Cleared Traditional

K261512 - OsteoSight Spine (v1)

K261512 is an FDA 510(k) clearance for OsteoSight Spine (v1), manufactured by Naitive Technologies, Ltd.. The device is a Class 2 Radiology device with product code SAO cleared through the Traditional 510(k) pathway after a 173-day FDA review.

K261512 · Naitive Technologies, Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
173d
Days
Class 2
Risk

K261512 is an FDA 510(k) clearance for the OsteoSight Spine (v1). Classified as Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density (product code SAO), Class II - Special Controls.

Submitted by Naitive Technologies, Ltd. (Cambridge, GB). The FDA issued a Cleared decision on October 27, 2026 after a review of 173 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1171 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K261512

510(k) Number K261512 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2026
Decision Date October 27, 2026
Days to Decision 173 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d slower than avg
Panel avg: 107d · This submission: 173d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

SAO Device Classification - Class 2, Special Controls

Product Code SAO Radiology Software For Opportunistic Evaluation Of Low Bone Mineral Density
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1171
Definition 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 this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

K261512 · OsteoSight Spine (v1)
Download PDF FDA Summary Naitive Technologies,…