Quicktome Software Suite

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION September 10, 2026 Omniscient Neurotechnology Pty, Ltd. Arie Henkin Chief Clinical Officer Suite L1.108, 477 Pitt St. Haymarket, NSW 2000 Australia Re: K261795 Trade/Device Name: Quicktome Software Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: QIH, LLZ Dated: August 6, 2026 Received: August 7, 2026 Dear Arie Henkin: 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 U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K261795 - Arie Henkin Page 2 Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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 {2} K261795 - Arie Henkin Page 3 (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Daniel M. Krainak, PhD Assistant Director 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. | | K261795 | ? | | --- | --- | --- | --- | | Please provide the device trade name(s). | | | ? | | Quicktome Software Suite | | | | | Please provide your Indications for Use below. | | | ? | | Quicktome Software Suite is composed of a set of modules intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, image fusion, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, automated and manual segmentation object creation, detection, and adjustment, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets. Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds. Quicktome can be used in conjunction with other clinical methods as an aid in visualization of deep brain structures, such as the subthalamic nuclei (STN), globus pallidus interna (GPi) and ventralis intermediate nucleus (VIM). Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists. | | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | | {4} 510(k) #: K261795 510(k) Summary Prepared on: 2026-09-09 # Contact Details 21 CFR 807.92(a)(1) Applicant Name Omniscient Neurotechnology Pty Ltd Applicant Address Suite L1.108, 477 Pitt Street Haymarket NSW 2000 Australia Applicant Contact Telephone 4165009985 Applicant Contact Mr. Arie Henkin Applicant Contact Email arie.henkin@o8t.com # Device Name 21 CFR 807.92(a)(2) Device Trade Name Quicktome Software Suite Common Name Medical image management and processing system Classification Name Automated Radiological Image Processing Software Regulation Number 892.2050 Product Code(s) QIH, LLZ # Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K241083 SIS System QIH # Device Description Summary 21 CFR 807.92(a)(4) Quicktome is a software-only, cloud-deployed, image processing package which can be used to perform DICOM image viewing, image processing, and analysis. Quicktome can receive ("import") DICOM images from picture archiving and communication systems (PACS), acquired with magnetic resonance imaging (MRI) or head computed tomography (CT). Image types including but not limited to T1, T2, FLAIR, and FGATIR images, and 4D sequences, including Diffusion Weighted Imaging (DWI) sequences and Resting State functional MRI (rs-fMRI) blood-oxygen-level-dependent (BOLD) datasets. Once received, Quicktome removes protected health information (PHI) and links the dataset to an encryption key, which is then used to relink the data back to the patient when the data is exported to hospital PACS or other DICOM device. Quicktome is structured as a configurable base platform with optional Application Modules. The base platform supports DICOM image viewing, image manipulation, basic measurement, multi-modality image fusion (including MRI-MRI and MRI-CT fusion), 3D visualization (MPR reconstructions and 3D volume rendering), workflow-driven quality checks, and target export creation and selection. The Application Modules extend the base platform with workflow-specific processing and visualization tools (e.g., tractography generation). This submission module includes the ability to co-register a CT with the patient's MRI, automatically extract the geometry of an implanted deep brain stimulation (DBS) lead from the CT, and present the lead model alongside registered deep-brain structures as an adjunctive visualization aid. The software provides a set of module-based workflows for a clinician to: * Select (an) image(s) for planning and visualization, * Validate image quality, * Explore available anatomical regions (including deep-brain structures), network templates, tractography bundles, and parcels, {5} * Create, detect, select, and adjust segmentation objects, including regions of interest, * Fuse multiple imaging modalities for combined visualization (for example, anatomical MRI with secondary MRI sequences, DWI, BOLD, or CT), * Display resting-state fMRI (BOLD) correlation maps using task-analogous seeds for Motor, Vision, and Language networks, * Visualize an implanted DBS lead's position and orientation in a CT and against the patient MR data and processing, and * Export black-and-white and color DICOMs for use in systems that can view DICOM images. Selected processing steps - including skull stripping and atlas registration - are performed by locked machine-learning components. The identity, training population, and lifecycle controls applicable to these components are described in an AI/ML Model Card. ## Intended Use/Indications for Use 21 CFR 807.92(a)(5) Quicktome Software Suite is composed of a set of modules intended for display of medical images and other healthcare data. It includes functions for image review, image manipulation, basic measurements, planning, image fusion, 3D visualization (MPR reconstructions and 3D volume rendering) and display of BOLD (blood oxygen level dependent) resting-state MRI scan studies. Modules are available for image processing, atlas-assisted visualization and segmentation, resting state analysis and visualization, automated and manual segmentation object creation, detection, and adjustment, and target export creation and selection, where an output can be generated for use by a system capable of reading DICOM image sets. Quicktome is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white-matter tracts based on constrained spherical deconvolution methods and for the use of said maps to select and create exports. Quicktome can generate motor, language, and vision resting state fMRI correlation maps using task-analogous seeds. Quicktome can be used in conjunction with other clinical methods as an aid in visualization of deep brain structures, such as the subthalamic nuclei (STN), globus pallidus interna (GPi) and ventralis intermediate nucleus (VIM). Typical users of Quicktome are medical professionals, including but not limited to surgeons, clinicians, and radiologists. ## Indications for Use Comparison 21 CFR 807.92(a)(5) The subject device and the primary predicate share the same intended use: both are software-only, adjunctive image-processing, image-fusion, and visualization tools that aid medical professionals in the visualization and review of anatomical structures in neurological procedures. Both devices are limited to providing adjunctive information to the clinician; neither performs diagnosis, actively guides surgical lead placement, performs DBS programming, or models volume of tissue activated. Two differences in scope exist between the subject and predicate. Each is a reduction in scope relative to the predicate: 1. Workflow scope. The primary predicate is indicated for pre-operative planning, intraoperative functional planning (with 3D output usable by stereotactic image-guided surgery or other devices), and post-operative review. The subject device is limited to adjunctive visualization and post-operative review of pre-operative MRI co-registered to post-operative CT. 2. Deep brain anatomical coverage. The primary predicate's atlas-assisted segmentation covers STN, GPe, GPi, and VIM. The subject device covers STN, GPi, and VIM only; GPe is not included and no claim regarding GPe is made. The differences are not critical to the intended use of the device, and they do not affect its safety and effectiveness when used as labeled. The device is adjunctive and non-therapeutic; it does not itself diagnose, treat, or guide a surgical procedure, and its outputs are returned to PACS in DICOM format for clinician review with no direct interface to surgical-navigation or DBS-programming systems. The device is fully verified and validated for the targets and capabilities it does claim, therefore, these differences in Indications for Use do not raise new or different questions of safety or effectiveness. ## Technological Comparison 21 CFR 807.92(a)(6) The subject device (Quicktome Software Suite) shares the same fundamental technological characteristics as the primary predicate device (SIS System, K241083). Both are software-only, Class II (21 CFR 892.2050) medical devices cleared under product codes QIH and LLZ, operate on off-the-shelf hardware, are DICOM-compliant, and provide only adjunctive information to clinicians. Neither device applies energy to the patient or has any physical, electrical, mechanical, chemical, thermal, or radiation output, and biocompatibility and sterility are not applicable to either. In terms of core functionality, technology, and performance, both the subject device and the primary predicate: 1. Allow import and export of DICOM images to and from a hospital PACS; 2. Provide a graphical user interface for the visualization and review of medical images; 3. Ingest pre-operative MRI and post-operative CT and perform automated image fusion (co-registration) using rigid and deformable registration methodologies; 4. Produce patient-specific anatomical overlays of deep brain structures, including STN, GPi, and VIM; 5. Automatically detect implanted DBS leads in post-operative CT and provide manual tools for adjustment of the lead model; 6. Are software-only, hardware-agnostic solutions that require no proprietary local installation or specialized hardware to perform their intended medical function; {6} 7. Require user authentication and logon; 8. Provide adjunctive information only - neither device performs surgical guidance, DBS programming, or VTA modeling. The technological characteristics carried over from the predecessor Quicktome Software Suite clearance (K222359) are unchanged in the subject device. These include DWI-based constrained-spherical-deconvolution (CSD) tractography, resting-state fMRI correlation mapping for motor, language, and vision networks, cortical atlas-assisted visualization using a modified Glasser/HCP-MMP1 atlas, network templates and tractography bundles, target export generation, the three-tier cloud architecture (browser-based Web Viewer, on-premises Gateway for PACS integration and de-identification, and a cloud Processing Core), and two-factor user authentication. These features are configurable per facility and were not modified for this submission; their equivalence was confirmed by comparison testing against Quicktome (K222359). Two technological differences are identified between the subject device and the primary predicate. Neither raises new or different questions of safety or effectiveness, for the reasons summarized below; each was verified and validated and did not lead to any additional questions of safety or effectiveness. Difference 1: Segmentation algorithm The predicate generates anatomical overlays using pre-trained deep-learning neural network models. The subject device generates equivalent patient-specific overlays by deformably registering a locked, Omniscient-built atlas into each patient's MRI space. Both approaches deliver the same output to the clinician: a patient-specific 3D anatomical overlay derived from a clinical MR acquisition, displayed adjunctively, using a population-derived reference and producing locked, deterministic outputs at deployment. Algorithmic verification against an independent atlas-derived reference standard (the AHEAD 7T atlas, preceded by reference device K253379) demonstrated STN and GPi pass at acceptance criteria consistent with the primary predicate's 2.0 mm threshold. Clinician-based clinical validation by three board-certified DBS-experienced neurosurgeons demonstrated STN, GPi, and VIM are acceptable using pre-defined acceptance criteria. Difference 2: Automated lead roll / yaw (rotational orientation) detection The predicate provides automated rotational-orientation (roll / yaw) detection of directional DBS leads from post-operative CT. The subject device performs automated lead segmentation and localization (position, length, diameter, and lead positions) but does not output an automated estimate of rotational orientation. The summative evaluation conducted per IEC 62366-1 and FDA Human Factors guidance with representative DBS-experienced neurosurgeons, passed with no critical use errors or use-related hazards traceable to the absence of this feature, confirming that the intended adjunctive post-operative review workflow is performed acceptably without it. Comparison to the primary predicate device, in conjunction with the design verification and validation activities described in this submission, supports the substantial equivalence of the Quicktome Software Suite. The device performs as intended under the specified conditions of use and does not raise new or different questions of safety or effectiveness when compared to the legally marketed predicate device. # Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b) Substantial equivalence is supported by nonclinical software verification and validation testing, including bench performance testing against independent reference standards and clinician-based clinical validation of the device's outputs. The following FDA-recognized consensus standards were applied: - IEC 62304 - Medical device software - Software life cycle processes; - IEC 62366-1 - Application of usability engineering to medical devices; - ISO 14971 - Application of risk management to medical devices; - NEMA PS 3.1–3.20 - Digital Imaging and Communications in Medicine (DICOM); - TIR97 - Principles for medical device security - Postmarket risk management for device manufacturers; - SW96 - Standard for medical device security - Security risk management for device manufacturers; - TIR57 - Principles for medical device security - Risk management. Comparative performance testing followed the methodology used by the primary predicate (K241083) where applicable. Established reference methodologies were used where appropriate: the AHEAD ultra-high-field 7T atlas, an approach preceded by reference device K253379, was used as an independent reference standard for STN and GPi segmentation testing. The following testing was conducted: - Skull stripping verification. - Cortical anatomical region and atlas generation. Comparison to the previously cleared Quicktome Software Suite (K222359) confirmed equivalence of the generated cortical anatomical regions. - Tractography bundle generation. Comparison to the previously cleared Quicktome Software Suite (K222359) confirmed equivalence of the generated tractography bundles. - Deep structure segmentation (STN, GPi). A 7T T1 atlas was used to establish the segmentation reference standard. Prespecified acceptance criteria (≥ 90% of center-of-mass and mean symmetric surface distances ≤ 2.0 mm, consistent with the threshold cleared for {7} the primary predicate, K241083) were met for STN and GPi bilaterally. - CT-MRI co-registration. Acceptance criteria were aligned with the primary predicate methodology. - CT lead extraction (lead segmentation and localization). Positional-error acceptance criteria (tip and centerline ≤ 1.5 mm) were modeled on the predicate (K241083). - Clinical validation of deep structure segmentation (STN, GPi, VIM). Algorithm-derived overlays were rated against the patient's underlying MRI anatomy by three board-certified, DBS-experienced neurosurgeons. Prespecified acceptance criteria were met for all three structures. - Design validation and summative usability evaluation, conducted in accordance with IEC 62366-1 and FDA Human Factors guidance with representative end users (DBS-experienced neurosurgeons). All verification and validation activities required by the verification and validation plan were performed using a production-equivalent deployment of the software. Each identified technological difference between the subject device and the primary predicate was verified and validated and did not lead to any additional questions of safety or effectiveness. Risk management activities concluded that the benefits of the device outweigh the residual risks. No clinical tests were submitted to support this submission. Based on the comparison of intended use and technological characteristics, the nonclinical testing summarized above, and the risk-management conclusions, Omniscient Neurotechnology concludes that the Quicktome Software Suite is substantially equivalent to the predicate device, the SIS System (K241083). The subject device has the same intended use as the primary predicate - image processing, image fusion, visualization, and adjunctive review of deep brain structures (STN, GPi, VIM) in neurological procedures. The subject device and the predicate share the same product codes (QIH, LLZ), the same regulation (21 CFR 892.2050), the same Class II classification, the same software-only modality on off-the-shelf hardware, the same DICOM compatibility, the same adjunctive (non-therapeutic, non-navigational) role, and the same general algorithmic approach to MRI-CT fusion, deep-structure overlay generation, and DBS lead identification from post-operative CT. The bench performance testing demonstrated that the device's segmentation, co-registration, and lead-extraction outputs meet prespecified acceptance criteria consistent with those cleared for the predicate, evaluated against independent reference standards. The clinician-based clinical validation demonstrated that the device's anatomical overlays are rated as adequate for the intended use by board-certified, DBS-experienced neurosurgeons. The summative usability evaluation confirmed that representative users perform the intended adjunctive post-operative review workflow safely and effectively. Taken together, the design verification and validation conducted support the conclusion that the Quicktome Software Suite performs as intended under the specified conditions of use, and that it is at least as safe and as effective as, and performs as well as, the legally marketed predicate device. The device does not raise new or different questions of safety or effectiveness when compared to the predicate device and is therefore substantially equivalent.