LOGIQ S8

K111582 · GE Healthcare · IYN · Jul 26, 2011 · Radiology

Device Facts

• Record ID: K111582
• Device Name: LOGIQ S8
• Applicant: GE Healthcare
• Product Code: IYN · Radiology
• Decision Date: Jul 26, 2011
• 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 and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Device Story

Logiq S8 is a mobile, general-purpose diagnostic ultrasound system (approx. 62x88x175 cm). It features a computer keyboard, specialized controls, 9-inch LCD touch screen, and 19-inch color LCD display. The system acquires, processes, and displays digital ultrasound data. It is operated by qualified physicians in clinical settings. The device uses various transducers (e.g., C1-5-D, 9L-D, ML6-15-D, M5S-D, IC5-9-D, 3CRF-D, L8-18i-D, P2D, P6D) to perform B-mode, M-mode, PW/CW Doppler, Color/Power Doppler, and combined modes. It supports advanced features like elastography, 3D imaging, needle guidance, and volume navigation. Output is displayed for clinical evaluation, aiding in diagnosis and patient management across multiple anatomical regions.

Clinical Evidence

No clinical studies were required to support substantial equivalence. The device was evaluated through bench testing, including module verification, system integration testing, and final validation, confirming compliance with applicable safety and performance standards.

Technological Characteristics

Mobile ultrasound console with 19-inch LCD display and 9-inch touch interface. Supports B, M, PW/CW Doppler, Color/Power Doppler, and combined modes. Features include elastography, 3D imaging, needle guidance, and volume navigation. Biocompatible patient-contact materials. Complies with medical device safety standards for acoustic output, electrical, and electromagnetic safety.

Indications for Use

Indicated for diagnostic ultrasound imaging or fluid flow analysis in fetal, abdominal, pediatric, small organ, neonatal/adult cephalic, cardiac, peripheral vascular, musculoskeletal, urological, transrectal, transvaginal, 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 E9 Diagnostic Ultrasound System (K092271)
• Logiq 7 Diagnostic Ultrasound System (K052441)

Submission Summary (Full Text)

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.

JUL 2 6 2011

K111582

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: | June 3, 2011 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Healthcare<br>9900 Innovation Dr<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:[phone]<br>F:[phone] |
| Alternate Contact Person: | Seiji Oikawa<br>Regulatory Affairs Specialist<br>GE Healthcare Japan Corporation<br>T: [phone]<br>F: [phone] |
| Device: | Logiq S8 Ultrasound System |
| Trade Name: | |
| Common/Usual Name: | Logiq S8 |
| Classification Names: | Class II |
| Product Code: | 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): | K092271 Logiq E9 Diagnostic Ultrasound System<br>K052441 Logiq 7 Diagnostic Ultrasound System |
| Device Description: | The LOGIQ S8 is a full featured, general purpose diagnostic<br>ultrasound system which consists of a mobile console<br>approximately 62 cm wide, 88 cm deep and 175 cm high that<br>provides digital acquisition, processing and display capability.<br>The user interface includes a computer keyboard, specialized<br>controls, 9-inch LCD touch screen and color 19-inch LCD image<br>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;<br>Musculo-skeletal Conventional and Superficial; Urology<br>(including prostate); Transrectal; Transvaginal and Intraoperative<br>(abdominal, thoracic, vascular and neurosurgical). |

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Image /page/1/Picture/0 description: The image shows a black and white logo. The logo is circular and contains the letters 'GE' intertwined in the center. The letters are stylized and have a vintage appearance.

#### Technology:

The Logig S8 employs the same fundamental scientific technology as its predicate devices

Determination of Substantial Equivalence:

#### 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 S8 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket 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)
- . 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 S8, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the Logiq S8 to be as safe, as effective. and performance is substantially equivalent to the predicate device(s).

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W. Innovation Dr., RP-2138 WAUWATOSA WI 53226

JUL 26 2011

Re: K111582

Trade/Device Name: Logiq S8 Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: May 20, 2011 Received: June 6, 2011

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 Logiq S8 Ultrasound System, as described in your premarket notification:

| | Transducer Model Number | |
|----------|-------------------------|----------|
| C1-5-D | | 3CRF-D |
| 9L-D | | L8-18i-D |
| ML6-15-D | | S4-10-D |
| M5S-D | | P2D |
| IC5-9-D | | P6D |

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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 (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, Ph.D. at (301) 796-XXXX.

Sincerely Yours,

Machal D. Then Re

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure(s)

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Image /page/4/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters 'GE' are stylized and appear to be connected in a flowing manner. The logo is black and white, with the letters and border appearing in black against a white background.

510(k) Number (if known):

Device Name: Logiq S8

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)

Mary S Pastil
(Division Sign-Off)

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

510(k) Number K111582

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Image /page/5/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 are stylized and connected in a way that forms a unique and recognizable symbol.

#### Diagnostic Ultrasound Indications for Use Form GE Logig S8 Uitrasound System

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] | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Small Organ(2) | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Cardiac | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Other [4] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Intraoperative Neurological | N | N | N | N | N | N | N | N | N | N | |
| 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 İmaging mode

[6] Needle guidance im aging

[7] Includes infertility monitoring of follicle development

[8] Intraoperative includes abdominal, t horacic (cardiac), and vascular (PV)

[9] Volume navigation

510K

(*) 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)

18

Prescription User (Per 21 CFR 801.109)

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

Office of In Vitro Diagnostic Device Evaluation and Safety

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Image /page/6/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 are stylized and connected, creating a distinctive and recognizable emblem.

## Diagnostic Ultrasound Indications for Use Form GE Logiq S8 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<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 | 5,6,9 |
| 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] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal [8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

previously cleared by FDA(t on: 1

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 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.

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

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

Prescription User (Per 21 CFR 801.109)

Mary S. Postell
(Division Sign Off)

Division of Radioloo Office of In aluation and Safety

510K K111582

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Image /page/7/Picture/0 description: The image shows a logo for General Electric (GE). The logo is a circular design with the letters "GE" intertwined in the center. The letters are stylized and have a vintage look. The logo is black and white.

#### Diagnostic Ultrasound Indications for Use Form GE Logig S8 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 | | 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 | | | | | | | | | | | |
| Peripheral Vascular | 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 | 3,5,6,9 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

indication; P = previously cleared by FDA (K092271)

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 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.

(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)

Mary Pastil
(Division Sign-Off)

Office of In Vitro Diagnostic Device Evaluation

510K K111582

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

Image /page/8/Picture/0 description: The image shows a black and white logo. The logo is circular and contains two intertwined letters that appear to be "G" and "E". The logo is likely for General Electric, a well-known company. The image is simple and recognizable.

## Diagnostic Ultrasound Indications for Use Form GE Logig S8 with ML6-15-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] | | | | | | | | | | | |
| 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 | P | P | P | | P | P | P | P | P | P | 9 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | 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 | 3,5,6,9 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal(8) | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

indication: P = previously cleared by P DATK092

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 Imaging mode

[6] Needle guidance im aging

[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.

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

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

21

Prescription User (Per 21 CFR 801.109)

Marei S. Pastil

\$10K

Division of Radiological De Office of In Vitro Diagnostic D ion and Safety

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo, which consists of the letters 'G' and 'E' intertwined within a circular border. The letters are stylized with curved lines and loops, creating a distinctive and recognizable design. The logo is presented in black and white, with the letters and border appearing in black against a white background. The overall design is simple yet iconic, representing the General Electric brand.

## Diagnostic Ultrasound Indications for Use Form GE Logiq S8 with M5S-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 | 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 | P | P | P | P | P | P | P | P | P | P | 9 | |
| Cardiac | 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 | | | | | | | | | | | | |

= new indication; P = previously cleared by FDA(K092271)

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 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.

(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)

Man S Pastd
(Division Sign-Off)

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

510k

22

{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 within a circular border. The logo is black and white and appears to be a slightly pixelated or low-resolution image.

#### Diagnostic Ultrasound Indications for Use Form GE Logiq S8 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><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 | 5,6,9 |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| 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[8] | 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 |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

ndication; P = previously cleared by FDA(K092271)

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 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

[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 Diagnostic Devices (OIVD)

23

Prescription User (Per 21 CFR 801.109)

Man Sastle
(Division Sign-Off)

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

510K

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

Image /page/11/Picture/0 description: The image shows a logo of General Electric (GE). The logo is a circular emblem with the letters 'GE' intertwined in a stylized, cursive font. The letters are surrounded by a decorative pattern within the circle, giving the logo a classic and recognizable appearance.

## Diagnostic Ultrasound Indications for Use Form GE Logiq S8 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<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 | 5,6,9 | |
| Abdominal[1] | N | N | N | | N | N | N | N | N | N | 5,6,9 | |
| Pediatric | N | N | N | | N | N | N | N | N | N | 5,6,9 | |
| Small Organ[2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Other [4] | N | N | N | | N | N | N | N | N | N | 5,6,9 | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal [8] | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | | |

= 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 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.

(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)

Mary S. Postel
(Division Sign Or)

n of Radiological Office of In Vitro Diagnostic

610K 111582

24

{12}------------------------------------------------

Image /page/12/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'G' and 'E' intertwined within a circle. The letters are stylized with curved lines and a vintage design, and the circle has a thick outline.

#### Diagnostic Ultrasound Indications for Use Form GE Logig S8 with L8-18i-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 | 3,5,6,9 |
| 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 | 5,6,9 |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | | | | | | | | | | | |
| Peripheral Vascular | 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 | 3,5,6,9 |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Other[4] | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal[8] | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | | P | P | P | P | P | P | 3,5,6,9 |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |

new indication; P = previously cleared by FDA(K092271)

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 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.

(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)

Marie S. Patel
(Division Sign Off)

Divisioning Asdiala Office of In Vitro Diagnos ation and Safety

510K K111582

રટ

{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 frame. The letters are stylized and have a flowing, cursive appearance. The logo is black and white.

## Diagnostic Ultrasound Indications for Use Form GE Logiq S8 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><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] | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 5,6,9 |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac | N | N | N | N | N | N | N | N | N | N | |
| 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

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 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.

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

ટર્સ

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

Prescription User (Per 21 CFR 801.109)

Massy Patel
(District Sign Off)

Division of Radiological Office of In Vitro Diagnostic uation and Safety

510K

{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 circular border. The logo is black and white and has a vintage look.

#### Diagnostic Ultrasound Indications for Use Form GE Logiq S8 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…