Versana Active
Device Facts
| Record ID | K191798 |
|---|---|
| Device Name | Versana Active |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Aug 9, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
Device Story
Versana Active is a compact, portable diagnostic ultrasound system for use by trained healthcare professionals in clinical settings. It acquires, processes, and displays ultrasound data using various convex, linear, and sector transducers. Input sources include an operator control panel (keys, trackball, keyboard), external ECG module for gating/triggering, and optional USB/WiFi/LAN connectivity. The system supports B, M, Doppler (PW/CW), Color, Color M, Power, combined modes, harmonic imaging, and coded pulse. It provides image guidance for freehand needle/catheter placement and includes TI-RADS (ACR) for thyroid assessment. Output is viewed on an integrated display monitor or external HDMI-connected display. Data can be exported via USB, DVD, or network. The device aids clinicians in diagnostic imaging and fluid flow analysis, potentially improving patient management through real-time visualization and measurement.
Clinical Evidence
No clinical studies were required to support substantial equivalence. Evidence is based on bench testing, including acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Portable ultrasound system with operator control panel, display, and transducers (convex, linear, sector). Materials are biocompatible per ISO 10993-1. Complies with AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-2-37, and NEMA UD 2. Connectivity via HDMI, USB, LAN, WiFi, and Bluetooth. Supports DICOM (NEMA PS 3.1-3.20).
Indications for Use
Indicated for qualified healthcare professionals to perform diagnostic ultrasound imaging, measurement, and analysis of human body and fluid. Applications include fetal/obstetrics, abdominal (GYN/urological/prostate), pediatric, small organ (breast/thyroid/testes), neonatal/adult cephalic, cardiac (adult/pediatric), peripheral vascular, musculoskeletal, thoracic/pleural, transcranial, transrectal, transvaginal, and interventional guidance (biopsy/fluid drainage/vascular access).
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
- Versana Premier (K182277)
- LOGIQ e (K151028)
- LOGIQ P9 (K181783)
- Vivid iq (K181727)
- Venue Go (K183362)
Related Devices
- K200998 — Versana Active · GE Medical Systems Ultrasound and Primary Care Diagnostics · Jun 11, 2020
- K191792 — Versana Balance · GE Medical Systems Ultrasound and Primary Care Diagnostics · Aug 9, 2019
- K223407 — Versana Essential · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 15, 2023
- K182277 — Versana Premier · GE Medical Systems Ultrasound and Primary Care Diagnostics · Nov 21, 2018
- K210438 — Versana Premier · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 10, 2021
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
### Re: K191798
Trade/Device Name: Versana Active Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2019 Received: July 3, 2019
Dear Tracey Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
August 9, 2019
{1}------------------------------------------------
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
### Indications for Use
510(k) Number (if known) K191798
Device Name
Versana Active
Indications for Use (Describe)
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
| Type of Use (Select one or both, as applicable) |
|-----------------------------------------------------------------------------------------------------|
| <div> <span> <b> ☑ </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
{3}------------------------------------------------
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
Image /page/4/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 border. The logo is colored in a light blue hue. The logo is simple and recognizable, representing the well-known multinational corporation.
### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Versana Active. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
### The following Indication for Use forms are appended:
System: Versana Active Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: E8Cs-RS Transducer: L6-12-RS Transducer: 12L-RS Transducer: L8-18i-RS Transducer: 9L-RS Transducer: LK760-RS
{5}------------------------------------------------
Image /page/5/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 blue circle, creating a recognizable and iconic brand symbol.
### GE Versana Active Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | | | | | | | | | | | |
|-------------------------------|---|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | | N | | N | N | N | N | [8] |
| Abdominal[1] | N | N | N | | N | | N | N | N | N | [3][8] |
| Pediatric | N | N | N | | N | | N | N | N | N | [8] |
| Small Organ [2] | N | N | N | | N | | N | N | N | N | [5][8] |
| Neonatal Cephalic | N | N | N | | N | | N | N | N | N | |
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Cardiac - Adult | N | N | N | N | N | N | N | N | N | N | [8] |
| Cardiac - Pediatric | N | N | N | N | N | N | N | N | N | N | [8] |
| Peripheral Vascular | N | N | N | | N | | N | N | N | N | [8] |
| Musculo-skeletal Conventional | N | N | N | | N | | N | N | N | N | [5][8] |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N | [5][8] |
| Thoracic/Pleural[6] | N | N | N | | N | | N | N | N | N | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | N | N | N | | N | | N | N | N | N | [8] |
| Transvaginal | N | N | N | | N | | N | N | N | N | [8] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | |
| Drainage[4] | N | N | N | | N | N | N | N | N | | [8] |
| Vascular Access[7] | N | N | N | | N | N | N | N | N | | [8] |
| Non-vascular access | N | N | N | | N | N | N | N | N | | [8] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028;
P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[ ] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{6}------------------------------------------------
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 3Sc-RS Transducer
| Clinical Application | Mode of Operation | | | | | | | | | | |
|---------------------------------|-------------------|----|---------------|----|-------|---------|--------------------|---------------------|----------------|-------|-----|
| | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
| | | | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P | P | P | | P | | P | P | P | | [8] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | | |
| Cardiac - Adult | P | P | P | P | P | P | P | P | P | | [8] |
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | | [8] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | P | P1 | P1 | | P | P1 | P | P | P | | [8] |
| Vascular Access[7] | P1 | P1 | P1 | | P1 | P1 | P1 | P1 | P1 | | [8] |
| Non-vascular access | N | N | N | | N | N | N | N | N | | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD:
[♪] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{7}------------------------------------------------
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Active with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|-----------------------------------|----|----|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|-------|
| | | | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{8}------------------------------------------------
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 12S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|----|---------------|----|-------|---------|-------|--------------------|---------------------|---------------------|-------|
| Clinical Application | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse • | Other |
| | | | PW | CW | Color | Color M | Power | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P3 | P3 | P3 | | P3 | | P3 | P3 | P3 | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | P | P | P | P | P | P | P | P | P | | |
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | | P | P | P | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{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 blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 4C-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse Color PW CW Color M Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P [3][8] Pediatric P P P P P P P P [8] Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular P P P P P P P P [8] Musculo-skeletal Conventional P P P P P P P P [8] Musculo-skeletal Superficial Thoracic/Pleural[6] p1 pl p1 P1 P1 P1 P1 p1 [8] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal Transvaginal Intraoperative Interventional Guidance P1 Tissue Biopsy/Fluid Drainage[4] P PI P P P P [8] Vascular Access[7] N N N N N N N 81 Non-vascular access P N N N N P P [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
WD;
21 Coded D
[P] Coded Pulse is for digitally encoded harmonic
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{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 in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 8C-RS Transducer
| | Mode of Operation | | | | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|-----------------------------------|-------------------|----|----|----|-------|---------|-------|----|--------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | P2 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | | P | | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | | |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{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 blue circle. The letters are stylized and appear to be handwritten or cursive. The blue color of the circle is a light shade.
### Diagnostic Ultrasound Indications for Use Form Versana Active with E8C-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse CW Color | Color M PW Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P (8) Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural[6] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal P P P P P P P P [8] Transvaginal P P P P P P P P [8] Intraoperative Interventional Guidance Tissue Biopsy/Fluid Drainage[4] P pl P1 P P P P [8] Vascular Access[7] N N N N N N N [8] Non-vascular access N N N N N N N [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[P] Coded Pulse is for digitally encoded harmonics
(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 Use (Per 21 CFR 801.109)
{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 blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
### Diagnostic Ultrasound Indications for Use Form Versana Active with E8Cs-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse PW CW Color Color M Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P [8] Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural[6] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal P P P P P P P P [8] Transvaginal P P P P P P P P [8] Intraoperative Interventional Guidance Tissue Biopsy/Fluid Drainage[4] P P P P P P P 181 Vascular Access[7] N N N N N N N [8] Non-vascular access N N N N N N N [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[P] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{13}------------------------------------------------
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
### Diagnostic Ultrasound Indications for Use Form Versana Active with L6-12-RS Transducer
| | Mode of Operation | | | | | | | | | | |
|-----------------------------------|-------------------|----|----|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P3 | P | | P | | P | P | P | P | [8] |
| Small Organ [2] | P | P3 | P | | P | | P | P | P | P | [5][8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P3 | P | | P | | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P3 | P | | P | | P | P | P | P | [5][8] |
| Musculo-skeletal Superficial | P | P3 | P | | P | | P | P | P | P | [5][8] |
| Thoracic/Pleural[6] | N | N | N | | N | | N | N | N | N | [8] |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance[4]</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | P | N | N | | P | | P | P | P | P | [8] |
| Vascular Access [7] | P | N | N | | P | | P | P | P | P | [8] |
| Non-vascular access | P | N | N | | N | | N | P | P | P | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate: Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(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 Use (Per 21 CFR 801.109)
{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 shape. The logo is colored in a light blue hue, and the design is simple and recognizable.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 12L-RS Transducer
| | Mode of Operation | | | | | | | | | | |
|---------------------------------|-------------------|----|----|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P1 | P | | P | | P | P | P | P | [8] |
| Small Organ [2] | P | P1 | P | | P | | P | P | P | P | [5][8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P1 | P | | P | | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | P1 | P | | P | | P | P | P | P | [5][8] |
| Musculo-skeletal Superficial | P | P1 | P | | P | | P | P | P | P | [5][8] |
| Thoracic/Pleural[6] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | P | P1 | P1 | | P | | P | P | P | | [8] |
| Vascular Access[7] | P | P1 | P | | P | | P | P | P | | [8] |
| Non-vascular access | P | P2 | P2 | | P2 | | P | P | P | | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate: Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(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 Use (Per 21 CFR 801.109)
{15}------------------------------------------------
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### Diagnostic Ultrasound Indications for Use Form Versana Active with L8-18i-RS 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<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{16}------------------------------------------------
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### Diagnostic Ultrasound Indications for Use Form Versana Active with 9L-RS Transducer
| Clinical Application | | Mode of Operation | | | | | | | | | |
|---------------------------------|----|-------------------|----|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| | B | M | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Pediatric | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Small Organ [2] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [5][8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Musculo-skeletal Conventional | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [5][8] |
| Musculo-skeletal Superficial | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [5][8] |
| Thoracic/Pleural[6] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Vascular Access[7] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] |
| Non-vascular access | P2 | P2 | P2 | | P2 | | P2 | P2 | P2 | P2 | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD:
[P] Coded Pulse is for digitally encoded harmonics
(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 Use (Per 21 CFR 801.109)
{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 in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
### Diagnostic Ultrasound Indications for Use Form Versana Active with LK760-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other | |
|---------------------------------|---|----|---------------|----|-------|---------|--------------------|---------------------|----------------|-------|--|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P1 | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{18}------------------------------------------------
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle.
### 510(k) Summary
K191798
| Date: | July 2, 2019 |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Tracey Ortiz<br>Regulatory Affairs Director<br>GE Healthcare<br>T:(262)676-6120 |
| Secondary Contact Person: | Gao Gan<br>Regulatory Affairs<br>GE Healthcare |
| Device Trade Name: | Versana Active |
| Common/Usual Name: | Diagnostic Ultrasound System…
