GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND
Device Facts
| Record ID | K091374 |
|---|---|
| Device Name | GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND |
| Applicant | Ge Medical Systems China Co., Ltd. |
| Product Code | IYO · Radiology |
| Decision Date | May 26, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Attributes | Pediatric, 3rd-Party Reviewed |
Indications for Use
The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
Device Story
GE Compact Ultrasound (LOGIQ i/e, Vivid e) is a portable diagnostic ultrasound system; features integrated keyboard, LCD display, and interchangeable electronic-array transducers. System performs digital acquisition, processing, and display of ultrasound signals. Used in clinical settings by physicians for imaging and fluid flow analysis. Provides B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, and harmonic imaging. Output displayed on integrated GUI; assists clinicians in diagnostic evaluation of various anatomical regions. Benefits include portable, real-time diagnostic visualization of internal structures and blood flow.
Clinical Evidence
No clinical data. Bench testing only, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, electromagnetic compatibility, and thermal/electrical/mechanical safety testing.
Technological Characteristics
Portable ultrasound system with integrated keyboard and LCD. Uses interchangeable electronic-array transducers. Supports B, M, PW/CW Doppler, Color/Power Doppler, and harmonic imaging modes. Conforms to 21 CFR 892.1560, 892.1550, and 892.1570. Quality system conforms to 21 CFR 820, ISO 9001:2000, and ISO 13485.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body in patients requiring Fetal/OB, Abdominal, Pediatric, Small Organ, Neonatal/Adult Cephalic, Cardiac, Peripheral Vascular, Intra-operative, Musculo-skeletal, Transrectal, Transvaginal, or Thoracic/Pleural exams. Contraindications: None stated.
Regulatory Classification
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Predicate Devices
Submission Summary (Full Text)
{0}------------------------------------------------
K091374
MAY 26 2009
GE Healthcare
# Attachment B
Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).
| GE Medical Systems (China) Co., Ltd<br>No. 19 Changjiang Road, National Hi-Tech Development Zone<br>Wuxi, Jiangsu Province, CHINA 214028 | | |
|------------------------------------------------------------------------------------------------------------------------------------------|------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Section a): | |
| 1. | Submitter: | GE Medical Systems (China) Co., Ltd.<br>No. 19 Changjiang Road, National Hi-Tech Development Zone, Wuxi, Jiangsu Province,<br>CHINA 214028 |
| | Contact Person: | Yalan Wu,<br>Manager, Safety and Regulatory<br>Telephone: 86-510-85278652; Fax: 86-510-85227347 |
| | Date Prepared: | April 20, 2009 |
| 2. | Device Name: | GE LOGIQ i/e, Vivid e Ultrasound<br>Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO<br>Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN<br>Diagnostic Ultrasonic Transducer, 21 CFR 892.1570, 90-ITX |
| 3. | Marketed Device: | GE LOGIQ-i/e & Vivid-e Compact Ultrasound, 510(k) No: K072797<br>(90-IYO/IYN/ITX) A device currently in commercial distribution. |
| | | GE Venue 40 Compact Ultrasound, 510(k) No: K091164<br>(90-IYO/IYN/ITX) A device currently cleared and starting to commercial distribution. |
4. Device Description: The GE Compact Ultrasound is a very compact and portable diagnostic ultrasound system having three variations: LOGIQ e and Vivid e, each with options and features suited for its market niche. It has an integrated keyboard, LCD display and several interchangeable electronic-array transducers with an approximate size of 34 cm wide, 29 cm deep and 6 cm high in transport configuration and provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, an intuitive layout of specialized controls, color GUI display and Doppler audio.
5. Indications for Use: The subject modified device is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculo-skeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
6. Comparison with Predicate Device: The modified device is of a comparable type and substantially equivalent to the current GE LOGIQ e and Venue 40 with overall performance in a small and compact package. It has the same overall characteristics, key safety and effectiveness features, physical overall construction, and materials. And all technological characteristics and safety and effectiveness features are equivalent.
#### Section b):
Nor-clinical Tests: The device has been evaluated for acoustic output, biocompatibility, cleaning and 1 disinfection effectiveness, electromagnetic compatibility, 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.
Intended uses and other key features are consistent with traditional clinical practice, FDA 3. Conclusion: guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with Diagnostic ultrasound has accumulated a long history of safe and effective ongoing factory surveillance. performance. Therefore, it is the opinion of GE Healthcare that the GE LOGIQ ife Vivid e Ultrasound imaging device is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of what appears to be an eagle or bird-like figure with three stylized lines representing its body and wings.
MAY 26 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25" Street NW BUFFALO MN 55313
Re: K091374
Trade/Device Name: GE LOGIQ i/e & Vivid e Compact Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 8, 2009 Received: May 11, 2009
Dear Mr. Job:
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 i/e & Vivid e Compact Ultrasound System, as described in your premarket notification:
| | Transducer Model Number | |
|--------|-------------------------|-----------|
| 4C-RS | 9L-RS | i/t739-RS |
| 8C-RS | 12L-RS | 3S-RS |
| E8C-RS | 16L-RS | 6S-RS |
| 8L-RS | i12L-RS | P2D |
{2}------------------------------------------------
Enclosure(s)
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 letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed, predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
If you have any questions regarding the content of this letter, please contact Lauren Hefner at (240) 276-3666.
Sincerely yours,
Vorge M. Wkay
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
{3}------------------------------------------------
# Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: GE LOGIQ i/e & Vivid e Compact Ultrasound
Indications For Use:
The LOGIQ i/e & Vivid e is a general purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Intra-operative (abdominal, thoracic and PV), Musculoskeletal Conventional & Superficial, Transrectal and Transvaginal, and Thoracic/Pleural for motion/sliding and fluid detection.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
hogu Khha
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices K691374 510(k) Number _
Page 1 of 1
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### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound System
### LOGIQ İ, LOGIQ e, Vivid e
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 | P | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| 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 | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | |
| Thoracic/Pleural (specify) [4] | N | N | N | N | N | N | N | N | N | N | |
| Other [5] | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | | |
| Transvaginal | P | P | P | | P | | P | P | P | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative | P | P | P | | P | | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[1] Outlet use includes are BM, B/PWD, B/Color/PWD, B/PowerfF100(K) Number
Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
(Division Sign-Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Division of Reproductive, Abdominal and
(Division Sign-Off)
Radiological Device
E-2
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## GE Compact Ultrasound with 4C-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | |
| Abdominal [1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ (specify) | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) [4] | N | N | N | | N | | N | N | N | N | |
| Other [5] | 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 and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
1*1 Combined modes are B/M. B/PWD. B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
e of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Division of Reproductive, Abdominal and Radiological Device 510(k) Number
{6}------------------------------------------------
i
----
ﯩﺴﺮﯨ
### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with 8C-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ (specify) | P | P | P | | P | | P | P | P | | |
| Neonatal Cephalic | P | P | P | | P | | P | P | P | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | | P | | P | P | P | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) (4) | N | N | N | | N | | N | N | N | | |
| Other (5) | | | | | | | | | | | |
| 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 and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is for digitally encoded harmonics .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
fo
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
{7}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with E8C-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | P | |
| Abdominal[1] | P | P | P | | P | | P | P | P | |
| Pediatric | | | | | | | | | | |
| Small Organ (specify) | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | |
| Thoracic/Pleural (specify)[4] | | | | | | | | | | |
| Other[5] | P | P | P | | P | | P | P | P | |
| Exam Type, Means of Access | | | | | | | | | | |
| Transesophageal | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | |
| Transvaginal | P | 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 and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ØDE)
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
Prescription User (Per 21 CFR 801.109)
.i -
E-S
{8}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
## GE Compact Ultrasound with 8L-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ (specify)[2] | P | P | P | | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | 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 | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify) (4) | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
----:
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
Coded Pulse is for digitally encoded harmonics.
(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 | |
| Prescription User (Per 21 CFR 801.109) | Radiological Devices |
| 510(k) Number | K091374 |
{9}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with 9L-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ (specify)[2] | P | P | P | | P | | P | P | P | P | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify)[4] | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | P | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics .
(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 a Radiological Devices 510(k) Number
E-7
{10}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with 12L-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|
| | 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 | P |
| Small Organ[2] | P | P | P | | P | | P | P | P | P |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N |
| Thoracic/Pleural (specify)[4] | N | N | N | | N | | N | N | N | N |
| Other (specify) (5) | | | | | | | | | | |
| 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: [1] Abdominal includes GYN and Urological
": -
ું --- [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics.
(Please do not write below this line - continue on another Page if needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
forn h. Wry
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with 16L-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | E | E | E | | E | | E | E | E | E |
| Small Organ(2) | E | E | E | | E | | E | E | E | E |
| Neonatal Cephalic | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | |
| Cardiac | | | | | | | | | | |
| Peripheral Vascular | E | E | E | | E | | E | E | E | E |
| Musculo-skeletal Conventional | E | E | E | | E | | E | E | E | E |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N |
| Thoracic/Pleural (specify)(4) | | | | | | | | | | |
| Other (specify) (5) | | | | | | | | | | |
| 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: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
[5] Other use includes Urology/Prostate
(*) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
f Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devic 510(k) Number
{12}------------------------------------------------
### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with i12L-RS Transducer
### LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ (specify)[2] | P | P | P | | P | | P | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | 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 | | | |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | | | |
| Thoracic/Pleural (specify)[4] | | | | | | | | | | | | |
| Other[5] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes GYN and Urological
[2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] For detection of fluid and pleural motion/sliding;
{51 Other use includes Urology/Prostate
(*) Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD.
*] Coded Pulse is for digitally encoded harmonics .
(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 Device 510(k) Number
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form
### GE Compact Ultrasound with i/t739-RS Transducers
LOGIQ i, LOGIQ e, Vivid e
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 | | | | | | | | | | | |
| Abdominal [1] | P | P | P | | P | | P | P | P | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ (specify)[2] | P | P | P | | P | | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | P | P | P | | P | | P | P | P | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural (specify)[4] | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative (specify)[5] | P | P | P | | P | | P | P | P | | |
| Intraoperative Neurological | | |…
