(77 days)
Not Found
No
The document does not mention AI, ML, or any related terms like deep learning or neural networks. The description focuses on standard ultrasound technology and image processing.
No
The device is intended for imaging, measurement, and analysis, not for treatment or therapy.
Yes
The device is an ultrasound system intended for imaging, measurement, and analysis of the human body for various clinical applications, which are diagnostic activities.
No
The device description clearly states it is a "laptop ultrasound console" with physical dimensions, integrated hardware components (keyboard, display, probe ports), and operates from a battery or power supply. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body". This describes a device used for in vivo (within the living body) imaging and diagnosis, not for testing samples in vitro (outside the living body).
- Device Description: The description details a physical ultrasound console with probes, designed to interact directly with the patient's body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device is an imaging system used to visualize structures within the body.
N/A
Intended Use / Indications for Use
The LOGIQ V ! / LOGIQ V2 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The LOGIQ V1 / LOGIQ V2 systems are a laptop ultrasound console approximately 120mm in height, 368mm in width and 396mm in length with integrated keyboard, a color video LCD type display, one inbuilt active probe ports and two probe port adapters. It has digital acquisition, processing and display capability and operates from an integrated battery or separate power supply/charger. LOGIQ V1 and LOGIQ V2 have the same hardware and system features.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal.
Indicated Patient Age Range
Adult & pediatric, Neonatal.
Intended User / Care Setting
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 V1 / LOGIQ V2, did not require clinical studies to support substantial equivalence.
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The LOGIQ V1 / LOGIQ V2 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety
- IEC60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37. Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- ISO14971, Application of risk management to medical ● devices
- NEMA, 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) ●
- Integration testing (System verification) ●
- Performance testing (Verification) ●
- Safety testing (Verification)
- Simulated use Testing (Validation) ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 4, 2016
GE Medical Systems Ultrasound & Primary Care Diagnostics LLC % Ms. Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K153037
Trade/Device Name: LOGIQ V1/ LOGIQ V2 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: December 22, 2015 Received: December 23, 2015
Dear Ms. Ortiz:
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 (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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert Oels
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K153037
Device Name LOGIQ V1 / LOGIQ V2
Indications for Use (Describe)
The LOGIQ V ! / LOGIQ V2 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vasculoskeletal Conventional & Superficial; Urology; Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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:
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"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."
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Diagnostic Ultrasound Indications for Use Form LOGIQ V1 / LOGIQ V2 Ultrasound System
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color | |||||||||||
| M | PDI | Combined | ||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | N | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | N | |
| Small Organ [2] | N | N | N | N | N | N | N | N | N | N | N | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | N | |
| Cardiac [3] | N | N | N | N | N | N | N | N | N | N | N | |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | N | N | N | |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | N | |
| Thoracic/Pleural | ||||||||||||
| Other[5] | N | N | N | N | N | N | N | N | N | N | N | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | N | N | N | N | N | N | N | N | N | N | N | |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | N | |
| Intraoperative | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid Drainage | N | N | N | N | N | N | N | N | N | N | 4 | |
| Vascular Access (IV, PICC) | N | N | N | N | N | N | N | N | N | N | 4 | |
| Nerve Block | N | N | N | N | N | N | N | N | N | N | 4 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
] Coded Pulse is for digitally encoded harmonics.
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Image /page/5/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 border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a slightly darker blue background.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with 4C-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse• | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | |||
| Abdominal[1] | P | P | P | P | P | P | P | P | |||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | |||
| Thoracic/Pleural | |||||||||||
| Other[5] | P | P | P | P | P | P | P | P | |||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | P | 4 | ||
| Vascular Access (IV, PICC) | |||||||||||
| Nerve Block | P | P | P | P | P | P | P | P | 4 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA 151028; P= previously cleared by FDA K141768
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
] Coded Pulse is for digitally encoded harmonics.
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Image /page/6/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 border. The color of the logo is blue.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with 8C-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse` | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | N | |||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | N | |||
| Adult Cephalic | |||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | N | |||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | N | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | N | |||
| Thoracic/Pleural | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | |||||||||||
| Vascular Access (IV, PICC) | |||||||||||
| Nerve Block |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a stylized script, enclosed within a circular border. The logo is colored in blue, with the letters and border appearing in a lighter shade of blue against a slightly darker blue background.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with E8C-RS Transducer
| Clinical Application | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color
M | PDI | Combined
Modes* | Harmonic
Imaging | Coded
Pulse' | Other |
|-----------------------------------|---|---|---------------|---------------|------------------|------------|-----|--------------------|---------------------|-----------------|-------|
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P1 | |
| Abdominal[1] | P | P | P | | P | | P | P | P | P1 | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other[5] | P | P | P | | P | | P | P | P | N | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | N | |
| Transvaginal | P | P | P | | P | | P | P | P | P1 | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage | P | P | P | | P | | P | P | P | N | 4 |
| Vascular Access (IV, PICC) | | | | | | | | | | | |
| Nerve Block | | | | | | | | | | | |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P = previously cleared by FDA 141768
[1] Abdominal includes GYN and Urological; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac is Adult and Pediatric;
- [4] Includes image guidance for freehand needle placement
- [5] Other is Urology and includes Prostate;
- [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
- [*] Coded Pulse is for digitally encoded harmonics.
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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 in a stylized script, enclosed within a circular border. The color of the logo is blue.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with 12L-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse' | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | |||
| Small Organ[2] | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac[3] | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | |||
| Thoracic/Pleural | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | P | 4 | ||
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | P | 4 | ||
| Nerve Block | P | P | P | P | P | P | P | P | 4 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768
Notes: [1] Abdominal includes GYN and Urological;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac is Adult and Pediatric;
- [4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
- [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
- ["] Coded Pulse is for digitally encoded harmonics.
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Image /page/9/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 circle has a decorative border with small, curved elements around the perimeter. The logo is simple and recognizable, representing the company's brand.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with 3Sc-RS Transducer
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse` | Other | ||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | ||||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | ||||
| Cardiac[3] | P | P | P | P | P | P | P | ||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | P | P | P | P | P | P | P | 4 | |||
| Vascular Access (IV, PICC) | P | P | P | P | P | P | P | 4 | |||
| Nerve Block |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P1= previously cleared by FDA K141768
Notes: [1] Abdominal includes GYN and Urological;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac is Adult and Pediatric;
- [4] Includes image guidance for freehand needle placement
- [5] Other is Urology and includes Prostate;
- [*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
- ["] Coded Pulse is for digitally encoded harmonics.
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Image /page/10/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 border. The color of the logo is blue.
Diagnostic Ultrasound Indications for Use Form
LOGIQ V1 / V2 with L6-12-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse' | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Small Organ [2] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Musculo-skeletal Conventional | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Musculo-skeletal Superficial | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | |||
| Thoracic/Pleural | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N | 4 | ||
| Vascular Access (IV, PICC) | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N | 4 | ||
| Nerve Block | P1 | P1 | P1 | P1 | P1 | P1 | P1 | N | 4 |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768
Notes: [1] Abdominal includes GYN and Urological;
- [2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
] Coded Pulse is for digitally encoded harmonics.
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Image /page/11/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 border. The color of the logo is blue.
Diagnostic Ultrasound Indications for Use Form LOGIQ V1 / V2 with LK760-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color | ||||||||||
| M | PDI | Combined | |||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | N | |||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | N | |||
| Thoracic/Pleural | |||||||||||
| Other[5] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage | |||||||||||
| Vascular Access (IV, PICC) | |||||||||||
| Nerve Block |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K151028; P= previously cleared by FDA K141768
Notes: [1] Abdominal includes GYN and Urological;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac is Adult and Pediatric;
[4] Includes image guidance for freehand needle placement
[5] Other is Urology and includes Prostate;
[*]Combined modes are B/M, B/PWD, B/Color/PWD, B/Power/PWD;
"] Coded Pulse is for digitally encoded harmonics.
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Image /page/12/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 also blue, and there are decorative swirls around the letters within the circle.
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
October 16, 2015 Date: GE Medical Systems Ultrasound and Primary Care Diagnostics, Submitter: 9900 Innovation Drive Wauwatosa, WI 53226
| Primary Contact Person: Tracey Ortiz |
|---|
| Regulatory Affairs Director |
| GE Healthcare |
| T:(262)676-6120 |
| F:(414)918-8275 |
| Secondary Contact Person: Jian Xie |
|---|
| Regulatory Affairs |
| GE Medical Systems (China) Co, Ltd. |
| T: +86 510 8527 8651 |
| F: +86 510 8522 7347 |
| Device: | Trade Name: LOGIQ V1 / LOGIQ V2 |
|---|---|
| Common/Usual Name: | Ultrasound system |
| Classification Names: | |
| Product Code: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-IYN | |
| Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, 90-IYO | |
| Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | |
| Predicate Device(s): | LOGIQ e - K151028 |
| LOGIQ V3 / LOGIQ V5 - K141768 | |
| Device Description: | The LOGIQ V1 / LOGIQ V2 systems are a laptop ultrasound |
| console approximately 120mm in height, 368mm in width and | |
| 396mm in length with integrated keyboard, a color video LCD | |
| type display, one inbuilt active probe ports and two probe port | |
| adapters. It has digital acquisition, processing and display | |
| capability and operates from an integrated battery or separate | |
| power supply/charger. LOGIQ V1 and LOGIQ V2 have the same | |
| hardware and system features. |
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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 script, enclosed within a circular frame. The frame has a swirling design around the letters, and the entire logo is in a light blue color.
- The LOGIQ V1 / LOGIQ V2 is intended for ultrasound imaging, Intended Use: measurement and analysis of the human body for multiple clinical applications including: Fetal/OB; GYN; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Urology: Transrectal; Transvaginal; imaging guidance of interventional procedures (e.g. Nerve Block, Vascular Access, Tissue Biopsy/Fluid Drainage).
- The LOGIQ V1 / LOGIQ V2 employs the same fundamental Technology: scientific technology as its predicate devices.
Determination of Comparison to Predicates
Substantial Equivalence:
The LOGIQ V1 / LOGIQ V2 is substantially equivalent to the predicate devices with regards to intended use, imaging capabilities, technologicial characteristics and safety and effectiveness.
- o The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e have the same intended use and similar clinical applications.
- The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e ● system have the same imaging modes.
- The system is manufactured with materials which have ● been evaluated and found to be safe for the intended use of the device.
- The system has acoustic power levels which are below the applicable FDA limits.
- The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e system have the same capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The LOGIQ V1 / LOGIQ V2 and predicate LOGIQ e ● system have been designed in compliance with approved electrical and physical safety standards.
- The transducer L6-12-RS is cleared in predicate LOGIQ ● V3 / LOGIO V5 (K141768), other transducers are cleared in predicate LOGIQ e system (K151028).
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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 frame. The frame has decorative, swirling elements around the letters. The logo is colored in a light blue hue.
- o Software features are the same as is on the predicate LOGIQ e plus Sonobiometry(AFB) and ScanCoach features have been added from predicate LOGIQ V3 / LOGIQ V5 (K141768).
Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform to applicable medical device safety standards. The LOGIQ V1 / LOGIQ V2 and its applications comply with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -● Part 1: General Requirements for Safety
- IEC60601-1-2, Medical Electrical Equipment Part 1-● 2:General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility Requirements and Tests
- IEC60601-2-37. Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic Medical Diagnostic and Monitoring Equipment
- NEMA UD 3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
- ISO10993-1, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment
- ISO14971, Application of risk management to medical ● devices
- NEMA, 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) ●
- Integration testing (System verification) ●
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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 script, enclosed within a circular frame. The color of the logo is a light blue.
- Performance testing (Verification) ●
- Safety testing (Verification)
- Simulated use Testing (Validation) ●
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ V1 / LOGIQ V2, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the LOGIQ V1 / LOGIQ V2 to be as Conclusion: safe, as effective, and performance is substantially equivalent to the predicate device(s).