Who is the manufacturer of AIBOLIT 3D+?

Aibolit Technologies, LLC filed the 510(k) submission for AIBOLIT 3D+ (K222458).

What is the FDA product code for AIBOLIT 3D+?

LLZ. It is classified under 21 CFR 892.2050 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for AIBOLIT 3D+?

510(k) clearance (submission type: Traditional).

Does AIBOLIT 3D+ use AI or machine learning?

Yes. AIBOLIT 3D+ (K222458) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

What are the predicate devices for AIBOLIT 3D+?

Aibolit Technologies, LLC 3D+ System (K211443); Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System (K173274).

Who can help prepare an FDA 510(k) submission like AIBOLIT 3D+?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Can an AI/ML device like AIBOLIT 3D+ get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

AIBOLIT 3D+

K222458 · Aibolit Technologies, LLC · LLZ · Jan 12, 2023 · Radiology

Device Facts

Record ID	K222458
Device Name	AIBOLIT 3D+
Applicant	Aibolit Technologies, LLC
Product Code	LLZ · Radiology
Decision Date	Jan 12, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.2050
Device Class	Class 2
Attributes	AI/ML, Software as a Medical Device

Intended Use

Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MR imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions.

Device Story

Web-based, standalone software; processes CT/MRI DICOM images. Physician uploads images; radiologist performs manual segmentation/annotation of anatomical structures (e.g., vessels, ducts, lesions, calcifications). AI/ML-based algorithm assists in generating additional segmentations; radiologist reviews and approves all outputs. System generates 3D models with differential color-coding and labeling. Used in hospitals/clinics by healthcare professionals. Output displayed on standard monitors; allows rotation, zoom, transparency, and show/hide functions. Assists surgeons in preoperative planning and intraoperative visualization; potentially reduces errors from anatomical misidentification.

Clinical Evidence

Bench testing only. Validation included software verification and validation per FDA guidance. Performance testing comprised: 1) segmentation validation, 2) repeatability and reproducibility (R&R) study on multiple organ/structure anatomies, and 3) accuracy study on 3D model generation. MRI validation involved multiple organ structures, radiologists, and view perspectives, demonstrating conservation of shape dimensions and volume compared to a 'ground truth' standard.

Technological Characteristics

Web-based, standalone software. Processes DICOM CT/MRI images. Features include organ segmentation, structure identification, 3D model generation, multi-axis rotation, and organ transparency. Utilizes 3rd party software (3D Slicer) for 3D generation. Includes optional AI/ML-based segmentation module. HIPAA compliant, data coded. No body contact.

Indications for Use

Indicated for health care professionals to process, review, analyze, and display multi-dimensional CT and MRI images for preoperative surgical planning, training, patient information, and intraoperative reference. No specific age or gender contraindications stated.

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

Aibolit Technologies, LLC 3D+ System (K211443)
Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System (K173274)

Related Devices

K211443 — AIBOLIT 3D+ · Aibolit Technologies, LLC · Jan 7, 2022
K250237 — InferOperate Suite · Beijing Infervision Healthcare Medical Technology Co., Ltd. · Sep 15, 2025
K232339 — Augmented Reality Application · Sira Medical, Inc. · Feb 1, 2024
K243933 — Ceevra Reveal 3+ · Ceevra, Inc. · Mar 4, 2025
K250369 — Axial3D Insight · Axial Medical Printing Limited · Sep 18, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Aibolit Technologies, LLC % Howard Schrayer Regulatory Consultant Howard Schrayer 8 Lookout HILTON HEAD ISLAND SC 29928 #### Re: K222458 Trade/Device Name: Aibolit 3D+ Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: QIH, LLZ, Dated: December 5, 2022 Received: December 5, 2022 January 12, 2023 Dear Howard Schrayer: 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 (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 located 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. 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 of medical device-related adverse events) (21 CFR 803) for {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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 Jessica Lamb, Ph.D. Assistant Director Imaging Software Team DHT 8B: Division of Radiological Imaging Devices and Electronic Products OHT 8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### INDICATIONS FOR USE DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. 510(k) Number (if known) K222458 Device Name AIBOLIT 3D+ Indications for Use (Describe) Arbolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MRI imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. "DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # K222458 # | Contact: | Howard Schrayer Albolit Technologies, LLC 9616 Moritz Way Delray Beach, FL 33446 | |---------------------|----------------------------------------------------------------------------------------------------| | | Telephone: 609-273-7350 hs.ss@lucidmedical.net | | Date Prepared: | January 11, 2023 | | Device Trade Name: | AIBOLIT 3D+ | | Manufacturer: | Albolit Technologies, LLC 9616 Moritz Way Delray Beach, FL 33446 | | Common Name: | Automated Radiological Image Processing Software Medical image management and processing system | | Classification: | Class II | | Product Code: | QIH - LLZ | | Regulation: | 21 CFR 892.2050 | | Predicate Devices: | | | Primary Predicate | Aibolit Technologies, LLC 3D+ System [510(k) K211443]. | | Reference Predicate | Ceevra, Inc. Ceevra Reveal 2.0 Image Processing System [510(k) K173274] | {4}------------------------------------------------ #### Indications for Use: Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT and MR imaging devices. Aibolit 3D+ is intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. #### Device Description: Aibolit 3D+ is a web-based stand-alone application that can be presented on a computer connected to the internet. Once the enhanced images are created, they can be used by the physician for case review, patient education, professional training and intraoperative reference. Aibolit 3D+ is a software only device, which processes CT and MR images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective. The software also allows for transparent viewing of anatomical structures artifacts inside organs such as ducts, vessels, lesions and entrapped calcifications (stones). Anatomical structures are identified by name and differential coloration to highlight them within the region of interest. The software may help to facilitate the surgeon's decision-making during planning, review and conduct of surgical procedures and, hence, may potentially help them to decrease or prevent possible errors caused by the misidentification of anatomical structures and their positional relationship. #### Substantial Equivalence and Predicate Devices: The reason for this submission was to add the processing of images derived from MRI DICOM files to the functioning of the primary Aibolit predicate. This functionality is present in the referenced Ceevra predicate. The device was shown to be substantially equivalent to itself [510(k) K211443] and a previously cleared video image processing system, the Ceevra Reveal 2.0 Image Processing System [510(k) K173274]. {5}------------------------------------------------ Predicate Comparison Table | Manufacturer | Albolit Technologies, LLC | Ceevra | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade Name | AIBOLIT 3D+ Image Processing System | Ceevra Reveal 2.0 Image Processing System | | 510(k) Number | Subject Device - TBD | K173274 | | Type of Device/ Product Code / | Radiological Image Processing System / QIH - LLZ | Radiological Image Processing System / LLZ | | Regulation / Class | 21 CFR 892.2050 – Class II | 21 CFR 892.2050 – Class II | | Indications for Use | Aibolit 3D+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi- dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, training, patient information and as software for the intraoperative display of the multidimensional digital images. Aibolit 3D+ is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. | Ceevra Reveal 2.0 is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi- dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to assist the clinician who is responsible for making all final patient management decisions. | | Mechanism of Action | Capture and enhancement of (DICOM) digital video images via software-based conversion to 2-D and 3-D anatomical structure images that can be manipulated for viewing | Capture and enhancement of (DICOM) digital video images via software-based conversion to 2- D and 3-D anatomical structure images that can be manipulated for viewing | | Intended Users | Health care professionals | Health care professionals | | Intended Use Environment | Healthcare facilities such as hospitals and clinics | Healthcare facilities such as hospitals and clinics | | Format of Captured Images | DICOM | DICOM | | Intended Use | | | | AIBOLIT 3D+ is intended for use as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of multi-dimensional digital images. AIBOLIT 3D+ is designed for use by health care professionals and is intended to assist the | Intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi- dimensional digital images acquired from CT or MR imaging devices. It is also intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multi- dimensional digital images. Ceevra Reveal 2.0 is designed for use by health care professionals and is intended to | | | | clinician who is responsible for making patient management decisions. | assist the clinician who is responsible for making all final patient management decisions. | | Security | Data coded and HIPAA compliant | Data coded and HIPAA compliant | | Form of Device | AIBOLIT 3D+ is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a mobile device or standard computer monitor. | The Ceevra Reveal 2.0 Video Processor is a software only device that permits electronic image uploads, provides image conversion and allows viewing on a mobile device or standard computer monitor. | | Image processing | High-definition digital images | High-definition digital images | | Functions | Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency | Generation of 2D and 3D images from DICOM data Organ segmentation and structure identification Dimensional and volume references Multi-axis image rotation Organ transparency | | Body contact | None | None | | User Interface and System Work-Flow | Physician uploads DICOM images and specifies desired anatomical segments of interest Radiologist annotates sample (segments) images | Physician uploads DICOM images and specifies desired anatomical segments of interest Imaging technician annotates sample (segments) images | | | Radiologist may use add-on software to facilitate annotation of DICOM images under guidance and full control of the Radiologist Radiologist generates multi-axis rotatable image and returns output file to requesting physician | Imaging technician generates multi-axis rotatable image and returns output file to requesting physician | | External / Internet Connections | Web-based software | Web-based software | | CT / MRI Image Uploading | By requesting physician | By requesting physician | | Other User Inputs | List of organ structures to be annotated and displayed, patient ID and demographics | List of organ structures to be annotated and displayed, patient ID and demographics | | Image Segmentation | By Radiologist (MD) – Manual annotation is done for all CT and MRI slices with optional use of software as determined by Radiologist and with Radiologist's approval and control | By Imaging Technician – Manual annotation done for all CT and MRI slices - No software used for annotation | | Organ identification | By Radiologist | Unknown proprietary method used to identify organ structures | | 3D Image generation | 3D image file generated by 3rd party software (3D Slicer) following Radiologist review and approval of annotation | 3D image file generated by 3rd party software | | Organ structure identification | Proprietary software assigns color coding to each structure identified by Radiologist and displays color-coded image with labeled key to color/structure identity | Proprietary software assigns color coding to each structure identified by imaging technician and displays color-coded image with key to color/structure identity | | Image editing permission | Only the radiologist can edit images following review – User physicians cannot edit images – Physicians have option to show or hide organs on display | Imaging technician can edit images generated by the system software – User physicians cannot edit images - Physicians have option to show or hide organs on display | | Device Output Devices | 3D image can be displayed on standard monitor or another appropriate display | 3D image can be displayed on standard monitor, smart phone (with separate software) or Virtual Imaging 3D headset | | Supplemental outputs | Organ structure dimensions, volume, organ labels, patient ID, image date and demographics | Organ structure dimensions, volume, organ labels, patient ID and demographics | | Output image manipulation by user | Physician user can show or hide individual organ structures, zoom capability, rotational capability and transparency capability | Physician user can show or hide individual organ structures, zoom capability, rotational capability, transparency capability (current version) | {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ ### Performance Testing: Non-clinical performance data was included in the 510(k) submission to demonstrate that the Aibolit software has been validated for its intended use and to support substantial equivalence to the predicate device. Software verification and validation were performed, and documentation was included in this submission in accordance with FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". This includes verification against defined requirements, and validation against user needs. In addition, performance testing included 1) segmentation validation of the Customize software, 2) Repeatability and Reproducibility (R&R) study on the segmentation of multiple internal organ/structure anatomies and 3) accuracy study on 3D model generation for multiple organ structures. For image segmentation, the device includes optional artificial intelligence including machine learning followed by review by a radiologist. The Al-based algorithm is based on a system that has been trained to identify organs/structures using a dataset of 108 anatomical structures as obtained from medical images (MRI scans) and their corresponding segmentation. The images were evaluated from 3 perspectives by 4 radiologists. After a radiologist establishes contours. the system produces additional seqmentations for review by the radiologist. The following documentation was previously submitted. - Hardware Requirements Level of Concern Statement Software Description Architecture Design User Manual and Instructions for Use Software Design Specification Risk Analysis Traceability Analysis Software Validation Report Usability Evaluation Software Development Lifecycle Unresolved Anomalies Cybersecurity ## Additional Testing Expansion of Software Validation to include MRI validation using multiple organ structures, multiple radiologists and multiple view perspectives. The validation was conducted in accordance with a written protocol with pre-determined acceptance criteria. The validation demonstrated conservation of shape dimensions, volume of the structures in a side-by-side testing comparison with a "ground truth" accepted standard independent of radiologist, organ structure and view perspective. {10}------------------------------------------------ ### Conclusion AIBOLIT 3D+ is substantially equivalent to the previously cleared Aibolit 3D+ system (K211443) and to the Ceevra Reveal 2.0 Image Processing System (K173274) with respect to intended use, principle of operation, general technological characteristics and performance.