(85 days)
K181783 LOGIQ P9/P7 Diagnostic Ultrasound System
No
The document does not mention AI, ML, or related terms, and the description focuses on standard ultrasound functionalities and hardware.
No.
The device is described as a "general purpose diagnostic ultrasound system" and its "Intended Use / Indications for Use" explicitly state it is for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which are diagnostic rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "general purpose diagnostic ultrasound system."
No
The device description clearly states it is a "mobile console" with physical dimensions, a keyboard, touch screen, and image display, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Device Function: The description clearly states the LOGIQ P10, P9, and P8 are "general purpose diagnostic ultrasound systems." Ultrasound works by sending sound waves into the body and interpreting the echoes to create images. It does not involve analyzing specimens taken from the body.
- Intended Use: The intended use describes imaging and analysis of the human body and fluid within the body, not analysis of samples from the body.
- Lack of IVD-specific language: The description does not mention any processes or components related to handling or analyzing biological specimens.
Therefore, the LOGIQ P10, LOGIQ P9, and LOGIQ P8 are diagnostic imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, Track 3 device, primarily intended for general purpose diagnostic ultrasound system which consists of a mobile console approximately 55 cm wide, 74 cm deep and 160 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Indicated Patient Age Range
Adult, Pediatric, Neonatal, Fetal
Intended User / Care Setting
qualified and trained healthcare professional physician / hospital or medical clinic.
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 P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence.
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.
K181783 LOGIQ P9/P7 Diagnostic Ultrasound System
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.
K170445 LOGIQ S8 Diagnostic Ultrasound System, K180535 Voluson P6 Voluson P8, K173555 LOGIQ E10, K200119 LOGIQ E10s
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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GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Mr. Bryan Behn Regulatory Affairs Director 9900 Innovation Drive WAUWATOSA WI 53226
Re: K203114
Trade/Device Name: LOGIO P10, LOGIO P9, LOGIO P8 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: October 14, 2020 Received: October 15, 2020
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. 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.
January 8, 2021
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
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https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203114
Device Name LOGIQ P10, LOGIQ P9, LOGIQ P8
Indications for Use (Describe)
The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectar, Transvaginal; Transesophageal and Intraoperative (abdominal, vascular).
Modes of operation include: B, M, PW, Doppler, CW Doppler, Color M Doppler, Power Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are intended to be used in a hospital or medical clinic.
| 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)
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Image /page/3/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 shape. The circle has a swirling design around the letters, giving it a dynamic and recognizable appearance. The color of the logo is a bright blue.
GE Healthcare 510(k) Premarket Notification Submission
Section 5: 510(k) Summary K203114
LOGIQ P10, LOGIQ P9 and LOGIQ P8
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GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary K203114
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Date: | October 14, 2020 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics, |
| LLC | |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Manufacturer: | GE Ultrasound Korea, Ltd. |
| 9, Sunhwan-ro 214 beon-gil, Jungwon-gu, Seongnam-si, | |
| Gyeonggi-do, Republic of Korea | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)-247-5502 | |
| Alternate Contact Person: | Chae-Rin, Song Regulatory Affairs Specialist |
| GE Healthcare | |
| GE Ultrasound Korea, Ltd. | |
| T: +82-31-740-6310 | |
| Device: Trade Name: | LOGIQ P10, LOGIQ P9 and LOGIQ P8 |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN(primary), IYO, ITX(secondary) |
| 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 | |
| Primary Predicate Device: | K181783 LOGIQ P9/P7 Diagnostic Ultrasound System |
| Reference Predicate Device(s): | K170445 LOGIQ S8 Diagnostic Ultrasound System |
| K180535 Voluson P6 Voluson P8 | |
| K173555 LOGIQ E10, K200119 LOGIQ E10s | |
| Device Description: | The LOGIQ P10, LOGIQ P9 and LOGIQ P8 are full featured, |
| Track 3 device, primarily intended for general purpose diagnostic | |
| ultrasound system which consists of a mobile console | |
| approximately 55 cm wide, 74 cm deep and 160 cm high that | |
| provides digital acquisition, processing and display capability. | |
| The user interface includes a computer keyboard, specialized |
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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" in a stylized script, enclosed within a blue circle. There are decorative swirls around the outer edge of the circle, giving it a dynamic and recognizable appearance. The logo is simple, yet iconic, representing the brand's long history and global presence.
controls, 10.4-inch LCD touch screen and color 23.8-inch LCD image display. The LOGIQ P10, LOGIQ P9, LOGIQ P8 are general purpose Indications for Use: diagnostic ultrasound system intended for use by a qualified and trained healthcare professional physician for ultrasound imaging, measurement, display and analysis of the human body and fluid. The LOGIO P10, LOGIO P9 and LOGIO P8 clinical applications include: evaluation of Fetal/Obstetrics; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, vascular). Modes of operation include: B, M, PW, Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography, Attenuation Imaging and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. The LOGIO P10, LOGIO P9 and LOGIO P8 are intended to be used in a hospital or medical clinic. The LOGIQ P10, LOGIQ P9 and LOGIQ P8 employs the same Technology: fundamental scientific technology as its predicate devices. Comparison to Predicates Determination of The proposed LOGIQ P10, LOGIQ P9 and LOGIQ P8 systems Substantial Equivalence: are substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed LOGIQ P10, LOGIQ P9 and LOGIQ P8 and the predicate LOGIQ P9 and LOGIQ P7(K181783). . The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis. . The LOGIQ P10/P9/P8 and predicate LOGIQ P9/P7 systems have the same clinical intended uses. . The LOGIQ P10/P9/P8 and predicate LOGIQ P9/P7 systems have the similar imaging modes. LOGIQ P10, LOGIQ P9 and LOGIQ P8 have additional UGAP mode cleared in LOGIQ E10s(K200119). The LOGIQ P9/P7 and predicate LOGIQ P9/P7 systems ●
- transducers are identical except for the addition of 5 new transducers C1-6-D, C3-10-D, C2-7-D, M5Sc-RS, 10C-D. C1-6-D, C3-10-D, C2-7-D have been migrated from LOGIQ E10s(K200119), M5Sc-RS has been migrated
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510(k) Premarket Notification Submission
from Vivid iq and 10C-D has been migrated from LOGIO S8(K170445).
- . The LOGIO P10/P9/P8 and predicate LOGIO P9/P7 systems have the same indications for use with the addition of Obstetric exams
- The systems are manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- . The systems have acoustic power levels which are below the applicable FDA limits.
- . The LOGIQ PO10/P9/P8 and predicate LOGIQ P9/P7 systems have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- . The LOGIQ P10/P9/P8 and predicate LOGIQ P9/P7 systems have been designed in compliance with approved electrical and physical safety standards.
- The software features supported in proposed LOGIQ P10/P9/P8 and predicate LOGIQ P9/P7 are identical except:
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 P10, LOGIQ P9 and LOGIQ P8 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 Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbance - Requirements and Tests, Edition 4.0, 2014
- IEC60601-2-37. Medical Electrical Equipment Part 2-● 37:Particular Requirements for the Safety of Ultrasonic
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510(k) Premarket Notification Submission
Medical Diagnostic and Monitoring Equipment, Edition 2.1. 2015ISO10993-1. Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing- Third Edition, 2009
- ISO14971, Application of risk management to medical ● devices: Second edition 2007
- . NEMA PS 3.1 - 3.20 (2016), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
- IEC 62359, Ultrasonics Field characterization Test ● methods for the determination of thermal and mechanical indices related to medical diagnostic ultrasonic fields, Edition 2.1, 2017
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) ●
- Performance testing (Verification) ●
- Safety testing (Verification) ●
Transducer materials and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ P10, LOGIQ P9 and LOGIQ P8, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the LOGIO P10, LOGIO P9 and LOGIQ P8 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).