Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a standard diagnostic ultrasound system with digital processing capabilities, but there is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
Explanation: The Intended Use / Indications for Use section clearly states "Diagnostic ultrasound imaging or motion analysis", indicating its use for diagnosis, not therapy.

Diagnostic

Yes

The "Intended Use / Indications for Use" section explicitly states "Diagnostic ultrasound imaging or motion analysis of the human body," and the "Device Description" calls it a "general purpose diagnostic ultrasound system."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "small, general purpose diagnostic ultrasound system" consisting of a "mobile console" with "digital acquisition, processing and display capability," a "computer keyboard," "specialized controls," and a "color video LCD display." This indicates a physical hardware system, not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens taken from the human body. The intended use and device description clearly state that this is a diagnostic ultrasound system used for imaging or motion analysis of the human body itself, not on samples taken from the body.
The device description focuses on imaging and processing capabilities of the ultrasound system. It does not mention any components or processes related to analyzing biological samples.

Therefore, the GE LOGIQ A3, as described, falls under the category of a diagnostic imaging device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.

Diagnostic ultrasound imaging or motion analysis of the human body as follows:

General: Fetal / Obstetrics; Abdominal (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (Adult and Pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Other (includes Urology/Prostate). Exam Type, Means of Access: Transrectal; Transvaginal; Intraoperative; Intraoperative Neurological.

Specific Transducers:
GE LOGIQ A3 with 4C Transducer: Fetal / Obstetrics; Abdominal (includes GYN); Pediatric; Other (includes Urology). Exam Type, Means of Access: Not specified for this transducer.

GE LOGIQ A3 with E8C Transducer: Fetal / Obstetrics; Abdominal (includes GYN/Pelvic); Neonatal Cephalic; Other (includes Urology/Prostate). Exam Type, Means of Access: Transrectal; Transvaginal.

GE LOGIQ A3 with 8L Transducer: Abdominal; Pediatric; Small Organ (includes breast, testes, thyroid); Peripheral Vascular; Musculo-skeletal Conventional; Musculo-skeletal Superficial; Intraoperative; Intraoperative Neurological. Exam Type, Means of Access: Not specified for this transducer.

GE LOGIQ A3 with 3S Transducer: Fetal / Obstetrics; Abdominal (includes GYN); Pediatric; Adult Cephalic; Cardiac (Adult and Pediatric); Other (includes Urology). Exam Type, Means of Access: Not specified for this transducer.

Product codes (comma separated list FDA assigned to the subject device)

IYO, IYN, ITX

Device Description

The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.

Indicated Patient Age Range

Neonatal, Pediatric, Adult

Intended User / Care Setting

Qualified physician

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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. Clinical Tests: None required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020263

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

K012015

Attachment B:

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

AUG 2 9 2007

GE Healthcare

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

Section a):

| 1. | Submitter: GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC
PO Box 414
Milwaukee, WI 53201 |
|----|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: Allen Schuh,
Manager, Ultrasound Regulatory Affairs
Telephone: 414-721-3992; Fax: 414-721-3899 |
| | Date Prepared: July 26, 2007 |
| 2. | Device Name: GE LOGIQ A3 Diagnostic Ultrasound System
Ultrasonic 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 3 Diagnostic Ultrasound System, 510(k) No: K020263.
Device Description: The GE LOGIQ A3 is a small, general purpose diagnostic ultrasound system. It consists of a mobile console approximately 42 cm wide, 59 cm deep and 125 cm high that provides digital acquisition, processing and display capability. The user interface consists of a computer keyboard, specialized controls and color video LCD display. The modification provides for a more compact, lighter weight and easily maneuverable system with updated and efficient electronic hardware.
Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculo-skeletal (conventional & superficial); Intraoperative including neurological, Transrectal; and Transvaginal.
Comparison with Predicate Device: The LOGIQ A3 Diagnostic Ultrasound System is of a comparable type and substantially equivalent to the GE LOGIQ 3 and LOGIQ 200MD. It has the same technological characteristics, is comparable in key safety and effectiveness features, it utilizes similar design, construction, and materials, and has the same intended uses. Basic acquisition and operating modes are identical to that of the LOGIQ 200MD.

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.

1. 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, ISO 9001 and 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation by a Nationally Recognized Testing Lab. (NRTL) with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ A3 is substantially equivalent with respect to safety and effectiveness to diagnostic ultrasound devices currently cleared for market.

1

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming a wing-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Allen Schuh Manager Regulatory Affairs General Electric Company GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226

AUG 2 9 2007

Re: K072075

Trade/Device Name: GE LOGIQ A3 Ultrasound System Regulation Number: 21 CFR §892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYO, IYN, ITX Dated: July 26, 2007 Received: July 30, 2007

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 Covisions 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 LOGIQ A3 Ultrasound System, as described in your premarket notification:

Transducer Model Number

GE LOGIQ A3 with 8L GE LOGIQ A3 with E8C GE LOGIO A3 with 4C GE LOGIQ A3 with 3S

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.

2

Page 2 - Mr. Allen Schuh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 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 Ms. Lauren Hefner at (240) 276-3666.

Sincerely vours,

logui Thhang GNCB

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

Enclosures

3

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 Ultrasound System

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

	Mode of Operation
Clinical Application
Anatomy/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	P	P		P	P
Abdominal[1]	P	P		P	P
Pediatric	P	P		P	P
Small Organ(2)	P	P		P	P
Neonatal Cephalic	P	P		P	P
Adult Cephalic	P	P		P	P
Cardiac[3]	P	P		P	N
Peripheral Vascular	P	P		P	N
Musculo-skeletal Conventional	P	P		P	P
Musculo-skeletal Superficial	P	P		P	P
Other[4]	P	P		P	P
Exam Type, Means of Access
Transesophageal
Transrectal	P	P		P	P
Transvaginal	P	P		P	P
Transuretheral
Intraoperative	P	P		P	N
Intraoperative Neurological	P	P		P	N
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.

(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)

J.Whang

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

4

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 4C Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	P	P						P	P
Abdominal(1)	P	P						P	P
Pediatric	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
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Transperineal

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.

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

JWhang

510(k) Number.

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

Prescription User (Per 21 CFR 801.109)

5

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with E8C Transducer

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

| Clinical Application
Anatomy/ 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 | | |
| Abdominal[1] | P | P | | | | | | P | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | N | N | | | | | | N | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | P | P | | | | | | P | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | P | P | | | | | | P | | |
| Transvaginal | P | P | | | | | | P | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |

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.

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

JWhang

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

Prescription User (Per 21 CFR 801.109)

6

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 8L Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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	N	N		N	N
Pediatric	N	N		N	N
Small Organ [2]	N	N		N	N
Neonatal Cephalic
Adult Cephalic
Cardiac
Peripheral Vascular	N	N		N	N
Musculo-skeletal Conventional	N	N		N	N
Musculo-skeletal Superficial	N	N		N	N
Other (specify)
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative	N	N		N	N
Intraoperative Neurological	N	N		N	N
Intravascular

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.

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

Jzhan

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

Prescription User (Per 21 CFR 801.109)

7

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ A3 with 3S Transducer

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

	Mode of Operation
Clinical Application
Anatomy/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
Abdominal[1]	P	P						P	P
Pediatric	P	P						P	P
Small Organ (specify)
Neonatal Cephalic
Adult Cephalic	P	P						P	P
Cardiac[3]	P	P						P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P						P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative (specify)
Intraoperative Neurological
Intravascular
Intraluminal

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.

(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)

TWhan

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