Not Found
No
The document describes a standard ultrasound system with digital processing capabilities but makes no mention of AI, ML, or related technologies in the intended use, device description, or performance studies.
No
The Versana Premier is described as a "general purpose, diagnostic ultrasound system" and its intended use is for "ultrasound imaging and analysis systems," indicating it is used for diagnosis rather than treatment.
Yes
The "Device Description" explicitly states, "The Versana Premier is a general purpose, diagnostic ultrasound system." The "Intended Use / Indications for Use" section also describes the system as one that provides "digital acquisition, processing and display capability and clinical applications," which are characteristic of diagnostic devices.
No
The device description explicitly states that the system consists of a mobile console, operator control panel, display monitor, and transducers, which are all hardware components.
Based on the provided information, the Versana Premier is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The intended use and device description clearly state that the Versana Premier is an ultrasound imaging and analysis system used for imaging and visualizing internal structures of the human body in vivo. It does not analyze samples like blood, urine, or tissue outside of the body.
- The device description focuses on imaging capabilities and anatomical sites. The information provided details the types of transducers, access methods, and anatomical regions the system is used for, all of which are consistent with an in-vivo imaging device.
Therefore, the Versana Premier is a diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transvaginal, Tissue Biopsy/Fluid Drainage.
Product codes (comma separated list FDA assigned to the subject device)
IYN, ITX, IYO
Device Description
The Versana Premier is a general purpose, diagnostic ultrasound system for use by qualified healthcare professionals. The system consists of a mobile console, operator control panel, display monitor and some transducers. The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. The operator control panel includes an ultrasound keyboard, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound imaging
Anatomical Site
Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac, Muscular, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transvaginal, Tissue Biopsy/Fluid Drainage.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified healthcare professionals / Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LOGIQ F8 Expert (K160277), LOGIQ P9 (K163596), LOGIQ e (K151028), Vscan Extend (K180995), Vivid iq (K161706), Vivid T8 (K160078)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
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
1
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
2
Indications for Use
510(k) Number (if known)
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the 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
Modes* | Harmonic
Imaging | Coded
Pulse | Other | | |
|------------------------------------|---|---|---------------|----|-------|--------------------|---------------------|----------------|-------|---|-----------|
| | | | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| 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 | [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
Modes* | Harmonic
Imaging | Coded
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
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 | |||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| 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 | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| 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 | ||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| Anatomy/Region of Interest | ||||||||||||
| 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 | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | P | P | P | P3 | P | P | P | P | P | |||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid | ||||||||||||
| 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)
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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
Modes* | Harmonic Imaging | Coded
Pulse | Other | |
|-----------------------------------|---|---|---------------|----|-------|---------|--------------------|------------------|----------------|-------|--------|
| | | | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| 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 | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance[4] | | | | | | | | | | | |
| 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)
["] 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 | |||||||
| Modes* | Harmonic Imaging | Coded | |||||||||
| 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 | |||||||||||
| 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 | ||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| 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 | ||||||||||||
| 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 | |||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| 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 | |||||||||||
| 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 | |
| Anatomy/Region of Interest | |||||||||||
| 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 | |||||||||||
| 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 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
Anatomy/Region of Interest | B | M | Doppler Modes | | | | | Combined
Modes* | Harmonic
Imaging | Coded
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
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 | ||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| 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 | ||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| Anatomy/Region of Interest | ||||||||||||
| 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 | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid | ||||||||||||
| 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 | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | Doppler Modes | Combined | ||||||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| PW | CW | Color | Color M | Power | ||||||||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | p1 | p1 | p1 | p1 | p1 | p1 | p1 | p1 | p1 | p1 | [8] | |
| Small Organ [2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac[3] | p4 | p4 | p4 | p4 | p4 | p4 | N | p4 | p4 | [8] | ||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | ||||||||||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural | ||||||||||||
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | p3 | p3 | p3 | p3 | p3 | p3 | p3 | p3 | p3 | |||
| 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 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)
17
Image /page/17/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 LK760-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 | ||||
| Modes* | Harmonic | |||||||||||
| Imaging | Coded | |||||||||||
| Pulse | Other | |||||||||||
| Anatomy/Region of Interest | ||||||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ [2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac[3] | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculo-skeletal Conventional | p2 | p2 | p2 | p2 | p2 | p2 | N | |||||
| Musculo-skeletal Superficial | ||||||||||||
| Thoracic/Pleural | ||||||||||||
| 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 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)
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 circular frame. The logo is colored in a shade of blue.
Diagnostic Ultrasound Indications for Use Form
Versana Premier with RIC5-9A-RS Transducer
Intended Use: Ultrasound imaging, measurement and analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other | ||||||
|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | Color | Color M | Power | |||
| Anatomy/Region of Interest | PW | CW | ||||||
| Ophthalmic | ||||||||
| Fetal / Obstetrics | p1 | p1 | p1 | p1 | p1 | [5][8] | ||
| Abdominal[1] | p1 | p1 | p1 | p1 | p1 | [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 | N | N | N | N | ||||
| Transvaginal | p1 | p1 | p1 | p1 | ||||
| Intraoperative | ||||||||
| Interventional Guidance | ||||||||
| Tissue Biopsy/Fluid Drainage[4] | N | N | N | 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; P = previously cleared by FDA K161706, P P = 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
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19
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
| Date: | August 17, 2018 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Tracey Ortiz |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)676-6120 | |
| tracey.ortiz@ge.com | |
| Secondary Contact Person: | Gao Gan |
| Regulatory Affairs | |
| GE Healthcare | |
| Device Trade Name: | Versana Premier |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, |
| 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, | |
| 90-ITX | |
| Primary Predicate Device: | LOGIQ F8 Expert (K160277) |
| Secondary Predicate Device(s): | LOGIQ P9 (K163596) |
| LOGIQ e (K151028) | |
| Vscan Extend (K180995) | |
| Predicates used only for changes to transducer applications: | |
| Vivid iq (K161706) and Vivid T8 (K160078) | |
| Device Description: | The Versana Premier is a general purpose, diagnostic ultrasound |
| system for use by qualified healthcare professionals. The system | |
| consists of a mobile console, operator control panel, display | |
| monitor and some transducers. |
The console provides digital acquisition, processing and display
capability. The system has an internal battery to allow for
acquisition while the system is not plugged into a power source.
The operator control panel includes an ultrasound keyboard,
trackball, an alfa-numeric keyboard and a touch panel as input
sources of the device. |
Image /page/19/Picture/4 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 enclosed within a circular frame, and the entire logo is colored in a shade of blue.
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Image /page/20/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 blue circle has a swirling pattern around the letters, giving the logo a dynamic and recognizable appearance.
The variety of transducers include convex, linear, sector and mechanical 4D transducers. The access types include trans- body surface, transrectal, transvaginal and transcranial. Intended Use: 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, Peripheral Vascular, Musculos-keletal Conventional, Musculos-keletal Superficial, Transcranial, Transrectal, Transvaginal, Tissue Biopsy/Fluid Drainage.
Technology: The Versana Premier employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices Substantial Equivalence:
The Versana Premier system is a new platform substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed Versana Premier and the predicates LOGIQ F8 Expert (K160277). The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
- . The Versana Premier and predicate LOGIQ F8 Expert (K160277) have same clinical indications for use.
- The Versana Premier and predicate LOGIQ F8 Expert ● (K160277) have similar imaging modes.
- The Versana Premier and predicate LOGIO F8 Expert . (K160277) systems transducers are similar. Coded Pulse mode is added to 8C-RS, E8C-RS, RAB2-6-RS, E8Cs-RS transducers. Non-vascular access application is added to 4C-RS transducer. Vascular access and Non-vascular access are added to L6-12-RS transducer. The RIC5-9A-RS transducer is added to Versana Premier which was cleared in LOGIQ P9 (K163596) andhe applications of Transrectal, Tissue Biopsy/Fluid Drainage are being added. The Versana Premier includes the 12L-RS transducer which was cleared in LOGIO P9 (K163596) however Coded Pulse mode and Non-vascular access are being added. The Versana Premier includes the LK760-RS transducer which was cleared in LOGIQ e (K151028) and Coded Pulse mode is being added. The Versana Premier includes the 12S-RS transducer which was
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Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular frame. The color of the logo is a light blue.
GE Healthcare
510(k) Premarket Notification Submission
cleared in LOGIO P9 (K163596) and Power Doppler Imaging mode is being added. The applications of Cardiac is being added per Vivid T8 (K160078) and Transcranial is being added per Vivid iq (K161706) to the 12S-RS.
- Features added from LOGIQ P9 (K163596): Vocal, . Breast Productivity, Thyroid productivity, Tissue Velocity M Mode image (TVM).
- . Features added from LOGIQ e (K151028): Needle recognition and Follow-Up tool.
- . Features added from Vscan Extend (180995): Auto Bladder Volume and Tricefy Uplink.
- Adding new features called Breast Care 2.0 and Whizz.
- Adding some new hardware ●
- The Versana Premier and predicate LOGIO F8 Expert ● (K160277) have similar capability in terms of performing measurements, capturing digital images, reviewing and reporting studies.
- The system is manufactured with materials which have . been evaluated and found to be safe for the intended use of the device.
- . The system has acoustic power levels which are below the applicable FDA limits.
- The Versana Premier and predicate LOGIO F8 Expert ● (K160277) have been designed in compliance with approved electrical and physical safety standards.
Summary of Non-Clinical Tests:
Versana Premier has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to comply with applicable medical device safety standards. The Versana Premier complies with voluntary standards:
- AAMI/ANSI ES60601-1, Medical Electrical Equipment -. Part 1: General requirements for basic safety and essential performance - 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
- IEC60601-1-2, Medical electrical equipment Part 1-2: ● General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic
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Image /page/22/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.
GE Healthcare
510(k) Premarket Notification Submission
disturbances - Requirements and tests - Edition 4.0 2014-02
- IEC60601-2-37, Medical electrical equipment Part 2-37: . Particular requirements for the basic safety and essential performance of ultrasonic medical diagnostic and monitoring equipment - Edition 2.1 2015
- ISO10993-1, Biological evaluation of medical devices -● Part 1: Evaluation and testing within a risk management process - Fourth edition 2009-10-15
- NEMA UD 2, Acoustic Output Measurement Standard for . Diagnostic Ultrasound Equipment - revisions 3 - 2004 (R2009)
- ISO14971, Application of risk management to medical . devices, 2007
- NEMA PS 3.1 3.20, Digital Imaging and . Communications in Medicine (DICOM) Set - 3.1 - 3.20 (2016)
The following quality assurance measures are applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews
- Testing on unit level (Module verification) ●
- Integration testing (System verification) ●
- Performance testing (Verification) .
- Safety testing (Verification) ●
Transducer material and other patient contact materials are biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Versana Premier, did not require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Versana Premier to be as safe, as effective, and performance is substantially equivalent to the predicate devices.