Not Found
No
The document describes a standard diagnostic ultrasound system with digital processing capabilities but makes no mention of AI or ML features, algorithms, or training/test data.
No
The device is described as a "general purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis", not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Versana Active is a general purpose diagnostic ultrasound system..." and further details its use for "ultrasound imaging, measurement, display and analysis of the human body and fluid." The "Device Description" also refers to it as a "general purpose, Track 3, diagnostic ultrasound system."
No
The device description explicitly states it is a "general purpose, Track 3, diagnostic ultrasound system" and includes physical components such as an "operator control panel, display monitor and transducers." It also mentions being powered by an electrical outlet or internal battery, and having various ports and connections for external devices. This indicates it is a hardware-based system with integrated software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood and tissue samples, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Versana Active Function: The Versana Active is a diagnostic ultrasound system. It uses sound waves to create images of internal body structures. It does not examine specimens in vitro (outside the body).
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This is an in vivo (within the body) diagnostic method.
The information provided about the device description, imaging modality (Ultrasound), anatomical sites, and intended user all support that this is an in vivo diagnostic imaging device, not an IVD.
N/A
Intended Use / Indications for Use
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Versana Active is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The Versana Active is a compact, portable system, the device includes operator control panel, display monitor and transducers.
The system provides digital acquisition, processing and display capability.
The system can be powered through an electrical wall outlet for long term use or from an internal battery for a short time use. The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device.
The Versana Active design enables the system to be attached to an optional mobile cart.
The variety of transducers include convex, linear and sector. The access types include trans- body surface, transrectal, transvaginal and transcranial.
Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning.
The system has a HDMI port connection. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
Mentions image processing
The system provides digital acquisition, processing and display capability.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified and trained healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission. Versana Active, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K182277, K151028, K181783, K181727, K183362
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 Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K191798
Trade/Device Name: Versana Active Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: July 2, 2019 Received: July 3, 2019
Dear Tracey Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
August 9, 2019
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K191798
Device Name
Versana Active
Indications for Use (Describe)
The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circular border. The logo is colored in a light blue hue. The logo is simple and recognizable, representing the well-known multinational corporation.
Indications for Use Forms
The following forms represent indications with clinical applications and exam types along with the modes of operation for the Versana Active. Combinations identified "P" represents those previously cleared with another GE Ultrasound system. Combinations identified as "N" are new.
The following Indication for Use forms are appended:
System: Versana Active Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 12S-RS Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: E8Cs-RS Transducer: L6-12-RS Transducer: 12L-RS Transducer: L8-18i-RS Transducer: 9L-RS Transducer: LK760-RS
5
Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script. The letters are enclosed within a blue circle, creating a recognizable and iconic brand symbol.
GE Versana Active Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | Doppler Modes | Combined | |||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | PW | CW | Color | Color M | Power | ||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | [8] | ||
| Abdominal[1] | N | N | N | N | N | N | N | N | [3][8] | ||
| Pediatric | N | N | N | N | N | N | N | N | [8] | ||
| Small Organ [2] | N | N | N | N | N | N | N | N | [5][8] | ||
| Neonatal Cephalic | N | N | N | N | N | N | N | N | |||
| Adult Cephalic | N | N | N | N | N | N | N | N | N | N | |
| Cardiac - Adult | N | N | N | N | N | N | N | N | N | N | [8] |
| Cardiac - Pediatric | N | N | N | N | N | N | N | N | N | N | [8] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | [8] | ||
| Musculo-skeletal Conventional | N | N | N | N | N | N | N | N | [5][8] | ||
| Musculo-skeletal Superficial | N | N | N | N | N | N | N | N | [5][8] | ||
| Thoracic/Pleural[6] | N | N | N | N | N | N | N | N | [8] | ||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | N | N | N | N | N | N | N | N | N | ||
| Transesophageal | |||||||||||
| Transrectal | N | N | N | N | N | N | N | N | [8] | ||
| Transvaginal | N | N | N | N | N | N | N | N | [8] | ||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid | |||||||||||
| Drainage[4] | N | N | N | N | N | N | N | N | [8] | ||
| Vascular Access[7] | N | N | N | N | N | N | N | N | [8] | ||
| Non-vascular access | N | N | N | N | N | N | N | N | [8] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028;
P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
[2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[ ] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
6
Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
Diagnostic Ultrasound Indications for Use Form Versana Active with 3Sc-RS Transducer
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | Combined | ||||||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| PW | CW | Color | Color M | Power | |||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P | P | P | P | P | P | P | [8] | |||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | ||
| Cardiac - Adult | P | P | P | P | P | P | P | P | P | [8] | |
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | [8] | |
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural[6] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | |||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | P | P | P | P | P | P | P | P | P | ||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage[4] | P | P1 | P1 | P | P1 | P | P | P | [8] | ||
| Vascular Access[7] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Non-vascular access | N | N | N | N | N | N | N | N | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD:
[♪] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
7
Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
Diagnostic Ultrasound Indications for Use Form
Versana Active with 6S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | | Combined
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 | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | | | | | | | | | | | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | 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 K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
8
Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
Diagnostic Ultrasound Indications for Use Form Versana Active with 12S-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | Doppler Modes | Combined | |||||||
| 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 | ||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | P3 | P3 | P3 | P3 | P3 | P3 | P3 | ||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | P | P | P | P | P | P | P | P | P | ||
| Cardiac - Pediatric | P | P | P | P | P | P | P | P | P | ||
| Peripheral Vascular | |||||||||||
| Musculo-skeletal Conventional | |||||||||||
| Musculo-skeletal Superficial | |||||||||||
| Thoracic/Pleural[6] | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | 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 K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
9
Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
Diagnostic Ultrasound Indications for Use Form Versana Active with 4C-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse Color PW CW Color M Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P [3][8] Pediatric P P P P P P P P [8] Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular P P P P P P P P [8] Musculo-skeletal Conventional P P P P P P P P [8] Musculo-skeletal Superficial Thoracic/Pleural[6] p1 pl p1 P1 P1 P1 P1 p1 [8] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal Transvaginal Intraoperative Interventional Guidance P1 Tissue Biopsy/Fluid Drainage[4] P PI P P P P [8] Vascular Access[7] N N N N N N N 81 Non-vascular access P N N N N P P [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
[2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
WD;
21 Coded D
[P] Coded Pulse is for digitally encoded harmonic
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
10
Image /page/10/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
Diagnostic Ultrasound Indications for Use Form Versana Active with 8C-RS Transducer
| | Mode of Operation | | | | | | | | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other |
|-----------------------------------|-------------------|----|----|----|-------|---------|-------|----|--------------------|---------------------|----------------|-------|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | P | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | P2 | |
| Adult Cephalic | | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | | P | | P | P | P | P | | |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P | P | | P | | P | P | P | P | | |
| Musculo-skeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | | |
| Other | | | | | | | | | | | | |
| 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: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
11
Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and appear to be handwritten or cursive. The blue color of the circle is a light shade.
Diagnostic Ultrasound Indications for Use Form Versana Active with E8C-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse CW Color | Color M PW Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P (8) Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural[6] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal P P P P P P P P [8] Transvaginal P P P P P P P P [8] Intraoperative Interventional Guidance Tissue Biopsy/Fluid Drainage[4] P pl P1 P P P P [8] Vascular Access[7] N N N N N N N [8] Non-vascular access N N N N N N N [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[P] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
12
Image /page/12/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are stylized and connected, creating a recognizable and iconic symbol for the company.
Diagnostic Ultrasound Indications for Use Form Versana Active with E8Cs-RS Transducer
Mode of Operation Clinical Application Doppler Modes Combined Harmonic Coded Other B M Modes* Imaging Pulse PW CW Color Color M Power Anatomy/Region of Interest Ophthalmic Fetal / Obstetrics P P P P P P P P [8] Abdominal[1] P P P P P P P P [8] Pediatric Small Organ [2] Neonatal Cephalic Adult Cephalic Cardiac - Adult Cardiac - Pediatric Peripheral Vascular Musculo-skeletal Conventional Musculo-skeletal Superficial Thoracic/Pleural[6] Other Exam Type, Means of Access Transcranial Transesophageal Transrectal P P P P P P P P [8] Transvaginal P P P P P P P P [8] Intraoperative Interventional Guidance Tissue Biopsy/Fluid Drainage[4] P P P P P P P 181 Vascular Access[7] N N N N N N N [8] Non-vascular access N N N N N N N [8]
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[P] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
13
Image /page/13/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a blue circle. The letters are white, and the circle has a slightly lighter blue outline, giving it a three-dimensional appearance.
Diagnostic Ultrasound Indications for Use Form Versana Active with L6-12-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | |||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P3 | P | P | P | P | P | P | [8] | ||
| Small Organ [2] | P | P3 | P | P | P | P | P | P | [5][8] | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | P | P3 | P | P | P | P | P | P | [8] | ||
| Musculo-skeletal Conventional | P | P3 | P | P | P | P | P | P | [5][8] | ||
| Musculo-skeletal Superficial | P | P3 | P | P | P | P | P | P | [5][8] | ||
| Thoracic/Pleural[6] | N | N | N | N | N | N | N | N | [8] | ||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance[4] | |||||||||||
| Tissue Biopsy/Fluid Drainage[4] | P | N | N | P | P | P | P | P | [8] | ||
| Vascular Access [7] | P | N | N | P | P | P | P | P | [8] | ||
| Non-vascular access | P | N | N | N | N | P | P | P | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate: Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
14
Image /page/14/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circular shape. The logo is colored in a light blue hue, and the design is simple and recognizable.
Diagnostic Ultrasound Indications for Use Form Versana Active with 12L-RS Transducer
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | |||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | |||||||||||
| Pediatric | P | P1 | P | P | P | P | P | P | [8] | ||
| Small Organ [2] | P | P1 | P | P | P | P | P | P | [5][8] | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | P | P1 | P | P | P | P | P | P | [8] | ||
| Musculo-skeletal Conventional | P | P1 | P | P | P | P | P | P | [5][8] | ||
| Musculo-skeletal Superficial | P | P1 | P | P | P | P | P | P | [5][8] | ||
| Thoracic/Pleural[6] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage[4] | P | P1 | P1 | P | P | P | P | [8] | |||
| Vascular Access[7] | P | P1 | P | P | P | P | P | [8] | |||
| Non-vascular access | P | P2 | P2 | P2 | P | P | P | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
[1] Abdominal includes GYN and Urological/Prostate: Notes:
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
15
Image /page/15/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
Diagnostic Ultrasound Indications for Use Form Versana Active with L8-18i-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical Application | B | M | PW | CW | Color | Color M | Power | Combined | |||
| 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 | ||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | P | P | P | P | P | P | P | ||||
| Musculo-skeletal Conventional | P | P | P | P | P | P | P | ||||
| Musculo-skeletal Superficial | P | P | P | P | P | P | P | ||||
| Thoracic/Pleural[6] | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage[4] | |||||||||||
| Vascular Access[7] | |||||||||||
| Non-vascular access |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
16
Image /page/16/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
Diagnostic Ultrasound Indications for Use Form Versana Active with 9L-RS Transducer
| Clinical Application | Mode of Operation | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| B | M | PW | CW | Color | Color M | Power | Combined | ||||
| Modes* | Harmonic | ||||||||||
| Imaging | Coded | ||||||||||
| Pulse | Other | ||||||||||
| Anatomy/Region of Interest | |||||||||||
| Ophthalmic | |||||||||||
| Fetal / Obstetrics | |||||||||||
| Abdominal[1] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Pediatric | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Small Organ [2] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [5][8] | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Musculo-skeletal Conventional | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [5][8] | ||
| Musculo-skeletal Superficial | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [5][8] | ||
| Thoracic/Pleural[6] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid Drainage[4] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Vascular Access[7] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [8] | ||
| Non-vascular access | P2 | P2 | P2 | P2 | P2 | P2 | P2 | P2 | [8] |
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD:
[P] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Prescription Use (Per 21 CFR 801.109)
17
Image /page/17/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle that surrounds them.
Diagnostic Ultrasound Indications for Use Form Versana Active with LK760-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | B | M | Doppler Modes | | | | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other | |
|---------------------------------|---|----|---------------|----|-------|---------|--------------------|---------------------|----------------|-------|--|
| Anatomy/Region of Interest | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculo-skeletal Conventional | P | P1 | P | | P | | P | P | P | P | |
| Musculo-skeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[6] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid Drainage[4] | | | | | | | | | | | |
| Vascular Access[7] | | | | | | | | | | | |
| Non-vascular access | | | | | | | | | | | |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028; P2=previously cleared by FDA K183362; P3= previously cleared by FDA K181783;
Notes: [1] Abdominal includes GYN and Urological/Prostate;
- [2] Small Organ includes breast, testes, thyroid;
[3] Contrast Imaging;
[4] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[5] Elastography imaging-Elasticity
[6] For detection of fluid and pleural motion/sliding;
[7] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[8] Image guidance for freehand needle/catheter placement;
[*] Combined modes are B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or CWD, B/Power/PWD or CWD;
[*] Coded Pulse is for digitally encoded harmonics
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The letters are also blue, matching the color of the circle.
510(k) Summary
| Date: | July 2, 2019 |
|---|---|
| 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 | |
| Secondary Contact Person: | Gao Gan |
| Regulatory Affairs | |
| GE Healthcare | |
| Device Trade Name: | Versana Active |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code: | Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- |
| IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560, | |
| 90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570, | |
| 90-ITX | |
| Primary Predicate Device: | Versana Premier (K182277) |
| Secondary Predicate Device(s): | LOGIQ e (K151028) |
| LOGIQ P9 (K181783) | |
| Vivid iq (K181727) | |
| Predicates used only for changes to transducer applications: | |
| Venue Go (K183362) | |
| Device Description: | The Versana Active is a general purpose, Track 3, diagnostic |
| ultrasound system for use by qualified and trained healthcare | |
| professionals. The Versana Active is a compact, portable system, | |
| the device includes operator control panel, display monitor and | |
| transducers. |
The system provides digital acquisition, processing and display
capability.
The system can be powered through an electrical wall outlet for
long term use or from an internal battery for a short time use. |
19
Image /page/19/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by swirling, decorative elements, also in blue, giving the logo a classic and recognizable appearance.
The operator control panel includes function keys, trackball and an alfa-numeric keyboard as input sources of the device.
The Versana Active design enables the system to be attached to an optional mobile cart.
The variety of transducers include convex, linear and sector. The access types include trans- body surface, transrectal, transvaginal and transcranial.
Data can be imported or exported by DVD, USB, LAN or WiFi if the USB wireless adapter is connected to the system. An external ECG module has been verified to use as input for gating/triggering during scanning.
The system has a HDMI port connection. The system has an option for an external Printer USB Isolator for printers to connect. The system supports one way, Bluetooth communication capability from the system to a personal device to allow for sharing of the patient's data/images when the Bluetooth USB adapter is connected to the system.
- Intended Use: The Versana Active is a general purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. Versana Active clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN and Urological/Prostate), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleural, Transcranial, Transrectal, Transvaginal, and Tissue Biopsy/Fluid Drainage.
- Technology: The Versana Active employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices Substantial Equivalence: The Versana Active system is substantially equivalent to the predicate devices. The following is an overview of the differences between the proposed Versana Active and the predicates. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis.
- . The Versana Active and predicate Versana Premier (K182277) have similar clinical indications for use; however, the applications of Neonatal Cephalic, Adult
20
Image /page/20/Picture/0 description: The image shows the General Electric (GE) logo, which is a blue circle with the letters 'GE' in a stylized script in the center. The letters are white and have a vintage look. The circle is surrounded by a pattern of swirling lines, also in white, that give the impression of movement or energy.
Cephalic and Thoracic/Pleural is being added which have been cleared on LOGIQ e (K151028).
- The Versana Active and predicate Versana Premier ● (K182277) have similar imaging modes; however, Contrast Imaging is being added which has been cleared on LOGIQ P9 (K181783)
- . The Versana Active and predicate Versana Premier (K182277) have similar transducers, however, some of the transducers applications and modes are different.
- 3Sc-RS transducer: Adult Cephalic, Thoracic/Pleural -& Vascular Access are being added per LOGIQ e (K151028); Non-Vascular Access is being added; M mode and PW mode added to Tissue Biopsy/Fluid Drainage per LOGIO e (K151028):
- -6S-RS transducer: Neonatal Cephalic is being added per LOGIQ e (K151028);
- 4C-RS transducer: Thoracic/Pleural is being added per LOGIQ e (K151028); Vascular access is being added; M mode and PW mode added Tissue Biopsy/Fluid Drainage per LOGIO e (K151028); M mode, PW mode, Color mode and Power mode added to Non-Vascular access:
- 8C-RS transducer: B Mode, M mode, PW mode, Color mode, Power mode, Combined mode and Harmonic Imaging added to Neonatal Cephalic per LOGIQ e (K151028); Coded Mode added to Neonatal Cephalic per Venue Go (K183362).
- E8C-RS transducer: Vascular access and Non-vascular access are being added: M mode and PW mode added to Tissue Biopsy/Fluid Drainage per LOGIQe (K151028);
- -E8Cs-RS transducer: Vascular access and Nonvascular access are being added;
- L6-12-RS transducer: Thoracic/Pleural is being added; M mode added to Pediatric, Small Organ (includes breast, testes, thyroid), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial per LOGIQ P9 (K181783); M mode and PW mode added to Tissue Biopsy/Fluid Drainage; M mode and PW mode added to Vascular Access; M mode, PW mode, Color mode and Power mode added to Non-vascular access:
21
Image /page/21/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'g' and 'e' intertwined in a stylized script, enclosed within a blue circle. The circle has small white teardrop shapes around its perimeter, giving it a dynamic, swirling appearance.
GE Healthcare
510(k) Premarket Notification Submission
12L-RS transducer: Thoracic/Pleural is being added per LOGIQ e (K151028); M mode added to Pediatric, Small Organ (includes breast, testes, thyroid), Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial per LOGIO e (K151028): M mode and PW mode added to Tissue Biopsy/Fluid Drainage per LOGIQ e (K151028); M mode added to Vascular Access per LOGIQ e (K151028); M mode, PW mode, Color mode and Power mode added to Non-vascular access per Venue Go (K183362).
- LK760-RS transducers: M mode added to -Musculoskeletal Conventional per LOGIQ e (K151028).
- 12S-RS transducer: Neonatal Cephalic is being added per LOGIQ P9 (K181783);
Adding the 9L-RS transducer which was cleared in LOGIQ e (K151028); Non-vascular access is being added to the 9L-RS per Venue Go (K183362);
- Features added from LOGIQ P9 (K181783): Contrast ● Imaging.
- Features added from Vivid iq (K181727): Standby
- Adding new features called TI-RADS (ACR) based on the American College of Radiology (ACR).
- . The Versana Active and predicate Versana Premier (K182277) 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 Active and predicate Versana Premier ● (K182277) have been designed in compliance with approved electrical and physical safety standards.
Summary of Non-Clinical Tests:
Versana Active 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 Active complies with voluntary standards:
22
Image /page/22/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. There are decorative, curved elements surrounding the circle, giving it a distinctive and recognizable appearance. The logo is simple, yet iconic, representing the well-known multinational conglomerate.
-
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 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 Active, did not require clinical studies to support substantial equivalence.
23
Image /page/23/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 is decorated with swirling, leaf-like designs around its perimeter. The logo is simple, yet recognizable, representing the multinational conglomerate corporation.
Conclusion: GE Healthcare considers the Versana Active to be as safe, as effective, and performance is substantially equivalent to the predicate devices.