LOGIQ 3
Device Facts
| Record ID | K020263 |
|---|---|
| Device Name | LOGIQ 3 |
| Applicant | General Electric Co. |
| Product Code | IYN · Radiology |
| Decision Date | Feb 6, 2002 |
| 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 (includes renal, GYN/Pelvic); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult Cephalic; Cardiac (Adult & Pediatric); Peripheral Vascular; Musculo-skeletal (conventional & superficial); Intraoperative; Transrectal; and Transvaginal.
Device Story
GE LOGIQ 3 is a mobile, general-purpose diagnostic ultrasound system; console dimensions approx 49cm x 85cm x 135cm. System performs digital acquisition, processing, and display of ultrasound signals via transducers. User interface includes keyboard and color CRT display. Operated by qualified physicians in clinical settings. Provides B-mode, M-mode, PW/CW Doppler, Color Doppler, Color M-Doppler, Power Doppler, and harmonic imaging. Output allows real-time visualization of anatomy and blood flow for diagnostic evaluation. Benefits include non-invasive patient assessment consistent with established clinical ultrasound practices.
Clinical Evidence
No clinical data required. Safety and effectiveness established through bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety testing. Device conforms to applicable medical device safety standards.
Technological Characteristics
Mobile console with digital acquisition, processing, and CRT display. Supports multiple transducer types (3C, 5C, E8C, 10L, 3S, 7S, P6D). Operating modes: B, M, PW/CW Doppler, Color/Power Doppler, Harmonic Imaging. Energy source: electrical. Connectivity: standard ultrasound system interfaces. Sterilization: compatible with standard cleaning/disinfection protocols for ultrasound transducers.
Indications for Use
Indicated for use by qualified physicians for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal/obstetrics, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculo-skeletal, intraoperative, transrectal, and transvaginal applications. Prescription use only.
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
- K030934 — GE LOGIQ 9 MODEL 2375600 · Ge Medical Systems, Inc. · Apr 17, 2003
- K032182 — GE LOGIQ 7, MODEL 2354858 · General Electric Co. · Jul 25, 2003
- K112371 — LOGIQ P3 · GE Healthcare · Sep 27, 2011
- K091374 — GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND · Ge Medical Systems China Co., Ltd. · May 26, 2009
- K964617 — GE LOGIQ 700 DIAGNOSTIC ULTRASOUND SYSTEM · GE Medical Systems · Oct 3, 1997
Submission Summary (Full Text)
{0}------------------------------------------------
# Attachment B:
Summary of Safety and Effectiveness FEB 0 6 2002 Prepared in accordance with 21 CFR Part 807.92(c).
Image /page/0/Picture/4 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. Three arrowheads are spaced evenly around the outside of the circle, suggesting motion or dynamism. The logo is black and white.
GE Medical Systems
General Electric Company P.O. Box 414, Milwaukee, WI 53201
#### Section a):
| 1. Submitter: | GE Medical Systems<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: | January 24, 2002 |
| 2. Device Name: | GE LOGIQ 3 Diagnostic Ultrasound System<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN |
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX
3. Marketed Device: GE LOGIQ 5 Diagnostic Ultrasound System, 510(k) No: K014097.
4. Device Description: The GE LOGIQ 3 is a small, general purpose diagnostic ultrasound system. It 4. Device Desombile console approximately 49 cm wide, 85 cm deep and 135 cm high that provides digital ourisition, processing and display capability. The user interface consists of a computer keyboard, acquisition, processing and color video CRT display. The modification provides a system with numerous high end features on a product intended for diagnostic ultrasound users in a value market segment.
5. Indications for Use: The device is intended for use by a qualified physician for ultrasound evaluation of 5: Indicallone in Goo. The & Hology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal & Adult r പ്രവംബം (Grillac (GTN & Site), Peripheral Vasculo-skeletal (conventional & superticial); Intraoperative, Transrectal; and Transvaginal.
6. Comparison with Predicate Device: The LOGIQ 3 Diagnostic Ultrasound System is of a comparable type and substantially equivalent to the GE LOGIQ 5. It has the same technological characteristics, is ifye and Substaniany oquration to the and eatures, it utilizes similar design, construction, and materials, and has the same intended uses and basic operating modes as the predicate device.
#### Section b):
1. Non-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, clearing and disiniection effectiveness as well as thermal, electrical and mechanical safety, and has been found to conform with applicable medical device safety standards.
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 guldelines, and coludibliou monous of patient on the 46001 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and with ongoing racery carveneer Therefore, it is the opinion of GE Medical Systems that the GE LOGIQ 3 is ententially equivalent with respect to safety and effectiveness to diagnostic ultrasound devices currently cleared for market.
{1}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# FEB 0 6 2002
Mr. Allen Schuh Manager, GE Ultrasound Safety and Regulatory Affairs GE Medical Systems General Electric Company P.O. Box 414 MILWAUKEE WI 53201
Re: K020263
Trade Name: GE LOGIQ 3 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Product Code: 90 IYN Regulatory Class: II Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Product Code: 90 IYO Dated: January 24, 2002 Received: January 25, 2002
Dear Mr. Schuh:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo may rother and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mersate commored prive to that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include the general connent provision, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
This determination of substantial equivalence applies to the following transducers intended for use with the GE LOGIQ 3 Diagnostic Ultrasound System, as described in your premarket notification:
Transducer Model Number
3C રુ
{2}------------------------------------------------
Image /page/2/Picture/1 description: The image shows a series of alphanumeric codes stacked vertically and separated by horizontal lines. The codes are E8C, 10L, 3S, 7S, and P6D. The codes appear to be labels or identifiers, possibly from a list or inventory.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it your device is enasified (600 acon controls. Existing major regulations affecting your device it may be subject to back assiments, Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. may publish fiarther announce of a substantial equivalence determination does not mean 1 that FDA has made a determination that your device complies with other requirements of the Act that I Dr has intact a sond regulations administered by other Federal agencies. You must or any 1 occur banates and registements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by south (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed noutheation. The I Dr I milling ssification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801, please If you desire specific at (301) 594-4591. Additionally, for questions on the connotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket 4057. Also, promotion and 108.97). Other general information on your responsibilities under the nothroution (2) Son the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".
If you have any questions regarding the content of this letter, please contact Rodrigo C. Perez at (301) 594-1212.
Sincerely yours,
Jarid A. Argnon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
{3}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical 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 | | | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | | |
| Other[4] | P | P | P | P | P | P | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | | | |
| Transvaginal | P | P | P | | P | | P | P | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | | P | P | | | |
| Intraoperative Neurological | P | P | P | | P | | P | P | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Ligenon
Division Sian Off Division productive. A and Ra 510(k) Num
Prescription User (Per 21 CFR 801.109)
{4}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 with 3C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical 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 | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | | P | | P | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David G. Liegerson
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
U Prescription User (Per 21 CFR 801.109)
{5}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 with 5C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|-------|
| Clinical 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 | | | |
| Abdominal [1] | P | P | P | | P | | P | P | N | | |
| Pediatric | P | P | P | | P | | P | P | N | | |
| Small Organ (specify) | N | N | N | | N | | N | N | N | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other [4] | P | P | P | | P | | P | P | N | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Lanaroscopic | | | | | | | | | | | |
N = new indication/mode for this probe; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[4] Other includes urology
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elvin C. Sygnor
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription User (Per 21 CFR 801.109)
E-4
{6}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 with E8C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|-----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|
| Clinical 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 | | |
| Abdominal[1] | P | P | P | | P | | P | P | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | P | P | P | | P | | P | P | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | | |
| Transvaginal | P | P | P | | P | | P | P | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN/Pelvic;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
David A. Segerson
(Division Sign-Off)
Division of Reproductive, Abdomin and Radiological Devices 510(k) Number _
E-5
{7}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 3 with 10L Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: '
| Clinical 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 | P | P | P | | P | | P | P | N | |
| Pediatric | P | P | P | | P | | P | P | N | |
| Small Organ [2] | P | P | P | | P | | P | P | N | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | N | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | N | |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative | P | P | P | | P | | P | P | | |
| Intraoperative Neurological | P | P | P | | P | | P | P | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication/mode for this probe; P = previously cleared by FDA; E = added under Appendix E Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel G. Lyman
(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 51(i(k) Number E-6
Prescription User (Per 21 CFR 801.109)
{8}------------------------------------------------
## Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 with 3S Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | Coded<br>Pulse |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | |
| Ophthalmic | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | |
| Abdominal[1] | P | P | P | | P | | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[3] Cardiac is Adult and Pediatric;
[4] Other use includes Urology;
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Symon
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number
Prescription User (Per 21 CFR 801.109)
E-7
{9}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE LOGIQ 3 with 7S Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|
| Clinical 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 | P | P | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN;
[3] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel A. Beyers
Division Sign Off
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices Prescription User (Per 21 CFR 801.109) 510(k) Number _
{10}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
# GE LOGIQ 3 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical 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 | | | | | | | | | | |
| Abdominal | | | | | | | | | | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac[3] | | | | P | | | | | | |
| Peripheral Vascular | | | | P | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Other (specify) | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | | | | | | | | | | |
| Transvaginal | | | | | | | | | | |
| Transuretheral | | | | | | | | | | |
| Intraoperative (specify) | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | |
| Intravascular | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E Notes: [3] Cardiac is Adult and Pediatric.
> (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription User (Per 21 CFR 801.109)
Daniel A. Hegeman
(Division Sign-Off) Division of Reproductive, Abdon and Radiological Devic 510(k) Number
E-d
