EchoPAC Software Only / EchoPAC Plug-in (v211)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 16, 2026 GE Medical Systems Ultrasound and Primary Care Diagnostics Charlotte Joergensen Sr. Regulatory Affairs Leader 3200 N Grandview Blvd. Waukesha, WI 53188 Re: K261623 Trade/Device Name: EchoPAC Software Only / EchoPAC Plug-in (v211) Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: August 18, 2026 Received: August 18, 2026 Dear Charlotte Joergensen: 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 (the 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 available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP). Under section 515C(b)(1) of the Act, a new premarket notification is not required for a change to a device cleared under section 510(k) of the Act, if such change is consistent with an U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261623 - Charlotte Joergensen Page 2 established PCCP granted pursuant to section 515C(b)(2) of the Act. Under 21 CFR 807.81(a)(3), a new premarket notification is required if there is a major change or modification in the intended use of a device, or if there is a change or modification in a device that could significantly affect the safety or effectiveness of the device, e.g., a significant change or modification in design, material, chemical composition, energy source, or manufacturing process. Accordingly, if deviations from the established PCCP result in a major change or modification in the intended use of the device, or result in a change or modification in the device that could significantly affect the safety or effectiveness of the device, then a new premarket notification would be required consistent with section 515C(b)(1) of the Act and 21 CFR 807.81(a)(3). Failure to submit such a premarket submission would constitute adulteration and misbranding under sections 501(f)(1)(B) and 502(o) of the Act, respectively. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. {2} K261623 - Charlotte Joergensen Page 3 Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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, Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} # Indications for Use | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | | K261623 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | EchoPAC Software Only / EchoPAC Plug-in (v211) | | | | | Please provide your Indications for Use below. | | | ? | | EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D). Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | | Please select the age group(s) for which the device(s) is to be used. | ☑ Neonates/Newborns (Birth to < 29 days old) ☑ Infants (29 days old to < 2 years old) ☑ Children (2 years old to < 12 years old) ☑ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | | {4} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission # 510(k) Summary In accordance with 21 CFR 807.92 the following summary of information is provided: | Date | September 15, 2026 | | --- | --- | | Submitter / Manufacturer | GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 3200 N Grandview Blvd Waukesha, WI 53188, US GE Vingmed Ultrasound AS Strandpromenaden 45 3193 Horten, Norway | | Primary Contact Person | Charlotte Jørgensen Senior Regulatory Affairs Leader GE HealthCare Tel: +47 970 62 646 Email: charlotte.joergensen@gehealthcare.com | | Secondary Contact Person | Michelle Huettner Regulatory Affairs Director GE HealthCare Tel: +1 901 558 8035 Email: michelle.huettner@gehealthcare.com | | Device Trade Name | EchoPAC Software Only / EchoPAC Plug-in (v211) | | Device Common/Usual Name | Workstation Software for ultrasound image review, analysis and reporting | | Classification / Product Codes | Class II QIH (primary), LLZ (secondary) Automated Radiological Image Processing Software, 21 CFR 892.2050, QIH Picture Archiving and Communications System, 21 CFR 892.2050, LLZ | Page 1 of 7 {5} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission | Primary Predicate Device(s) | EchoPAC Software Only / EchoPAC Plug-in (K251342) Vivid E95 (K220882) | | --- | --- | | Predicate Classification / Product Codes | Class II QIH (primary), LLZ, IYN, IYO, ITX (secondary) | | | Automated Radiological Image Processing Software, 21 CFR 892.2050, QIH Picture Archiving and Communications System, 21 CFR 892.2050, LLZ Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN Ultrasonic Pulsed Echo Imaging System, 21 CFR 892.1560, 90-IYO Diagnostic Ultrasound Transducer, 21 CFR 892.1570, 90-ITX | # Device Description: EchoPAC Software Only / EchoPAC Plug-in (v211) provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the GE Healthcare Vivid family of ultrasound systems, as well as DICOM images from other ultrasound systems. EchoPAC Software Only (v211) will be offered as SW only to be installed directly on customer PC hardware and EchoPAC Plug-in (v211) is intended to be hosted by a generalized PACS host workstation. EchoPAC Software Only / EchoPAC Plug-in (v211) is DICOM compliant, transferring images and data via LAN between systems, hard copy devices, file servers and other workstations. # Intended Use/Indication for Use: EchoPAC Software Only / EchoPAC Plug-in (v211) is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in (v211) allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic, 3D, and Real time (RT) 3D Mode (4D). Clinical applications include: Fetal/Obstetrics; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); Intraoperative (vascular); Intra-Cardiac; Thoracic/Pleural and Intra-Luminal. Page 2 of 7 {6} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission Technology: EchoPAC Software Only / EchoPAC Plug-in (v211) employs the same fundamental scientific technology as its predicate device. Determination of Substantial Equivalence: Comparison to Predicates: The proposed EchoPAC Software Only / EchoPAC Plug-in (v211) is substantially equivalent to the predicate device. The following is an overview of the differences between the proposed EchoPAC Software Only / EchoPAC Plug-in (v211) and the predicate EchoPAC Software Only / EchoPAC Plug-in (K251342). Indications for Use The proposed EchoPAC Software Only / EchoPAC Plug-in (v211) and predicate EchoPAC Software Only / EchoPAC Plug-in (K251342) have identical clinical indications for use. The following are the new and revised features and functionality in scope of the proposed EchoPAC Software Only / EchoPAC Plug-in (v211). Software Features/Functionality: - LV Diastolic Function Tool: provides an on-screen, guideline-supported decision tree that organizes the inputs commonly used to evaluate left-ventricular diastolic function, guides the user to identify missing measurements, and summarizes the intermediate states and conclusion directly on the proposed device. - AI Cardiac Auto Doppler, previously cleared on the predicate device EchoPAC Software Only / EchoPAC Plug-in (K251342), is enhanced to support cardiac cycle detection and analysis of Doppler spectrum recordings independent of ECG data through an AI Doppler Spectrum Cycle Detection model. The workflow, supported Doppler spectrum types, and calculated clinical parameters of the modified AI Cardiac Auto Doppler, when used with or without ECG, are the same as those cleared on the predicate device EchoPAC Software Only / EchoPAC Plug-in (K251342). - A Predetermined Change Control Plan (PCCP) is included and applies exclusively to the AI Cardiac Auto Doppler software feature. Modifications Page 3 of 7 {7} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission implemented under the PCCP are limited to controlled updates that remain within the cleared intended use of AI Cardiac Auto Doppler. These modifications do not introduce new measurement types, new diagnostic claims, expanded clinical indications, or changes to clinical interpretation of AI Cardiac Auto Doppler results. The type, format, and clinical meaning of AI Cardiac Auto Doppler outputs remain unchanged. - Planned modifications under the PCCP may include, as applicable: - Modification to the core AI algorithms, including the three constituent AI models: - Doppler Spectrum Cycle Detection Model - Tissue Doppler Network - Doppler Trace Network - Optimization of software implementation, including supporting post-processing components, provided that algorithm outputs, measurement definitions, clinical results, and user interactions remain unchanged - Support for additional cardiac ultrasound TTE and TEE probes within the limits defined by the PCCP. - Implementation of PCCP Modifications: Modifications under the PCCP are implemented only through controlled software releases. - Before implementation, each modification under the PCCP is evaluated using predefined verification and validation procedures. - A modification is implemented only if all applicable predefined performance requirements and acceptance criteria are met. - Performance Requirements for PCCP Modifications - Each modification implemented under the PCCP must maintain acceptable AI Cardiac Auto Doppler performance according to predefined verification and validation criteria. - PCCP modifications are not implemented if testing identifies unacceptable performance degradation or an unresolved risk to safe and effective use. - Notification of Implemented PCCP Modifications - Users will be informed of PCCP modifications through software release notes, software version information, customer communications, updated labeling, or other appropriate Page 4 of 7 {8} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission product documentation. - For each applicable software release, GE HealthCare will provide information describing the implemented modification, affected software version, and other relevant information, as appropriate. - ViewLabel is based on the previously cleared View Recognition functionality included in predicate EchoPAC Software Only / EchoPAC Plug-in (K251342). In the proposed device, the recognized view label for adult TTE cardiac B-mode recordings is displayed on the analysis screen. When no scanner-provided view identification is present, EchoPAC may add the recognized view identification upon storage. - DICOM Character Set Support: Supports a broader set of DICOM character sets, enabling correct handling of patient names, demographics, and study information in multiple international languages # Summary of Non-Clinical Tests: The EchoPAC Software Only / EchoPAC Plug-in (v211) complies with voluntary standards: - ISO 14971, Application of risk management to medical devices, 2019 - NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology), 2024e - IEC 62304 Edition 1.1 2015 - Medical device software - Software life cycle process - IEC 62366-1: 2015 + A1:2020 – Medical Device-Part 1: Application of Usability. The following quality assurance measures were 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) Page 5 of 7 {9} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission # AI Auto Doppler Summary of Testing: Performance testing was conducted to verify the proposed AI Cardiac Auto Doppler when operating without ECG signals. The same verification test methods were performed on the proposed device to make sure the performance was unchanged, and a separate testing dataset was used to verify the AI Cardiac Auto Doppler on the proposed device when operating without ECG signals. The test methods and acceptance criteria were unchanged. The results demonstrated that the proposed AI Cardiac Auto Doppler meets the performance specifications under ECG-absent conditions and does not affect the safety and effectiveness. Summary of test statistics and other results, including acceptance criteria and information supporting the appropriateness of the characterized performance, are provided below. The AI Cardiac Auto Doppler feature utilizes 3 AI algorithms, AI Doppler Spectrum Cycle Detection, Tissue Doppler and Doppler Trace, which are referenced below. # Testing dataset: - Testing dataset representatives of standard clinical practices used to collect typical cardiac images in clinical environments were assessed by experts for accuracy. - AI Doppler Spectrum Cycle Detection testing dataset included 3197 recordings from 816 individuals - Tissue Doppler testing dataset included 1570 recordings from 235 individuals. - Doppler Trace testing dataset included 1628 recordings from 582 individuals. # Distribution of testing dataset (Demographics and Ultrasound System): - Gender: Male and Female - Age: Adult and Pediatric - Ethnicity/Country: USA (several locations), Australia, France, Spain, Norway, Italy, Germany, Thailand, Philippines, China (several locations) - Ultrasound Console(s): Vivid E80, Vivid E95, Vivid E9, Vivid IQ, Vivid S70N, Vivid T9, Vivid iq, Vivid Pioneer, Vivid Explorer, Vivid Advanced, Vivid Focus - Probe(s): 6Sc, 6Vc, 3Sc, 4Sc, 4Vc, 4V, M5S, 6S, M4S, M5Sc, M5S, 12S, 9VT, 6VT, 10T # Information about clinical subgroups and confounders present in the testing dataset: - The algorithm performance was verified across a range of confounders: Ethnicity/Country (USA - several locations, Australia, France, Spain, Norway, Italy, Germany, Thailand, Philippines, China – several locations), wide range of Vivid consoles, wide range of probes. Page 6 of 7 {10} GE HealthCare K261623 GE HealthCare 510(k) Premarket Notification Submission Characterized performance: - The verification requirement included a step to check for a feasibility score of more than 95%, as well as an expected accuracy threshold calculated as the mean absolute difference in percentage for each measured parameter. The total number of samples used for developing the AI Doppler Spectrum Cycle Detection model is 9607 recordings from 20 unique clinical sites (not used for testing dataset). Information about equipment and protocols used to collect images: - Development dataset included images obtained with the M5Sc, M5S, 4Vc, M4S, M3S probes on a variety of Vivid cardiovascular ultrasound systems (Vivid E80, Vivid E9, Vivid 7, Vivid IQ, Vivid T9, and Vivid S70N) Information about how the reference standard was derived from the dataset (i.e. the “truthing” process): Ground truth annotations of the development and verification datasets were obtained as follows: - In all Training, Validation, and Testing datasets, annotators performed manual measurements after assessing Doppler signal quality and ECG signal quality of curated images. - Four cardiologists performed the annotations following US ASE based annotation guidelines. - A review panel of five clinical experts provided feedback on the annotations which were corrected (as needed) until a consensus agreement was reached between the annotators and reviewers. Description of how independence of test data from training data was ensured: - The testing dataset is selected from independent clinical research institutions that have never been used for training and validation (tuning), ensuring the elimination of potential data leakage. # Summary of Clinical Tests: The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in (v211), did not require clinical studies to support substantial equivalence. # Conclusion: Based on the design similarities, conformance to recognized performance standards, and performance testing, GE HealthCare considers the proposed EchoPAC Software Only / EchoPAC Plug-in (v211) to be as safe, effective, and performs in a substantially equivalent manner as the predicate EchoPAC Software Only / EchoPAC Plug-in (K251342). Page 7 of 7