Versana Premier
Device Facts
| Record ID | K182277 |
|---|---|
| Device Name | Versana Premier |
| Applicant | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| Product Code | IYN · Radiology |
| Decision Date | Nov 21, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1550 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
Ultrasound imaging, measurement and analysis of the human body as follows: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Tissue Biopsy/Fluid Drainage.
Device Story
Versana Premier is a mobile diagnostic ultrasound system for use by healthcare professionals. It acquires, processes, and displays ultrasound images for clinical applications including fetal, abdominal, cardiac, and musculoskeletal imaging. The system consists of a console with an operator control panel (keyboard, trackball, touch panel), display monitor, and various transducers (convex, linear, sector, mechanical 4D). It operates on AC power or an internal battery. The device supports multiple imaging modes (B, M, PW/CW Doppler, Color, Power, Harmonic, Coded Pulse). Clinicians use the system to perform measurements, capture images, and generate reports. It includes productivity tools like 'Whizz' and 'Breast Care 2.0', and features for needle recognition, bladder volume measurement, and cloud connectivity (Tricefy). The device aids in clinical decision-making by providing real-time visualization and analysis of internal anatomy, facilitating diagnostic assessments and interventional guidance.
Clinical Evidence
No clinical studies were required to support substantial equivalence. The device was evaluated through non-clinical bench testing, including acoustic output measurement, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, electromagnetic, and mechanical safety testing.
Technological Characteristics
Mobile ultrasound console with digital acquisition/processing. Transducers: convex, linear, sector, mechanical 4D. Modes: B, M, PW/CW Doppler, Color, Power, Harmonic, Coded Pulse. Connectivity: DICOM (NEMA PS 3.1-3.20), Tricefy. Safety standards: AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, NEMA UD 2. Biocompatible patient-contact materials.
Indications for Use
Indicated for general purpose diagnostic ultrasound imaging and analysis in fetal/obstetrics, abdominal (including GYN/urological/prostate), pediatric, small organ (breast, testes, thyroid), cardiac, peripheral vascular, musculoskeletal, transcranial, transrectal, transvaginal, and interventional guidance (tissue biopsy/fluid drainage, vascular/non-vascular access) applications.
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
- LOGIQ F8 Expert (K160277)
- LOGIQ P9 (K163596)
- LOGIQ e (K151028)
- Vscan Extend (K180995)
- Vivid iq (K161706)
- Vivid T8 (K160078)
Related Devices
- K210438 — Versana Premier · GE Medical Systems Ultrasound and Primary Care Diagnostics · Sep 10, 2021
- K200138 — Versana Premier · Ge Medical Systems Ultrasound And · Jul 1, 2020
- K223407 — Versana Essential · GE Medical Systems Ultrasound and Primary Care Diagnostics · Feb 15, 2023
- K191792 — Versana Balance · GE Medical Systems Ultrasound and Primary Care Diagnostics · Aug 9, 2019
- K221089 — P12 Elite Series Digital Color Doppler Ultrasound System · Sonoscape Medical Corp. · Sep 15, 2022
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound and Primary Care Diagnostics Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA, WI 53226
November 21, 2018
### Re: K182277
Trade/Device Name: Versana Premier Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic Pulsed Doppler Imaging System Regulatory Class: Class II Product Code: IYN, ITX, IYO Dated: November 10, 2018 Received: November 13, 2018
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/cfpmn/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
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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### Indications for Use
510(k) Number (if known)
K182277
Device Name Versana Premier
#### Indications for Use (Describe)
The Versana Premier are general purposed ultrasound imaging and analysis systems providing digital acquisition, processing and display capability and clinical applications including: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Muscular, Musculoskeletal Conventional, Musculos-keletal Superficial, Transcranial, Transvaginal, Tissue Biopsy/Fluid Drainage.
Type of Use (Select one or both, as applicable)
| <div> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|------------------------------------------------------------------------------------------------------|
| <div> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, giving the logo a distinctive and recognizable appearance.
### Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Versana Premier. 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 Premier Transducer: 4C-RS Transducer: 8C-RS Transducer: 3Sc-RS Transducer: L6-12-RS Transducer: E8C-RS Transducer: RAB2-6-RS Transducer: 6S-RS Transducer: L8-18i-RS Transducer: E8Cs-RS Transducer: BE9Cs-RS Transducer: 12L-RS Transducer: 12S-RS Transducer: LK760-RS Transducer: RIC5-9A-RS
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. A thin blue line encircles the letters, creating a border within the circle.
### GE Versana Premier Ultrasound System
Intended Use: Ultrasound imaging, measurement and 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 | N | N | N | | N | | N | N | N | N | [5][8] |
| Abdominal[1] | N | N | N | | N | | N | N | N | N | [5][6][8] |
| Pediatric | N | N | N | N | N | | N | N | N | N | [8] |
| Small Organ [2] | N | N | N | | N | | N | N | N | N | [6][8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | 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 | [8] |
| Musculo-skeletal Superficial | N | N | N | | N | | N | N | N | N | [8] |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | N | N | N | | N | | N | N | N | N | [8] |
| Vascular Access[7] | N | | N | | N | | N | N | N | N | [8] |
| Non-vascular access | N | | | | | | | N | N | N | [8] |
N = new indication;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. The letters are stylized and connected, and there are small, curved shapes around the letters, adding to the design.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 4C-RS Transducer
| 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 | P | P | P | | P | | P | P | P | P | [8] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [6][8] |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P | | | | P | | P | P | P | P | [8] |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | N | | | | | | | N | N | N | [8] |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
["] Coded Pulse is for digitally encoded harmonic
(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)
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Image /page/6/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 blue circle. The circle has decorative swirls around the perimeter, giving it a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 8C-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 | P | P | | P | | P | P | P | N | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | P | P | P | | P | | P | P | P | N | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | N | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | |
| Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
["] 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)
{7}------------------------------------------------
Image /page/7/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 circular frame. The logo is colored in a shade of blue.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 3Sc-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | 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[3] | P | P | P | P1 | P | P | P | P | P | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transcranial | P | P | P | P3 | P | P | P | P | P | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P | P | | | P | | P | P | P | | [8] | |
| Vascular Access[7] | | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
- [D] 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 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with L6-12-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic 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 | [8] |
| Small Organ [2] | P | | P | | P | | P | P | P | P | [6][8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | P | | P | | P | | P | P | P | P | [8] |
| Musculo-skeletal Conventional | P | | P | | P | | P | P | P | P | [8] |
| Musculo-skeletal Superficial | P | | P | | P | | P | P | P | P | [8] |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| <i>Interventional Guidance[4]</i> | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | |
| Drainage[4] | P | | P | | 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 | [8] |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, 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)
<sup>[&</sup>quot;] Coded Pulse is for digitally encoded harmonics
{9}------------------------------------------------
Image /page/9/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 circular frame. The logo is colored in a shade of blue.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with E8C-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|------------------------------------|-------------------|---|---------------|----|-------|---------|--------------------|------------------|----------------|-------|-----|
| Clinical Application | B | M | Doppler Modes | | | | Combined<br>Modes* | Harmonic Imaging | Coded<br>Pulse | Other | |
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | N | [8] |
| Abdominal[1] | P | P | P | | P | | P | P | P | N | [8] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | N | [8] |
| Transvaginal | P | P | P | | P | | P | P | P | N | [8] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P | | | | P | | P | P | P | N | |
| Vascular Access [7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
- [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, B/Color/PWD, B/Power/PWD;
- [*] Coded Pulse is for digitally encoded harmonics
(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 'GE' intertwined in a stylized script, enclosed within a circular frame. The logo is colored in a shade of blue.
#### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with RAB2-6-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | N | [5][8] | |
| Abdominal[1] | P | P | P | | P | | P | P | P | N | [5][8] | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P | | | | P | P | P | P | P | N | [8] | |
| Vascular Access[7] | | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
- [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, B/Color/PWD, B/Power/PWD;
- [*] 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 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 6S-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | P | P | P | P | P | P | P | P | P | | [8] |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | P | P | P | P | P | P | P | P | P | | [8] |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| 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<br>Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
- [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, B/Color/PWD, B/Power/PWD;
- [*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{12}------------------------------------------------
Image /page/12/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 circular frame. The logo is colored in a shade of blue.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with L8-18i-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | | | Mode of Operation | | | | | | | | |
|-----------------------------------|---|---|-------------------|----|-------|---------|-------|-----------------|------------------|--------------|-------|
| | B | M | PW | CW | Color | Color M | Power | Combined Modes* | Harmonic Imaging | Coded Pulse• | Other |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | P | P | P | | P | | P | P | P | | [8] |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | | [8] |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | P | P | P | | P | | P | P | P | | [8] |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| 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 K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
- [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, B/Color/PWD, B/Power/PWD;
- [*] 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 in a stylized, cursive font. The letters are white and are set against a blue circular background. The outer edge of the blue circle has a swirling, wave-like design.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with E8Cs-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application<br>Anatomy/Region of Interest | B | M | Doppler Modes | | | | | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | Other |
|----------------------------------------------------|---|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | N | |
| Abdominal[1] | P | P | P | | P | | P | P | P | N | [6][8] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac [3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | N | [8] |
| Transvaginal | P | P | P | | P | | P | P | P | N | [8] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P | P | P | | P | | P | P | P | N | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by
#### FDA K160078
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
- [*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
{14}------------------------------------------------
Image /page/14/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 circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with BE9CS-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | |
|-------------------------------|-------------------|---|----|----|-------|---------------|-------|--------------------|---------------------|----------------|-------|
| Clinical Application | B | M | | | | Doppler Modes | | | | | Other |
| | | | PW | CW | Color | Color M | Power | Combined<br>Modes* | Harmonic<br>Imaging | Coded<br>Pulse | |
| 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 | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | | [8] |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid | P | P | P | | P | | P | P | P | | |
| Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596; P= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
- [3] Cardiac includes Adult and Pediatric;
- [4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
- [5] 3D/4D imaging Mode
- [6] Elastography imaging-Elasticity
- [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, B/Color/PWD, B/Power/PWD;
- [*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE JE NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
{15}------------------------------------------------
Image /page/15/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 circle has a swirling pattern around the letters, giving it a dynamic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 12L-RS Transducer
Intended Use: Ultrasound imaging, measurement and 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 | |
| <i>Anatomy/Region of Interest</i> | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P1 | | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] | |
| Small Organ [2] | P1 | | P1 | | P1 | | P1 | P1 | P1 | P1 | [6][8] | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac[3] | | | | | | | | | | | | |
| Peripheral Vascular | P1 | | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] | |
| Musculo-skeletal Conventional | P1 | | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] | |
| Musculo-skeletal Superficial | P1 | | P1 | | P1 | | P1 | P1 | P1 | P1 | [8] | |
| Thoracic/Pleural | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| <i>Exam Type, Means of Access</i> | | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| <i>Interventional Guidance</i> | | | | | | | | | | | | |
| Tissue Biopsy/Fluid<br>Drainage[4] | P2 | | | | P2 | | P2 | P2 | P2 | P2 | [8] | |
| Vascular Access[7] | P2 | | P2 | | P2 | | P2 | P2 | P2 | P2 | [8] | |
| Non-vascular access | N | | | | N | | N | N | N | N | [8] | |
N = new indication; P= previously cleared by FDA K160277; P1= previously cleared by FDA K163596;
P2= previously cleared by FDA K151028; P3= previously cleared by FDA K161706, P4= previously cleared by FDA K160078
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Cardiac includes Adult and Pediatric;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] 3D/4D imaging Mode
[6] Elastography imaging-Elasticity
[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, B/Color/PWD, B/Power/PWD;
["] 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)
{16}------------------------------------------------
Image /page/16/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 circle has decorative swirls or flourishes around the perimeter, giving it a classic and recognizable appearance.
### Diagnostic Ultrasound Indications for Use Form
#### Versana Premier with 12S-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| | Mode of Operation | | | | | | | | | | | |
|------------------------------------|-----…
