GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM

K073408 · Ge Medical Systems Ultrasound and Primary Care Dia · IYN · Dec 19, 2007 · Radiology

Device Facts

• Record ID: K073408
• Device Name: GE LOGIQ BT08 DIAGNOSTIC ULTRASOUND SYSTEM
• Applicant: Ge Medical Systems Ultrasound and Primary Care Dia
• Product Code: IYN · Radiology
• Decision Date: Dec 19, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal / Obstetrics; 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 Story

Mobile diagnostic ultrasound system (58cm x 141cm console) with digital acquisition, processing, and display; features 10-inch touch screen and 19-inch color LCD. Operates via pulsed echo and Doppler imaging; supports B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D acquisition with specialized probes. Used in clinical settings by physicians for real-time imaging and fluid flow analysis. Output provides visual diagnostic data for clinical decision-making, including biopsy guidance and infertility monitoring. Modification adds probe options and improves user interface and image enhancement.

Clinical Evidence

Bench testing only. Evaluated for acoustic output, biocompatibility, cleaning/disinfection, and thermal/electrical/mechanical safety. Conforms to 21 CFR 820, ISO 9001, and ISO 13485. No clinical data required.

Technological Characteristics

Mobile console with digital acquisition/processing. Supports B, M, PW/CW Doppler, Color/Power Doppler, and 3D/4D imaging. Connectivity includes specialized 4D probes. Conforms to medical device safety standards for acoustic output and electrical/mechanical safety.

Indications for Use

Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transvaginal, transesophageal, and intraoperative applications. Used by qualified physicians.

Regulatory Classification

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.

Predicate Devices

• GE LOGIQ 7 Diagnostic Ultrasound System (K010329, K032182, K041813)

Submission Summary (Full Text)

{0}------------------------------------------------

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 | | <b>GE Healthcare</b> | |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|--|
| | | General Electric Company<br>P.O. Box 414, Milwaukee, WI 53201 | |
| Section a): | | | |
| 1. Submitter: | GE Healthcare, Ultrasound and Primary Care Diagnostics, LLC<br>PO Box 414, Milwaukee, WI 53201 | | |
| Contact Person: | Nicole Landreville, Eng. RAC<br>Leader, Diagnostic Ultrasound Regulatory Affairs<br>Telephone: [phone]; Fax: [phone] | | |
| Date Prepared: | November 29, 2007 | | |
| 2. Device Name: | GE LOGIQ BT08 Diagnostic Ultrasound System<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic 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

5. 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).

6. 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.

1. 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.
3. 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.

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

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 [phone]. 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 [phone] or [phone] 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 [phone].

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)

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

## 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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[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 | | |…