P		P		P	P	P
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]	P	P	P		P		P	P	P
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN.

[2] Small organ includes breast, testes, thyroid.

[3] Cardiac is Adult and Pediatric.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel A. Szymm
Division Sign-Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with i/t739-RS Transducers

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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P		P		P	P	P
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	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 (specify)[5]	P	P	P		P		P	P	P
Intraoperative Neurological
Intravascular

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

Notes: J3] Cardiac is Adult and Pediatric via intraoperative.

[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sygm

(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological D 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 3S-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
Ophthalmic
Fetal / Obstetrics	P	P	P	P	P	P	P	P	P
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
l anarosconic

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

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

Concurrence of CDRH, Office of Device Eyaluation (ODE)

David A. Segeen

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

Prescription User (Per 21 CFR 801.109)

Radiological Devices
K133124

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 7S-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	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic
Cardiac[3]	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN.

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K033139

Prescription User (Per 21 CFR 801 109)

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 10S-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	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]	P	P	P	P	P	P	P	P	P
Pediatric	P	P	P	P	P	P	P	P	P
Small Organ (specify)[2]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P
Adult Cephalic	P	P	P	P	P	P	P	P	P
Cardiac[3]	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 (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [1] Abdominal includes GYN/Pelvic.

[3] Cardiac is Adult and Pediatric.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Sezem

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic

510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 6T-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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	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	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segura
(Division Sign-Off)

Division of Reproductive, Abdominal, and Radiological Devic

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with 9T-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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	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	P	P	P	P	P	P	P	P	P
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

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

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

David A. Lyon

Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D 510(k) Number

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

....

Diagnostic Ultrasound Indications for Use Form

GE Marlin 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	PW Doppler	CW Doppler	Color Doppler	Color M Doppler	Power Doppler	Combined Modes	Harmonic Imaging	Coded Pulse	Other
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

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

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

David A. Legum

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE Marlin with P6D 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
Ophthalmic
Fetal / Obstetrics
Abdominal[1]
Pediatric
Small Organ (specify)[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]			P	P
Peripheral Vascular			P	P
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)[5]
Intraoperative Neurological
Intravascular
Laparoscopic

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

Notes: [3] Cardiac is Adult and Pediatric.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel R. Legge

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological I 510(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.