(45 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and does not describe any features or functionalities that would typically indicate the use of AI/ML.
No.
The device is described as a diagnostic ultrasound system intended for imaging and analysis, not for treatment.
Yes
The "Device Description" explicitly states, "GE Vivid E9 is a Track 3 diagnostic ultrasound system." The "Predicate Device(s)" also list several devices with "Diagnostic Ultrasound System" in their name.
No
The device description explicitly states it is a "mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices," and incorporates "electronic array transducers," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The GE Vivid E9 ultrasound system is an imaging device. It uses ultrasound waves to create images of internal structures of the body. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for "ultrasound imaging and analysis" of various anatomical sites within the body. This is consistent with an imaging device, not an IVD.
Therefore, based on the provided information, the GE Vivid E9 ultrasound system is a diagnostic imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Product codes (comma separated list FDA assigned to the subject device)
90-IYN, 90-IYO, 90-ITX
Device Description
GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis, but which also includes vascular and general radiology applications. The Vivid E9 incorporates a variety of electronic array transducers operating in linear, curved linear, sector/phased array or matrix array format, including two dedicated CW transducers and several real time 3D transducers. It consists of a mobile console with keyboard control panel; color LCD/TFT touch panel, LCD color video display and optional image storage and printing devices. It provides high performance ultrasound imaging and analysis and has comprehensive networking and DICOM capability.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Indicated Patient Age Range
Adult and Pediatric (for cardiac applications)
Intended User / Care Setting
qualified physician
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, Vivid E9, 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.
K120201 GE Vivid E9 Diagnostic Ultrasound System, K031663 GE Vivid 7 Diagnostic Ultrasound System, K123564 GE Logiq E9 Diagnostic Ultrasound System, K120221 GE EchoPac Workstation
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.
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/0 description: The image shows a document with the text 'K131514 Page 1 of 4' at the top, indicating a document identification number and page information. Below this, the text 'GE Healthcare 510(k) Premarket Notification GE Vivid E9, May 23, 2013' is present. This suggests that the document is a premarket notification for GE Healthcare's Vivid E9 product, dated May 23, 2013, and is related to the 510(k) regulatory pathway.
Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circular border. The letters are stylized and appear to be hand-drawn or calligraphic, giving the logo a classic and recognizable look.
510(k) Summary
JUL 1 2 2013
| Date: | May 24, 2013 |
|---|---|
| Submitter: | GE Healthcare, GE Vingmed Ultrasound AS |
| Strandpromenaden 45 | |
| N-3191, Horten, Norway | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Manager | |
| GE Healthcare, GE Medical Systems Ultrasound and Primary | |
| Care Diagnostics, LLC. | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Jan Tore Thollefsen |
| Regulatory Affairs Manager | |
| GE Vingmed Ultrasound AS | |
| T:(+47)3302-1269 | |
| F:(+47)3302-1357 | |
| Device: | Vivid E9 Diagnostic Ultrasound System |
| Common/Usual Name: | Vivid E9 |
| Classification Names: | Class II |
| Product Code: | 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): | K120201 GE Vivid E9 Diagnostic Ultrasound System |
| K031663 GE Vivid 7 Diagnostic Ultrasound System | |
| K123564 GE Logiq E9 Diagnostic Ultrasound System | |
| K120221 GE EchoPac Workstation | |
| Device Description: | GE Vivid E9 is a Track 3 diagnostic ultrasound system, which is |
| primarily intended for cardiac imaging and analysis, but which | |
| also includes vascular and general radiology applications. The | |
| Vivid E9 incorporates a variety of electronic array transducers | |
| operating in linear, curved linear, sector/phased array or matrix | |
| array format, including two dedicated CW transducers and | |
| several real time 3D transducers. It consists of a mobile console | |
| with keyboard control panel; color LCD/TFT touch panel, LCD | |
| color video display and optional image storage and printing | |
| devices. It provides high performance ultrasound imaging and | |
| analysis and has comprehensive networking and DICOM | |
| capability. |
1
Image /page/1/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 letters and the border are in black, contrasting with the white background.
- Intended Use: GE Vivid E9 ultrasound system is a general-purpose ultrasound system, specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Device Modification The following is a brief overview of the differences between the Overview: proposed Vivid E9 and the predicate Vivid E9 (K120201).
Detailed information is found in section 11 of this submission, while section 12 includes a discussion of substantial equivalence with the predicate device(s).
The modified Vivid E9 will provide users with 5 additional transducers. 4 of which are already cleared with other GE ultrasound devices, while one is new.
- . The additional transducers are: M5Sc-D, C2-9-D, C1-5-D, iC5-9-D and 8C.
The subject modified Vivid E9 will also introduce two optional plug-in features originally cleared in their own right by their OEM manufacturers, TomTec and Sony Electronics.
The TomTec feature was also previously cleared for use with GE EchoPAC Workstation software for ultrasound image review. analysis and reporting (K120221).
- Mitral Valve Quantification Tool, TomTec 4D MV . Assessment, K103782, is a software plug-in which will open and run in a separate window when launched on Vivid E9.
- StereoVision, visualization of real time 3D data on Sony . LMD-2451MT LCD monitor, K113203, intended for 3D and 2D color video displays of clinical images.
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The following modifications of existing features available on the predicate Vivid E9 will be introduced with the modified Vivid E9:
- Alternative automated ROI tracing for the Auto EF and AFI . features.
The Intended Use and Indications for Use of the device have not changed by this modification.
These modifications all lead to overall quality, image enhancement and ease of use of the Vivid E9.
The Vivid E9 employs the same fundamental scientific Technology: technology as its predicate devices.
Summary of Non-Clinical Tests:
Determination of Substantial Equivalence:
The device has been evaluated for acoustic output safety, 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 Vivid E9 and its applications comply with voluntary standards:
-
- IEC60601-1, 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- Fourth Edition.
-
- NEMA UD 2, Acoustic Output Measurement Standard for Diagnostic Ultrasound Equipment.
-
- ISO14971, Application of risk management to medical devices
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Image /page/3/Picture/0 description: The image shows handwritten text, "K131514 Page 4 of 4". The text is written in black ink on a white background. The handwriting is somewhat stylized, with the numbers and letters having a distinct, cursive appearance.
Image /page/3/Picture/2 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame have a textured, slightly pixelated appearance, suggesting the image may be a scan or a low-resolution version of the logo.
-
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
The following quality assurance measures were applied to the development of the system:
- NEMA, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
-
Risk Analysis .
-
. Requirement 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, Vivid E9, did not require clinical studies to support substantial equivalence.
- GE Healthcare considers the Vivid E9 to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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 an abstract symbol that resembles an eagle or bird in flight, rendered in a stylized, minimalist design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2013
GE VINGMED ULTRASOUND AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K131514
Trade/Device Name: GE Vivid E9 Diagnostic Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN, IYO, ITX Dated: July 1, 2013 Received: July 2, 2013
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
This determination of substantial equivalence applies to the following transducers intended for use with the GE Vivid E9 Diagnostic Ultrasound Imaging System, as described in your premarket notification:
| Transducer Model Number | ||
|---|---|---|
| ML6-15-D | C1-5-D | 3V-D |
| 12S-D | C2-9-D | 6VT-D |
| i13L | 9L-D | 6T/6T-RS |
| iC5-9-D | 11L-D | 6Tc/6Tc-RS |
| 4C-D | M5S-D | 9T/9T-RS |
| 8C | M5Sc-D | P2D |
| 6S-D | P6D |
5
Page 2-Mr. Behn
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K131514
Vivid E9 Diagnostic Ultrasound System Device Name:
Indications for Use:
GE Vivid E9 ultrasound system is a general-purpose ultrasound system. specialized for use in cardiac imaging. It is intended for use by, or under the direction of a qualified physician for ultrasound imaging and analysis of Fetal; Abdominal (including renal and GYN); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular (PV); Musculo-skeletal Conventional; Urology (including prostate), Transesophageal; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Prescription Use: _ X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use: N/A (Part 21 CFR 801 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
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Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Vivid 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 Vivid E9 and "P*" represents new transducers that have been previously cleared on another GE Ultrasound System. The subject modification does not alter the previously cleared system level indications, clinical applications or modes of operation.
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Image /page/8/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 letters and the border are black, contrasting with the white background.
Diagnostic Ultrasound Indications for Use Form GE Vivid E9 Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | RT3D
Mode* |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | P | P | P | P | P | P | P | P | P | P | |
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other[4] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | P | P | P | P | P | P | P | P | | P | |
| Transvaginal | P | P | P | P | P | P | P | P | | P | |
| Transuretheral | | | | | | | | | | | |
| Intraoperative[5] | P | P | P | P | P | P | P | P | P | P | |
| 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] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
System provides real-time 3D and 4D acquisition when used with special 4D probes.
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Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 2 of 23
9
Image /page/9/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, with the letters and border in black and the background in white.
GE Vivid E9 with ML6-15-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| 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 | RT3D
Mode* |
|----------------------------------------------------|---|---|---------------|---------------|------------------|--------------------|------------------|-------------------|---------------------|----------------|---------------|
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal | | | | | | | | | | | |
| Pediatric[2] | P | P | P | | P | P | P | P | P | P | P |
| Small Organ[1][2] | P | P | P | | P | P | P | P | P | P | P |
| Neonatal Cephalic | P | P | P | | P | P | P | P | P | P | P |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac Adult | | | | | | | | | | | |
| Cardiac Pediatric | | | | | | | | | | | |
| Peripheral Vascular[2] | P | P | P | | P | P | P | P | P | P | P |
| Musculo-skeletal Conventional[2] | P | P | P | | P | P | P | P | P | P | P |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Transurethral | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Intraoperative Neurological | | | | | | | | | | | |
| Intravascular | | | | | | | | | | | |
| Laparoscopic | | | | | | | | | | | |
N = new indication, P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Small organ includes breast, testes, thyroid.
[2] Needle guidance imaging
[*] Combined modes are B/M, 8/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD.
[ + ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 3 of 23
10
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The letters and the frame are in black, contrasting with the white background.
GE Vivid E9 with 12S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | P | |
| Small Organ | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | |
| Adult Cephalic | |||||||||||
| Cardiac (1) | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Cardiac is Adult and Pediatric.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ • ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(Please do not write below this line - continue on another page if néeded)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 4 of 23
11
Image /page/11/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 letters and the border are black, contrasting with the white background.
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 4V-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal[1] | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Cardiac[2] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[3] | P | P | P | P | P | P | P | P | P | P | P |
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| 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] Cardiac is Adult and Pediatric.
[3] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆ ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 5 of 23
12
Image /page/12/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 letters and the border are black, while the background is white.
Diagnostic Ultrasound Indications for Use Form GE Vivid E9 with i13L Transducer
intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode* | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | P | ||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac[2] | P | P | P | P | P | P | P | P | ||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative[3] | P | P | P | P | P | P | P | P | ||||
| 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] Cardiac is Adult and Pediatric via Intraoperative;
[3] Intraoperative includes abdominal, thoracic, and vascular.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 6 of 23
13
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circular frame. The letters and the frame are in black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
GE Vivid 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 | |||||||||||
| Anatomy/ Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Transvaginal | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA on LOGIQ E9 (K123564); E = added under Appendix E
Notes: [4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 7 of 23
14
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular border. The letters and the border are solid black, contrasting with the white background. The logo is a well-known symbol associated with the multinational conglomerate company.
Diagnostic Ultrasound Indications for Use Form GE Vivid E9 with 4C-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode* | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | ||
| Abdominal | P | P | P | P | P | P | P | P | P | P | ||
| Pediatric | P | P | P | P | P | P | P | P | P | P | ||
| Small Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | P | ||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P | P | P | P | P | P | P | P | P | P | ||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 8 of 23
15
GE Vivid E9 with 8C Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Pediatric | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Small Organ (specify) | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Neonatal Cephalic | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P* | P* | P* | P* | P* | P* | P* | P* | |||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA on Vivid 7 (K031663); E = added under Appendix E Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 9 of 23
16
Diagnostic Ultrasound Indications for Use Form GE Vivid 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 | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Abdominal1) | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Pediatric | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Small Organ(2) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | |||||||||||
| Peripheral Vascular | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA on LOGIQ E9 (K123564); E = added under Appendix E
Notes: [1} Abdominal includes Renal, GYN/Pelvic
[2] Small organ includes breast, testes, thyroid.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ •] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 10 of 23
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular frame. The logo is black and white.
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with C2-9-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | |||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Abdominal[1] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Pediatric | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | P* | P* | P* | P* | P* | P* | P* | P* | P* | P* | ||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P* = previously cleared by FDA on LOGIQ E9(K123564); E = added under Appendix E Notes: [1] Abdominal includes GYN/Pelvic, Renal and Aorta-iliac artery;
[4] Other use includes Urology/Prostate;
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
.
Page 11 of 23
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the interior of the circle are filled with a dark color, while the border is white.
Diagnostic Ultrasound Indications for Use Form GE Vivid 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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | RT3D | |||||||||||
| Mode * | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ(2) | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | ||||||||||||
| Other(4) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
{ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(Please do not write below this line - continue on another page if needed)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 12 of 23
19
Image /page/19/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.
Diagnostic Ultrasound Indications for Use Form GE Vivid 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 | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppler | Combined | |||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | RT3D* | |||||||||||
| Mode | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | P | P | P | P | P | P | P | P | P | |||
| Small Organ(2) | P | P | P | P | P | P | P | P | P | |||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | ||||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | P | P | |||
| Musculo-skeletal Superficial | ||||||||||||
| Other[4] | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative(5) | P | P | P | P | P | P | P | P | P | |||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[5] Intraoperative includes abdominal, thoracic (cardiac), and vascular (PV).
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 13 of 23
20
Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular frame. The letters and the frame are black, contrasting with the white background. The logo is a well-known symbol associated with the General Electric company.
Diagnostic Ultrasound Indications for Use Form GE Vivid E9 with M5S-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode* | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Smali Organ[2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiací31 | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other(4) | P | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ •] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 14 of 23
21
Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular shape. The logo is black and white.
Diagnostic Ultrasound Indications for Use Form GE Vivid E9 with M5Sc-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode* | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | N | |
| Abdominal | 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) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| 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 | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other(4) | N | N | N | N | N | N | N | N | N | N | N | |
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ ◆] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(Please do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 15 of 23
22
Image /page/22/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 letters and the border are black, contrasting with the white background.
Diagnostic Ultrasound Indications for Use Form GE Vivid 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 | |||||||||||
| Anatomy/Region of Interest | B | M | PW | ||||||||
| Doppler | CW | ||||||||||
| Doppler | Color | ||||||||||
| Doppler | Color M | ||||||||||
| Doppler | Power | ||||||||||
| Doppler | Combined | ||||||||||
| Modes | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P |
| Small Organ[2] | |||||||||||
| Neonatal Cephalic | P | P | P | P | P | P | P | P | P | P | P |
| Adult Cephalic | |||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other[4] | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
.
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[ • ] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 16 of 23
23
Image /page/23/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 letters and the border are black, contrasting with the white background.
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 3V-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | ||||||||||||
| Anatomy/Region of Interest | B | M | PW | |||||||||
| Doppler | CW | |||||||||||
| Doppler | Color | |||||||||||
| Doppler | Color M | |||||||||||
| Doppler | Power | |||||||||||
| Doppier | Combined | |||||||||||
| Modes | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | RT3D | |||||||||||
| Mode* | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | P | P | P | P | P | P | P | P | P | P | P | |
| Abdominal | P | P | P | P | P | P | P | P | P | P | P | |
| Pediatric | P | P | P | P | P | P | P | P | P | P | P | |
| Small Organ(2) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | P | P | P | P | P | P | P | P | P | P | P | |
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (4) | P | P | P | P | P | P | P | P | P | P | P | |
| Exam Type, Means of Access | ||||||||||||
| Transesophagea! | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [2] Small organ includes breast, testes, thyroid.
[3] Cardiac is Adult and Pediatric.
[4] Other use includes Urology/Prostate
[*] Combined modes are B/M, B/Color M, B/PWD, B/Color/PWD, B/Power/PWD.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 17 of 23
24
Image /page/24/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 letters and the border are black, contrasting with the white background.
GE Vivid E9 with 6VT-D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 18 of 23
25
Image /page/25/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. There are three small circles placed around the border of the logo.
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with 6T/6T-RS Transducer
· Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode * | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(Please do not write below this line - continue on another page if needed) Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 19 of 23
26
Image /page/26/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 letters and the frame are solid black, contrasting with the white background. The logo is a well-known corporate symbol.
GE Vivid E9 with 6Tc/6Tc-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode * | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac | P | P | P | P | P | P | P | P | P | P | P |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | P | P | P | P | P | P | P | P | P | P | P |
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [1] Combined modes are B/M, B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 20 of 23
27
Image /page/27/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.
GE Vivid E9 with 9T/9T-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | |||||||||||
| Mode * | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ (specify) | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac [3] | P | P | P | P | P | P | P | P | P | P | P | |
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Other (specify) | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transesophageal - | P | P | P | P | P | P | P | P | P | P | P | |
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Transuretheral | ||||||||||||
| Intraoperative (specify) | ||||||||||||
| Intraoperative Neurological | ||||||||||||
| Intravascular | ||||||||||||
| Laparoscopic |
´N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [*] Combined modes are B/M; B/Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD. [3] Cardiac is Adult & Pediatric
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription User (Per 21 CFR 801.109)
Page 21 of 23
28
Image /page/28/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 letters and the border are solid black, contrasting with the white background.
Diagnostic Ultrasound Indications for Use Form
GE Vivid E9 with P2D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | Harmonic | Coded | RT3D |
| Anatomy/ Region of Interest | Doppler | Doppler | Doppler | Doppler | Doppler | Modes | Imaging | Pulse | Mode * | ||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac(3) | P | P | |||||||||
| Peripheral Vascular | P | P | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transurethral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric.
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
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Prescription User (Per 21 CFR 801.109)
Page 22 of 23
29
Image /page/29/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. The letters are enclosed within a circular border, and there are small decorative elements resembling dots or flourishes placed around the circle.
GE Vivid E9 with P6D Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | RT3D | ||||||||||
| Mode* | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal | |||||||||||
| Pediatric | |||||||||||
| Small Organ (specify) | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac [3] | P | P | |||||||||
| Peripheral Vascular | P | P | |||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Other (specify) | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Transuretheral | |||||||||||
| Intraoperative (specify) | |||||||||||
| Intraoperative Neurological | |||||||||||
| Intravascular | |||||||||||
| Laparoscopic |
N = new indication; P = previously cleared by FDA; E = added under Appendix E
Notes: [3] Cardiac is Adult and Pediatric
[*] RT3D is Realtime 3D / 4D volume tissue scan acquisition (with or w/o color flow);
. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Prescription User (Per 21 CFR 801.109)
$\sin(h,p)$
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
510(k): K131514
Page 23 of 23