LOGIQ S7 EXPERT, LOGIQ S7 PRO

K122114 · GE Healthcare · IYN · Oct 3, 2012 · Radiology

Device Facts

• Record ID: K122114
• Device Name: LOGIQ S7 EXPERT, LOGIQ S7 PRO
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Oct 3, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1550
• Device Class: Class 2
• Attributes: Pediatric

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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Story

LOGIQ S7 Expert and LOGIQ S7 Pro are mobile, general-purpose diagnostic ultrasound systems. They acquire, process, and display ultrasound data using various transducers. The system features a console with a keyboard, specialized controls, a 7-inch LCD touch screen, and a 19-inch LCD display. Operated by qualified physicians in clinical settings, the device provides real-time imaging and fluid flow analysis. Outputs include B-mode, M-mode, PW/CW Doppler, Color Doppler, Power Doppler, and 3D/4D imaging. These outputs assist clinicians in diagnostic evaluations, such as infertility monitoring, needle guidance, and elastography. The system aids clinical decision-making by providing visual diagnostic information, potentially improving patient outcomes through accurate assessment of anatomy and pathology.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including acoustic output measurements, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing in accordance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, and ISO 10993-1 standards.

Technological Characteristics

Mobile ultrasound console (62x86x175 cm) with 19-inch LCD display and 7-inch touch interface. Supports multiple transducers (e.g., C1-5-D, L8-18i-D, 11L-D, 9L-D, S4-10-D, 8C, ML6-15, P2D, 3Sp-D, IC5-9-D, 3CRF-D, RAB4-8-D). Imaging modes: B, M, PW/CW Doppler, Color/Power Doppler, 3D/4D, Harmonic, Coded Pulse. Connectivity: DICOM. Biocompatible patient-contact materials. Safety compliance: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2/3, ISO 10993-1.

Indications for Use

Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urological (prostate), transrectal, transvaginal, and intraoperative (abdominal, thoracic, vascular, neurosurgical) applications. Prescription use only.

Regulatory Classification

Identification

An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• LOGIQ S8 Diagnostic Ultrasound System (K111582)
• LOGIQ E9 Diagnostic Ultrasound System (K092271)
• LOGIQ P6 Diagnostic Ultrasound System (K101874)
• LOGIQ e Diagnostic Ultrasound System (K113690)
• Voluson E6/E8/E8 Expert Diagnostic Ultrasound System (K112213)

Submission Summary (Full Text)

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Superficial;

Urology

and

Conventional

Image /page/0/Picture/1 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 are stylized and have a flowing, cursive appearance. The logo is black and white.

ОСТ Э 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:

Date: July 16, 2012

Submitter: GE Healthcare 9900 Innovation Dr Wauwatosa, WI 53226

| Primary Contact Person: Bryan Behn |
|------------------------------------|
| Regulatory Affairs Manager |
| GE Healthcare |
| T:[phone] |
| F:[phone] |

| Device: Trade Name: | LOGIQ S7 Expert and LOGIQ S7 Pro Ultrasound System |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | LOGIQ S7 Expert and LOGIQ S7 Pro |
| Classification Names:<br>Product Code: | Class II<br>Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN<br>Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO<br>Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Predicate Device(s): | K111582 LOGIQ S8 Diagnostic Ultrasound System<br>K092271 LOGIQ E9 Diagnostic Ultrasound System<br>K101874 LOGIQ P6 Diagnostic Ultrasound System<br>K113690 LOGIQ e Diagnostic Ultrasound System<br>K112213 Voluson E6/E8/E8 Expert Diagnostic Ultrasound<br>System |
| Device Description: | The LOGIQ S7 Expert AND LOGIQ S7 Pro is a full featured,<br>general purpose diagnostic ultrasound system which consists of a<br>mobile console approximately 62 cm wide, 86 cm deep and 175<br>cm high that provides digital acquisition, processing and display<br>capability. The user interface includes a computer keyboard,<br>specialized controls, 7-inch LCD touch screen and color 19-inch<br>LCD image display. |
| Intended Use: | The device is intended for use by a qualified physician for<br>ultrasound evaluation of Fetal; Abdominal; Pediatric; Small<br>Organ (breast, testes, thyroid); Neonatal Cephalic; Adult<br>Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; |

Musculo-skeletal

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Image /page/1/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.

(including prostate); Transrectal; Transvaginal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

The LOGIO S7 Expert and LOGIQ S7 Pro employs the same Technology: fundamental scientific technology as its predicate devices

Summary of Non-Clinical Tests: Determination of

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 to applicable medical device safety standards. LOGIQ S7 Expert and LOGIO S7 Pro and its applications comply with voluntary standards:

- IEC60601-1, Medical Electrical Equipment -1. 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- Third Edition
- 6. NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- 7. ISO14971, Application of risk management to medical devices
- 8. NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)

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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)
- . 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, LOGIQ 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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10903 New Hampshire Avenue Silver Spring, MD 20993

OCT 3 2012

GE Healthcare c/o Brvan Behn 9900 Innovation Dr. Wauwatosa. WI 53226

Re: K122114 Trade Name: LOGIO S7 Expert LOGIO S7 Pro Ultrasound System Regulation Number: 21 CFR 8892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Codes: IYN, IYO, ITX Dated: July 16, 2012 Received: July 17, 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 LOGIO S7 Expert and LOGIQ S7 Pro, as described in your premarket notification:

Transducer Model Number

| C1-5-D | L8-18i-D | 11L-D |
|---------|----------|-------|
| 9L-D | S4-10-D | 8C |
| ML6-15 | P2D | 3Sp-D |
| IC5-9-D | P6D | |
| 3CRF-D | RAB4-8-D | |

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If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 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 (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 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 Joshua Nipper at [phone].

Sincerely Yours.

Mark D. Okerblom

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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510(k) Number (if known):

### K122114

Device Name:

LOGIQ S7 Expert and LOGIQ S7 Pro

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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Prescription Use_X_ (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NA (Part 21 CFR 801 Subpart C)

### (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Mhhmf D. O
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

/2-11.

510(k) Number

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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] | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6 |
| Cardiac Adult & Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Other[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal(8) | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative(8) | N | N | N | N | N | N | N | N | N | N | 3,5,6 |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N | |
| 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, 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Muhi D. Khm
(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Division of Haclological Dovice Evaluation and Safety

610K 122 114

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular border. The letters and the border are white, set against a black background, creating a high-contrast design. The logo is simple, recognizable, and represents the General Electric brand.

### 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:

| | 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[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[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[3] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K111582)

[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

15| 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)
(Division Sign Off)

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Devices

510K 12.2 11.4

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters are stylized and connected, creating a unique and recognizable design. The logo is in 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 / Obstetrics(7) | P | P | P | | P | P | P | P | P | P | 5,6 |
| Abdominal[1] | 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 Organ(2) | 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 |
| Other(4) | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication: P = previously cleared by FDA (K111582)

[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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801,109)

(Division Sign-Off)
Devices

Division of Radiological Devices Division of Radiological Devices
Office of in Vitro Diagnostic Device Evaluation and Safety

S'OK. 112 114

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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 letters and the border are black, contrasting with 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 ML6-15 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[7] | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Small Organ[2] | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Neonatal Cephalic | N | N | N | | N | N | N | N | N | N | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac Adult & Pediatric | | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Musculo-skeletal Conventional | N | N | N | | N | N | N | N | N | N | 3,5,6 | |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | N | N | N | 3,5,6 | |
| Other[4] | | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K101874)

[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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mhhael D. Khm
(Division signa

Division of Radiological Devices Division of Radiological Device Evaluation and Safety

510K 112.114

{10}------------------------------------------------

Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized, cursive font. The letters are white and are set against a black circular background. The black circle has a white outline with small white accents around the perimeter.

# 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 | B | M | PW | CW | Color | Color M | Power | Combined Harmonic | | Coded | Other | | |
| Anatomy/Region of Interest | | | Doppler | Doppler Doppler | | Doppler | Doppler | Modes | Imaging | Pulse | [Notes) | | |
| Ophthalmic | | | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | b | P | P | 5,6 | | |
| Abdominal(!) | | | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | | | |
| 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 | b | 3,5,6 | | |
| Exam Type, Means of Access | | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | | |
| Transrectal[8] | 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 | | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K111582)

[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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

*(Division Sign-Off)*

Division of Radiological Devices Division of Radiological Device Evaluation and Safety

510K 172 119

{11}------------------------------------------------

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 logo is black and white.

## 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(7) | 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(8) | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative(8) | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K111582)

[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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

---

(Division Sign-Off)

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

510K-

ડર્

{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. The logo is simple, recognizable, and represents the General Electric brand.

# 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 | 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] | | | | | | | | | | | | |
| 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[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | | P | P | P | P | P | P | 3,5,6 | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA(K111582)

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)

[*] 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

*(Division Sign-Off)*

Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

810K 172114

ﺮ

{13}------------------------------------------------

Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a stylized circular border. The letters and the border are solid black, contrasting with the white background. The logo has a slightly rough or textured appearance, possibly due to the image's source or reproduction method.

# 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 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 | 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 | P | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | | |
| Exam Type. Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K111582)

(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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Archi D. Ofil
(Division Sign-Off)

Division of Radiological Devices Office of In Diagnostic Device Evaluation and Safety

510K

{14}------------------------------------------------

Image /page/14/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 black, creating a strong contrast. The logo is simple and recognizable.

### 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:

| 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 | | | 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[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA(K111582)

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)

[*] 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Marl D. Kirk

(Division Sign-Off) Division of Radiological Devices Office of In Vitro Division of Radiological Dovice Evaluation and Safety

510K. 12-114

{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 letters are stylized and connected, creating a recognizable and iconic symbol for the company.

# 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<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(7) | | | | | | | | | | | | |
| 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[8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative(8) | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

N = new indication; P = previously cleared by FDA (K111582)

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)

[*] 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 Diagnostic Devices (OIVD)

Prescription User (Per 21 CFR 801.109)

Mull D. O'K
(Division Sign-Off)

Division of Radiological Devices Division of Radiological Device Evaiuation and Safety

510K D2-114

{16}------------------------------------------------

Image /page/16/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, contrasting with the white background.

# Diagnostic Ultrasound Indications for Use Form GE LOGIQ S7 Expert and LOGIQ S7 Pro with RAB4-8-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>Mo…