← Product Code [LLZ](/productcode/LLZ) · K261855

# Elucid PlaqueIQ (K261855)

_Elucid Bioimaging, Inc. · LLZ · Sep 18, 2026 · Radiology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K261855

## Device Facts

- **Applicant:** Elucid Bioimaging, Inc.
- **Product Code:** [LLZ](/productcode/LLZ.md)
- **Decision Date:** Sep 18, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 892.2050
- **Device Class:** Class 2
- **Review Panel:** Radiology
- **Attributes:** Software as a Medical Device

## Indications for Use

Elucid PlaqueIQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

## Device Story

Elucid PlaqueIQ is a cloud-based image analysis application for evaluating CT angiography images of arterial vessels. It provides multi-dimensional visualization, plaque quantification, and stenosis characterization. Unlike on-premise predicate devices where physicians perform segmentations, Elucid PlaqueIQ utilizes a service model where Elucid Analysts generate segmentations and apply plaque algorithms. The resulting data (plaque and %stenosis) is provided to the clinician via an internet-connected device. Clinicians review the analysis to inform their interpretation of arterial anatomy and pathology. The device does not contact the patient or control life-sustaining equipment; it serves as a supplemental diagnostic aid. Clinicians cannot edit the analysis directly but may request rework. The system supports 2D MPR, curved MPR, straightened views, and 3D visualization with interactive MIP controls.

## Clinical Evidence

Evidence includes histopathologic validation and a stenosis reader study. Histopathologic validation (n=not specified) showed Pearson correlation coefficients of 0.95 (CALC Area), 0.88 (LRNC Area), and 0.86 (Matrix Area). A stenosis reader study compared PlaqueIQ against expert consensus readers on CT: Patient-level >50% stenosis sensitivity 93.85% (95% CI: 85.2-97.6%), specificity 91.5% (95% CI: 83.4-95.8%); Vessel-level >50% stenosis sensitivity 86.42% (95% CI: 79.1-93.6%), specificity 93.97% (95% CI: 90.7-97.0%).

## Technological Characteristics

Cloud-based image analysis software; DICOM compatible. Features multi-dimensional visualization (2D MPR, curved MPR, straightened view, 3D), plaque quantification, and stenosis characterization. Operates on Windows and Mac OS. Software-based; no patient contact. Verification and validation performed per internal procedures.

## Regulatory 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

- Autoplaque add-on ORS Visual ([K122429](/device/K122429.md))

## Reference Devices

- Elucid PlaqueIQ ([K241524](/device/K241524.md))

## Submission Summary (Full Text)

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**U.S. FOOD & DRUG**
ADMINISTRATION

September 18, 2026

Elucid Bioimaging, Inc.
Hiral Vora
Lead Quality and Regulatory Affairs Specialist
399 Boylston St., Suite 400
Boston, Massachusetts 02116

Re: K261855

Trade/Device Name: Elucid PlaqueIQ

Regulation Number: 21 CFR 892.2050

Regulation Name: Medical Image Management And Processing System

Regulatory Class: Class II

Product Code: LLZ

Dated: August 20, 2026

Received: August 21, 2026

Dear Hiral Vora:

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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K261855 - Hiral Vora

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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-

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K261855 - Hiral Vora

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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,

for
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. | K261855 | ?  |
| --- | --- | --- |
|  Please provide the device trade name(s). |   | ?  |
|  Elucid PlaqueIQ  |   |   |
|  Please provide your Indications for Use below. |   | ?  |
|  Elucid PlaqueIQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.  |   |   |
|  Prescription use only.  |   |   |
|  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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Elucid PlaqueIQ

510(k) Summary

# K261855 510(k) Summary

## Submitter Information

|  **Submitter / Manufacturer Name** | Elucid Bioimaging, Inc. 399 Boylston Street, Suite 400, Boston, MA 02116  |
| --- | --- |
|  **Primary Correspondent & Contact Information** | Hiral Vora Lead Quality and Regulatory Affairs Specialist Email ID: hiral.vora@elucid.com  |
|  **Secondary Correspondent & Contact Information** | Windi Hary Chief Quality and Regulatory Officer Email ID: windi.hary@elucid.com  |
|  **Date Prepared** | 20 August 2026  |

## Device Identification

|  **Proprietary Name:** | Elucid PlaqueIQ  |
| --- | --- |
|  **Device Classification Name:** | System, Image Processing, Radiological  |
|  **Regulation Description:** | Medical image management and processing system  |
|  **Regulation Number:** | 892.2050  |
|  **Device Class** | Class II  |
|  **Product Code:** | LLZ  |

## Predicate

|  **Proprietary Name:** | Autoplaque add-on ORS Visual  |
| --- | --- |
|  **Device Classification Name:** | System, Image Processing, Radiological  |
|  **Regulation Description:** | Medical image management and processing system  |
|  **510(k) Number:** | K122429  |
|  **Regulation Number:** | 892.2050  |
|  **Device Class** | Class II  |
|  **Product Code:** | LLZ  |

Elucid BioImaging, Inc.

1

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Elucid PlaqueIQ

510(k) Summary

## Reference Device

|  **Proprietary Name:** | Elucid PlaqueIQ  |
| --- | --- |
|  **Device Classification Name:** | System, Image Processing, Radiological  |
|  **Regulation Description:** | Medical image management and processing system  |
|  **510(k) Number:** | K241524  |
|  **Regulation Number:** | 892.2050  |
|  **Device Class** | Class II  |
|  **Product Code:** | LLZ  |

## Device Description

Elucid PlaqueIQ is an image analysis application for evaluating CT angiography images of arterial vessels. Elucid PlaqueIQ provides multi-dimensional visualization, plaque quantification, and stenosis characterization to aid clinicians in their analysis of plaque anatomy and pathology (e.g., atherosclerosis). Elucid PlaqueIQ supports physician review and interrogation of the Elucid conducted segmentation to inform their clinical interpretation of the Elucid PlaqueIQ Analysis.

## Indications of Use

Elucid PlaqueIQ is intended to support qualified clinicians in the non-invasive evaluation and assessment of plaque quantification and morphology (e.g., atherosclerosis) from previously acquired CT angiography. The results are intended to support qualified clinicians in conjunction with the patient's clinical history, symptoms, and other diagnostic tests, as well as the clinician's professional judgment.

Prescription use only.

## Indications of Use comparison discussion

Autoplaque is an on-prem desktop plaque analysis application, where physicians generate segmentations and apply plaque algorithms for quantification. The results are then presented to the physician. Elucid PlaqueIQ is a cloud-based application, where Elucid Analysts generate segmentations (as a service) and apply plaque algorithms for quantification. The results (plaque and %stenosis) are then provided to the physician. Elucid monitors their analyst/product performance to ensure repeatability and reproducibility of the segmentations and plaque outputs. Therefore, we feel the differences in indications do not present any additional concerns of safety or effectiveness.

## Technological Characteristic Comparison

Elucid PlaqueIQ is an image analysis software that is used to process, review, and analyze CT images. It has the same technological characteristics as the predicate device. It does not come in contact with the patient, nor does it control any life-sustaining devices. It provides physicians with a tool that aids with interpretation of CT images and information displayed. Even though there are some technological differences between subject device and predicate device in terms of computer operating system, and provision of product as stand-alone device; these differences do not impact the safety and effectiveness of the product. Additionally, these differences are addressed through software verification and validation.

Elucid BioImaging, Inc.

2

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Elucid PlaqueIQ

510(k) Summary

# *Predicate Device Comparison*

|  Comparison Criteria | Elucid PlaqueIQ B.1P | Autoplaque add-on ORS Visual (Primary Predicate) | Elucid PlaqueIQ B.1P (Reference Device) | Comparison Assessment  |
| --- | --- | --- | --- | --- |
|  **510(k)** | K261855 | K122429 | K241524 | -  |
|  **Manufacturer** | Elucid Bioimaging, Inc. | Object Research Systems (ORS) inc. | Elucid Bioimaging, Inc. | -  |
|  **Product Code** | LLZ | LLZ | LLZ | Same as predicate  |
|  **Regulation Number** | 892.2050 | 892.2050 | 892.2050 | Same as predicate  |
|  **Regulation Description** | Medical image management and processing system | Medical image management and processing system | Medical image management and processing system | Same as predicate  |
|  **Device Classification Name** | System, Image Processing, Radiological | System, Image Processing, Radiological | System, Image Processing, Radiological | Same as predicate  |
|  **Device Class** | Class II | Class II | Class II | Same as predicate  |
|  **Intended Use** | See above discussion | See above discussion | See above discussion | Similar to predicate - Non-invasive application that is used to process, review and analyze CT images using semi-automated tool that aid in diagnosis of coronary artery diseases - Output plaque identification and quantification  |
|  **Data Source (input)** | CT | CT | CT | Same as predicate  |
|  **Output** | Graphics and text results of arterial anatomy that | Graphic and text results of coronary anatomy that can | Graphics and text results of arterial anatomy that can be | Similar to predicate  |

Elucid BioImaging, Inc.

3

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Elucid PlaquelQ

510(k) Summary

|   | can be accessed by end users/physicians using a device with internet connectivity. Plaque Quantification Stenosis Characterization | be accessed by end users/physicians using the product. Plaque Quantification Stenosis Characterization | accessed by end users/physicians using a device with internet connectivity. Plaque Quantification |   |
| --- | --- | --- | --- | --- |
|  **Physical Characteristics** | - Cloud-based segmentation and analysis as service - DICOM compatible | - Software installed and used by end-user - DICOM compatible | - Cloud-based segmentation and analysis as service - DICOM compatible | Similar to predicate  |
|  **Safety** | Clinician review and assessment of analysis prior to use as supplemental diagnostic aid | Clinician editable, review, and assessment of analysis prior to use as supplemental diagnostic aid | Clinician review and assessment of analysis prior to use as supplemental diagnostic aid | Similar to predicate except clinicians cannot edit the analysis; however, they can request rework of the analysis.  |
|  **Computer Operating System** | Windows OS and Mac OS | Windows OS | Windows OS and Mac OS | Similar to predicate except subject device can be operated on Mac OS system as well  |
|  **2D Imaging** | Review of arterial vessels in 2D MPR, curved MPR, and straightened view. | Review of coronary vessels in 2D MPR, curved MPR, and straightened view. | Review of arterial vessels in 2D MPR, curved MPR, and straightened view. | Similar to predicate  |
|  **3D Imaging** | Review of structures in 3D | Review of structures in 3D | Review of structures in 3D | Same as predicate  |
|  **Maximum intensity projection (MIP)** | MIP with interactive control | MIP with interactive control | MIP with interactive control | Same as predicate  |
|  **Multiplanar reformatting (MPR)** | MPR with oblique slicing and variable slab thickness | MPR with oblique slicing and variable slab thickness | MPR with oblique slicing and variable slab thickness | Same as predicate  |

Elucid BioImaging, Inc.

4

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Elucid PlaqueIQ

510(k) Summary

## Summary of Tests

The software was designed, developed, verified and validated for performance per the written procedures. Verification, validation and usability testing data demonstrated that the device meets all of its specifications demonstrating substantial equivalence to the predicate device.

Any risks identified during product development were controlled and mitigated by a risk management plan including risk analysis, risk evaluation, risk control and evaluation of residual risks.

The following non-clinical tests were performed:

1. Verification testing verified the overall functionality and repeatability conforming to the software specifications.
2. Validation testing confirmed that the performance of the software met the pre-defined acceptance criteria.
3. Usability testing was conducted with intended users of the device and ensures the acceptability of the device.

The nonclinical verification and validation test results established that the device meets its design requirements and intended use.

## Histology Validation

Plaque-IQ algorithms were validated on histopathologic specimens, including calculations of anatomic structure and calculations of tissue characteristics. The histopathologic validation demonstrated the following performance:

|  Histopathology Values (mm2) | Plaque-IQ Results Pearson Correlation Coefficient [95% CI]  |
| --- | --- |
|  CALC Area | 0.95  |
|  0 - 22.73 mm² | [0.91, 0.97]  |
|  LRNC Area* | 0.88  |
|  0 - 56.36 mm2 | [0.80, 0.93]  |
|  Matrix Area | 0.86  |
|  7.43 - 55.91 mm2 | [0.76, 0.92]  |

*LRNC Area includes areas of LRNC and Intra-Plaque Hemorrhage as identified by pathologists

Elucid BioImaging, Inc.

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Elucid PlaquelQ

510(k) Summary

## Stenosis Reader Study

PlaquelQ performance in identification of obstructive or non-obstructive stenosis compared to ground truth results produced by expert readers against CT are shown below.

|  Plaque-IQ Stenosis Compared to consensus L3 reader performance | Sensitivity (95% CI) | Specificity (95% CI) | NPV  |
| --- | --- | --- | --- |
|  Patient level >50% | 93.85% (85.2%, 97.6%) | 91.5% (83.4%, 95.8%) | 95%  |
|  Vessel level >50% | 86.42% (79.1%, 93.6%) | 93.97% (90.7%, 97.0%) | 95%  |

## Conclusion

Based on the intended use, technological characteristic, summary of tests and comparison to the predicate, Elucid PlaquelQ raises no new questions of safety and effectiveness as compared to the predicate and is substantially equivalent to the predicate device in terms of safety, efficacy, and performance.

Elucid BioImaging, Inc.

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**Source:** [https://fda-staging.innolitics.com/device/K261855](https://fda-staging.innolitics.com/device/K261855)

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