BoneVue

{0} **FDA U.S. FOOD & DRUG** ADMINISTRATION September 11, 2026 Curvebeam AI / Curvebeam, LLC % Ryan Conlon Director of Quality and Regulatory Affairs 2800 Bronze Dr. Suite 110 HATFIELD, PA 19440 Re: K254072 Trade/Device Name: BoneVue Regulation Number: 21 CFR 892.1170 Regulation Name: Bone Densitometer Regulatory Class: Class II Product Code: KGI Dated: August 12, 2026 Received: August 13, 2026 Dear Ryan Conlon: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254072 - Ryan Conlon Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory- {2} K254072 - Ryan Conlon Page 3 assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Lu Jiang, Ph.D. Assistant Director DHT8B: Division of Radiologic Imaging Devices and Electronic Products 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. | K254072 | ? | | Please provide the device trade name(s). | | ? | | BoneVue | | | | Please provide your Indications for Use below. | | ? | | The BoneVue is intended to measure bone mineral density (BMD) in the proximal femur. It is a post-processing software tool for assessing a patient's proximal femur BMD from existing CT scans. The BoneVue is not intended to replace DXA or any other tests dedicated to BMD measurement. It is designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. | | | | 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) | ? | {4} K254072 # 510(k) Summary ## Contents Table 1 Device Information ... 1 Predicate Device: ... 2 Indications for Use: ... 2 Device Description: ... 2 Substantial Equivalence Discussion: ... 4 Performance Data: ... 4 Conclusion: ... 5 Table 1 Device Information | 510 (k) Submitter/Owner | CurveBeam, LLC 2800 Bronze Drive, Suite 112 Hatfield, PA 19440 Phone: 267-483-8081 Fax: 267-483-8086 | | --- | --- | | Contact Person | Ryan Conlon Director of Quality and Regulatory Affairs 267-483-8081 Email: Ryan.Conlon@curvebeamai.com | | Date Prepared | September 9, 2026 | | Trade Name | BoneVue | | Version Number | Version 1.0.0 | | Common Name | BoneVue | | Classification Name | Bone Densitometer | | Product Code | KGI | | 510(k) Type | Traditional | | Regulation Number | 892.1170 | | Device Classification | Class II | This is the first 510(k) submission for this device. There were no prior submissions. CurveBeam, LLC – BoneVue 510(k) Application Page 1 {5} K254072 ## Predicate Device: Table 2 Predicate Device | Company | Device name | Product Code | 510(k) | Regulation Number | Device Classification | | --- | --- | --- | --- | --- | --- | | Mindways Software In. | CTXA Hip | KGI | K002113 | 892.1170 | Class II | ## Indications for Use: The BoneVue is intended to measure bone mineral density (BMD) in the proximal femur. It is a post-processing software tool for assessing a patient's proximal femur BMD from existing CT scans. The BoneVue is not intended to replace DXA or any other tests dedicated to BMD measurement. It is designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. ## Device Description: BoneVue software is a Software as a Medical Device (SaMD) that estimates bone mineral density of the proximal femur. BoneVue is to be used by healthcare professionals and should be used by healthcare providers in conjunction with clinical evaluation. BoneVue is a post-processing software that works on existing CT scans. A qualified healthcare professional manually identifies and defines the region of interest in the proximal femur. After the region of interest has been manually defined and confirmed, BoneVue calculates the BMD value for the region of interest. BoneVue outputs a report in HTML and PDF formats, which visually displays the regions of interest used for the BMD calculation. The end user can change or edit the regions of interest through the software's user interface. Once the end user manually changes the regions of interest, the bone mineral densities will be recalculated using the updated regions of interest and the BoneVue report will be regenerated. The healthcare professionals must be authenticated and authorized by the Data Management Platform software (DMP) to request for BoneVue analysis and access the BoneVue report. The BoneVue software generates the BoneVue report which includes estimation of the bone mineral density of the proximal femur. The report is used by physicians as an aid in determining fracture risk. The device is not intended to replace DXA scanners. It is only intended to be used on existing CT scans or CT scans ordered for reasons other than measuring BoneVue so that it will prevent extra radiation doses from being introduced to the patients. CurveBeam, LLC – BoneVue 510(k) Application Page 2 {6} K254072 | Feature | BoneVue Subject Device (K254072) | CTXA Hip Predicate Device (K002113) | ABMD Software Reference Device (K213760) | | --- | --- | --- | --- | | Manufacturer | Curvebeam AI Ltd. | Mindways Software Inc. | Heart Lung Corp. | | Intended Use | The BoneVue is intended to measure bone mineral density (BMD) in the proximal femur. It is a post-processing software tool for assessing a patient's proximal femur BMD from existing CT scans. The BoneVue is not intended to replace DXA or any other tests dedicated to BMD measurement. It is designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. | The CTXA Hip Bone Mineral Densitometer is intended to estimate Bone mineral content and Bone mineral density in the Proximal femur. The BMD estimates can be compared with CTXA Hip derived reference data. T-scores are calculated with respect to CTXA Hip young normal female reference data and the T-scores can be used by the physicians as an aid in determining fracture risk. | The Automated Bone Mineral Density Software Module (ABMD) is a post-processing AI-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic AI-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure. | | Modality | CT scan images (DICOM) | CT scan images (DICOM) | CT scan images (DICOM) | | Device provides estimate of bone mineral density | With hip | With hip | With spine | | Device provides bone mineral density value | Yes | Yes | Yes | | Z-score | No | Yes | Yes | | T-score | No | Yes | Yes | | User | Health Care Provider | Health Care Provider | Health Care Provider | | Operating System | Windows | Windows | Linux | | Retrospective measurements from CT scans | CT scan images can be selected and inputted to the software | CT scan images can be selected and inputted to the software | CT scan images can be selected and inputted to the software | | Automatic Averaging HU | Software measures and averages Hounsfield units in the Trabecular region of proximal femur bone. | Software automatically measures and averages Hounsfield units in the Trabecular region of spinal bones/ proximal femur | Software automatically measures and averages Hounsfield units in the Trabecular region of spinal bones. | | Calibration | Inputting CT scanner-specific calibration factor is required by scanning the density calibration phantom. | Simultaneous scanning of calibration phantom is required. Software outputs calibrated BMD score. | Inputting CT scanner-specific calibration factor is required. Software outputs calibrated BMD score. | CurveBeam, LLC – BoneVue 510(k) Application Page 3 {7} K254072 ## Substantial Equivalence Discussion: BoneVue is intended for the calculation of bone mineral density (BMD) at the proximal femoral bone and is substantially equivalent in terms of indications for use and anatomical region to the legally marketed Mindways device (K002113). Mindways serves as the primary predicate as it shares the same clinical application and employs same image-based analysis technology DICOM for BMD estimation. Although Mindways demonstrates very high Pearson correlation coefficients (R = 0.90–0.97) with gold standard DEXA scans, this level of agreement may reflect optimal conditions and exceeds values typically observed in broader independent published peer-reviewed literature. To provide a more balanced and clinically representative performance context, the ABMD device (K213760) is included as a reference device. ABMD has previously received FDA clearance for the same intended use and demonstrates BMD correlation values with DEXA that are somewhat lower than those of Mindways but still fall within accepted clinical and regulatory norms. - BoneVue is substantially equivalent to Mindways in terms of indication for use and anatomical region. - ABMD serves as a valid performance benchmark, illustrating that slightly lower but consistent BMD correlation values with DEXA can still meet FDA clearance standards. - The combined reference to Mindways (predicate) and ABMD (performance reference) presents a robust and evidence-supported rationale for the substantial equivalence of BoneVue. Therefore, BoneVue is considered substantially equivalent to Mindways based on shared indication, anatomy, and comparable technological characteristics, while ABMD supports the acceptability of clinically valid correlation ranges. Together, these two devices provide a strong basis for demonstrating substantial equivalence of BoneVue under 21 CFR 807.100. ## Performance Data: A comprehensive comparison of BoneVue with the predicate device CTXA-Hip and the reference device ABMD has been conducted to demonstrate substantial equivalence. BoneVue and CTXA-Hip assess the same anatomical region (hip) and share similar intended use, indications for use, technological characteristics, and principles of operation. To establish clinical performance equivalence, BoneVue's bone mineral density (BMD) measurements were validated against dual-energy X-ray absorptiometry (DXA), the recognized clinical gold standard for BMD assessment. A retrospective, multi-site clinical study was performed to evaluate the agreement between BMD values obtained using BoneVue and those obtained using DXA for the same patients. The paired retrospective CT scans and DXA reports were collected for the evaluation of bone mineral density (BMD) at Total Hip and Femoral Neck, drawn from a cohort of 666 unique patients. All CT data used in this evaluation were collected from clinical sites within the United States, supporting the applicability of the study results to U.S. clinical practice and CurveBeam, LLC – BoneVue 510(k) Application Page 4 {8} K254072 imaging environments. The cohort spans a demographically diverse patient population across age (≥ 35 years), sex (male and female), BMI (underweight, normal, overweight, and obese), and racial-ethnic groups (White, Black American, Hispanic, and Asian and Other races) reflective of the clinical population receiving hip imaging. BoneVue demonstrated negligible overall systematic bias relative to DXA at both anatomical regions. Mean bias was 0.001 g/cm² at the total hip and 0.000 g/cm² at the femoral neck, compared with predicate published mean differences of 0.02 and 0.01 g/cm², respectively. BoneVue's mean bias was therefore superior to the predicate-derived benchmark. The observed standard deviations of the differences were 0.056 g/cm² at the total hip and 0.057 g/cm² at the femoral neck. These values were 0.006 and 0.017 g/cm² higher, respectively, than the predicate published point estimates. These differences were judged insignificantly different from the predicate derived benchmark when considered in the context of the substantially larger and more heterogeneous BoneVue validation dataset, which included 666 unique patients from 31 U.S. clinical sites and examinations acquired using four CT manufacturers and 19 scanner models. By region (DXA BMD – BoneVue BMD): - Total Hip: Mean Bias (SD) = 0.001 (0.056) g/cm²; 95% Limits of Agreement = -0.108 to 0.111 g/cm²; Pearson correlation coefficient r = 0.937; - Femoral Neck: Mean Bias (SD) = 0.000 (0.057) g/cm²; 95% Limits of Agreement = -0.112 to 0.111 g/cm²; Pearson correlation coefficient r = 0.925; Pearson correlation exceeded the predicate-derived benchmark of r > 0.80 at both anatomical regions, with r=0.937 at the total hip and r=0.925 at the femoral neck. Overall regression estimates were close to the identity line, and the 95% confidence intervals for the slopes included 1 while the confidence intervals for the intercepts included 0. At the total hip, the regression slope was 0.980 (95% CI 0.952 to 1.008), and the intercept was 0.017 g/cm², (95% CI -0.008 to 0.041 g/cm²). At the femoral neck, the regression slope was 1.003 (95% CI 0.972 to 1.035), and the intercept was -0.002 g/cm², (95% CI - 0.029 to 0.024 g/cm²). Bland–Altman differences were centred near zero, indicating no clinically meaningful overall systematic overestimation or underestimation. # Conclusion: CurveBeam, LLC has demonstrated through its comparison of characteristics with the predicate device and comparison of performance data with the predicate device that BoneVue is substantially equivalent to the predicate device. CurveBeam, LLC – BoneVue 510(k) Application Page 5