Eden PACS
Device Facts
| Record ID | K261788 |
|---|---|
| Device Name | Eden PACS |
| Applicant | Higia., Inc. d/b/a Eden |
| Product Code | LLZ · Radiology |
| Decision Date | Oct 21, 2026 |
| Decision | SESE |
| Submission Type | Abbreviated |
| Regulation | 21 CFR 892.2050 |
| Device Class | Class 2 |
| Attributes | Software as a Medical Device, Pediatric |
Indications for Use
Eden PACS (Picture Archiving and Communications System, per 21 CFR 892.2050) is software intended as a Digital Imaging and Communications in Medicine (DICOM) information, storage, data management and analysis system. Ancillary non-DICOM content is supported for storage and review alongside DICOM studies and is not intended for primary diagnostic interpretation. The Eden PACS is indicated for the display, processing, storage and transfer of medical data from original equipment manufacturers (OEM) that support the DICOM standards, in the field of radiology. It is intended for use by trained healthcare professionals in radiology and related clinical settings to support image interpretation and clinical reporting.
Device Story
Eden PACS is a software-only Picture Archiving and Communication System (PACS) for managing, storing, and viewing medical images. It accepts DICOM-compliant data from various OEM imaging modalities (e.g., CT, MR, US, XR, MG). The system provides tools for image manipulation (rotation, flipping, windowing, magnification), enhancement filters (noise reduction, resolution enhancement), and user-driven measurements (angles, distance, goniometry, coxometry, pelvic deviation, cardiothoracic ratio, spine labels). It includes specific mammography interpretation tools, including semi-automated nipple-to-lesion measurements and automated nipple detection. Used in radiology and clinical settings by trained healthcare professionals, the software runs on standard personal/business computers. It supports clinical reporting and image interpretation. By centralizing image access and providing analysis tools, it assists radiologists in diagnostic workflows and clinical decision-making.
Clinical Evidence
No clinical data. Evidence consists of bench testing, including software verification and validation, risk management, and performance testing against specified requirements. Compliance with NEMA PS 3.1-3.22 (DICOM), IEC 62304 (software life cycle), and EN ISO 14971 (risk management) was demonstrated.
Technological Characteristics
Software-only PACS; client-server architecture; web/HTML technology. Supports DICOM and non-DICOM data. Features include image viewing, manipulation, enhancement filters, and measurement tools (goniometry, coxometry, nipple detection). Complies with NEMA PS 3.1-3.22 (DICOM), IEC 62304, and ISO 14971. Cybersecurity managed per FDA guidance.
Indications for Use
Indicated for display, processing, storage, and transfer of DICOM medical data in radiology settings. Intended for use by trained healthcare professionals for patients of all ages, including neonates, infants, children, adolescents, and adults. Not intended for primary diagnostic interpretation of non-DICOM content.
Regulatory Classification
Identification
A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.
Special Controls
*Classification.* Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
Predicate Devices
- Image Management V15 (K240822)
Reference Devices
- Carestream PACS (K110919)
Submission Summary (Full Text)
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**FDA U.S. FOOD & DRUG**
ADMINISTRATION
October 21, 2026
Higia., Inc. d/b/a Eden
Michael Pogose
Director of Quality Assurance and Regulatory Affairs
Hardian Ltd. d/b/a Hardian Health
167-169 Great Portland St.
London, W1W 5PF
United Kingdom
Re: K261788
Trade/Device Name: Eden PACS
Regulation Number: 21 CFR 892.2050
Regulation Name: Medical Image Management And Processing System
Regulatory Class: Class II
Product Code: LLZ
Dated: May 29, 2026
Received: May 29, 2026
Dear Michael Pogose:
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
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Before making any change significantly affecting the safety or effectiveness of the device, you must submit a new premarket notification in accordance with 21 CFR 807.81. 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
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K261788 - Michael Pogose
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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
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| 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. | | ? |
| Please provide the device trade name(s). | | ? |
| Eden PACS | | |
| Please provide your Indications for Use below. | | ? |
| Eden PACS (Picture Archiving and Communications System, per 21 CFR 892.2050) is software intended as a Digital Imaging and Communications in Medicine (DICOM) information, storage, data management and analysis system. Ancillary non-DICOM content is supported for storage and review alongside DICOM studies and is not intended for primary diagnostic interpretation. The Eden PACS is indicated for the display, processing, storage and transfer of medical data from original equipment manufacturers (OEM) that support the DICOM standards, in the field of radiology. It is intended for use by trained healthcare professionals in radiology and related clinical settings to support image interpretation and clinical reporting. | | |
| 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) | ? |
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eden®
QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
# QR005(01) 510(k) Summary
| **eva-pacs.atlassian.net** **Record** | Document ID: **QR005** Revision: **01** Released: **19 Oct 2026** |
| --- | --- |
| **510(k)** **#:** | **K261788** | Prepared on: | **19 Oct 2026** |
| --- | --- | --- | --- |
| **Contact Details** | |
| --- | --- |
| Applicant Name | Higia, Inc. d/b/a Eden |
| Applicant Address | 300 Delaware Ave. Suite 210 #215 Wilmington Delaware DE 19801 United States of America |
| Applicant Contact Telephone | +52 55 7974 890 |
| Applicant Contact | Dr Daniel Medina |
| Applicant Contact Email | daniel.medina@edenmed.com |
| Correspondent Name | Hardian Ltd. d/b/a Hardian Health |
| Correspondent Address | 167-169 Great Portland Street London W1W 5PF United Kingdom |
| Correspondent Contact Telephone | +44 7958 656882 |
| Correspondent Contact | Mr. Michael Pogose |
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| Correspondent Contact Email | mike@hardianhealth.com | |
| --- | --- | --- |
| **Device Name** | | |
| Device Tradename | Eden PACS | |
| Common Name | Medical image management and processing system | |
| Classification Name | System, Image Processing, Radiological | |
| Regulation Number | 892.2050 | |
| Product Code(s) | LLZ | |
| **Legally Marketed Predicate Devices** | | |
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K240822 | Image Management V15 | LLZ |
| **Device Description Summary** | | |
| | | |
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eden®
QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
Eden PACS (Picture Archiving and Communication System) is software intended as a Digital Imaging and Communications (DICOM) and non-DICOM information, storage, data management and analysis system. Significant software features and functions:
- Viewing images
- General image manipulation (scroll, magnification, layout handling, preset windows, contrast inversion)
- Rotation and flipping
- Annotations
- Image enhancement filters, including noise reduction and resolution enhancement
- User-driven measurements (angles, distance measurements, goniometry, coxometry, RoI measurements)
- Measurements of pelvic deviation
- Cardiothoracic ratio
- Spine labels
- Specific tools for mammography interpretation: semi-automated nipple-to-lesion measurements
- Automated nipple detection
# Intended Use/ Indications for Use
Eden PACS (Picture Archiving and Communications System, per 21 CFR 892.2050) is software intended as a Digital Imaging and Communications in Medicine (DICOM) information, storage, data management and analysis system. Ancillary non-DICOM content is supported for storage and review alongside DICOM studies and is not intended for primary diagnostic interpretation.
The Eden PACS is indicated for the display, processing, storage and transfer of medical data from original equipment manufacturers (OEM) that support the DICOM standards, in the field of radiology.
It is intended for use by trained healthcare professionals in radiology and related clinical settings to support image interpretation and clinical reporting.
# Indications for Use Comparison
Eden PACS and the identified predicate device are software-only PACS solutions intended to display, process, store and transfer DICOM and non-DICOM information.
# Technological Comparison
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
Eden PACS and the identified predicate device are software-only PACS solutions intended to display, process, store and transfer DICOM and non-DICOM information. Eden PACS is as safe and effective as its predicate device, Philips Image Management V15. Both devices have similar indications for use, technological characteristics, and principles of operation. The minor technological differences between Eden PACS and its predicate device, as described in the submitted tabular substantial equivalence comparison, raise no new issues of safety or effectiveness.
### Non-Clinical and/or Clinical Tests Summary & Conclusions
Non-clinical testing included the use of data obtained through the internal risk management process and software verification and validation testing. Testing was conducted to verify compliance with specified requirements in accordance with:
- EN ISO 14971 Medical devices – Application of risk management to medical devices,
- IEC 62304 Medical device software – Software life cycle processes, and
- NEMA PS 3.1-3.22 Digital Imaging and Communications in Medicine (DICOM) Standard.
Verification and validation testing were conducted to ensure specifications and performance of the device and were performed per the FDA Guidance documents “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices”.
The test results conducted for this 510(k) premarket notification demonstrate that Eden PACS complies with the above international and FDA standards and guidance documents, and is substantially equivalent to the predicate device.
**Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and non-clinical performance testing, Eden PACS raises no new questions of safety and effectiveness and is substantially equivalent to the predicate device in terms of safety and effectiveness.**
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| | Subject Device | Predicate Device | Significance of any differences |
| --- | --- | --- | --- |
| Manufacturer | Higia Inc. | Philips Medical Systems Technologies Ltd. | N/A |
| Device Name | Eden PACS | Image Management V15 | N/A |
| 510(k) Number | N/A | K240822 | N/A |
| Device Class | Class II | Class II | N/A |
| Classification panel | Radiology | Radiology | N/A |
| Regulation | 21 CFR 892.2050 | 21 CFR 892.2050 | N/A |
| Regulation description | System, Image Processing, Radiological | System, Image Processing, Radiological | N/A |
| Product Code(s) | LLZ | LLZ | N/A |
| Indications for Use Statement | Eden PACS (Picture Archiving and Communication System) is software intended as a Digital Imaging and Communications (DICOM) and non-DICOM information, storage, data management and analysis system. The Eden PACS is indicated for the display, processing, storage and transfer of | Image Management is intended to provide complete and scalable local and wide area PACS solutions for hospital and related institutions/sites, which will archive, distribute, retrieve, process and display medical images and data from hospital medical imaging and information systems. The device contains clinical applications that assist the processing, analysis and | No significant differences. |
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| | medical data from original equipment manufacturers (OEM) that support the DICOM standards, in the field of radiology. It provides the capability to store images and patient information from OEM equipment where intended users can perform basic filtering, manipulation, user-driven measurement, and report writing. The client software is designed to run on standard personal and business computers. For interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. | processing, analyzing and comparing of medical images. It is a single device that integrates the review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. The Image Management viewers are used for patient exam management by clinicians in order to access and display patient data, medical reports, medical data and medical images from different modalities including but not limited to CR, DR, CT, MR, NM, ECG, US, MG*, DBT*, OP and OPT. The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard HTML. *For primary interpretation and review of mammography images, only use display hardware that is specifically designed for and cleared by FDA for mammography. | |
| --- | --- | --- | --- |
| Year of clearance | N/A | 2024 | N/A |
| Predicate (Name and K number) | Proposed: Image Management V15 (K240822) | Carestream PACS (K110919) | N/A |
| Technical | Web/HTML technology; | Web/HTML technology; Client- | No significant |
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| implementation | Client–server architecture. | server architecture. | differences. |
| --- | --- | --- | --- |
| Mobile use | Not intended for diagnostic use on mobile devices. | Does not mention mobile devices, but says "The device provides wireless and portable access to medical images for remote reading or referral purposes from web browsers using current standard Html.". | No significant differences. |
| Imaging modalities | Non-lossy compressed DICOM images including but not limited to: Computed Tomography (CT), Magnetic Resonance (MR), Nuclear Medicine (NM), Ultrasound (US), X-Ray (XR), X-Ray Angiography (XA), Positron Emission Tomography (PET), Computed Radiography (CR), Digital Radiography (DX), Digital X-ray image (DR), Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Ophthalmic Tomography (OPT). Ancillary non-DICOM content is supported for storage and review alongside DICOM studies and is not intended for primary diagnostic interpretation. | Including but not limited to: Computed Tomography (CT), Magnetic Resonance (MR), Nuclear Medicine (NM), Ultrasound (US), X-Ray (XR), X-Ray Angiography (XA), Positron Emission Tomography (PET), Computed Radiography (CR), Digital Radiography (DX), Digital Radiography (Abbreviation not defined by the DICOM standard) (DR), Radio Fluoroscopy (RF), Radiation Therapy (RT), Mammography (MG), Secondary Capture (SC), Visible Light (VL), Optical Coherence Tomography (OCT), Electrocardiogram (ECG) and Ophthalmic Photography (OP) as well as hospital/radiology information systems. | Minor variation in listed modalities, but no significant differences since a) the predicate device states these modalities are "included but not limited to", and b) the intended purpose of image management and viewing remains the same. Non-DICOM content displayed by the subject device is not intended for primary |
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| | | | diagnostic interpretation. |
| --- | --- | --- | --- |
| Basic PACS features | Medical images viewing, archive, distribute, retrieve, process and display images. The device contains clinical applications that assist the processing, analyzing and comparing medical images. It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. | Medical images viewing, archive, distribute, retrieve, process and display images. The device contains clinical applications that assist the processing, analyzing and comparing medical images. It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. | No significant differences. |
| More advanced features | • 3D reconstruction application • MPR application | • Vessel analysis application • 3D analysis application • Mammography image display Application • MPR application • Plus: Cardiac CT Application, ECG Application, Cardiology (Echocardiography, XA), Coronary Artery Analysis application, digital subtraction Application, Calcium Scoring application, Volume matching application, Hybrid NM Viewer application, PowerViewer application, CT Perfusion application, MR perfusion application, MR diffusion application, lesion management application. | Minor differences (predicate has additional applications such as a calcium scoring and vessel analysis application where the subject device does not). These differences of omission are not significant enough to affect the risk profile of the subject device |
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QR005(01) 510(k) Summary - QMS - Confluence
Higia, Inc.
| | | | subject device. |
| --- | --- | --- | --- |
| Reporting | It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. | It is a single device that integrates review, dictation and reporting tools to create a productive work environment for the radiologists and physicians. | No significant differences. |
| Performance level | Tests according to Higia Inc. verification and validation processes (technical performance testing and usability). | Image Management V15 has been tested in accordance with Philips verification and validation processes. Verification and validation tests have been performed to address intended use, technological characteristics, specifications and risk management results. | No significant differences. |
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