K Number
K110943
Device Name
LOGIQ E9
Manufacturer
Date Cleared
2011-07-22

(109 days)

Product Code
Regulation Number
892.1550
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).
Device Description
The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.
More Information

No
The summary describes a general-purpose ultrasound system with standard image processing capabilities and does not mention AI, ML, or related concepts.

No
The device is described as a "general purpose diagnostic ultrasound system" and its intended use is for "ultrasound evaluation," which indicates diagnostic rather than therapeutic function.

Yes
The device description explicitly states, "The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system."

No

The device description explicitly states it is a "full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability," clearly indicating it includes significant hardware components beyond just software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The description clearly states the device is a "diagnostic ultrasound system." Ultrasound is an imaging modality that uses sound waves to create images of internal body structures. It does not involve testing samples taken from the body.
  • Intended Use: The intended uses listed are all related to imaging various anatomical sites within the body.
  • Device Description: The description focuses on the physical console, user interface, and imaging capabilities.
  • Lack of IVD-Specific Information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with in vitro diagnostics.

Therefore, the LOGIQ E9 is a diagnostic imaging device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows: Ophthalmic, Fetal/Obstetrics, Abdominal, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other, Transesophageal, Transrectal, Transvaginal, Transurethral, Intraoperative, Intraoperative Neurological, Intravascular, Laparoscopic.

Product codes

IYN, IYO, ITX

Device Description

The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound system which consists of a mobile console approximately 58 cm wide, 86cm deep and 141 cm high that provides digital acquisition, processing and display capability. The user interface includes a computer keyboard, specialized controls, 10-inch LCD touch screen and color 19-inch LCD image display.

Mentions image processing

digital acquisition, processing and display capability.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Ultrasound

Anatomical Site

Fetal, Abdominal, Pediatric, Small Organ (breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (adult and pediatric), Peripheral Vascular, Musculo-skeletal Conventional and Superficial, Urology (including prostate), Transrectal, Transvaginal, Transesophageal, Intraoperative (abdominal, thoracic, vascular and neurosurgical), Ophthalmic.

Indicated Patient Age Range

Adult, Pediatric, Neonatal, Fetal.

Intended User / Care Setting

Qualified physician. Care setting implied to be a clinical environment where ultrasound evaluations are performed.

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)

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 E9 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

  • Risk Analysis.
  • Requirements Reviews.
  • Design Reviews.
  • Testing on unit level (Module verification).
  • Integration testing (System verification).
  • Performance testing (Verification).
  • Safety testing (Verification).
  • Final Acceptance testing (Validation).

Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence.

Conclusion: GE Healthcare considers the LOGIQ E9 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K092271, K052441

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 892.1550 Ultrasonic pulsed doppler imaging system.

(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.

0

K110943

JUL 2 2 2 2011

510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:
Date:April 1, 2011
Submitter:GE Healthcare, GE Medical Systems Ultrasound and Primary
Care Diagnostics, LLC.
9900 Innovation Dr.
Wauwatosa, WI 53226
Contact Person:Bryan Behn
Regulatory Affairs Manager
GE Healthcare, GE Medical Systems Ultrasound and Primary
Care Diagnostics, LLC.
Phone: 414-721-4214
Fax: 414-918-8275
Device: Trade Name:GE LOGIQ E9 Diagnostic Ultrasound System
Common/Usual Name:LOGIQ E9
Classification Names:Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-ΙΥΝ
Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO
Product Code:Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX
Predicate Device(s):K092271 GE LOGIQ E9 Diagnostic Ultrasound System
K052441 GE LOGIQ 7 Diagnostic Ultrasound System
Device Description:The LOGIQ E9 is a full featured, general purpose diagnostic
ultrasound system which consists of a mobile console
approximately 58 cm wide, 86cm deep and 141 cm high that
provides digital acquisition, processing and display capability.
The user interface includes a computer keyboard, specialized
controls, 10-inch LCD touch screen and color 19-inch LCD
image display.
Intended Use:The device is intended for use by a qualified physician for
ultrasound evaluation of Fetal; Abdominal; Pediatric; Small
Organ (breast, testes, thyroid); Neonatal Cephalic; Adult
Cephalic; Cardiac (adult and pediatric); Peripheral Vascular;
Musculo-skeletal Conventional and Superficial; Urology
(including prostate); Transrectal; Transvaginal; Transesophageal
and Intraoperative (abdominal, thoracic, vascular and
neurosurgical).
Technology:The LOGIQ E9 employs the same fundamental scientific
technology as its predicate device(s).
Determination of Substantial Equivalence:Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output,
biocompatibility, cleaning and disinfection effectiveness as well

: :

1

as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:

  • Risk Analysis .
  • Requirements Reviews .
  • Design Reviews .
  • Testing on unit level (Module verification) .
  • . Integration testing (System verification)
  • . Performance testing (Verification)
  • . Safety testing (Verification)
  • . Final Acceptance testing (Validation)

Summary of Clinical Tests:

The subject of this premarket submission, LOGIQ E9, did not require clinical studies to support substantial equivalence.

  • Conclusion: GE Healthcare considers the LOGIQ E9 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

2

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of a human face in profile, with flowing lines representing hair or other features.

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

Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Dr. WAUWATOSA WI 53226

JUL 222 2011

Re: K110943

Trade/Device Name: LOGIC E9 Diagnostic Ultrasound System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, and ITX Dated: July 18, 2011 Received: July 19, 2001

Dear Mr. Behn:

We have reviewed vour Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

This determination of substantial equivalence applies to the following transducers intended for use with the LOGIC E9 Diagnostic Ultrasound System, as described in your premarket notification:

Transducer Model Number

C1-5-D

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

3

Page 2 - Mr. Behn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

If you have any questions regarding the content of this letter, please contact Shahram Vaezy, Ph.D. at (301) 796-6242.

Sincerely Yours,

Mary S. Patil

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

Enclosure(s)

4

Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined within a circular border. The logo is black and white and has a vintage look.

GE Healthcare 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: LOGIQ E9 Diagnostic Ultrasound System

Indications for Use:

The device is intended for use by a qualified physician for ultrasound evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transrectal; Transvaginal; Transesophageal and Intraoperative (abdominal, thoracic, vascular and neurosurgical).

Prescription Use x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (Part 21 CFR 801 Subpart C)

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

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

Mary Patil

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

510(k) Number K110943
Page 1 of 1

5

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 Ultrasound System

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

Mode of Operation
Clinical Application
Anatomy/Region of InterestBMPW
DopplerCW
DopplerColor
DopplerColor M
DopplerPower
DopplerCombined
Modes'Harmonic
ImagingCoded
Pulse"Other
[Notes]
OphthalmicPPPPPPPPPP
Fetal/Obstetrics[7]PPPPPPPPPP[5,6,9]
Abdominal[1]PPPPPPPPPP[3,5,6,9]
PediatricPPPPPPPPPP[3,5,6,9]
Small Organ[2]PPPPPPPPPP[3,5,6,9]
Neonatal CephalicPPPPPPPPPP[5,6,9]
Adult CephalicPPPPPPPPPP[5,6,9]
Cardiac AdultPPPPPPPPPP
Cardiac PediatricPPPPPPPPPP
Peripheral VascularPPPPPPPPPP[3,5,6,9]
Musculo-skeletal ConventionalPPPPPPPPPP[3,5,6,9]
Musculo-skeletal SuperficialPPPPPPPPPP[3,5,6,9]
Other[4]PPPPPPPPPP[3,5,6,9]
Exam Type, Means of Access
TransesophagealPPPPPPPPPP
TransrectalPPPPPPPPPP[3,5,6,9]
TransvaginalPPPPPPPPPP[3,5,6,9]
Transurethral
Intraoperative[8]PPPPPPPPPP[3,5,6,9]
Intraoperative NeurologicalPPPPPPPPPP
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 im aging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.

System provides real-time 3D and 4D acquisition when used with special 4D probes

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

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

Mary S. Postle


(Division Sign-Off)

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

510K

110943

6

Diagnostic Ultrasound Indications for Use Form GE LOGIQ E9 with C1-5-D Transducer

| Clinical Application
Anatomy/Region of Interest | B | M | PW
Doppler | CW
Doppler | Color
Doppler | Color M
Doppler | Power
Doppler | Combined
Modes' | Harmonic
Imaging | Coded
Pulse' | Other
[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|--------------------|---------------------|-----------------|------------------|
| | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |

P

P

P

P

P

P

P

P

P

P

P

P

P

b

P

.

P

P

P

P

P

P

P

P

P

P

P

P

P

P

P

[5,6,9]

[3,5,6,9]

[3,5,6,9]

[3,5,6,9]

[3,5,6,9]

Intended Use: Diagnostic Ultrasound imaging or fluid flow analysis of the human body as follows:

P

P

P

P

P

N = new indication; P = previously cleared by FDA; E = added under Appendix E

P

P

P

P

P

P

P

P

P

P

P

P

P

P

P

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 quidance im aging

[7] Includes infertility monitoring of follicle development

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

[9] Volume navigation

[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD,

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 Diagnostic Devices (OIVD)

Mary S/Postif
(Division Sign-Off)

Fetal/Obstetrics™

Abdominal[1]

Small Organ (21 Neonatal Cephalic Adult Cephalic Cardiac Adult Cardiac Pediatric Peripheral Vascular

Musculo-skeletal Conventional Musculo-skeletal Superficial

Exam Type, Means of Access

Intraoperative Neurological

Transesophageal Transrectal Transvaginal Transurethral

Intraoperative[в]

Intravascular Laparoscopic

Pediatric

Other 141

Division of tadiological Devices Office of in Vitro Diagnostic Device Evaluation and Safety

510K K110943