Radiology · 510(k) · 2025
OsteoSight Hip (v1)
Naitive Technologies Ltd. Cleared by FDA on 2 September 2025 under submission K251408, product code SAO (radiology software for opportunistic evaluation of low bone mineral density). What FDA's record says, in FDA's words.
Device record · K251408
- Device. OsteoSight Hip (v1)DEVICE
- Company. Naitive Technologies Ltd (GB)COMPANY
- Decision. 2 September 2025, 510(k), substantially equivalent (traditional review); received 6 May 2025DECISION
- Panel. RadiologyPANEL
- Product code. SAO, Radiology Software For Opportunistic Evaluation Of Low Bone Mineral DensityCODE
- Regulation. 21 CFR 892.1171, Class IIREG
- Source. FDA database entry · decision document (21 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
OsteoSight is a software application intended for use opportunistically with standard anteroposterior (AP) radiographs of the hip or pelvis performed in patients aged 50 years and older. OsteoSight provides a notification in the form of a report to aid radiologists and/or physician interpreters in identifying patients with possible low bone mineral density (BMD) at the femoral neck to prompt a clinical assessment of bone health. OsteoSight should not be used to rule out low BMD. Radiologists and referring clinicians should follow recommended practices for screening and assessment, regardless of the absence of an OsteoSight report.
The product code's definition, from FDA's classification record. This device is software which opportunistically assesses radiological images to estimate bone mineral density (BMD) intended to assist in a healthcare professional's decision to evaluate patients for possible low BMD within a bone health screening program. The software employs an algorithm that estimates BMD using eligible radiological image data obtained for other clinical purposes.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Modalities namedradiographs (X-ray)
- Mentionsan adjunct to the clinician, not a replacement
- Mentionstriage or notification
- Mentionsdetection or identification of findings
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 0 reports filed against devices carrying product code SAO. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification.
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code SAO, in Radiology, or cleared in 2025. The whole record is at FDA AI-enabled medical devices.
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