GE LOGIQ 5 PRO OR EXPERT
Device Facts
| Record ID | K032974 |
|---|---|
| Device Name | GE LOGIQ 5 PRO OR EXPERT |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Oct 21, 2003 |
| 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; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric): Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurological).
Device Story
The GE LOGIQ 5 Pro/Expert is a mobile, general-purpose diagnostic ultrasound system. It acquires, processes, and displays ultrasound images using a console with a CRT display and touch screen. The system utilizes various transducers to perform B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, and harmonic imaging. The modification introduces coded pulse modes to the Expert version. Operated by qualified physicians in clinical settings, the device provides real-time imaging and flow analysis to assist in diagnostic evaluations across multiple anatomical regions. The output is visualized by the clinician to inform clinical decision-making and patient management.
Clinical Evidence
No clinical data required. The device's safety and effectiveness were established through non-clinical bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing in accordance with applicable standards.
Technological Characteristics
Mobile console ultrasound system; digital image acquisition, processing, and display; CRT display and LCD touch screen; supports B, M, PW/CW Doppler, Color/Power Doppler, and harmonic imaging modes; includes coded pulse technology. Conforms to 21 CFR 820, ISO 9001, and EN 46001 quality systems.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, and urological applications, including transesophageal, transvaginal, and intraoperative procedures.
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 5 diagnostic ultrasound system (K014097)
Related Devices
- K060993 — GE LOGIQ P5 AND A5 · General Electric Co. · May 3, 2006
- K030934 — GE LOGIQ 9 MODEL 2375600 · Ge Medical Systems, Inc. · Apr 17, 2003
- K970901 — GE LOGIQ 500 DIAGNOSTIC ULTRASOUND SYSTEM · GE Medical Systems · Dec 22, 1997
- K020263 — LOGIQ 3 · General Electric Co. · Feb 6, 2002
- K032182 — GE LOGIQ 7, MODEL 2354858 · General Electric Co. · Jul 25, 2003
Submission Summary (Full Text)
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K032974
# Attachment B:
OCT 2 1 2003
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has a swirling pattern, giving the logo a classic and recognizable appearance.
GE Ultrasound
GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue Milwaukee, WI 53219
#### Section a):
| 1. Submitter: | GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC<br>PO Box 414<br>Milwaukee, WI 53201 |
|---------------------|----------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Allen Schuh,<br>Manager, Safety and Regulatory Engineering<br>Telephone: 414-647-4385; Fax: 414-647-4090 |
| Date Prepared: | September 23, 2003 |
| 2. Device Name: | GE LOGIQ 5 Pro/Expert Diagnostic Ultrasound System<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO |
| 3. Marketed Device: | GE LOGIQ 5 diagnostic ultrasound system, 510(k) Numbers K014097 currently in |
commercial distribution.
4. Device Description: The GE LOGIQ 5 is a full featured general purpose diagnostic ultrasound system available in Expert (full featured) or Pro (reduced feature) versions consists of a mobile console approximately 52 cm wide. 99 cm deep and 135 cm high that provides digital image acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, color video CRT display and LCD touch screen. The modification adds coded pulse modes from high-end LOGIQ systems to the Expert version and removes provides limited options for the Pro version.
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); Transesophageal; Transvaginal; and Intraoperative (abdominal, thoracic, vascular and neurological).
6. Comparison with Predicate Device: The GE LOGIQ 5 Pro & Expert versions are comparable with and substantially equivalent to the current GE LOGIQ 5. They have technological characteristics, are comparable in kev safety and effectiveness features, utilize the same overall design, construction, and materials, and have the same intended uses and basic operating modes as the predicate device.
#### Section b):
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 with 21 CFR 820, ISO 9001 and EN 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 5 Pro/Expert 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 U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 1 2003
Mr. Allen Schuh Manager, GE Ultrasound Safety GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 4855 West Electric Avenue MILWAUKEE WI 53219
Re: K032974
Trade Name: GE LOGIQ 5 Pro/Expert Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic ultrasonic transducer Regulatory Class: II Product Code: 90 IYN, IYO, and ITX Dated: September 23, 2003 Received: September 24, 2003
#### Dear Mr. Schuh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the GE LOGIQ 5 Pro/Expert Ultrasound System, as described in your premarket notification:
#### Transducer Model Number
3C 3.5C
{2}------------------------------------------------
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3.5Cs
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8C
E8C
BE9C
7L
10L
12L
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35
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108
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P2D
P6D
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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This determination of substantial equivalence is granted on the condition that prior to shipping the first device, you submit a postclearance special report. This report should contain complete information, including acoustic output measurements based on production line devices, requested in Appendix G. (enclosed) of the Center's September 30, 1997 "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers." If the special report is incomplete or contains unacceptable values (e.g., acoustic output greater than approved levels), then the 510(k) clearance may not apply to the production units which as a result may be considered adulterated or misbranded.
The special report should reference the manufacturer's 510(k) number. It should be clearly and prominently marked "ADD-TO-FILE" and should be submitted in duplicate to:
> Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850
{3}------------------------------------------------
Page 3 - Mr. Schuh.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please contact the Office of Compliance at (301) 594-4591. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
David Lezama
for
Nancy C. Brogdon Director. Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{4}------------------------------------------------
#### Diaqnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert 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 |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | | |
| Pediatric | P | P | P | P | P | P | P | P | P | | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | |
| Other[4] | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | | P | | P | P | | | |
| Transvaginal | P | P | P | | P | | P | P | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | | P | | P | P | | | |
| Intraoperative Neurological | P | P | P | | P | | P | P | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] 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.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segmen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
{5}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with 3C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|-------|-------------------|-------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | Combined Harmonic | Coded | Other |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | p | P | P | | P | | P | P | P | | |
| Abdominal(1) | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other 4] | P | P | P | | P | | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | ﺎ | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
510(k) Number
David R. Lyman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological D
{6}------------------------------------------------
# Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with 3.5C 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 |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | E | E | E | | E | E | E | E | E | N | |
| Abdominal[1] | E | E | E | | E | E | E | E | E | N | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | E | E | E | | E | E | E | E | E | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | E | N | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | E | E | E | | E | E | E | E | E | N | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Segerson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological I 510(k) Number
{7}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with 3.5Cs 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 |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | E | E | E | | E | E | E | E | E | N | |
| Abdominal[1] | E | E | E | | E | E | E | E | E | N | |
| Pediatric | | | | | | | | | | | |
| Small Organ (specify) | E | E | E | | E | E | E | E | E | N | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | E | N | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | E | E | E | | E | E | E | E | E | N | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David R. Benson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Deyices
510(k) Number
{8}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 5 Pro/Expert with 5C 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 |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | | | |
| Abdominal1 | P | P | P | | P | | P | P | | | |
| Pediatric | P | P | P | | P | | P | P | | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[1] | P | P | P | | P | | P | P | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[4] Other includes urology
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Dev 510(k) Number
{9}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 5 Pro/Expert with 8C 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | |
| Abdominal[1] | E | E | E | E | E | E | E | E | E | N |
| Pediatric | E | E | E | E | E | E | E | E | E | N |
| Small Organ (specify) | E | E | E | E | E | E | E | E | E | N |
| Neonatal Cephalic | E | E | E | E | E | E | E | E | E | N |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDEO)
Concurrence of CDRH, Office of Deyice Evaluation (ODE
David A. Symm
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological De 510(k) Number
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 5 Pro/Expert with E8C 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | N | N |
| Abdominal[1] | P | P | P | | P | | P | P | N | N |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | P | P | P | | P | | P | P | N | N |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | N | N |
| Transvaginal | P | P | P | | P | | P | P | N | N |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Davidh Segunm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number K032474
{11}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with BE9C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 |
|-----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | E | E | E | | E | | E | E | N | N |
| Abdominal[1] | E | E | E | | E | | E | E | N | N |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | E | E | E | | E | | E | E | N | N |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | E | E | E | | E | | E | E | N | N |
| Transvaginal | E | E | E | | E | | E | E | N | N |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symm
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devic
510(k) Number K032974
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 5 Pro/Expert with 7L 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | E | E | E | | E | E | E | E | E | N |
| Abdominal | E | E | E | | E | E | E | E | E | N |
| Pediatric | | | | | | | | | | |
| Small Organ [2] | E | E | E | | E | E | E | E | E | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | E | N |
| Musculo-skeletal Conventional | E | E | E | | E | E | E | E | E | N |
| Musculo-skeletal Superficial | E | E | E | | E | E | E | E | E | N |
| Other[4] | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Deyice Evaluation (ODE)
David R. Bergman
(Division Sign-Off)
Division of Reproductiv e, Abdominal, and Radiological Dev
510(k) Number
{13}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with 10L 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | | N |
| Abdominal | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | | N |
| Small Organ[2] | P | P | P | | P | | P | P | | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | | N |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | | N |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | | N |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative[5] | P | P | P | | P | | P | P | | N |
| Intraoperative Neurological | P | P | P | | P | | P | P | | N |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic, and vascular.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Dence Evaluation (ODE)
510(k) Number
David A. Bergman
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
{14}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE LOGIQ 5 Pro/Expert with 12L 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 |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | N |
| Small Organ [2] | P | P | P | | P | | P | P | P | N |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | N |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | N |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | N |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative [5] (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniela Legson
(Division Sign-Off) 8 Division of Reproductive, Abdominal. and Radiological Devices
510(k) Number
{15}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 5 Pro/Expert with i12L 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 Harmonic Modes | Imaging | Coded Pulse | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | E | E | E | | E | E | E | E | | | |
| Pediatric | E | E | E | | E | E | E | E | | | |
| Small Organ (specify) | E | E | E | | E | E | E | E | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | E | E | E | | E | E | E | E | | | |
| Peripheral Vascular | E | E | E | | E | E | E | E | | | |
| Musculo-skeletal Conventional | E | E | E | | E | E | E | E | | | |
| Musculo-skeletal Superficial | E | E | E | | E | E | E | E | | | |
| Other (specify) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | |…
