(33 days)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
The LOGIQ E10 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 585 mm wide (keyboard), 900 mm deep and 1300 mm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 12-inch LCD touch screen and color widescreen monitor.
Here's an analysis of the provided text regarding the acceptance criteria and study for the LOGIQ E10 device:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study for novel performance claims. The document explicitly states that "The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence." Therefore, the information regarding acceptance criteria and a study proving the device meets those criteria will be limited, primarily referencing the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) for a diagnostic ultrasound system, the "acceptance criteria" are implied to be that the new device performs "as safe, as effective, and its performance is substantially equivalent to the predicate device(s)" (as stated in the conclusion). Specific quantitative acceptance criteria for image quality or diagnostic accuracy are not provided in this document, as clinical studies were not required. The performance is assessed by comparison to the established performance of the predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety equivalent to predicate devices | Conforms to applicable medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2). Acoustic power levels are below FDA limits. Transducer materials are biocompatible. |
| Effectiveness equivalent to predicate devices | Employs the same fundamental scientific technology as predicate device(s). Has the same clinical intended use and imaging modes as the predicate LOGIQ E9. Similar capability in terms of measurements, digital image capture, review, and reporting studies. |
| Substantial Equivalence to predicate devices | The new platform (LOGIQ E10) is substantially equivalent to the predicate devices (K163077 LOGIQ E9, K170445 LOGIQ S8, K172342 Voluson E6/E8/E10). This equivalence is based on similar technology, intended use, imaging modes, safety, and performance characteristics. Specific probes and features were migrated from other cleared GE devices. |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or associated sample size is mentioned for a clinical performance study since none was required. The "testing" referred to in the document is primarily non-clinical, focusing on engineering verification and validation against technical standards and comparisons to existing predicate devices.
- Sample Size for Test Set: Not applicable, as no clinical test set was used/required for performance evaluation.
- Data Provenance: Not applicable for clinical test data. Non-clinical data would originate from internal GE Healthcare testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no clinical test set was required, and thus no ground truth established by experts for such a set.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was required.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. The device described, LOGIQ E10, is a diagnostic ultrasound system, not an AI/CADe (Computer-Aided Detection/Diagnosis) device for image interpretation that would typically necessitate an MRMC study comparing human reader performance with and without AI assistance. The document focuses on the capabilities of the ultrasound system itself.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
Not applicable. The LOGIQ E10 is a diagnostic ultrasound imaging system; its "performance" is inherently tied to image acquisition and display, which is then interpreted by a human physician. It is not an algorithm designed for standalone diagnostic output.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
Not applicable for clinical performance studies. For non-clinical (engineering) verification, ground truth would be established through defined engineering specifications, phantom measurements (for acoustic output), and compliance with recognized standards.
8. The Sample Size for the Training Set
Not applicable, as this is not an AI/Machine Learning device that requires a training set for algorithm development.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is not an AI/Machine Learning device.
{0}------------------------------------------------
December 20, 2017
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Healthcare % Mr. Bryan Behn RA Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K173555
Trade/Device Name: LOGIO E10 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: November 15, 2017 Received: November 17, 2017
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
{1}------------------------------------------------
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone
(1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Ochs
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Image /page/2/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The circle is surrounded by a decorative border with swirling patterns. The logo is simple and recognizable, and it is associated with a well-known company.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
| Form Approved: OMB No. | 0910-0120 |
|---|---|
| Expiration Date: | 06/30/2020 |
| See PRA Statement below. |
| 510(k) Number (if known) | K173555 |
|---|---|
| Device Name |
Device Name LOGIO E10
Indications for Use (Describe)
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transvaginal; Transesophageal and Intraoperative (vascular).
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (7/17)
Page 1 of 1
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Image /page/3/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 a blue color.
GE Healthcare 510(k) Premarket Notification Submission
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ E10 system and for all of its probe/mode combinations. Combinations identified by "P" for probes represent those previously cleared with another GE Ultrasound system. "N" is new in this submission.
The subject modification does not alter the previously cleared system level indications and clinical applications.
{4}------------------------------------------------
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a white border with decorative swirls, giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 Ultrasound Systems
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Pediatric | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Small Organ[2] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | 3,5,9 |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | 3,5,9 |
| 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 | 3,5,6,9,10 |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Other[4] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9,10 |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | 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 | 3,5,6,7,9 |
| Transuretheral | |||||||||||
| Intraoperative[8] | N | N | N | N | N | N | N | N | N | N | 3,5,6,9 |
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{5}------------------------------------------------
Image /page/5/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. The logo is colored in a light blue hue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with L2-9-D/L2-9VN-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes) |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Abdominal[1] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Pediatric | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Small Organ [2] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| 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; E = added under Appendix E
[1] Abdominal includes Renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{6}------------------------------------------------
Image /page/6/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 logo is enclosed within a circular border, and the entire design is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with ML6-15-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes) |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Small Organ[2] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 9 | ||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Musculo-skeletal Superficial | 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 (K163077)
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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a light blue hue, with the letters and the frame sharing the same color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with ML4-16-D/ML4-16VN-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other(Notes) |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Small Organ[2] | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | 9 | ||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | N | N | N | N | N | N | N | N | 3,5,6,9 | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | 3,5,6,9,10 | ||
| 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; E = added under Appendix E
Notes: [1] Abdominal includes Renal, GYN/Pelvic.
[2] Small organ includes breast, testes and thyroid
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate
[5] 3D/4D Imaging mode
[6] Needle guidance imaging
[7] Includes infertility monitoring of follicle development, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{8}------------------------------------------------
Image /page/8/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, giving the logo a classic and recognizable appearance. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | 5,6 |
| Pediatric | |||||||||||
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | 5 |
| 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 |
N = new indication; P = previously cleared by FDA (K170445)
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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{9}------------------------------------------------
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] |
| Ophthalmic | |||||||||||
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Abdominal[1] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| 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 | 3,5,6,9 | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal[8] | P | P | P | P | P | P | P | P | 3,5,6,9 | ||
| Transvaginal | P | P | P | P | P | P | P | P | 3,5,6,7,9 | ||
| Transuretheral | |||||||||||
| Intraoperative[8] | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{10}------------------------------------------------
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle has a white border with decorative swirls, giving it a classic and recognizable appearance.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with L8-18i-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes) | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 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 | 5,6,9 | |||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{11}------------------------------------------------
Image /page/11/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a decorative swirl pattern. The logo is simple and recognizable, and it is often used to represent the company.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] | |
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | |||||||||||
| Cardiac | P | |||||||||||
| Peripheral Vascular | 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 (K163077)
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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{12}------------------------------------------------
Image /page/12/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The letters are also blue, and they are surrounded by a decorative swirl pattern. The logo is simple and recognizable, and it is often used to represent the company.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C2-9-D/C2-9VN-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW Doppler | CW Doppler | Color Doppler | Color M Doppler | Power Doppler | Combined Modes* | Harmonic Imaging | Coded Pulse | Other [Notes] | |
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | 3,5,6,9 | |
| 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 | P | P | P | P | P | P | P | P | 3,5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Other [4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{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 in a stylized, cursive font. The letters are enclosed within a circular border that has decorative swirls or flourishes around the perimeter. The logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with RAB6-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse | Other[Notes] | |
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | 5,6 | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | 5,6 | |||
| Pediatric | 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 | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{14}------------------------------------------------
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The color of the logo is a light blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 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] | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| 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 | 5,6 | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | 5,6 | |
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{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 that has decorative swirls or flourishes around the perimeter. The logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with 6Tc-RS 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 | |||||||||||
| 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 (K170445)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{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, and the entire logo is presented in a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C1-6-D/C1-6VN-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse® | Other[Notes] | |
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | 3,5,6,9,10 | |||
| Pediatric | P | P | P | P | P | P | P | P | 3,5,6,9,10 | |||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Other [4] | P | P | P | P | P | P | P | P | 3,5,6,9 | |||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{17}------------------------------------------------
Image /page/17/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 a blue color.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C2-7-D/C2-7VN-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical ApplicationAnatomy/Region of Interest | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse* | Other[Notes] | |
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | ||||||||||||
| Cardiac Pediatric | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are white, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form LOGIQ E10 with C3-10-D Transducer
Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PWDoppler | CWDoppler | ColorDoppler | Color MDoppler | PowerDoppler | CombinedModes* | HarmonicImaging | CodedPulse® | Other[Notes] | |
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal/Obstetrics[7] | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | 5,9 | |||
| Adult Cephalic | ||||||||||||
| Cardiac Adult | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Cardiac Pediatric | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Peripheral Vascular | P | P | P | P | P | P | P | P | 5,6,9 | |||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other [4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transurethral | ||||||||||||
| Intraoperative[8] | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA (K163077)
[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, GYN
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV)
[9] Volume navigation
[10] Shear wave elastography
[*] 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)
{19}------------------------------------------------
Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized script, enclosed within a circular frame. The frame has decorative flourishes resembling water droplets or stylized leaves. The logo is colored in a light blue hue.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | November 15, 2017 |
| Submitter: | GE Healthcare9900 Innovation DrWauwatosa, WI 53226 |
| Manufacturer: | GE Medical Systems Ultrasound and Primary Care Diagnostics,LLC.9900 Innovation DriveWauwatosa, WI 53226 USA |
| Primary Contact Person: | Bryan BehnRegulatory Affairs DirectorGE HealthcareT:(414)721-4214F:(414)918-8275 |
| Alternate Contact Person: | |
| Device:Trade Name: | LOGIQ E10 |
| Common/Usual Name: | LOGIQ E10 |
| Additional MarketingNames: | LOGIQ E10 Pro, LOGIQ E11, LOGIQ E20 |
| Classification Names:Product Code: | Class IIUltrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYNUltrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYODiagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX |
| Primary Predicate Device: | K163077 LOGIQ E9 Diagnostic Ultrasound System |
| Reference PredicateDevice(s): | K170445 LOGIQ S8 Diagnostic Ultrasound SystemK172342 Voluson E6/E8/E10 Diagnostic Ultrasound System |
| Device Description:Intended Use: | The LOGIQ E10 is a full featured, general purpose diagnosticultrasound system which consists of a mobile consoleapproximately 585 mm wide (keyboard), 900 mm deep and 1300mm high that provides digital acquisition, processing and displaycapability. The user interface includes a computer keyboard,specialized controls, 12-inch LCD touch screen and colorwidescreen monitor.The device is intended for use by a qualified physician for |
| Technology: | The LOGIQ E10 employs the same fundamental scientifictechnology as its predicate device(s). |
| ultrasound evaluation of Fetal/Obstetrics; Abdominal; Pediatric;Small Organ (breast, testes, thyroid); Neonatal Cephalic; AdultCephalic; Cardiac (adult and pediatric); Peripheral Vascular;Musculo-skeletal Conventional and Superficial; Urology(including prostate); Transrectal; Transvaginal; Transesophagealand Intraoperative (vascular). | |
| Determination ofSubstantial Equivalence: | Comparison to PredicatesThe proposed LOGIQ E10 is a new platform substantiallyequivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ E10 and the predicate LOGIQ E9 (K163077). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. The LOGIQ E10 and predicate LOGIQ E9 systems havethe same clinical intended use. The LOGIQ E10 and predicate LOGIQ E9 systems havethe same imaging modes The systems are manufactured with materials which havebeen evaluated and found to be safe for the intended useof the device. The systems have acoustic power levels which are belowthe applicable FDA limits. The LOGIQ E10 and predicate LOGIQ E9 systems havesimilar capability in terms of performing measurements,capturing digital images, reviewing and reporting studies. The LOGIQ E10 and predicate systems have beendesigned in compliance with approved electrical andphysical safety standards. The following probe and feature has been migrated fromthe LOGIQ S8 (K170445): M5Sc-D probe and powerassistant. The following features have been migrated from theVOLUSON E Series (K172342) STIC, ElastographyAnalysis and Omniview with VCI. The new probes L2-9-D, L2-9VN-D, ML4-16-D, ML4-16VN-D are incremental technology improvements topredicate probes 9L-D and ML6-15-D on the predicateLOGIQ E9 (K163077) |
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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 blue circular frame. The frame has decorative swirls around the perimeter, giving it a classic and recognizable appearance. The logo is simple, yet distinctive, representing the brand identity of General Electric.
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Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular border. The border has a swirling design, giving it a dynamic and fluid appearance. The logo is presented in a blue color scheme.
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 E10 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -Part 1: General Requirements for Safety, 2005/(R)2012 And A1:2012
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: ● General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility Requirements and Tests, 2007
- IEC60601-2-37, Medical Electrical Equipment Part 2-● 37: Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment, 2007
- ISO10993-1, Biological Evaluation of Medical Devices-. Part 1: Evaluation and Testing- Third Edition, 2009
- . NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment:2004
- ISO14971, Application of risk management to medical devices: Second edition 2007
- NEMA PS 3.1 - 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis ●
- Requirements Reviews ●
- Design Reviews ●
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Final Acceptance Testing (Validation) ●
- Performance testing (Verification) ●
- Safety testing (Verification) .
Transducer materials and other patient contact materials are biocompatible.
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Image /page/22/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by what appear to be stylized water droplets or swirls, also in blue. The logo is simple, recognizable, and represents the company's brand identity.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E10, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the LOGIQ E10 to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate device(s).
§ 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.