Not Found
No
The document describes a standard diagnostic ultrasound system with digital processing capabilities but does not mention any AI or ML features.
No.
The device is described as a "general purpose diagnostic ultrasound system" intended for "ultrasound imaging, measurement, display and analysis of the human body and fluid," which focuses on diagnosis rather than providing treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The Versana Balance 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" across various clinical applications.
No
The device description explicitly states it is a "mobile console that includes an operator control panel, display monitor and transducers," which are hardware components.
Based on the provided information, the Versana Balance is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes an imaging system used to visualize internal structures, not a device used to examine specimens derived from the human body (like blood, urine, or tissue samples) outside of the body.
- Device Description: The description details a console, transducers, and imaging capabilities. It doesn't mention any components or processes related to the analysis of biological specimens.
- Input Imaging Modality: The input modalities are "Ultrasonic pulsed doppler imaging system" and "Ultrasonic Pulsed Echo Imaging System," which are imaging techniques, not methods for analyzing biological samples.
IVD devices are specifically designed to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The Versana Balance is a diagnostic imaging system that uses ultrasound waves to create images of the body itself.
N/A
Intended Use / Indications for Use
The Versana Balance 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 Balance 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 Balance is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and 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. Acquisition can also be done while the system is connected to an AC power source. The operator control panel includes function keys, trackball and an alfa-numeric keyboard 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. 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, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other 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
Yes
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, Tissue Biopsy/Fluid Drainage.
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 Balance, 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, K181727, K183362, K181783
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.
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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 the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG 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: K191792
Trade/Device Name: Versana Balance 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) K191792
Device Name
Versana Balance
Indications for Use (Describe)
The Versana Balance 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 Balance 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
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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."
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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 Balance. 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 Balance Transducer: 3Sc-RS Transducer: 6S-RS Transducer: 4C-RS Transducer: 8C-RS Transducer: E8C-RS Transducer: E8Cs-RS Transducer: L6-12-RS Transducer: 12L-RS Transducer: LK760-RS Transducer: RAB2-6-RS
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GE Versana Balance Ultrasound System
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application
Anatomy/Region of Interest | B | M | Doppler Modes | | | | | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other |
|----------------------------------------------------|---|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|--------|
| | | | PW | CW | Color | Color M | Power | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | N | N | N | N | N | N | N | N | N | N | [4][7] |
| Abdominal[1] | N | N | N | N | N | N | N | N | N | N | [4][7] |
| Pediatric | N | N | N | N | N | N | N | N | N | N | [7] |
| Small Organ [2] | N | N | N | N | N | N | N | N | N | N | [7] |
| Neonatal Cephalic | N | N | 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 | [7] |
| Cardiac - Pediatric | N | N | N | N | N | N | N | N | N | N | [7] |
| Peripheral Vascular | N | N | N | N | N | N | N | N | N | N | [7] |
| Musculoskeletal Conventional | N | N | N | N | N | N | N | N | N | N | [7] |
| Musculoskeletal Superficial | N | N | N | N | N | N | N | N | N | N | [7] |
| Thoracic/Pleural[5] | N | N | N | N | N | N | N | N | N | N | [7] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | N | N | N | N | N | N | N | N | N | N | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | N | N | N | N | N | N | N | N | N | N | [7] |
| Transvaginal | N | N | N | N | N | N | N | N | N | N | [7] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid
Drainage[3] | N | N | N | N | N | N | N | N | N | N | [7] |
| Vascular Access[6] | N | N | N | N | N | N | N | N | N | N | [7] |
| Non-vascular access | N | N | N | N | N | N | N | N | N | N | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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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Diagnostic Ultrasound Indications for Use Form
Versana Balance with 3Sc-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] | P | P | P | | P | | P | | P | P | [7] | |
| Pediatric | | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | | |
| Adult Cephalic | p1 | p1 | p1 | p1 | p1 | p1 | p1 | | p1 | p1 | p1 | |
| Cardiac - Adult | P | P | P | P | P | P | P | | P | P | P | [7] |
| Cardiac - Pediatric | P | P | P | P | P | P | P | | P | P | P | [7] |
| Peripheral Vascular | | | | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | | |
| Thoracic/Pleural[5] | p1 | p1 | p1 | | p1 | | p1 | | p1 | p1 | p1 | [7] |
| Other | | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | | |
| Transcranial | P | P | P | P | P | P | P | | P | P | P | |
| Transesophageal | | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | | |
| Tissue Biopsy/Fluid | | | | | | | | | | | | |
| Drainage[3] | P | p1 | p1 | | P | p1 | P | | P | P | P | [7] |
| Vascular Access[6] | p1 | p1 | p1 | | p1 | p1 | p1 | | p1 | p1 | p1 | [7] |
| Non-vascular access | N | N | N | | N | N | N | | N | N | N | [7] |
N = new indication; P= previously cleared by FDA K182277; P1= previously cleared by FDA K151028 ; P= 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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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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Diagnostic Ultrasound Indications for Use Form
Versana Balance with 6S-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 | 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 | |||||||
| Musculoskeletal Conventional | |||||||
| Musculoskeletal Superficial | |||||||
| Thoracic/Pleural[5] | |||||||
| 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[3] | |||||||
| Vascular Access[6] | |||||||
| 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;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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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Diagnostic Ultrasound Indications for Use Form Versana Balance 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 | [7] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [7] |
| Pediatric | P | P | P | | P | | P | P | P | P | [7] |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | P | P | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Conventional | P | P | P | | P | | P | P | P | P | [7] |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P1 | [7] |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid
Drainage[3] | P | P1 | P1 | | P | | P | P | P | P | [7] |
| Vascular Access[6] | N | N | N | | N | | N | N | N | N | [7] |
| Non-vascular access | P | N | N | | N | | N | P | P | P | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
- [5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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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Diagnostic Ultrasound Indications for Use Form Versana Balance with 8C-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 | | | | | | | | | | | |
| Abdominal[1] | | | | | | | | | | | |
| Pediatric | P | P | P | | P | | P | P | P | P | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | P1 | P1 | P1 | | P1 | | P1 | P1 | P1 | P2 | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | P | P | P | | P | | P | P | P | P | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculoskeletal Conventional | P | P | P | | P | | P | P | P | P | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | | | | | | | | | | | |
| Transvaginal | | | | | | | | | | | |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid
Drainage[3] | | | | | | | | | | | |
| Vascular Access[6] | | | | | | | | | | | |
| 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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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/10/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 unique and recognizable design.
Diagnostic Ultrasound Indications for Use Form
Versana Balance with E8C-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 | P | P | P | P | P | P | P | P | [7] | ||
| Abdominal[1] | P | P | P | P | P | P | P | P | [7] | ||
| Pediatric | |||||||||||
| Small Organ [2] | |||||||||||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | |||||||||||
| Musculoskeletal Conventional | |||||||||||
| Musculoskeletal Superficial | |||||||||||
| Thoracic/Pleural[5] | |||||||||||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | P | P | P | P | P | P | P | P | [7] | ||
| Transvaginal | P | P | P | P | P | P | P | P | [7] | ||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid | |||||||||||
| Drainage[3] | P | P1 | P1 | P | P | P | P | P | [7] | ||
| Vascular Access[6] | N | N | N | N | N | N | N | N | [7] | ||
| Non-vascular access | N | N | N | N | N | N | N | N | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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/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 Balance with E8Cs-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | | | | | | | Combined
Modes* | Harmonic
Imaging | Coded
Pulse | Other |
|------------------------------------|-------------------|---|---------------|----|-------|---------|-------|--------------------|---------------------|----------------|-------|
| | B | M | Doppler Modes | | | | | | | | |
| | | | PW | CW | Color | Color M | Power | | | | |
| Anatomy/Region of Interest | | | | | | | | | | | |
| Ophthalmic | | | | | | | | | | | |
| Fetal / Obstetrics | P | P | P | | P | | P | P | P | P | [7] |
| Abdominal[1] | P | P | P | | P | | P | P | P | P | [7] |
| Pediatric | | | | | | | | | | | |
| Small Organ [2] | | | | | | | | | | | |
| Neonatal Cephalic | | | | | | | | | | | |
| Adult Cephalic | | | | | | | | | | | |
| Cardiac - Adult | | | | | | | | | | | |
| Cardiac - Pediatric | | | | | | | | | | | |
| Peripheral Vascular | | | | | | | | | | | |
| Musculoskeletal Conventional | | | | | | | | | | | |
| Musculoskeletal Superficial | | | | | | | | | | | |
| Thoracic/Pleural[5] | | | | | | | | | | | |
| Other | | | | | | | | | | | |
| Exam Type, Means of Access | | | | | | | | | | | |
| Transcranial | | | | | | | | | | | |
| Transesophageal | | | | | | | | | | | |
| Transrectal | P | P | P | | P | | P | P | P | P | [7] |
| Transvaginal | P | P | P | | P | | P | P | P | P | [7] |
| Intraoperative | | | | | | | | | | | |
| Interventional Guidance | | | | | | | | | | | |
| Tissue Biopsy/Fluid
Drainage[3] | P | P | P | | P | | P | P | P | | [7] |
| Vascular Access[6] | N | N | N | | N | | N | N | N | | [7] |
| Non-vascular access | N | N | N | | N | | N | N | N | | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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/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 blue circle. The letters are white, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form
Versana Balance with L6-12-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 | P | P3 | P | P | P | P | P | P | [7] | ||
| Small Organ [2] | P | P3 | P | P | P | P | P | P | [7] | ||
| Neonatal Cephalic | |||||||||||
| Adult Cephalic | |||||||||||
| Cardiac - Adult | |||||||||||
| Cardiac - Pediatric | |||||||||||
| Peripheral Vascular | P | P3 | P | P | P | P | P | P | [7] | ||
| Musculoskeletal Conventional | P | P3 | P | P | P | P | P | P | [7] | ||
| Musculoskeletal Superficial | P | P3 | P | P | P | P | P | P | [7] | ||
| Thoracic/Pleural[5] | N | N | N | N | N | N | N | N | [7] | ||
| Other | |||||||||||
| Exam Type, Means of Access | |||||||||||
| Transcranial | |||||||||||
| Transesophageal | |||||||||||
| Transrectal | |||||||||||
| Transvaginal | |||||||||||
| Intraoperative | |||||||||||
| Interventional Guidance | |||||||||||
| Tissue Biopsy/Fluid | |||||||||||
| Drainage[3] | P | N | N | P | P | P | P | P | [7] | ||
| Vascular Access[6] | P | N | N | P | P | P | P | P | [7] | ||
| Non-vascular access | P | N | N | N | N | P | P | P | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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 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 Balance with 12L-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 | P1 | P | P | P | P | P | [7] | ||
| Small Organ [2] | P | P1 | P | P | P | P | P | [7] | ||
| Neonatal Cephalic | ||||||||||
| Adult Cephalic | ||||||||||
| Cardiac - Adult | ||||||||||
| Cardiac - Pediatric | ||||||||||
| Peripheral Vascular | P | P1 | P | P | P | P | P | [7] | ||
| Musculoskeletal Conventional | P | P1 | P | P | P | P | P | [7] | ||
| Musculoskeletal Superficial | P | P1 | P | P | P | P | P | [7] | ||
| Thoracic/Pleural[5] | P1 | P1 | P1 | P1 | P1 | P1 | P1 | [7] | ||
| Other | ||||||||||
| Exam Type, Means of Access | ||||||||||
| Transcranial | ||||||||||
| Transesophageal | ||||||||||
| Transrectal | ||||||||||
| Transvaginal | ||||||||||
| Intraoperative | ||||||||||
| Interventional Guidance | ||||||||||
| Tissue Biopsy/Fluid | ||||||||||
| Drainage[3] | P | P1 | P1 | P | P | P | P | [7] | ||
| Vascular Access[6] | P | P1 | P | P | P | P | P | [7] | ||
| Non-vascular access | P | P2 | P2 | P2 | P2 | P | P | [7] |
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] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
[6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
[7] 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/14/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, creating a contrast against the blue background.
Diagnostic Ultrasound Indications for Use Form
Versana Balance with LK760-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Anatomy/Region of Interest | B | M | Doppler Modes | Power | Combined | |||||||
| Modes* | Harmonic Imaging | Coded Pulse | Other | |||||||||
| Ophthalmic | ||||||||||||
| Fetal / Obstetrics | ||||||||||||
| Abdominal[1] | ||||||||||||
| Pediatric | ||||||||||||
| Small Organ [2] | ||||||||||||
| Neonatal Cephalic | ||||||||||||
| Adult Cephalic | ||||||||||||
| Cardiac - Adult | ||||||||||||
| Cardiac - Pediatric | ||||||||||||
| Peripheral Vascular | ||||||||||||
| Musculoskeletal Conventional | P | P¹ | P | P | P | P | P | P | P | |||
| Musculoskeletal Superficial | ||||||||||||
| Thoracic/Pleural[5] | ||||||||||||
| Other | ||||||||||||
| Exam Type, Means of Access | ||||||||||||
| Transcranial | ||||||||||||
| Transesophageal | ||||||||||||
| Transrectal | ||||||||||||
| Transvaginal | ||||||||||||
| Intraoperative | ||||||||||||
| Interventional Guidance | ||||||||||||
| Tissue Biopsy/Fluid | ||||||||||||
| Drainage[3] | ||||||||||||
| Vascular Access[6] | ||||||||||||
| 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;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
- [7] 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/15/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 Balance with RAB2-6-RS Transducer
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | Other | ||||||
|---|---|---|---|---|---|---|---|---|
| B | M | Doppler Modes | ||||||
| PW | CW | Color | Color M | Power | ||||
| Anatomy/Region of Interest | ||||||||
| Ophthalmic | ||||||||
| Fetal / Obstetrics | P | P | P | P | P | [4][7] | ||
| Abdominal[1] | P | P | P | P | P | [4][7] | ||
| Pediatric | ||||||||
| Small Organ [2] | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Cardiac - Adult | ||||||||
| Cardiac - Pediatric | ||||||||
| Peripheral Vascular | ||||||||
| Musculoskeletal Conventional | ||||||||
| Musculoskeletal Superficial | ||||||||
| Thoracic/Pleural[5] | ||||||||
| Other | ||||||||
| Exam Type, Means of Access | ||||||||
| Transcranial | ||||||||
| Transesophageal | ||||||||
| Transrectal | ||||||||
| Transvaginal | ||||||||
| Intraoperative | ||||||||
| Interventional Guidance | ||||||||
| Tissue Biopsy/Fluid | ||||||||
| Drainage[3] | P | P | P | P | [7] | |||
| Vascular Access[6] | ||||||||
| 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;
[1] Abdominal includes GYN and Urological/Prostate; Notes:
- [2] Small Organ includes breast, testes, thyroid;
- [3] Interventional Guidance Tissue Biopsy is 2D biopsy guide
[4] 3D/4D imaging Mode
[5] For detection of fluid and pleural motion/sliding;
- [6] Vascular Access includes intravenous, intra-arterial, central and peripheral lines, upper extremity;
- [7] 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) Prescription Use (Per 21 CFR 801.109)
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 letters are also blue, matching the color of the circle.
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| 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 Balance |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90- | |
| 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: | Versana Premier (K182277) |
| Secondary Predicate Device(s): | LOGIQ e (K151028) |
| Vivid iq (K181727) | |
| Predicates used only for changes to transducer applications: | |
| Venue Go (K183362) | |
| LOGIQ P9 (K181783) | |
| Device Description: | The Versana Balance is a general purpose, Track 3, diagnostic |
| ultrasound system for use by qualified and trained healthcare | |
| professionals. The system is a mobile console that includes an | |
| operator control panel, display monitor and 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. | |
| Acquisition can also be done while the system is connected to an | |
| AC power source. | |
| The operator control panel includes function keys, trackball and | |
| an alfa-numeric keyboard as input sources of the device. |
17
Image /page/17/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 or flourishes around its perimeter, giving it a classic and recognizable appearance.
GE Healthcare 510(k) Premarket Notification Submission
The variety of transducers include convex, linear, sector and mechanical 4D transducers. 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, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other 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
Intended Use: The Versana Balance 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 Balance 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.
svstem.
-
Technology: The Versana Balance employs the same fundamental scientific technology as its predicate devices.
Determination of Comparison to Predicate Devices Substantial Equivalence: The Versana Balance system is substantially equivalent to the Versana Premier. The following is an overview of the differences between the proposed Versana Balance and the Versana Premier. The systems are intended for diagnostic ultrasound imaging and fluid flow analysis. -
The Versana Balance and predicate Versana Premier (K182277) have similar clinical indications for use however the applications of Neonatal Cephalic, Adult Cephalic and
18
Image /page/18/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a blue circle. There are decorative swirls around the outer edge of the circle, giving it a classic and recognizable appearance.
Thoracic/Pleural are being added which have been cleared on LOGIQ e (K151028).
-
The Versana Balance and predicate Versana Premier (K182277) have the same imaging modes.
-
The Versana Balance and predicate Versana Premier (K182277) transducers are similar. All transducers supported in Versana Balance are covered in Versana Premier (K182277). However, some of the transducers applications and modes are different.
-
3Sc-RS transducer: Adult Cephalic, Thoracic/Pleural & Vascular Access are being added per LOGIO e (K151028); Non-Vascular Access is being added; M mode and PW mode added to Tissue Biopsy/Fluid Drainage per LOGIQ e (K151028);
-
6S-RS transducer: Neonatal Cephalic is being added per LOGIQe (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 LOGIQ e (K151028);
-
E8Cs-RS transducer: Vascular access and Non-vascular 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;
-
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
19
Image /page/19/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. The circle has a textured or slightly wavy appearance, giving it a dynamic feel.
GE Healthcare
510(k) Premarket Notification Submission
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 transducer: M mode added to Musculoskeletal Conventional per LOGIQ e (K151028).
- Features added from Vivid iq (K181727): Standby ●
- Adding a new feature called TI-RADS based on the American College of Radiology (ACR).
- The Versana Balance 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 Balance and predicate Versana Premier (K182277) have been designed in compliance with approved electrical and physical safety standards.
Summary of Non-Clinical Tests:
Versana Balance 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 Balance 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 disturbances - Requirements and tests - Edition 4.0 2014-02
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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 Balance, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Versana Balance to be as safe, as Conclusion: effective, and performance is substantially equivalent to the predicate devices.