(90 days)
Not Found
No
The document describes a standard ultrasound system with digital processing capabilities, but there is no mention of AI, ML, or related concepts like deep learning or neural networks. The description of the device and its functions aligns with traditional ultrasound technology.
No.
The device is described as a "diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," indicating it is used for diagnosis rather than treatment.
Yes
The "Device Description" explicitly states, "The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system." Additionally, the "Intended Use / Indications for Use" section describes its use for "ultrasound evaluation" across various anatomical sites, which is a diagnostic purpose. The predicate devices are also explicitly named as "Diagnostic Ultrasound System."
No
The device description clearly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console" with physical components like a keyboard, controls, and displays, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The description clearly states that the LOGIQ S8 is a diagnostic ultrasound system. Ultrasound uses sound waves to create images of internal body structures. It does not involve the analysis of specimens taken from the body.
- Intended Use: The intended use describes imaging various anatomical sites within the body, which is consistent with the function of an ultrasound system.
Therefore, the LOGIQ S8 falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric): Peripheral Vascular; Musculo-skeletal Conventional and Superficial: Urology (including prostate); Transrectal; Transvaginal: Transesophageal and Intraoperative (abdominal, thoracic, and vascular).
Product codes
1YN, 1YO, ITX
Device Description
The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 88 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color 19-inch LCD image display.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Diagnostic ultrasound imaging or fluid flow analysis
Anatomical Site
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; Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, Adult
Intended User / Care Setting
Qualified physician / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, LOGIQ S8, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K111582, K123564, K122114, K113690, K101149
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
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.(b)
Classification. Class II.
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: Date: May 24, 2013 Submitter: GE Healthcare 9900 Innovation Dr AUG 2 6 2013 Wauwatosa. WI 53226 GE Ultrasound Korea, Ltd. Manufacturer: 65-1 Sangdaewon-Dong, Jungwon-Gu Seongnam-Si, Gyenonggi-Do, Korea 462-120 Primary Contact Person: Bryan Behn Regulatory Affairs Manager GE Healthcare T:(414)721-4214 F:(414)918-8275 Seiji Oikawa Alternate Contact Person: Regulatory Affairs Specialist GE Healthcare Japan Corporation T: +81-42-585-5123 F: +81-42-585-5950 LOGIQ S8 Ultrasound System Device: Trade Name: Common/Usual Name: LOGIO S8 Classification Names: Class II Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-1YN Product Code: Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-1YO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX K111582 LOGIQ S8 Diagnostic Ultrasound System Predicate Device(s): K 123564 LOGIQ E9 Diagnostic Ultrasound System K122114 LOGIQ S7 Diagnostic Ultrasound System K113690 LOGIQ e Diagnostic Ultrasound System K101149 Vivid E9 Diagnostic Ultrasound System
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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 circle. The letters and the circle are drawn with a textured, slightly rough line, giving the logo a vintage or slightly distressed appearance.
Device Description: The LOGIQ S8 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 62 cm wide, 88 cm deep and 175 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 9-inch LCD touch screen and color 19-inch LCD image display.
The following is an overview of the differences between the Device Modifications: proposed LOGIQ S8 and the predicate LOGIQ S8 (K111582). The proposed LOGIQ S8 has had several features and probes migrated to it currently cleared on other GE Ultrasound systems.
The following features have been migrated from the LOGIO E9 (K123564): 4D. Transesophageal application, Measure Assistant Breast. Measure Assistant OB. Compare Assistant, Breast and Thyroid Productivity Packages, Speed of Sound, VNAV Needle Tracking. The following probes have been migrated from the LOGIQ E9 (K123564): C2-9-D, 11L-D, 6S-D, S1-5-D, RAB6-D and RIC5-9-D.
The following features and probes have been migrated from the LOGIO S7 (K122114): BSteer+ and the 3Sp-D probe.
The following features and probes have been migrated from the Vivid E9 (K101149): Auto EF
The following are new features and probes added in this submission: Auto Sweep and the C2-6b-D and 10C-D probes.
- Intended Use: The device is intended for use by a qualified physician for ultrasound cvaluation 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, and vascular).
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| Technology: | The LOGIQ 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 with applicable medical device safety standards. The LOGIQ S8 and its applications comply with voluntary standards: | |
| AAMI/ANSI ES60601-1, Medical Electrical Equipment - Part 1: General Requirements for SafetyIEC60601-1-2,Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and TestsIEC60601-2-37, Medical Electrical Equipment – Part 2-37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring EquipmentNEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound EquipmentISO10993-1, Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third EditionNEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound EquipmentISO14971, Application of risk management to medical devicesNEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology) |
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)
3
K13/527
GE Healthcare
510(k) Premarket Notification Submission
- 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.
- GE Healthcare considers the LOGIQ S8 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
Image /page/3/Picture/12 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, circular design. The letters are in a bold, sans-serif font, and the entire logo is enclosed within a circular border with decorative swirls or flourishes around the edges.
4
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 26, 2013
BRYAN BEHN REGULATORY AFFAIRS MANAGER GE HEALTHCARE 9900 INNOVATION DR. WAUWATOSA WI 53226
Re: K131527
Trade/Device Name: LOGIQ S8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: May 24, 2013 Received: May 28, 2013 .
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 LOGIQ S8 Ultrasound System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| C1-5-D | 9L-D | ML6-15-D |
| M5S-D | IC5-9-D | 3CRF-D |
| L8-18i-D | S4-10-D | P2D |
| P6D | C2-9-D | 11L-D |
| 6S-D | S1-5-D | RAB6-D |
| RIC5-9-D | 6Tc-RS | 3Sp-D |
| C2-6b-D | 10C-D |
5
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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number -1800)-638-204-1-07-(301-)-796-7-100-or-at-its-Internet-addresshttp://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours,
for
Janine 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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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: Transesophageal 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)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Smh. 7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K131527 510(k) Number
Page 1 of 1
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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 S8 system. Combinations identified "P" for the transducers represents those previously cleared on LOGIQ S8 or another GE Ultrasound system. Combinations identified "E" for the transducers represents those that have been added to the LOGIQ S8 under Appendix E of "Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers Document issued on: September 9, 2008". Combinations identified "N" for the transducers represents those that are new. Please see section 11 Table 11.2.1 for information on previous clearance information on these transducers.
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Image /page/8/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 outer ring are white, while the background within the circle is black.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | P | 5,6,9 |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Pediatric | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | 5,6,9 |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5,6,9 |
| Cardiac | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Other[4] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | |
| Transrectal[8] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Transuretheral | |||||||||||
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | |
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA;
[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 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.
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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 letters and the border are black, while the background is white. The logo is a well-known symbol associated with the General Electric company.
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 | ||||||||||||
| 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 | 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 | P | 3,5,6,9 |
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P | 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 |
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.
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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 in a stylized, cursive font. The letters are enclosed within a circular border, and the entire logo is presented in black against a white background.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
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] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|----------------|------------------|
| | | | | | | | | | | | |
| Fetal / Obstetrics171 | P | P | P | | P | P | P | P | P | | 5,6,9 |
| Abdominal11 | 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 Organ21 | 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 |
| Other4 | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal (8) | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative1 | | | | | | | | | | | |
| 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 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.
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Diagnostic Ultrasound Indications for Use Form GE LOGIQ 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 | |||||||||||
| 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 | 3,5,6,9 | |
| 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 |
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)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
12
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 | ਲਿ | 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 / Obstetrics171 | P | P | P | b | P | P | P | 0 | P | P | 5,6,9 | |
| Abdominal™ | 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 Organ121 | ||||||||||||
| 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 ﺍﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮﺳﻂ ﺍﻟﻤﺘﻮ | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectall® | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative™ | ||||||||||||
| 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 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 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 are stylized and connected, creating a distinctive and recognizable emblem for the company.
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 | |||||||||||
| 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 | 5,6,9 | |
| 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 |
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 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 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 "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background. The logo has a vintage or slightly distressed appearance, with some imperfections or variations in the black fill.
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 | ||||||||||||
| 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 | 5,6,9 | ||
| Abdominal[11] | P | P | P | P | P | P | P | P | P | 5,6,9 | ||
| Pediatric | P | P | P | P | P | P | P | P | P | 5,6,9 | ||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | 5,6,9 | ||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[4] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| 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 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 Diagnostics and Radiological Health (OIR)
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 in a stylized, cursive font. The letters are enclosed within a circular border with decorative swirls or flourishes around the perimeter of the circle.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 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 | ||||||||||||
| 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 | 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] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[8] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA
[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 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 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 'G' and 'E' intertwined in a stylized, cursive font. The letters are enclosed within a circular border, creating a recognizable and iconic symbol.
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 | ||||||||||||
| 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 | 5,6,9 | |
| 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] | P | P | P | P | P | P | P | P | P | P | 5,6,9 | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | 5,6,9 | |
| Adult Cephalic | ||||||||||||
| 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[9] | ||||||||||||
| 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 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 Diagnostics and Radiological Health (OIR)
17
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:
| 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] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | ||||||||||
| Cardiac | P | P | ||||||||||
| Peripheral Vascular | P | P | ||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type. Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal[6] | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| 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 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 Diagnostics and Radiological Health (OIR)
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized, cursive font. The letters are enclosed within a circular border. The logo is black and white.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Harmonic | ||||
| Modes | Imaging | Coded Pulse | Other | |||||||||
| (Notes) | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics171 | ||||||||||||
| Abdominal1 | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | ||||||||||
| Cardiac | 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
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 Diagnostics and Radiological Health (OIR)
19
Image /page/19/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, creating a strong contrast against the white background.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C2-9-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Mode of Operation Clinical Application Harmonic Coded Other CW Color M Power Combined PW Color B M Doppler Doppler Doppler Doppler Doppler Modes® Imaging Pulse (Notes) Anatomy/Region of Interest Ophthalmic Fetal/Obstetrics[7] E [5,6,9] E E E E E E E E E Abdominal(1) E ш E E E E [3,5,6,9] E E E ട് E E E E [3,5,6,9] E E E E កា E Pediatric Small Organ/21 Neonatal Cephalic Adult Cephalic Cardiac Adult Cardiac Pediatric [3,5,6,9] E E E E E កា E E E E Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial 트 E [3,5,6,9] Other 41 E E E E E E E E Exam Type, Means of Access Transesophageal Transrectal Transvaginal Transurethral Intraoperative[8] Intraoperative Neurological Intravascular Laparoscopic N = new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared K123564) 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
181 Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
19] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
20
Image /page/20/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, with the letters and border appearing in white against a black background.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 11L-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™ | ||||||||||||
| Abdominal 11 | E | E | E | E | E | E | E | E | E | 3,5,6 | ||
| Pediatric | E | E | E | E | E | E | E | E | E | [3,5,6] | ||
| Small Organ/21 | E | E | E | E | 는 | E | E | E | E | [3,5,6] | ||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | E | E | E | E | E | E | E | E | E | [3,5,6] | ||
| Musculo-skeletal Conventional | E | E | E | പ | ಗಾ | E | に | ਜ | E | [3,5,6] | ||
| Musculo-skeletal Superficial | E | E | E | m | E | E | E | E | E | (3,5,6) | ||
| Other 41 | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative(6) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| İntravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared K123564)
[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)
19] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of in Vitro Diagnostics and Radiological Health (OIR)
21
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with 6S-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
| Anatomy/Region of Interest | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | ||||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes' | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse' | Other | |||||||||||
| [Notes] | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics7 | E | E | E | E | E | E | E | E | E | E | ||
| Abdominal1 | E | E | E | E | E | E | E | E | E | E | ||
| Pediatric | E | E | E | E | E | E | E | E | E | E | ||
| Small Organ2 | ||||||||||||
| Neonatal Cephalic | E | E | E | E | E | E | E | E | E | E | ||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | E | E | E | E | E | E | E | E | E | E | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other4 | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative8 | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared K123564)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
22
Image /page/22/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 S8 with S1-5-D Transducer
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||||
| Clinical Application | |||||||||||
| 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] | E | E | E | E | E | E | E | E | E | E | [5,6,9] |
| Abdominal[1] | E | E | E | E | E | E | E | E | E | E | [5,6,9] |
| Pediatric | E | E | E | E | E | E | E | E | E | E | [5,6,9] |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | E | E | E | E | E | E | E | E | E | E | [5,6,9] |
| Cardiac Adult | E | E | E | E | E | E | E | E | E | E | |
| Cardiac Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative[6] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E (previously cleared K123564)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
23
Image /page/23/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular shape. The letters and the circle are in black, while the background is white. There are some decorative swirls around the outer edge of the circle.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with RAB6-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 | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| (Notes) | |||||||||||
| Anatomy/Region of Interest | |||||||||||
| 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 | |||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P* | P* | P* | P* | P* | P* | P* | P* | P* | [5,6] | |
| Musculo-skeletal Superficial | |||||||||||
| Other(4) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative(6) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (previously cleared K123564)
Notes:
[2} Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
{6) Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
24
Image /page/24/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular shape. The letters and the circle are black, creating a strong contrast. The logo is a well-known symbol associated with the General Electric company.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with RIC5-9-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* | P* | P* | P* | P* | [5,6] |
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult | |||||||||||
| Cardiac Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | [3,5,6] |
| Exam Type. Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | 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] |
| Transurethral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (previously cleared K123564)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
(3) Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
25
Image /page/25/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 S8 with 6Tc-RS Transducer
| Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Mode of Operation | |||||||||||
| Clinical Application | |||||||||||
| 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 | |||||||||||
| Cardiac Adult | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | |
| Cardiac Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other(4) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative(8) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (*previously cleared K113690)
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
{3} Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
26
Image /page/26/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" 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 S8 with 3Sp-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 |
| [Notes] | |||||||||||
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes* | Imaging | Pulse | |||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 5,6 |
| Abdominal[1] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 5,6 |
| Pediatric | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | 5,6 |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | |
| Cardiac Adult & 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[4] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (previously cleared K122114)
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription User (Per 21 CFR 801.109)
27
Image /page/27/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters and the border are black, contrasting with the white background. The logo is a classic and recognizable symbol of the General Electric company.
Diagnostic Ultrasound Indications for Use Form GE LOGIQ S8 with C2-6b-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 Modes* | Harmonic Imaging | Coded Pulse | Other (Notes) |
| Anatomy/Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | ||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[17] | |||||||||||
| Abdominal[1] | N | N | N | N | N | N | N | N | 5,6,9 | ||
| Pediatric | |||||||||||
| Small Organ(2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac Adult & Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative[k] | |||||||||||
| 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)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OlR) Prescription User (Per 21 CFR 801.109)
28
Image /page/28/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 S8 with 10C-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | |||||||||||
| 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 | N | N | N | N | N | N | N | N | 5,6 | ||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 5,6 | ||
| Adult Cephalic | |||||||||||
| Cardiac Adult & Pediatric | N | N | N | N | N | N | N | N | 5,6 | ||
| Peripheral Vascular | N | N | N | N | N | N | N | N | 5,6 | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | 5,6 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | 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;
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR) Prescription User (Per 21 CFR 801.109)