GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4
Device Facts
| Record ID | K092271 |
|---|---|
| Device Name | GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 |
| Applicant | GE Healthcare |
| Product Code | IYN · Radiology |
| Decision Date | Nov 17, 2009 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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).
Device Story
LOGIQ E9 BT2010 is a mobile, general-purpose diagnostic ultrasound system. It acquires, processes, and displays ultrasound data via a console with keyboard, touch screen, and LCD display. Input consists of acoustic signals from various transducers; system transforms these into B-mode, M-mode, Doppler (PW/CW/Color/Power), and harmonic images. New features include Elastography Imaging (extracts/displays tissue mechanical properties by color-coding strain values) and enhanced Volume Navigation (uses electromagnetic sensors on transducer/needle for tracking). Used in clinical settings by physicians for diagnostic imaging. Output allows clinicians to visualize anatomy and blood flow, aiding in clinical assessment and decision-making. Benefits include improved diagnostic visualization and guidance for procedures like needle placement.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence provided via bench testing, including verification results for Elastography and Volume Navigation features, and compliance with acoustic output, biocompatibility, and electrical/mechanical safety standards.
Technological Characteristics
Mobile console with 19-inch LCD display and 10-inch touch screen. Supports multiple transducers (e.g., 3CRF, 6S-D, 6Tc, 9L-D, 11L-D, C1-5-D, IC5-9-D, L8-18i-D, M4S-D, M5S-D, M6C-D, ML6-15-D, P2D, P6D, RAB2-5-D, RAB4-8-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, S1-5, S4-10). Features include B-mode, M-mode, Doppler, harmonic imaging, Elastography, and electromagnetic-based Volume Navigation. Conforms to 21 CFR 820, ISO 9001, and ISO 13485.
Indications for Use
Indicated for ultrasound evaluation of fetal, abdominal, pediatric, small organ (breast, testes, thyroid), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal (conventional/superficial), urological (prostate), transrectal, transvaginal, transesophageal, and intraoperative (abdominal, thoracic, vascular, neurosurgical) applications in patients requiring diagnostic ultrasound imaging or fluid flow analysis.
Regulatory Classification
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.
Predicate Devices
- GE LOGIQ E9 Diagnostic Ultrasound System (K082185)
- GE Vivid E9 Diagnostic Ultrasound System (K081921)
- SonixTouch Ultrasound Scanner (K083095)
Submission Summary (Full Text)
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pg. 1 of 3
NOV 1 7 2009
#### 510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided: 2009-July-24 Date: K092271 510(k): Number: GE Healthcare, GE Medical Systems Ultrasound and Primary Care Submitter: Diagnostics, LLC. 9900 Innovation Drive Wauwatosa, WI, USA 53226 Nicole Landreville, Eng. RAC Primary Contact Person: USA Premarket Requlatory Affairs Leader GE Healthcare 3000 North Grandview Boulevard #W450 Waukesha, WI, USA 53188 Telephone: 289-208-2365 Fax: 414-918-4498 James T. Turner, MS, RAC Secondary Contact Person: USA Premarket Requlatory Affairs Leader GE Healthcare 3000 North Grandview Boulevard #W450 Waukesha, WI, USA 53188 Telephone: 262-544-3359 Fax: 414-908-9225 GE LOGIQ E9 BT2010 Diagnostic Ultrasound System Device/Trade Name: LOGIO Eg Common/Usual Name: Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Classification Names and Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Product Code: Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX Class II Classification: K082185 GE LOGIQ E9 Diagnostic Ultrasound System Predicate Device(s): K081921 GE Vivid E9 Diagnostic Ultrasound System K083095 SonixTouch Ultrasound Scanner The LOGIQ E9 is a full featured, general purpose diagnostic ultrasound Device Description: system which consists of a mobile console approximately 58 cm wide, 86 cm 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. This modification will provide users with 8 additional transducers, an additional optional feature called Elastography Imaging and an enhanced version of the commercially available Volume Navigation (V Nav) optional feature. These modifications all lead to overall quality and image enhancement.
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K092271
Pg. 2 of 3
The device is intended for use by a qualified physician for ultrasound Intended Use: evaluation of Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thvroid); 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).
The LOGIQ E9 BT2010 employs the same fundamental scientific technology Technology: as its predicate devices. In addition to the 13 transducers commercially released: 3CRF, 9L-D, 11L-D, C1-5-D, IC5-9-D, M4S-D, M6C-D, ML6-15-D, RAB2-5-D, RIC5-9-D, RNA5-9-D, RSP6-16-D, S1-5, the LOGIQ E9 Diagnostic Ultrasound System will be released with these additional 8 transducers: 6S-D, 6Tc, L8-18i-D, M5S-D, P2D, P6D, RAB4-8-D and S4-10.
Additional Features Description:
1. Elastography imaging mode on the LOGIO E9 is similar to the Elastography imaging mode on the Ultrasonix SonixTouch Ultrasound Scanner. Elastography is a method to extract and display the mechanical properties of tissue.
This imaging method involves applying a manual pressure with the hand on the transducer. The actual imaging sequence is similar to the B-mode sequence except that the system will acquire the RF signal instead of acquiring B-mode dota. The acoustic output transmission is identical to Bmode data. The algorithm extracts a strain value information for every point on the image. The Elastography image then color-codes the stiff versus softer structures. The clinical benefits of elastography imaging are still under evaluation. This feature allows the user to be able to determine whether or not a structure inside the patient is stiffer than another one; no clinical diagnostic claims are being made.
This submission includes a document "DOC0605013 Verification Results Summary for Elastography Imagina". The report provides evidence that the elasticity imaging algorithm can differentiate different structures with different stiffness.
2. Volume Navigation (V Nav) feature was modified from its previous version cleared under 510(k) K082185. The Volume Navigation feature is enhanced with needle tracking. Volume Navigation uses one or more Electromagnetic (EM) position sensors attached to the transducer to track its movement. Needle Tracking is achieved by using an additional EM sensor attached to the needle.
This submission includes a document "DOC0631792 Verification Results Summary for Volume Navigation". The report provides evidence that the V Nav feature functions according to requirements and specifications.
Determination of Substantial Equivalence:
#### Summary of Non-Clinical Tests:
The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic and mechanical safety, and has been found to conform with applicable medical device safety standards. The LOGIQ E9 BT2010 and its applications comply with voluntary standards as detailed in Section 9, 11, 15 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Management .
- Requirements Reviews
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K092271/
Pg. 3 of 3
- Design Reviews ●
- Testing on unit level (Module verification) .
- Integration testing (System verification) .
- Final acceptance testing (Validation) .
- . Performance testing (Verification)
- . Safety testing (Verification)
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
#### Summary of Clinical Tests:
The subject of this premarket submission, LOGIQ E9 BT2010, did not require clinical studies to support substantial equivalence.
The GE LOGIQ E9 BT2010 is of a comparable type and substantially Conclusion: equivalent to the current GE LOGIQ E9, GE Vivid E9 and the Elastography Imaging feature from SonixTouch Ultrasound Scanner. It has the same technological characteristics, key safety and effectiveness features, and is similar in physical design, construction and materials and has the same intended uses and basic operating modes as the predicate devices.
> Intended uses and other key features are consistent with traditional clinical practice, FDA quidelines, and established methods of patient examination. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and ISO 13485 quality management systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Diagnostic ultrasound has accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the LOGIQ E9 BT2010 is as safe, as effective, and performance is substantially equivalent to the predicate devices(s).
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 1 7 2009
Ms. Nicole Landreville USA Premarket RA Leader GE Healthcare 3000 N. Grandview Blvd., W450 WAUKESHA WI 53188
Re: K092271
Trade/Device Name: GE LOGIQ 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: October 15, 2009 Received: October 26, 2009
Dear Ms. Landreville:
We have reviewed your 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 GE LOGIQ E9 Diagnostic Ultrasound System, as described in your premarket notification:
| Transducer Model Number | | |
|-------------------------|----------|----------|
| 3CRF | 11L-D | M4S-D |
| 6S-D | C1-5-D | M5S-D |
| 6Tc | IC5-9-D | M6C-D |
| 9L-D | L8-18i-D | ML6-15-D |
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Page 2 - Ms. Landreville
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|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|
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| DO<br><br> | 1<br>1<br>-<br>. | 1<br>House, News<br>1 |
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 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); 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/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please i 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 at (301) 796-6242.
Sincerely yours,
Heidi Luman
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure(s)
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## Indications for Use
#### 510(k) Number (if known): K092271
·
GE LOGIQ E9 Diagnostic Ultrasound System Device Name:
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; Cardia; 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 × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
|--------------------------------------------------------|--|
Herreim
(Division'Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109)
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#### K092271
# Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the LOGIQ E9 system and for all of its probe/mode combinations. Combinations identified by "N" are new while "P" represents those previously cleared with the unmodified LOGIQ E9. In a similar manner, "E" represents combinations added to the unmodified LOGIQ E9 via Appendix E of the 510(k) Guidance. The subject modification does not alter the previously cleared system level indications, clinical applications or modes of operation.
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## 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<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| 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] | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Cardiac Adult | P | P | P | P | P | P | P | P | P | P | |
| Cardiac Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Other [4] | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Transvaginal | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Transurethral | | | | | | | | | | | |
| Intraoperative[8] | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Intraoperative Neurological | P | P | P | P | P | P | P | P | P | P | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | |
|---------------------------------------|--|
|---------------------------------------|--|
| | (Division Sign-Off) |
|---------------|------------------------------------------|
| | Division of Reproductive, Abdominal, and |
| | Radiological Devices |
| 510(k) Number | K092271 |
4-3
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# GE LOGIQ E9 with 3CRF Transducer
lntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | [5, 6, 9] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Small Organ[2] | | | | | | | | | | | |
| 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, 9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative[8] | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
F
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
(9) Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription User (Per 21 CFR 801.109) | 4-4 |
|----------------------------------------|-----|
|----------------------------------------|-----|
| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K092271 |
-
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### GE LOGIQ E9 with 6S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | |
| Pediatric | N | N | N | N | N | N | N | N | N | N | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | N | N | N | N | N | N | N | N | N | N | |
| 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; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|------------------------------------------|
| | (Division Sigh-Off) |
| | Division of Reproductive, Abdominal, and |
Radiological Devices
510(k) Number
Prescription User (Per 21 CFR 801.109)
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## GE LOGIQ E9 with 6Tc Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | N | N | N | N | N | N | N | N | N | N | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | N | N | N | N | N | N | N | N | N | N | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| 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, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV),
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (QDE)
(Division Sign-Off)
510(k) Ni
Radiological Devices
Division of Reproductive, Abdominal, and
Prescription User (Per 21 CFR 801.109)
4-6
{11}------------------------------------------------
## GE LOGIQ E9 with 9L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | N | N | N | N | N | N | N | N | N | N | [5, 6, 9] |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [3, 5, 6, 9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | [3, 5, 6, 9] |
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | N | N | [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; E = added under Appendix E
Notes: [1] Abdominal includes renal, GYN/Pelvic.
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, and
Radiological Devices
Prescription User (Per 21 CFR 801.109)
4-7
510(k) Number
{12}------------------------------------------------
## GE LOGIQ E9 with 11L-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | | | | | | | | | | | |
| Abdominal(1) | N | N | N | | N | N | N | N | N | N | [3, 5, 6] |
| Pediatric | P | P | P | | P | P | P | P | P | P | [3, 5, 6] |
| Small Organ(2) | P | P | P | | P | P | P | P | P | P | [3, 5, 6] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | P | P | P | P | P | [3, 5, 6] |
| Musculo-skeletal Conventional | P | P | P | | P | P | P | P | P | P | [3, 5, 6] |
| Musculo-skeletal Superficial | P | P | P | | P | P | P | P | P | P | [3, 5, 6] |
| 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; E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription User (Per 21 CFR 801.109) | |
|----------------------------------------|-----|
| | 4-8 |
| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K092271 |
{13}------------------------------------------------
# GE LOGIQ E9 with C1-5-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Pediatric | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Small Organ[2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | [5, 6, 9] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | N | N | N | N | N | N | N | N | N | N | [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; E = added under Appendix E
[1] Abdominal includes renal, GYN/Pelvic. Notes:
[2] Small organ includes breast, testes, thyroid.
[3] Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
P
[*] 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 Device Evaluation (ODE)
| (Division Sign-Off) | <img alt="Signature" src="signature.png"/> |
|---------------------------------------------------------------|--------------------------------------------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| Prescription User (Per 21 CFR 801.109) | |
| | 4-9 |
| 510(k) Number | 2092271 |
{14}------------------------------------------------
## GE LOGIQ E9 with IC5-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|----------------------------------------------------|-------------------|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>(Notes) |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics[7] | P | P | P | | P | P | P | P | P | P | [5, 6, 9] |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | N | N | N | | N | N | N | N | N | N | [3, 5, 6, 9] |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | | P | P | P | P | P | P | [3, 5, 6, 9] |
| Transrectal | P | P | P | | P | P | P | P | P | P | [3, 5, 6, 9] |
| Transvaginal | P | P | P | | P | P | P | P | P | P | [3, 5, 6, 9] |
| Transurethral | | | | | | | | | | | |
| 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, thyroid.
(3) Elastography Imaging - Elasticity.
[4] Other use includes Urology/Prostate.
[5] 3D/4D Imaging Mode.
[6] Needle guidance imaging.
[7] Includes infertility monitoring of follicle development.
[8] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[9] Volume Navigation.
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. System provides real-time 3D and 4D acquisition when used with special 4D probes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------|---------|
| Prescription User (Per 21 CFR 801.109) | 4-10 |
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | K092271 |
{15}------------------------------------------------
# GE LOGIQ E9 with L8-18i-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | PW<br>Doppler | CW<br>Doppler | Color<br>Doppler | Color M<br>Doppler | Power<br>Doppler | Combined<br>Modes | Harmonic<br>Imaging | Coded<br>Pulse | Other<br>[Notes] |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|------------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics7 | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | N | N | N | | N | N | N | N | N | N | [3, 5, 6, 9] |
| Small Organ[2] | N | N | N | | N | N | N | N | N | N | [3, 5, 6, 9] |
| Neonatal Cephalic | N | N | N | | N | N | N | N | N | N | [5, 6, 9] |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular | 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 | [3, 5, 6, 9] |
| Musculo-skeletal Superficial | N | N | N | | N | N | N | N | N | N | [3, 5, 6, 9] |
| Other[4] | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | |…
