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); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Description

The LOGIQ BT08 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image enhancement.

AI/ML Overview

The provided document is a 510(k) premarket notification for a diagnostic ultrasound system (GE LOGIQ BT08). It aims to demonstrate substantial equivalence to a predicate device. For devices like this, the acceptance criteria and study proving they meet such criteria are typically not presented as performance metrics of an AI model in the way you might expect for an AI/ML-driven diagnostic tool.

Instead, the "acceptance criteria" and "study" in this context refer to:

Acceptance Criteria: Conformance to recognized safety and performance standards for diagnostic ultrasound systems and transducers, as well as maintaining substantial equivalence to a predicate device in terms of intended use and technological characteristics.
Study: Non-clinical tests to verify compliance with these standards (e.g., acoustic output, biocompatibility, electrical/mechanical safety) and a comparison to a legally marketed predicate device. Clinical tests are often not required for these types of 510(k) submissions if substantial equivalence can be demonstrated through other means.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance / Evaluation Outcome
Intended Use	The device should be intended for diagnostic ultrasound evaluation in specific clinical applications (e.g., Fetal, Abdominal, Cardiac, Small Organ, etc.) and modes of operation (B-mode, M-mode, Doppler modes, Harmonic Imaging, Coded Pulse, 3D/4D imaging).	Main Device (GE LOGIQ BT08 System): 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); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical). Supported various operational modes (B, M, PW, CW, Color, Color M, Power Doppler, Combined, Harmonic, Coded Pulse, 3D/4D). Individual Transducers (e.g., 3CRF, 9L-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, SP10-16-D): Each transducer provides specific sets of indications/clinical applications and modes of operation, generally aligning with the overall system's intended uses but tailored to the probe's capabilities. All are marked as "P" (previously cleared by FDA) for their respective indications.
Technological Characteristics	The device should have comparable technological characteristics to the predicate device. Expected to be a full-featured, general-purpose diagnostic ultrasound system with digital acquisition, processing, display capabilities, user interface (keyboard, specialized controls, LCD touch screen, LCD image display).	The LOGIQ BT08 is described as a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console... that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display." The modification provides "additional probe options, improved user interface and overall quality and image enhancement." It is stated to have the "same technological characteristics" as the predicate.
Safety and Effectiveness	The device should meet applicable medical device safety standards for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, and mechanical safety. Should be safe and effective for its intended uses.	"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." The design and development process conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality management systems. Compliance verified through independent evaluation.
Substantial Equivalence	The device should be substantially equivalent to a legally marketed predicate device (GE LOGIQ 7 Diagnostic Ultrasound System – K010329, K032182, K041813, K052441).	The GE LOGIQ BT08 is stated to be "of a comparable type and substantially equivalent to the current GE LOGIQ 7. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable in the context of this 510(k). This submission relies heavily on non-clinical testing and comparison to a predicate device, rather than a clinical performance study with a "test set" of patient data.
Data Provenance: Not applicable. The "data" here refers to engineering and manufacturing specifications, test results against standards, and the specifications of the predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no "test set" requiring ground truth established by experts in the typical sense of a clinical performance study for an AI algorithm. The device itself is the diagnostic tool. Clinical equivalence is established by comparing the device's technological and functional characteristics to a predicate, and by demonstrating compliance with recognized performance and safety standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no "test set" or clinical study requiring adjudication.

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

No. This device is a diagnostic ultrasound system, not an AI-driven interpretive aid for human readers. Therefore, an MRMC comparative effectiveness study regarding "human readers improve with AI vs without AI assistance" was not performed and is not relevant to this 510(k) submission.

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

Not applicable. This device is a hardware diagnostic imaging system; it is not an algorithm being submitted for standalone performance evaluation in the context of AI. The performance is the overall system's ability to acquire and display ultrasound images.

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

Not applicable. In this 510(k), "ground truth" for proving safety and effectiveness primarily relates to:
- Engineering specifications and measurements: Verifying acoustic output, electrical safety, mechanical integrity against established industry standards.
- Regulatory standards: Demonstrating compliance with norms like 21 CFR 820, ISO 9001, ISO 13485.
- Predicate device characteristics: The "truth" of what is considered safe and effective for diagnostic ultrasound is established by legally marketed predicate devices, and the new device's equivalence to these characteristics forms the basis of clearance.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the context of machine learning model development.

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

Not applicable. As there is no training set for an AI model, there is no ground truth established for it.

Summary

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K073408

DEC 1 9 2007

Attachment B:

Summary of Safety and Effectiveness

Prepared in accordance with 21 CFR Part 807.92(c).

Image: GE Logo		GE Healthcare
		General Electric CompanyP.O. Box 414, Milwaukee, WI 53201
Section a):
1. Submitter:	GE Healthcare, Ultrasound and Primary Care Diagnostics, LLCPO Box 414, Milwaukee, WI 53201
Contact Person:	Nicole Landreville, Eng. RACLeader, Diagnostic Ultrasound Regulatory AffairsTelephone: 414-721-2272; Fax: 414-918-4498
Date Prepared:	November 29, 2007
2. Device Name:	GE LOGIQ BT08 Diagnostic Ultrasound SystemUltrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYOUltrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN
3. Marketed Device:	GE LOGIQ 7 Diagnostic Ultrasound System – K010329, K032182, K041813

K052441. A device currently in commercial distribution. 4. Device Description: The LOGIQ BT08 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display. This modification will provide users with additional probe options, improved user interface and overall quality and image

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); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Comparison with Predicate Devices: The GE LOGIQ BT08 is of a comparable type and substantially equivalent to the current GE LOGIQ 7 . It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate device.

Section b):

enhancement.

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 to 21 CFR 820, ISO 9001 and ISO 13485 quality management 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 effective performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ BT08 Diagnostic Ultrasound 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 seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Public Health Service

DEC 1 9 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Nicloe Landreville, RAC Leader, Diagnostic Ultrasound Regulatory Affairs GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226

Re: K073408

Trade/Device Name: GE LOGIQ BT08 Ultrasound System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 29, 2007 Received: December 4, 2007

Dear Ms. Landreville:

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 LOGIQ BT08 Ultrasound System, as described in your premarket notification:

Transducer Model Number

3CRF	RAB2-5-D
9L-D	RIC5-9-D
11L-D	RNA5-9-D
IC5-9-D	RSP6-16-D
M4S-D	SP10-16-D
M6C-D
ML6-15-D

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 - Ms. Landreville

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

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 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 Lauren Hefner at (240) 276-3666.

Sincerely yours,

An 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 BT08 Ultrasound System

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics(7)	P	P	P	P	P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P	P	P	P	P	P	P	P	[5, 6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5, 6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5, 6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial	P	P	P	P	P	P	P	P	P	P	[5, 6]
Other[4]	P	P	P	P	P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal	P	P	P	P	P	P	P	P	P	P
Transrectal	P	P	P	P	P	P	P	P	P	P	[5, 6]
Transvaginal	P	P	P	P	P	P	P	P	P	P	[5, 6]
Transuretheral
Intraoperative[8]	P	P	P	P	P	P	P	P	P	P
Intraoperative Neurological	P	P	P	P	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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
--------------------------------------------------------

(División Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices,
510(k) Number 02340

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with 3CRF 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]	P	P	P		P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(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	K073408

Prescription User (Per 21 CFR 801.109)
K073408

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with 9L-D 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]	P	P	P		P	P	P	P	P	P
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]	P	P	P		P	P	P	P	P	P
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
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

[8] Intraoperative Includes abdominal, thoracic (cardiac), and vascular (PV).

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation

(Division Sign-Off)
Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number 5073408

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with 11L-D 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]	P	P	P		P	P	P	P	P	P
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
Adult Cephalic
Cardiac[3]	P	P	P		P	P	P	P	P	P
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[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

(Please Do Not WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device &valuation

hymh

oductive, Abdominal and 510(k

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with IC5-9-D 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[4]
Exam Type, Means of Access
Transesophageal
Transrectal	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 [8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (OD

Homi M. Khan

ductive. Abdominal a

Prescription User (Per 21 CFR 80

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with M4S-D 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	[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	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic	P	P	P	P	P	P	P	P	P	P
Cardiac[3]	P	P	P	P	P	P	P	P	P	P
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Thoracoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Eyaluati

Mugu M. Wt

Division of Reproductive, Abdominal and
Radiological Devices
510(k) Number K073408

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with M6C-D 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	[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	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
Peripheral Vascular
Musculo-skeletal Conventional
Musculo-skeletal Superficial
Other[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
Intravascular
Laparoscopic

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

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

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

[3] Cardiac is Adult and Pediatric.

[4] Other use includes Urology/Prostate.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation

Dorothy Wheas

ductive. Abdomina 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with ML6-15-D 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 [Notes]
Ophthalmic
Fetal / Obstetrics [7]
Abdominal[1]
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
Adult Cephalic
Cardiac [3]	P	P	P		P	P	P	P	P	P	[5, 6]
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 [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (

home in the

Reproductive, Abdomi 510(k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with RAB2-5-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]	P	P	P		P	P	P	P	P	P	[5, 6]
Abdominal[1]	P	P	P		P	P	P	P	P	P	[5, 6]
Pediatric	P	P	P		P	P	P	P	P	P	[5, 6]
Small Organ[2]
Neonatal Cephalic
Adult Cephalic
Cardiac [3]
Peripheral Vascular
Musculo-skeletal Conventional	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Superficial
Other [4]	P	P	P		P	P	P	P	P	P
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (OD

Loryn M. White

Reproductive, Abdomi Radio 510/k) Number

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with RIC5-9-D 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 [4]
Exam Type, Means of Access
Transesophageal
Transrectal	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[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (OD

evice Evaluation (ODE)

(Division Sign-Off)

Division of Reproductive, Abdominal, and

f Reproductive, Abdom 510(k) Nur

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with RNA5-9-D 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	[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	P	[5,6]
Small Organ[2]	P	P	P	P	P	P	P	P	P	P	[5,6]
Neonatal Cephalic	P	P	P	P	P	P	P	P	P	P	[5]
Adult Cephalic
Cardiac [3]	P	P	P	P	P	P	P	P	P	P	[5]
Peripheral Vascular	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Conventional	P	P	P	P	P	P	P	P	P	P	[5,6]
Musculo-skeletal Superficial
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (6

formu h Whg

productive. Abdo

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with RSP6-16-D Transducer

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

	Mode of Operation
Clinical ApplicationAnatomy/Region of Interest	B	M	PWDoppler	CWDoppler	ColorDoppler	Color MDoppler	PowerDoppler	CombinedModes	HarmonicImaging	CodedPulse	Other[Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
Pediatric	P	P	P		P	P	P	P	P	P	[5,6]
Small Organ[2]	P	P	P		P	P	P	P	P	P	[5,6]
Neonatal Cephalic
Adult Cephalic
Cardiac[3]
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[4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative[8]	P	P	P		P	P	P	P	P	P
Intraoperative Neurological	P	P	P		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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation

form the other

Radio 510(k) Nu

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

Diagnostic Ultrasound Indications for Use Form

GE LOGIQ BT08 with SP10-16-D 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 [Notes]
Ophthalmic
Fetal / Obstetrics[7]
Abdominal[1]
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
Adult Cephalic
Cardiac [3]
Peripheral Vascular	P	P	P		P	P	P	P	P	P	[5, 6]
Musculo-skeletal Conventional
Musculo-skeletal Superficial	P	P	P		P	P	P	P	P	P	[5, 6]
Other [4]
Exam Type, Means of Access
Transesophageal
Transrectal
Transvaginal
Transuretheral
Intraoperative [8]
Intraoperative Neurological
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.

[5] 3D/4D Imaging Mode.

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

[7] Includes infertility monitoring of follicle development.

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

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

System provides real-time 3D and 4D acquisition when used with special 4D probes.

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

Concurrence of CDRH, Office of Device Evaluation (C

forger M. Whay
Division Sign-Off

Division of Reproductive, Abdominal and 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.