LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM
Device Facts
| Record ID | K123564 |
|---|---|
| Device Name | LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Dec 18, 2012 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended 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); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Device Story
LOGIQ E9 is a mobile, general-purpose diagnostic ultrasound system; console includes keyboard, specialized controls, 10-inch touch screen, and 19-inch display. System performs digital acquisition, processing, and display of ultrasound data. Used in clinical settings by physicians for imaging and fluid flow analysis across various anatomical regions. Supports multiple modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D imaging, and elastography. Healthcare providers use real-time visual output to guide clinical decision-making and diagnostic assessments. Benefits include non-invasive visualization of internal structures and blood flow.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device underwent extensive non-clinical bench testing, including acoustic output, biocompatibility, thermal, electrical, electromagnetic, and mechanical safety testing, all conforming to recognized standards.
Technological Characteristics
Mobile console (58x86x141 cm) with 19-inch LCD display and 10-inch touch interface. Supports B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, and elastography modes. Complies with IEC 60601-1, IEC 60601-2-37, ISO 10993-1, and NEMA UD 2/UD 3 standards. Connectivity includes DICOM. Sterilization/disinfection follows standard clinical protocols for ultrasound transducers.
Indications for Use
Indicated for qualified physician use for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urology (prostate), transrectal, transvaginal, transesophageal, and intraoperative (abdominal, thoracic, vascular, neurosurgical) applications.
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 E9 Diagnostic Ultrasound System (K110943)
- GE LOGIQ E9 Diagnostic Ultrasound System (K092271)
- GE Voluson E6/E8/E8Expert/E10 Diagnostic Ultrasound System (K122327)
- GE LOGIQ e Diagnostic Ultrasound System (K113690)
Related Devices
- K142160 — LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM · GE Healthcare · Oct 10, 2014
- K110943 — LOGIQ E9 · GE Healthcare · Jul 22, 2011
- K030934 — GE LOGIQ 9 MODEL 2375600 · Ge Medical Systems, Inc. · Apr 17, 2003
- K173555 — LOGIQ E10 · GE Healthcare · Dec 20, 2017
- K152309 — LOGIQ E9, LOGIQ E9 XDClear 2.0 · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 14, 2015
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The border has decorative elements resembling stylized lightning bolts or arcs. The logo is black and white.
# EC 1 8 2012
### GE Healthcare
510(k) Premarket Notification Submission
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
November 19, 2012 Date:
GE Healthcare, GE Medical Systems Ultrasound and Primary Submitter: Care Diagnostics, LLC. 9900 Innovation Dr.
Wauwatosa, WI 53226
Bryan Behn Contact Person:
> Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC. Phone: 414-721-4214
GE LOGIO E9 Diagnostic Ultrasound System
Fax: 414-918-8275
Trade Name: Device: Common/Usual Name: Classification Names: Product Code:
Predicate Device(s):
LOGIO E9
Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
K110943, K092271 GE LOGIQ E9 Diagnostic Ultrasound System
K 122327 GE Voluson E6/E8/E8ExpertE 10 Diagnostic :Ultrasound System
K113690 GE LOGIQ e Diagnostic Ultrasound System
#### Device Description:
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.
#### Intended 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); Transrectal; Transvaginal; Transesophageal
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### GE Healthcare
510(k) Premarket Notification Submission
and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
The LOGIQ E9 employs the same fundamental scientific technology as its predicate device(s).
Summary of Non-Clinical Tests: Determination of
Technology:
Substantial Equivalence:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards:
- 1 . IEC60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
- IEC60601-1-2,Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37, Medical Electrical Equipment -Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- 5. ISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition
- 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- ISO14971, Application of risk management to medical 7. devices
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
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## GE Healthcare
. . : . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
510(k) Premarket Notification Submission
The following quality assurance measures were applied to the development of the system:
- . : Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification)
- Integration testing (System verification)
- Performance testing (Verification)
- · Safety testing (Verification)
- Final Acceptance testing (Validation)
### Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ E9 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing its body and wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 18, 2012
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive WAUWATOSA WI 53226
Re: K123564
Trade/Device Name: GE LOGIQ E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasound pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: November 19, 2012 Received: November 20, 2012
Dear Mr. Behn:
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 E9 Ultrasound System, as described in your premarket notification:
| | Transducer Model Number | |
|----------|-------------------------|-----------|
| 3CRF | M5S-D | RSP6-16-D |
| 6S-D | M6C-D | S1-5 |
| 6Tc | ML6-15-D | S4-10 |
| 9L-D | P2D | S4-10-D |
| 11L-D | P6D | C2-9-D |
| C1-5-D | RAB2-5D | RAB6-D |
| IC5-9-D | RAB4-8-D | S1-5-D |
| L8-18i-D | RIC5-9-D | C1-6-D |
| M4S-D | RNA5-9-D | |
If your device is classified (see above) into either class II (Special Controls) or class III (PMA),
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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 895. 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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter, please contact Shahram Vaezy at (301) 796-6242.
Sincerely Yours,
Janine M. Morris -S
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure(s)
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# Indications for Use
#### 510(k) Number (if known): K123564
Device Name: LOGIQ E9 Diagnostic Ultrasound System
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); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use N/A (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In Vitho Diagnostics and Radiological Health (OIR)
allet
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
510(k)_K123564
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 Ultrasound System
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|--|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse† | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
(9) Volume navigation
(*) Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes
item provided real time QS and to acquisition finish time QS that specifies to process.
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
eal Health (SWR)
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B
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fice of in Vitro
510(k) K123564
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 3CRF Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|--|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
(9) Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Hea
Office of In Vitro Diagnostics and Ra
510(k) K123564
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 6S-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|-----------------|------------------|--------------|---------------|
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse^ | Other [Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | 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) | | | | | | | | | | | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
131 Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
(*) Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Prescription User (Per 21 CFR 801.109)
ical Health (Off)
(Division Sign Off)
Division of Radiological Health
19
Office of In Vitro Diagnostics and Radiological Health
510(k) K123564
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 6Tc Transducer
| Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative(8) | | | | | | | | | | | |
| · Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
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 and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
iston of Radiological Hea D
Office of In Vitro Diaguostics a
510(k) K12564
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 9L-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|--|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes" | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Pediatric | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
{7} Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Prescription User (Per 21 CFR 801 109)
iological Health (OIR)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Heatth
510(k) K123564
{11}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with 11L-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|--|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse* | Other<br>[Notes] | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | | | | | | | | | | | | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [3,5,6] | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
(9) Volume navigation
[*] Combined modes are BIM, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radfological Health
Office of In vitro Diagnostics and Radiological Health
510(k) K123564
{12}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C1-5-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | 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* | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological Health
510(k) K123564
{13}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with IC5-9-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|--------|------------------|--|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes' | Imaging | Pulse' | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5,6,9] | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [3,5,6,9] | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
Office of In Vitro Diagnostics and Radiological
510(k) K123564
{14}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with L8-18i-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|-------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|--|
| Clinical Application | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal/Obstetrics[7] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5,6,9] | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Other[4] | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | [3,5,6,9] | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast; testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
(Division Sign Off)
Division of Radiological Health
Office of In vitro Diagnostics and Radiological Health
510(k) K123564
{15}------------------------------------------------
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with M4S-D Transducer
| | Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:<br>Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse' | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5,6] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | |…
