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Repair Windows errors before they cause bigger problemsFix Now →Scan for outdated or missing drivers - takes under a minuteDriver Scan →Clear out junk files and repair common Windows errorsFree Scan →AIRS Medical announced on October 5, 2026, that the FDA granted 510(k) clearance to SwiftSight Body Composition, an AI tool that analyzes MRI images for measures of muscle, fat distribution, and liver fat. The company says SimonMed Imaging is expected to be its first customer. The specific FDA filing number and cleared labeling for this product were not identified in the FDA records surfaced in the available search, so the clearance and feature details below are attributed to AIRS Medical.
What SwiftSight Body Composition measures
AIRS Medical describes SwiftSight Body Composition as software that analyzes MRI images after a scan and produces quantitative measurements, percentile rankings, and visual summaries. The company says the comparison ranges are matched by age and sex. Its announcement lists measurements of:
- Visceral and subcutaneous fat.
- Abdominal and thigh muscle size, quality, and left-right balance.
- Liver fat, quantified using proton density fat fraction (PDFF).
AIRS Medical describes the workflow as taking less than five minutes for the MRI scan, followed by automated analysis. That timing is the company’s description of its intended workflow, not an independently verified performance result.
What FDA clearance does—and what is not yet established
AIRS Medical says the FDA granted 510(k) clearance to SwiftSight Body Composition. In the FDA records surfaced in the available search, however, the identified AIRS Medical entries were for different products: SwiftMR, K261349, with a July 24, 2026 decision date, and SwiftSight-Brain, K251483, with a September 23, 2025 decision date. Neither record establishes the body-composition tool’s filing or its precise cleared labeling.
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That distinction matters: FDA clearance should not be read as proof that the software diagnoses disease, improves health outcomes, or is validated as a screening service. The company materials reviewed do not provide independent clinical-performance data, outcome evidence, or the size and validation details of the body-composition reference population.
Who can use it and where
AIRS Medical presents SwiftSight Body Composition as an analysis service for imaging organizations, rather than a consumer device. The company names preventive-health, weight-management, and longevity programs as potential settings and says SimonMed Imaging is expected to be the first customer to deploy the system.
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The announcement does not specify public booking availability, rollout locations, prices, or referral requirements. SimonMed’s status as the named first customer is therefore not confirmation that the service is currently available to book at a particular location. Ask a provider directly whether it offers this analysis and what the report includes.
Do not confuse its reference data with SwiftSight-Brain
AIRS Medical’s September 30, 2026 update cites a normative database of 32,615 adults for SwiftSight-Brain. That figure pertains to the brain-imaging product; it is not the stated size of the reference population for SwiftSight Body Composition. The body-composition announcement describes age- and sex-matched comparisons but does not give the cohort size or validation details.
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What AIRS Medical says about the product’s purpose
AIRS Medical Chief Product Officer Ajit Shankaranarayanan described the company’s broader strategy this way: “The next phase of MRI is not just better images, but standardized quantitative information that can scale across an imaging organization.” This is the company’s perspective on its product direction, not independent evidence of clinical benefit.
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