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The Vivid is high-performance compact diagnostic ultrasound system designed for Cardiovascular and Shared Services. It is intended for use by qualified and trained Healthcare professionals for Ultrasound imaging, measurement, display and analysis of the human body and fluid. Vivid iq clinical applications include: Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vasculoskeletal Conventional, Musculoskeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Interventional Guidance (including Biopsy), Intraoperative(Vascular), Intracardiac and Intraluminal. Modes of operation include: B, M, PW Doppler, CW Doppler, Color M, Power Doppler, Harmonic Imaging, Real-Time (RT) 3D Mode (4D), Coded Pulse and Combined modes: B/M, B/Color M, B/WD, B/CWD, B/Color/PWD, B/Color/CWD, B/Power/PWD. The device is intended for use in an indoor hospital environment including echo lab, other hospital settings, operating room, Cath lab and EP lab, in private medical offices, and in limited settings outside of professional Healthcare facilities.

The proposed Vivid iq system is a general-purpose, Track 3, diagnostic ultrasound device, primarily intended for cardiovascular diagnostic use and shared service imaging. It is an ultrasound imaging & analysis system, consisting of a compact console with control panel including a track pad, numeric keyboard. There are options for image storage, USB wireless connectivity, cardiac signal input for cardiac gating and output capabilities to printing devices. Vivid iq utilizes a variety of linear, sector, convex, and phased array transducers which provide high imaging capability, supporting all standard acquisition modes.

The provided text does not contain information regarding the acceptance criteria of and performance of the device "Vivid iq". It also lacks details about a specific study designed to prove the device meets such criteria, as well as information on sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC).

The document is a 510(k) premarket notification for the Vivid iq, which primarily discusses the device's substantial equivalence to existing predicate devices based on technological characteristics and intended use. It lists various features and functions, noting that many are the "same feature as cleared on" other GE Healthcare devices.

However, based on the information provided in the text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given text. The document states that the Vivid iq uses the "same fundamental scientific technology as its predicate and reference devices" and lists various feature updates (e.g., AI Auto Measure, AFI 3.0, Auto EF 3.0) that are "same feature as cleared on" other GE Healthcare systems. Implicitly, the acceptance criteria for these features would have been met during the clearance of the previous devices, and the performance of the Vivid iq with these features is presumed to be equivalent. However, explicit numerical acceptance criteria and performance metrics for the Vivid iq itself are not detailed in this submission.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the given text. The document states, "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." This implies that no new clinical test set was used for this specific submission to prove the performance of the listed features.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission. For the features inherited from other devices, the original submissions for those devices would contain this information.

4. Adjudication Method for the Test Set

This information is not applicable/not provided as no new clinical test set was seemingly evaluated for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided in the given text. While some AI-based features are mentioned (e.g., "AI Auto Measure – 2D" and "AI Auto Measure – Spectrum Recognition"), the document does not detail any MRMC study conducted for the Vivid iq or the effect size of AI assistance on human readers. It only states that these are "same feature as cleared on Vivid S70N(K200497)," suggesting that any such studies would have been part of the K200497 submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not provided in the given text. Given that clinical studies were not required for this submission, standalone performance data for the AI algorithms specifically on the Vivid iq system are not detailed here.

7. The Type of Ground Truth Used

This information is not provided in the given text for the Vivid iq itself. For the features inherited from other devices (e.g., AI Auto Measure components), the ground truth type (e.g., expert consensus, manual measurements, pathology) would have been established during the development and clearance of those original devices.

8. The Sample Size for the Training Set

This information is not provided in the given text. For the AI-based features, the training set size would have been part of the K200497 submission.

9. How the Ground Truth for the Training Set was Established

This information is not provided in the given text. For the AI-based features, the method for establishing ground truth for the training set would have been part of the K200497 submission.

In summary, the provided document focuses on confirming "substantial equivalence" based on existing technologies and previously cleared features from other devices, rather than presenting new clinical study data with detailed acceptance criteria, test set specifics, or human-in-the-loop performance metrics for the Vivid iq specifically.

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The Vivid T9/Vivid T8 is a general-purpose ultrasound system, specialized for use in cardiac maging. It is intended for use by qualified and trained Healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid. The device is intended for use in a hospital environment including echo lab, other hospital settings, operating room, Cath lab, and in private medical offices. The systems support the following clinical applications: Fetal/ Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Peripheral Vascular, Musculosketal Conventional, Musculoskeletal Superficial, Transesophageal, Transvaginal, Interventional guidance (including Biopsy, Fluid Drainage), Intraoperative(Vascular). Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M, Power Doppler, Harmonic Imaging, Coded Pulse and Combined modes: B/M, B/PWD, B/Color/PWD, B/Power/PWD.

Vivid T8/Vivid T9 is a Track 3, diagnostic ultrasound system, which is primarily intended for cardiac imaging and analysis but also includes vascular and general radiology applications. It is a full featured diagnostic ultrasound system that provides digital acquisition, processing, analysis and display capability. The Vivid T8/Vivid T9 consists of a mobile console with control panel color LCD touch panel, LCD display monitor and optional image storage and printing devices. It includes a variety of electronic array transducers operating in linear, curved, sector/phased array, matrix array, and dual array including dedicated CW transducers. The system includes electronics for transmit and receive of ultrasound data, ultrasound signal processing, software computing, hardware for Image storage, hard copy printing, and network access to the facility through both LAN and wireless (supported by use of a wireless LAN USB-adapter) connection.

This document describes the 510(k) Pre-market Notification Submission for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid T8/T9 ultrasound system, primarily focusing on its substantial equivalence to predicate devices rather than the performance of a novel AI-driven feature with detailed acceptance criteria and a specific study proving those criteria.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (specifically for an AI/ML component) is not extensively described in this document. The document mentions the addition of several AI-based features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) that were previously cleared on the Vivid S70N (K200497). The submission states: "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This implies that the performance of these AI features was established and cleared in the previous submission (K200497) for the Vivid S70N, and no new clinical studies were conducted for the Vivid T8/T9 to demonstrate their performance against new acceptance criteria.

Based on the provided text, I cannot reconstruct a detailed table of acceptance criteria and reported device performance for the AI features or the specific study proving the device meets these criteria for the Vivid T8/T9 itself. The document implicitly relies on the prior clearance of these AI features on a different device to demonstrate substantial equivalence.

However, I can extract the information that is present regarding the AI features and the overall submission:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not provided in this document directly for the Vivid T8/T9. The document states that the AI features (AI Auto Measure 2D, AI Auto Measure Spectrum Recognition, AFI 3.0, Auto EF 3.0, AFI RV, AFI LA) are the "same feature as cleared on Vivid S70N (K200497)." This implies that their performance was assessed and accepted during the clearance of K200497, but the specific acceptance criteria and detailed performance data from that prior submission are not included here.

2. Sample Size Used for the Test Set and Data Provenance:

• Not specified in this document. Since no new clinical studies were conducted for the Vivid T8/T9 specifically for these AI features, details about the test set for the AI components are presumed to be part of the K200497 submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not specified in this document. This information would likely be found in the K200497 submission for the Vivid S70N, where these AI features were originally cleared.

4. Adjudication Method for the Test Set:

• Not specified in this document. Again, this would pertain to the information from the K200497 submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and the effect size:

• Not specified in this document. There is no mention of MRMC studies or human reader improvement with AI assistance for the Vivid T8/T9. Any such studies would have been part of the original K200497 submission for the Vivid S70N.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done:

• Not specified in this document. Details on standalone performance for the AI features would be in the K200497 submission.

7. The Type of Ground Truth Used:

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

8. The Sample Size for the Training Set:

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

9. How the Ground Truth for the Training Set was Established:

• Not specified in this document. This information would be specific to the K200497 submission for the Vivid S70N.

Summary based on the provided document:

The 510(k) submission for the Vivid T8/T9 leverages the substantial equivalence pathway, specifically by stating that new "AI Auto Measure" and "AFI" features are "same feature as cleared on Vivid S70N (K200497)." This means that the device's adherence to acceptance criteria for these AI features was established during the clearance of the Vivid S70N, and that information is not detailed in this specific document. The submission explicitly states, "The subject of this premarket submission, Vivid T8 / Vivid T9, did not require clinical studies to support substantial equivalence." This indicates that the performance data for the AI features was carried over from the prior clearance.

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The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. It offers an innovative ergonomic design, superb image quality, advanced connectivity, productivity tools and advanced technology. Compatibility with the Vivid product family offers flexibility in lab configuration and upgrade opportunities.

This FDA 510(k) summary for the GE Vivid iq ultrasound system (K181727) focuses on establishing substantial equivalence to predicate devices, rather than performing a de novo study with specific acceptance criteria related to disease detection performance.

Therefore, the document does not report specific acceptance criteria or performance metrics for detecting or diagnosing conditions, as it is a clearance based on the device's technological characteristics and intended use being equivalent to already cleared devices.

Here's a breakdown of the information that is available based on your request, with the understanding that specific diagnostic performance metrics are not provided:

1. Table of Acceptance Criteria and Reported Device Performance (as applicable for this type of submission):

| Criterion Type | Acceptance Criteria (Internal/Regulatory Compliance) | Reported Device Performance (Demonstrated Compliance) |
|:-----------------------------|:-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Safety and Effectiveness | Compliance with all relevant medical device safety standards (AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO10993-1, ISO14971, NEMA UD 2, NEMA DICOM Set). | The Vivid iq has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, thermal, electrical, electromagnetic, and mechanical safety and was found to comply with all applicable standards. Non-clinical verification testing covered system-level requirements and risk control measures. Non-clinical validation testing covered intended use, commercial claims, and usability with representative intended users. |
| Technological Equivalence| The device employs the same fundamental scientific technology as its predicate devices. Imaging capabilities, modes, and transducers are similar or identical to predicate devices. New features are cleared on other predicate devices. | The Vivid iq employs the same fundamental scientific technology as its predicate devices. It has identical imaging modes and transducers to its primary predicate (Vivid iq K161706). New features like 4D Markers, Tricefy Uplink, Qview, QuickApps, View-X, FlexiViews, Mitral Valve Quantification (MVQ), 4D AVQ, AFI, Auto EF, Cardiac AutoDoppler improvements, and Pediatric Z-score functionality are equivalent to those cleared in predicate devices such as Vivid E95 (K170823, K160078), Venue (K180599), and Vscan Extend (K161588). Transducer clinical application expansions are based on clearances from LOGIQ e (K151028), Vivid T8 (K160078), and LOGIQ P9/P7 (K163596). The system has similar capabilities in measurements, digital image capture, reviewing, and reporting. Materials are safe, and acoustic power levels are below FDA limits. |
| Intended Use Equivalence | The intended use of the Vivid iq system must be substantially equivalent to that of predicate devices. | The Vivid iq is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body for cardiovascular and shared services applications, including Fetal, OB, Abdominal, Pediatric, small Organ, Neonatal Cephalic, Adult Cephalic, Cardiac, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Transcranial, Transrectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal. This intended use is stated to be substantially equivalent to the predicate devices. |

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated as this was a 510(k) submission based on substantial equivalence, not a clinical trial proving diagnostic accuracy from scratch. The submission indicates "Non-Clinical validation testing covered the intended use and commercial claims as well as usability testing with representative intended users." This implies testing was done, but details on the size and nature of the "test set" for performance are not provided.
• Data Provenance: The document does not specify the country of origin for any non-clinical testing data. The submission relies heavily on demonstrating equivalence to predicate devices, which would mean leveraging the accepted performance of those existing devices. The testing mentioned (acoustic output, biocompatibility, etc.) would typically be performed by the manufacturer, GE Medical Systems Ultrasound and Primary Care Diagnostics, based in Wauwatosa, WI, USA, or their global affiliates. The context implies newly conducted non-clinical verification and validation, but not on a specific "dataset" from patients for diagnostic performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable/Not provided. The submission focuses on technical and safety equivalence. Ground truth for diagnostic performance is not established or reported as part of this 510(k) summary, as it relies on the predicate devices having already demonstated acceptable performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable/Not provided. Adjudication methods are typically relevant for clinical studies establishing diagnostic performance where human readers interpret outputs. This submission is for device clearance based on equivalence, not a clinical diagnostic performance study.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No MRMC comparative effectiveness study was described or performed. The document explicitly states: "The subject of this premarket submission, Vivid iq, did not require clinical studies to support substantial equivalence." This means no studies comparing human reader performance with or without AI assistance were conducted or reported in this submission. The new features mentioned are enhancements or integrations, not AI-driven diagnostic tools requiring such studies for this clearance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable/Not done. This device is an ultrasound system with various imaging modes and features. It's not a standalone AI algorithm for automated diagnosis or detection. The features mentioned, like "QuickApps," "4D Markers," etc., are productivity tools or display enhancements, not algorithms that act independently for diagnostic purposes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable/Not provided in the context of diagnostic performance. For the safety and effectiveness evaluations, the "ground truth" would be the established safety standards and regulatory requirements. For functional testing of new features, it would be the expected technical behavior and output of the features.

8. The sample size for the training set:

• Not applicable/Not provided. This submission does not describe the development or training of an AI algorithm in the traditional sense that would require a dedicated training set of medical images for diagnostic tasks. The new features detailed are mostly related to image processing, workflow, and connectivity, not machine learning models trained on vast datasets.

9. How the ground truth for the training set was established:

• Not applicable/Not provided, for the same reasons as point 8.

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The Vivid ig is a high-performance compact ultrasound for cardiovascular and shared services applications. The indications of the product will include Fetal, OB, Abdominal, Pediatal Cephalic, Adult Cephalic, Adult Cephalic, Cardiac, Penpheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal, Transcranial, Transvectal, Transvaginal, Transesophageal, Tissue biopsy, Intraoperative, IntraCardiac and Intraluminal.

The Vivid iq is a high-performance compact ultrasound system designed for cardiovascular and shared services applications. It offers an innovative ergonomic design, superb image quality, advanced connectivity, productivity tools and advanced technology. Compatibility with the Vivid product family offers flexibility in lab configuration and upgrade opportunities.

The provided document is a 510(k) Premarket Notification for the GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC Vivid iq diagnostic ultrasound system. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical studies or defining specific performance acceptance criteria for new algorithms.

Therefore, the document does not contain specific acceptance criteria, reported device performance metrics against those criteria, or details of a study designed to prove the device meets such criteria in the context of an AI/algorithm. Instead, it demonstrates substantial equivalence to existing devices for its intended use.

Here's an analysis of the provided information based on your request, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance
Not applicable. This document is a 510(k) summary for a diagnostic ultrasound system, not an AI/algorithm-specific submission with performance acceptance criteria. The claim is substantial equivalence to predicate devices, not performance against specific metrics for a novel algorithm.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
Not applicable. No separate test set for an algorithm is described. The document indicates that no clinical studies were required to support substantial equivalence (page 30). The "Indications for Use" tables list where indications are "new" (N) or "previously cleared" (P), which refers to the clearance of the transducer/system for that application, not performance evaluation of an AI algorithm on a dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
Not applicable. No ground truth establishment for a test set is described, as no efficacy study for an AI/algorithm is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No test set adjudication is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. No MRMC study is mentioned. This document is for a diagnostic ultrasound system, not an AI software.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. No standalone algorithm performance study is indicated.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No ground truth is described in the context of an algorithm's performance evaluation.

8. The sample size for the training set
Not applicable. No training set for an AI/algorithm is mentioned.

9. How the ground truth for the training set was established
Not applicable. No ground truth for a training set is mentioned.

Summary of Device and Evidence Presented:

The GE Vivid iq is a high-performance compact ultrasound system intended for cardiovascular and shared services applications.

Predicate Devices:

• Primary Predicate Device: Vivid i and Vivid q (K121062)
• Secondary Predicate Devices: Vivid E95 (K150087), Voluson S10 (K160184), LOGIQ F8 Expert (K160277), K140318 by Biosense Webster, Inc.

Substantial Equivalence Claim:
The Vivid iq system is substantially equivalent to its predicate devices in terms of intended use, imaging capabilities, technological characteristics, and safety and effectiveness.

Non-Clinical Tests:
The device underwent non-clinical evaluations for:

• Acoustic output (compliance with NEMA UD 3, NEMA UD 2)
• Biocompatibility (compliance with ISO10993-1)
• Cleaning and disinfection effectiveness
• Thermal, electrical, electromagnetic, and mechanical safety (compliance with AAMI/ANSI ES60601-1, IEC60601-1-2, IEC60601-2-37, ISO14971)

Clinical Tests:
No clinical studies were required to support the substantial equivalence claim (page 30).

Technology:
The Vivid iq employs the same fundamental scientific technology as its predicate devices. Changes noted include:

• Addition of tissue biopsy indication, previously cleared in LOGIQ F8 Expert (K160277).
• Addition of Real Time 3D mode, previously cleared in Vivid E95 (K150087).
• Addition of several new transducers (M5Sc-RS, E8Cs-RS, L8-18i-RS, ML6-15-RS, C1-5-RS, 6VT-D, SOUNDSTAR eco 8F (G version)) which were previously cleared on other GE systems or by Biosense Webster, Inc.
• The embedded operating system is Windows 7, similar to LOGIQ F8 Expert (K160277).

Conclusion:
GE Healthcare states that the Vivid iq is as safe, as effective, and its performance is substantially equivalent to the predicate device(s).

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