LOGIQ S7 EXPERT, LOGIQ S7 PRO
Device Facts
| Record ID | K141261 |
|---|---|
| Device Name | LOGIQ S7 EXPERT, LOGIQ S7 PRO |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Jun 5, 2014 |
| Decision | SESE |
| Submission Type | Traditional |
| 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).
Device Story
The LOGIQ S7 Expert and LOGIQ S7 Pro are mobile, general-purpose diagnostic ultrasound systems. They acquire, process, and display ultrasound data using various imaging modes (B, M, PW/CW Doppler, Color/Power Doppler, Harmonic, 3D/4D). The system features a 19-inch LCD display, a 7-inch touch screen, and specialized controls. It is operated by qualified physicians in clinical settings. The system includes software-based tools for measurements, image capture, and reporting. It supports multiple transducers for diverse anatomical applications. The device provides real-time diagnostic imaging and fluid flow analysis, aiding clinicians in evaluating various pathologies and physiological conditions. It benefits patients by providing non-invasive diagnostic information.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device's safety and effectiveness were established through non-clinical bench testing, including acoustic output measurements, biocompatibility, and compliance with electrical and electromagnetic safety standards (e.g., IEC 60601-1, IEC 60601-2-37).
Technological Characteristics
Mobile console (62x86x175 cm) with 19-inch LCD display and 7-inch touch screen. Employs ultrasonic pulsed echo and Doppler imaging. Supports various transducers. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, and NEMA UD 3. Biocompatible patient-contact materials per ISO 10993-1. Connectivity via DICOM.
Indications for Use
Indicated for diagnostic ultrasound imaging or fluid flow analysis of the human body, including fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transrectal, transvaginal, transesophageal, and intraoperative 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
- LOGIQ S7 Expert and LOGIQ S7 Pro (K122114)
- LOGIQ S8 Diagnostic Ultrasound System (K131527)
- LOGIQ P6 Diagnostic Ultrasound System (K101874)
Related Devices
- K122114 — LOGIQ S7 EXPERT, LOGIQ S7 PRO · GE Healthcare · Oct 3, 2012
- K160182 — LOGIQ S7 Expert · GE Healthcare · Feb 26, 2016
- K032182 — GE LOGIQ 7, MODEL 2354858 · General Electric Co. · Jul 25, 2003
- K133034 — LOGIQ F SERIES · GE Healthcare · Jan 31, 2014
- K170445 — LOGIQ S8 · GE Healthcare · Apr 11, 2017
Submission Summary (Full Text)
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K 141261
Page 1 of 4
#### JUN 0 5 2014
GE Healthcare 510(k) Premarket Notification Submission
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
May 14, 2014 Date:
Submitter: GE Healthcare 9900 Innovation Dr Wauwatosa, WI 53226
Primary Contact Person:
Bryan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 ·
Secondary Contact Person:
Chan Sook Kim Regulatory Affairs Leader GE Healthcare GE Ultrasound Korea, Ltd. T: +82 31 740 6307
LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System Device: Trade Name: LOGIQ S7 Expert and LOGIQ S7 Pro Common/Usual Name: Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX K122114 LOGIQ S7 Expert and LOGIQ S7 Pro Predicate Device(s): Diagnostic Ultrasound Systems K131527 LOGIQ S8 Diagnostic Ultrasound System K 101874 LOGIQ P6 Diagnostic Ultrasound System Device Description: The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 86 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard,
specialized controls, 7-inch LCD touch screen and color 19-inch
LCD image display.
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/ /
The purpose of this 510k is an incremental improvement to the LOGIO S7 Expert and LOGIQ S7 Pro to add additional software features, probes and the Transesophageal indication
The device is intended for use by a qualified physician for Intended Use: 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).
The LOGIO S7 Expert and LOGIO S7 Pro employs the same Technology: fundamental scientific technology as its predicate devices
#### Comparison to Predicate Devices
The LOGIO S7 Expert and Pro systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.
- . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The LOGIO S7 and predicate LOGIO S7 systems have . the same clinical intended use with the exception of Transesophageal which is substantially equivalent to Transesophageal on the LOGIQ S8 (K131527).
- The LOGIO S7 and predicate LOGIO S7 systems have . the same imaging modes.
- The LOGIQ S7 and predicate LOGIQ S7 systems . transducers are identical except for the 6S-D, RIC5-9-D, 10C-D. 6Tc-RS which are the same transducers on predicate LOGIO S8 (K131527), the BE9CS which is the same transducer on predicate LOGIO P6 (K101874) and L3-12-D and S1-4-D, which are new and equivalent to existing transducers.
- The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The LOGIQ S7 and predicate LOGIO S7 systems have similar capability in terms of performing measurements,
Determination of Substantial Equivalence:
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# GE Healthcare
510(k) Premarket Notification Submission
capturing digital images, reviewing and reporting studies.
- New software features added to LOGIQ S7: AutoEF, . Autosweep, Breast Measure Assistant, OB Measure Assistant, Compare Assistant and Preset Manager are the same features cleared on predicate LOGIQ S8 (K131527).
- The LOGIO S7 and predicate systems have been designed . in compliance with approved electrical and physical safety standards.
#### Summary of Non-Clinical Tests:
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 to applicable medical device safety standards. LOGIQ S7 Expert and LOGIQ S7 Pro and its applications comply with voluntary standards:
- l. AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
- 2. IEC60601-1-2.Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- 3. IEC60601-2-37, Medical Electrical Equipment Part 2-37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- 4. 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
- 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- 7. ISO14971, Application of risk management to medical devices: Second edition
- 8. NEMA Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
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K141261
Page 4 of 4
The following quality assurance measures are applied to the development of the system:
- Risk Analysis .
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- . Integration testing (System verification)
- . Final Acceptance Testing (Validation)
- Performance testing (Verification)
- . Safety testing (Verification)
Transducer materials and other patient contact materials are biocompatible.
#### Summary of Clinical Tests:
.
The subject of this premarket submission, LOGIO S7 Expert and LOGIQ S7 Pro, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the LOGIQ S7 Expert and LOGIQ S7 Pro to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
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#### DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings, body, and legs. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G600
Silver Spring, MD 20993-0002
Public Health Service
June 5, 2014
GE Healthcare % Mr. Bryan Behn Regulatory Affairs Manager 9900 Innovation Drive WAUWATOSA WI 53226
Re: K141261
Trade/Device Name: LOGIQ S7 Expert, LOGIQ S7 Pro Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 14, 2014 Reccived: May 15, 2014
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the Logig S7 Expert and Logig S7 Pro, as described in your premarket notification:
| | Transducer Model Number | |
|----------------------------------------------------------------------|--------------------------------------------------------|-------------------------------------------------------------|
| C1-5-D<br>9L-D<br>ML6-15<br>IC5-9-D<br>3CRF-D<br>L8-18i-D<br>S4-10-D | P2D<br>P6D<br>RAB4-8-D<br>11L-D<br>8C<br>3Sp-D<br>6S-D | RIC5-9-D<br>10C-D<br>6Tc-RS-D<br>BE9CS<br>L3-12-D<br>S1-4-D |
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Page 2-Mr. Behn
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Smh.7).
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known)
K141261
Device Name LOGIQ S7 Expert and LOGIQ S7 Pro
#### Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatio; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatic); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
### Please do not write below this line – continue on a separate page if needed.
#### FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.7)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
The burden time for this collection of Information is estimated to average 79 hours per response, including the time to review Instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
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### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ S7 Expert and LOGIQ S7 Pro system. Combinations identified "P" for the transducers represents those previously cleared with this or another GE Ultrasound system and those identified and "N" are new. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.
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#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System
| | 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 | 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 | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5.6 | |
| Cardiac Adult & 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 | |
| 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] | P | P | P | P | P | P | P | P | P | P | 3.5.6 | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | | |
| Transrectal[1] | P | P | P | P | P | P | P | P | P | P | 3,5,6 | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | 3,5.6 | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[1] | P | P | P | P | P | P | P | P | P | P | 3,5.6 | |
| 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
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, lestes 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)
[0] Intraded 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 In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The logo is in black and white.
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with C1-5-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br><i>Anatomy/Region of Interest</i> | 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 | 3,5,6 |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[1] | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes Renal, GYN/Pelvic Noles:
[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
(1) intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[0] Intravperative Includes 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 In Vitro Diagnostics and Radiological Health (OIR)
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Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circle. The logo is black and white.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes' | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics7) | P | P | P | | P | P | P | P | P | P | 5,6 |
| Abdominal1) | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Small Organ1) | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Other14) | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal1) | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative3) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[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)
[0] Introoperative 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 In Vitro Diagnostics and Radiological Health (O!R)
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are black, contrasting with the white background.
### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with ML6-15 Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|---|---------|---------|---------|---------|---------|----------|----------|-------|---------|
| Clinical Application | ਰਿ | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | Other |
| Anatomy Region of Interest | | | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | (Noics) |
| Ophthalmic | | | | | | | | | | | |
| lictal / Obstetrics"! | | | | | | | | | | | |
| Abdominal™ | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3.5.6 |
| Small Organ121 | P | p | P | | p | P | P | P | P | P | 3,5,6 |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephatic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | P | P | P | | P | P | b | P | P | P | 3.5.6 |
| Musculo-sketetal Superficial | P | P | ું જ | | P | P | ﺎ ﺍﻟ | P | P | P | 3.5.6 |
| Other المحاركة المحاركة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحافظة المحاف | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectallet | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative 11 | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
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) Intracperative includes abdominal, thoracic (cardiac), and vascular (PV)
["] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE . CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics1 | P | P | P | | P | P | P | P | P | P | 5,6 |
| Abdominal1 | P | P | P | | P | P | P | P | P | P | |
| Pediatric | | | | | | | | | | | |
| Small Organ2 | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other4 | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal1 | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Transvaginal | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative4 | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[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)
{"} 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 In Vitro Diagnostics and Radiological Health (OIR)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, contrasting with the white background.
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with 3CRF-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|------------|------------|---------------|-----------------|---------------|----------------|------------------|-------------|---------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes | Harmonic Imaging | Coded Pulse | Other [Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[1] | P | P | P | | P | P | P | P | P | P | 5.6 |
| Abdominal[1] | P | P | P | | P | P | P | P | P | P | 5.6 |
| Pediatric | P | P | P | | P | P | P | P | P | P | 5.6 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | | P | P | P | P | P | P | 5.6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[5] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[6] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes Renal. GYN/Pelvic Notes:
[2] Small organ includes breast, testes and thyrold
[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)
["] 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 UNE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro 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<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[1] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 5,6 |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | / | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3.5.6 |
| Other[4] | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[4] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[4] | P | P | P | | P | P | P | P | P | P | 3,5,6 |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes Renal, GYN/Pelvic. Noles:
[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)
[1] 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 In Vitro Diagnostics and Radiological Health (GIR)
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The logo is black and white.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with S4-10-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(1) | P | P | P | P | P | P | P | P | P | P | 5 | |
| Abdominal(1) | P | P | P | P | P | P | P | P | P | P | 5 | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 5 | |
| Small Organ(2) | P | P | P | P | P | P | P | P | P | P | 5 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | 5 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & 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(1) | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative(6) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, lestes 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)
[1] 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 In Vitro Diagnostics and Radiological Health (OIR)
{16}------------------------------------------------
Image /page/16/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 shape. The letters and the circle are solid black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the multinational conglomerate company.
#### Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with P2D 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[1] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | P | P | | | | | | | | |
| Cardiac Adult & Pediatric | | | P | P | | | | | | | | |
| Peripheral Vascular | | | P | P | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other(4) | | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal(4) | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative(5) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |
N = new Indication; P = previously cleared by FDA
[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)
[0] 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 In Vitro Diagnostics and Rudiological Health (OIR)
{17}------------------------------------------------
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circle. The letters and the circle are black, while the background is white. There are also some white swirls around the letters.
## Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with P6D 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[1] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | P | P | | | | | | | | |
| Cardiac Adult & Pediatric | | | P | P | | |…
