Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular (conventional & superficial); Intraoperative; Transrectal; and Transvaginal. Other use includes Urology/Prostate.

Device Description

The GE LOGIQ 3 is a small, general purpose diagnostic ultrasound system. It is a mobile console approximately 49 cm wide, 85 cm deep and 135 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, trackball and color video CRT display. The modification provides a system with numerous high end features on a product intended for diagnostic ultrasound users in a value market segment.

AI/ML Overview

The GE LOGIQ 3 Diagnostic Ultrasound System is a general-purpose ultrasound system for a variety of clinical applications. Its acceptance for market clearance is primarily based on substantial equivalence to a predicate device (GE LOGIQ 5) and adherence to safety standards, rather than specific performance metrics from a dedicated clinical study.

Here's an analysis based on the provided documents:

Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the GE LOGIQ 3 Diagnostic Ultrasound System is substantial equivalence to a previously cleared predicate device, the GE LOGIQ 5. This means the device must demonstrate comparable technological characteristics, intended uses, and safety/effectiveness profiles.

The provided documents do not specify quantitative performance metrics (e.g., sensitivity, specificity, accuracy) that would typically be found in a study proving the device meets numerical acceptance criteria. Instead, the "performance" accepted is its ability to function as a diagnostic ultrasound system for its stated indications, with safety and technological characteristics comparable to its predicate.

Acceptance Criteria (Inferred)	Reported Device Performance	Study Type to Demonstrate Performance
Substantial Equivalence to Predicate Device (GE LOGIQ 5) in:	The device has the same technological characteristics, is similar in its operating modes and features, utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.	Comparison with Predicate Device (Section b), Clinical Tests: None required.)
Safety and Effectiveness for Stated Indications: Uses are consistent with traditional clinical practice, FDA guidelines, and established patient examination methods.	The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation and ongoing factory surveillance. Diagnostic ultrasound has a long history of safe and effective use.	Non-clinical Tests (Section b), Historical Safety of Ultrasound (Section b))
Conformance to Applicable Medical Device Safety Standards: Includes acoustic output, biocompatibility, cleaning/disinfection effectiveness, thermal, electrical, and mechanical safety.	The device has been evaluated and found to conform with applicable medical device safety standards.	Non-clinical Tests (Section b))

Study Information

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. No dedicated clinical test set with patient data was used to establish performance metrics.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As no clinical test set was used to establish performance, no ground truth experts were involved for that purpose. The indications for use were compared against established clinical practice and FDA guidelines, which are implicitly derived from expert consensus over time.

4. Adjudication method for the test set:

Not applicable. No test set requiring expert adjudication was conducted.

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 device is a diagnostic ultrasound system itself, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. This is a hardware diagnostic device, not a standalone algorithm.

7. The type of ground truth used:

For the purpose of clearance, the "ground truth" relied upon is the established safety and effectiveness of Diagnostic Ultrasound technology generally, and the specific performance characteristics of the predicate device (GE LOGIQ 5). This is a historical and regulatory "ground truth" based on prior clearances and medical consensus rather than new, primary clinical data for this specific device.

8. The sample size for the training set:

Not applicable. As a diagnostic ultrasound system cleared via substantial equivalence, there is no mention of a "training set" in the context of an algorithm. The development of the device likely involved engineering design and testing, but not machine learning training on patient data.

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

Not applicable. No training set as typically understood in the context of algorithm development was used.

Summary

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Attachment B:

Summary of Safety and Effectiveness FEB 0 6 2002 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 'GE' in a stylized script, enclosed within a circular frame. Three arrowheads are spaced evenly around the outside of the circle, suggesting motion or dynamism. The logo is black and white.

GE Medical Systems

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

Section a):

1. Submitter:	GE Medical SystemsPO Box 414Milwaukee, WI 53201
Contact Person:	Allen Schuh,Manager, Safety and Regulatory EngineeringTelephone: 414-647-4385; Fax: 414-647-4090
Date Prepared:	January 24, 2002
2. Device Name:	GE LOGIQ 3 Diagnostic Ultrasound SystemUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN

Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX

Marketed Device: GE LOGIQ 5 Diagnostic Ultrasound System, 510(k) No: K014097.
Device Description: The GE LOGIQ 3 is a small, general purpose diagnostic ultrasound system. It 4. Device Desombile console approximately 49 cm wide, 85 cm deep and 135 cm high that provides digital ourisition, processing and display capability. The user interface consists of a computer keyboard, acquisition, processing and color video CRT display. The modification provides a system with numerous high end features on a product intended for diagnostic ultrasound users in a value market segment.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5: Indicallone in Goo. The & Hology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult r പ്രവംബം (Grillac (GTN & Site), Peripheral Vasculo-skeletal (conventional & superticial); Intraoperative, Transrectal; and Transvaginal.
Comparison with Predicate Device: The LOGIQ 3 Diagnostic Ultrasound System is of a comparable type and substantially equivalent to the GE LOGIQ 5. It has the same technological characteristics, is ifye and Substaniany oquration to the and eatures, it utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.

Section b):

Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, clearing and disiniection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
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 guldelines, and coludibliou monous of patient on the 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and with ongoing racery carveneer Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 3 is ententially equivalent with respect to safety and effectiveness to diagnostic ultrasound devices currently cleared for market.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 6 2002

Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Affairs GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201

Re: K020263

Trade Name: GE LOGIQ 3 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulatory Class: II Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Dated: January 24, 2002 Received: January 25, 2002

Dear Mr. Schuh:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo may rother 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 mersate commored prive to 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 the general connent provision, 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 LOGIQ 3 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

3C રુ

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Image /page/2/Picture/1 description: The image shows a series of alphanumeric codes stacked vertically and separated by horizontal lines. The codes are E8C, 10L, 3S, 7S, and P6D. The codes appear to be labels or identifiers, possibly from a list or inventory.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is enasified (600 acon controls. Existing major regulations affecting your device it may be subject to back assiments, Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. may publish fiarther announce of a substantial equivalence determination does not mean 1 that FDA has made a determination that your device complies with other requirements of the Act that I Dr has intact a sond regulations administered by other Federal agencies. You must or any 1 occur banates and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by south (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Dr I milling ssification 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 If you desire specific at (301) 594-4591. Additionally, for questions on the connotion 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 4057. Also, promotion and 108.97). Other general information on your responsibilities under the nothroution (2) Son 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,

Jarid A. Argnon

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 LOGIQ 3 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[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
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
Transrectal	P	P	P		P		P	P
Transvaginal	P	P	P		P		P	P
Transuretheral
Intraoperative	P	P	P		P		P	P
Intraoperative Neurological	P	P	P		P		P	P
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate

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

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

David A. Ligenon

Division Sian Off Division productive. A and Ra 510(k) Num

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

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

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

Notes: [1] Abdominal includes GYN;

[4] Other use includes Urology;

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

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

David G. Liegerson
(Division Sign-Off)

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

U Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

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

N = new indication/mode for this probe; P = previously cleared by FDA; E = added under Appendix E

Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;

[4] Other includes urology

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elvin C. Sygnor

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

Prescription User (Per 21 CFR 801.109)

E-4

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Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 3 with E8C 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
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P
Abdominal[1]	P	P	P		P		P	P
Pediatric
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P		P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P	P		P		P	P
Transvaginal	P	P	P		P		P	P
Transuretheral
Intraoperative (specify)
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/Prostate;

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

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

Prescription User (Per 21 CFR 801.109)

David A. Segerson
(Division Sign-Off)

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

E-5

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 3 with 10L 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	PowerDoppler	CombinedModes	HarmonicImaging
Ophthalmic
Fetal / Obstetrics
Abdominal	P	P	P	P	P	P	N
Pediatric	P	P	P	P	P	P	N
Small Organ [2]	P	P	P	P	P	P	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	P	P	P	P	P	P
Musculo-skeletal Conventional	P	P	P	P	P	P	N
Musculo-skeletal Superficial	P	P	P	P	P	P	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	P	P
Intravascular
Laparoscopic

N = new indication/mode for this probe; P = previously cleared by FDA; E = added under Appendix E Notes: [2] Small organ includes breast, testes, thyroid.

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

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

Daniel G. Lyman

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 51(i(k) Number E-6

Prescription User (Per 21 CFR 801.109)

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 3 with 3S 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
Ophthalmic
Fetal / Obstetrics	P	P	P		P		P	P	P
Abdominal[1]	P	P	P		P		P	P	P
Pediatric	P	P	P		P		P	P	P
Small Organ (specify)
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)
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/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)

David A. Symon

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

Prescription User (Per 21 CFR 801.109)

E-7

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 3 with 7S 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
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)
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 (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
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.

[*] 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)

Daniel A. Beyers
Division Sign Off

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Prescription User (Per 21 CFR 801.109) 510(k) Number _

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ 3 with P6D Transducer

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

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

N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [3] Cardiac is Adult and Pediatric.

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

Prescription User (Per 21 CFR 801.109)

Daniel A. Hegeman

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

E-d

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.