I-View®

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 2, 2026 Hologic, Inc. Manuela Restrepo Parra Senior Regulatory Affairs Specialist 600 Technology Dr. NEWARK, DE 19702 Re: K254090 Trade/Device Name: I-View® Regulation Number: 21 CFR 892.1715 Regulation Name: Full-Field Digital Mammography System Regulatory Class: Class II Product Code: MUE Dated: December 16, 2025 Received: December 19, 2025 Dear Manuela Restrepo Parra: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254090 - Manuela Restrepo Parra Page 2 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. 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- {2} K254090 - Manuela Restrepo Parra Page 3 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, YANNA S. KANG -S Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices 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. | K254090 | ? | | Please provide the device trade name(s). | | ? | | I-View® | | | | Please provide your Indications for Use below. | | ? | | Contrast-Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Envision platform. The CEDM application (I-View® software) shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. | | | | Please select the types of uses. | ☑ 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} K254090 Hologic, Inc. 510(k) Premarket Notification I-View® # Traditional 510(k) Summary This 510(k) summary is submitted in accordance with the requirements of 21 CFR Part 807.92 Date Prepared: September 2, 2026 Manufacturer: Hologic, Inc. 600 Technology Drive Newark, DE 19702 USA Establishment Registration #: 3005496266 Contact Person: Manuela Restrepo Parra Senior Regulatory Affairs Specialist Phone: 302-501-0329 Email: Manuela.Restrepoparra@hologic.com Secondary Contact Person: Heather Taylor Director, Regulatory Affairs Email: Heather.Taylor@hologic.com Identification of the Device: Proprietary/Trade Name: I-View® Common/usual Name: I-View 3.0 Classification Name: Full Field Digital Mammography System Regulatory Number: 21 CFR 892.1715 Product Code: MUE Device Class: Class II Review Panel: Radiology Identification of the Legally Marketed Predicate Device: Trade Name: I-View® Common/usual Name: I-View Classification Name: Full Field Digital Mammography System Regulatory Number: 21 CFR 892.1715 Product Code: MUE Device Class: Class II Review Panel: Radiology Submitter/510(k) Holder: Hologic, Inc. Clearance: K123873 (cleared January 29, 2013) 2 {5} Hologic, Inc. 510(k) Premarket Notification I-View® # **Device Description:** I-View® is Hologic's optional Contrast Enhanced Digital Mammography (CEDM) software, also known as dual energy imaging, designed for use with the Envision Mammography Platform (P080003/S009). CEDM image acquisition involves capturing two sequential 2D images during a single breast compression. The first is a standard 2D Full-Field Digital Mammography (FFDM) image, referred to as the "low energy" image, which is acquired in the same manner as conventional FFDM imaging. Immediately following this, a second image, the "high energy" image, is obtained. A weighted subtraction method is then applied to remove the contents of the low energy image from the high energy image, resulting in the "subtracted image." Prior to image acquisition, the patient receives a contrast agent; however, the administration and management of the contrast agent are not part of the system or this submission. Both the low energy and subtracted images can be viewed side-by-side on the Envision platform's Acquisition Workstation (AWS) and are used for clinical evaluation of the patient. All acquired images conform to the DICOM standard for storage, display, and transmission. # **Indications for Use:** Contrast-Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Envision platform. The CEDM application (I-View® software) shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. # **Standards:** - IEC 62304: 2015 – Medical device software – Software Life Cycle Processes - ISO 14971: 2019 – Medical Devices – Application of Risk Management to Medical Devices 3 {6} Hologic, Inc. 510(k) Premarket Notification I-View® Summary of Substantial Equivalence: | Features and Characteristics | Subject Device Hologic, Inc. I-View®, CEDM Software K254090 | Predicate Device Hologic, Inc. I-View®, CEDM Software K123873 | Differences and Comments | | --- | --- | --- | --- | | Regulation Number/Name | 21 CFR 892.1715/Full-field digital mammography system | 21 CFR 892.1715/Full-field digital mammography system | N/A – same | | Product Code | MUE | MUE | N/A – same | | Regulation Description | A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. | A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories. | N/A – same | | Trade Name | I-View® | I-View® | Same | | Software Version | 3.0 | 1.0 | Difference reflects version of software. | | Indications for Use | Contrast-Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the **Envision platform**. The CEDM application (I-View® software) shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography | Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the **Selenia Dimensions system**. The CEDM application (I-View® software) shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound | The only difference in the indications for use is the digital breast tomosynthesis platform used to obtain the images. | 4 {7} Hologic, Inc. 510(k) Premarket Notification I-View® | | and/or ultrasound exams to localize a known or suspected lesion. | exams to localize a known or suspected lesion. | | | --- | --- | --- | --- | | Dual Energy Technology | Image acquisition from x-ray exposures from two different energy levels (“dual energy”). Exposures are performed with a general FFDM mammographic system. The high and low energy images are subtracted to create the dual energy image. | Image acquisition from x-ray exposures from two different energy levels (“dual energy”). Exposures are performed with a general FFDM mammographic system. The high and low energy images are subtracted to create the dual energy image. | N/A - same | | High energy X-Ray Filtration | copper | copper | N/A – same | | High Energy kVp | 45 to 49 kVp | 45 to 49 kVp | N/A – same | | Clinical Output | To inform the primary diagnostic and patient management decisions that are made by the clinical user. | To inform the primary diagnostic and patient management decisions that are made by the clinical user. | N/A – same | | Patient Population | This software is intended to be used in the population of patients undergoing mammography. | This software is intended to be used in the population of patients undergoing mammography. | N/A – same | | End Users | MQSA- Qualified Interpreting Physicians and Radiologists | MQSA- Qualified Interpreting Physicians and Radiologists | N/A – same | | Image Source Modalities | 2D dual energy contrast enhanced digital breast tomosynthesis images obtained during a single compression. | 2D dual energy contrast enhanced digital breast tomosynthesis images obtained during a single compression. | N/A – same | | Output Device | Softcopy Workstation | Softcopy Workstation | N/A – same | | Deployment | Stand-alone computer | Stand-alone computer | N/A – same | | Supported Views | RCC, RMLO, LCC, LMLO | RCC, RMLO, LCC, LMLO | N/A – same | | | Display of low energy and subtracted image for clinical use. | Display of low energy and subtracted image for clinical use. | N/A – same | | X-Ray Image Device | Envision Mammography Platform | Selenia Dimensions FFDM | The Envision Mammography Platform (approved via P080003/S009) supports the | 5 {8} Hologic, Inc. 510(k) Premarket Notification^{}[] I-View® | | | | I-View® requirements. No impact to safety and effectiveness. | | --- | --- | --- | --- | | Visualization Features | Introduction of estimation algorithm which: 1. Applies background inhomogeneity correction by estimating and removing non-uniform signal patterns, helping preserve enhancement associated with iodine concentration. 2. Introduces peripheral region correction to account for anatomical and positioning variations, supporting consistent signal representation across the breast. | No estimation algorithm. | No impact to safety and effectiveness. | | Documentation Level or Level of Concern | Basic Documentation | Moderate Level of Concern | Predicate device was assessed per *Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices* published on May 11, 2005. Subject device is being assessed per *Content of Premarket Submissions for Device Software Functions* published on June 14, 2023. | 6 {9} Hologic, Inc. 510(k) Premarket Notification I-View® # Comparison with Predicate Device: The Summary of Substantial Equivalence table above details the similarities and differences between the subject device, I-View® version 3.0, and its predicate device, I-View® version 1.0, K123873. The main differences between the predicate and subject device are the enhanced visualization features due to a new estimation algorithm, and the introduction of a new host device, the Envision Mammography Platform (approved via P080003/S009). The new estimation algorithm applies background inhomogeneity correction by estimating and removing non-uniform signal patterns, helping preserve the enhancement associated with iodine concentration, and introduces peripheral region correction to account for anatomical and positioning variations, supporting consistent signal representation across the breast. Both the subject and predicate device use the same fundamental technology per 21 CFR 892.1715. Consistent with the predicate device, the subject device enables contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Hologic's CEDM I-View® version 3.0 option is substantially equivalent to the predicate device, Hologic's CEDM I-View® version 1.0, K123873, in that the same indications for use, the same filtration (copper), the same high energy kVp range, and the same "dual energy" imaging technique are used to generate the contrast image. The subject device provides the same performance in terms of image quality and intended clinical application. As such, there is no change in the safety and effectiveness of the subject device as compared to the predicate device. # Standalone Performance Testing: I-View® is a device software function. In accordance with the FDA Guidance "Content of Premarket Submissions for Device Software Functions", issued on June 14, 2023, I-View® software requires Basic Documentation as it is a Class II device that is intended to be used as an extension of the existing indications for diagnostic mammography with the Envision Mammography Platform (P080003/S009). The I-View® application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Verification and validation testing consists of software unit testing, software integration testing and software system testing. The verification and validation testing shows that the software application satisfies the design requirements. Dedicated bench testing was performed for I-View® on the Envision Mammography Platform (P080003/S009), with additional bench testing on the host device also leveraged. The bench testing included physical and mechanical characterization phantom testing which evaluated performance of the subject device and the predicate device. Testing included: - Iodine Signal Linearity and Accuracy Testing - Spatial Uniformity Assessment 7 {10} Hologic, Inc. 510(k) Premarket Notification I-View® - Peripheral Region Performance Testing - Performance Across Breast Thicknesses and Densities - Artifact Assessment - Comparative Testing with the Predicate Device All defined acceptance criteria were met for the bench testing, and the results indicated that I-View® is non-inferior to the predicate device. A Clinical Image Evaluation (CIE) was performed with six CEDM cases (image sets), acquired on the FDA-approved Envision Mammography Platform (P080003/S009) and processed with I-View® CEDM software. This study demonstrated that the six CEDM clinical image sets acquired on the Envision Mammography Platform and the I-View® software were considered of sufficiently acceptable quality for mammography usage by MQSA-certified, board-certified radiologists. Based on results of verification and validation testing and the clinical image evaluation, it is concluded that I-View® is safe and effective to meet its intended use. ### Assessment of Benefit-Risk and Safety and Effectiveness: Risk management is ensured through risk analysis which is used to identify and mitigate potential hazards. Any potential hazards are controlled via software development, verification, and validation testing. In addition, device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Hologic finds that the proposed device has a positive balance in terms of probable benefits versus probable risks and thus may be considered safe and effective based on verification and validation testing. ### Conclusion: Based on the required information submitted in this premarket notification, the proposed CEDM device, I-View® version 3.0, has been found to be substantially equivalent to the predicate CEDM device, I-View® version 1.0, K123873. Both CEDM devices have the same clinical indications for use and enable contrast enhanced breast imaging using a dual energy technique. In both devices, the imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known suspected lesion. Standalone performance testing demonstrates that I-View® version 3.0 achieves equivalent image quality performance compared to the predicate I-View® version 1.0. There are no issues of safety and effectiveness of the proposed I-View® version 3.0 device. 8