RadioViewAI Receives FDA 510(k) Clearance, K260936

Key Highlights

• FDA 510(k) clearance number K260936 for RadioViewAI, letter dated July 31, 2026
• Cleared as a Medical Image Management and Processing System (21 CFR 892.2050, Class II, product code LLZ)
• Covers a web-based PACS for viewing and assessing multi-modality DICOM studies: DX, DR, CR, CT, MR, US, RF, XA, XR, NM, PT, and 2D/3D mammography
• Zero-footprint browser access, with no software installed on the workstation
• Substantially equivalent to the predicate device K232891
• Developed to IEC 62304, ISO 14971, IEC 62366-1 and ISO 13485:2016, with DICOM conformance to NEMA PS 3.1 to 3.20
• Prescription use only, for proficient and certified medical experts including physicians, radiologists and medical technicians

A platform clearance, not a module clearance

Every previous SaveLife.AI clearance covered a single AI module inside the platform. K260936 covers the platform itself: the imaging layer that studies are received into, stored on, moved across and viewed through.

That distinction matters when a health system procures it. The imaging layer is now a cleared device in its own right, rather than infrastructure hosting cleared devices.

What the clearance covers, and what it does not

The clearance covers image management and processing: viewing, transmission, storage and visualization.

It does not make RadioViewAI a diagnostic device. Per the 510(k) Summary, the software does not perform diagnostic analysis and does not alter medical images, and it is not intended to replace dedicated diagnostic workstations. Evaluating output, validating results and reaching a diagnosis remain the responsibility of the interpreting clinician.

The clearance is supported by non-clinical validation testing and a determination of substantial equivalence. It is not a finding about clinical accuracy or patient outcomes.

Third-party AI models

RadioViewAI can optionally display output from FDA-cleared third-party AI models. Each algorithm's clearance is verified against the FDA database before integration, the integrated list is managed by NEUROCAREAI rather than configured by customers, and the platform displays model output without modifying it. Two models are integrated today: Hyper Insight - ICH (K240353) and NeuroICH (K241719).

Each module clearance applies only to its own module, and the platform clearance applies only to the platform.

Conditions of use

• DICOM images should only be viewed on a monitor that adheres to the technical specifications outlined by the FDA.
• Lossy compressed mammographic images and digitized film screen images received from hospitals must be reviewed for reference purposes only, and not for primary diagnostic interpretation on RadioViewAI.

RadioViewAI is HITRUST CSF Certified and HIPAA Compliant. See the RadioViewAI product page.