RadioLens v1.0
K222174Synapsica · cleared 2023-03-28 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“RadioLens v1.0 software is a medical diagnostic application that displays, processes, stores, and transfers DICOM data, with the exception of mammography.”
Algorithmartificial intelligence (AI) module
source quote (p.4)
“The SpindleX is an artificial intelligence (AI) module that works on digital stress x-rays of the spine and assists with clinical interpretation”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.7)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Validation studies (1)
Retrospective clinical
n=600 cases · 200 site(s)
endpoints: sensitivity; specificity; agreement
standards: ANSI AAMI IEC 62304:2006/A1:2016 - Medical device software – Software life cycle processes, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submission for Management of Cybersecurity in Medical Devices.
Reported performance (36 observations)
sensitivity100
source quote (p.8)
“For identification of body part among cervical and lumbar scans, the model had 100% sensitivity for the scans used in the validation study.”
sensitivityas written: “Sensitivity for patient position (flexion)”96.8
source quote (p.8)
“For identification of patient position among flexion, extension and neutral the model had 96.8%, 92.0%, and 90.5% sensitivities respectively.”
sensitivityas written: “Sensitivity for patient position (extension)”92
source quote (p.8)
“For identification of patient position among flexion, extension and neutral the model had 96.8%, 92.0%, and 90.5% sensitivities respectively.”
sensitivityas written: “Sensitivity for patient position (neutral)”90.5
source quote (p.8)
“For identification of patient position among flexion, extension and neutral the model had 96.8%, 92.0%, and 90.5% sensitivities respectively.”
agreement_kappaas written: “ICC (Radiologists) - Cervical Stress Lines (degrees)”0.957CI E
source quote (p.8)
“Stress Lines (degrees) 0.957 (Ε)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Stress Lines (degrees)”0.953CI E
source quote (p.8)
“Stress Lines (degrees) 0.953 (Ε)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Canal Diameter (mm)”0.95CI E
source quote (p.8)
“Canal Diameter (mm) 0.950 (Ε)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Canal Diameter (mm)”0.955CI E
source quote (p.8)
“Canal Diameter (mm) 0.955 (Ε)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Vertebral Offset Neutral (mm)”0.698CI M
source quote (p.8)
“Vertebral Offset Neutral (mm) 0.698 (M)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Vertebral Offset Neutral (mm)”0.707CI M
source quote (p.8)
“Vertebral Offset Neutral (mm) 0.707 (M)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Angular MSI (degrees)”0.769CI G
source quote (p.8)
“Angular MSI (degrees) 0.769 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Angular MSI (degrees)”0.781CI G
source quote (p.8)
“Angular MSI (degrees) 0.781 (G)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Translational Motion 5th Edition (mm)”0.712CI M
source quote (p.8)
“Translational Motion 5th Edition (mm) 0.712 (M)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Translational Motion 5th Edition (mm)”0.717CI M
source quote (p.8)
“Translational Motion 5th Edition (mm) 0.717 (M)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Translational Motion 6th Edition - Flexion (mm)”0.793CI G
source quote (p.8)
“Translational Motion 6th Edition - Flexion (mm) 0.793 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Translational Motion 6th Edition - Flexion (mm)”0.802CI G
source quote (p.8)
“Translational Motion 6th Edition - Flexion (mm) 0.802 (G)”
agreement_kappaas written: “ICC (Radiologists) - Cervical Translational Motion 6th Edition - Extension (mm)”0.707CI M
source quote (p.8)
“Translational Motion 6th Edition - Extension (mm) 0.707 (M)”
agreement_kappaas written: “ICC (Rads & Model) - Cervical Translational Motion 6th Edition - Extension (mm)”0.716CI M
source quote (p.8)
“Translational Motion 6th Edition - Extension (mm) 0.716 (M)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Stress Lines (degrees)”0.979CI E
source quote (p.8)
“Stress Lines (degrees) 0.979 (Ε)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Stress Lines (degrees)”0.968CI E
source quote (p.8)
“Stress Lines (degrees) 0.968 (E)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Canal Diameter (mm)”0.826CI G
source quote (p.9)
“Canal Diameter (mm) 0.826 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Canal Diameter (mm)”0.784CI G
source quote (p.9)
“Canal Diameter (mm) 0.784 (G)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Ferguson's Angle (degrees)”0.968CI E
source quote (p.9)
“Ferguson's Angle (degrees) 0.968 (E)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Ferguson's Angle (degrees)”0.939CI E
source quote (p.9)
“Ferguson's Angle (degrees) 0.939 (Ε)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Integrity of 3rd Lumbar Vertebra (mm)”0.997CI E
source quote (p.9)
“Integrity of 3rd Lumbar Vertebra (mm) 0.997 (Ε)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Integrity of 3rd Lumbar Vertebra (mm)”0.996CI E
source quote (p.9)
“Integrity of 3rd Lumbar Vertebra (mm) 0.996 (Ε)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Vertebral Offset Neutral (mm)”0.82CI G
source quote (p.9)
“Vertebral Offset Neutral (mm) 0.820 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Vertebral Offset Neutral (mm)”0.777CI G
source quote (p.9)
“Vertebral Offset Neutral (mm) 0.777 (G)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Angular MSI (degrees)”0.792CI G
source quote (p.9)
“Angular MSI (degrees) 0.792 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Angular MSI (degrees)”0.771CI G
source quote (p.9)
“Angular MSI (degrees) 0.771 (G)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Translational Motion 5th Edition (mm)”0.71CI M
source quote (p.9)
“Translational Motion 5th Edition (mm) 0.710 (M)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Translational Motion 5th Edition (mm)”0.656CI M
source quote (p.9)
“Translational Motion 5th Edition (mm) 0.656 (M)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Translational Motion 6th Edition - Flexion (mm)”0.809CI G
source quote (p.9)
“Translational Motion 6th Edition - Flexion (mm) 0.809 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Translational Motion 6th Edition - Flexion (mm)”0.774CI G
source quote (p.9)
“Translational Motion 6th Edition - Flexion (mm) 0.774 (G)”
agreement_kappaas written: “ICC (Radiologists) - Lumbar Translational Motion 6th Edition - Extension (mm)”0.823CI G
source quote (p.9)
“Translational Motion 6th Edition - Extension (mm) 0.823 (G)”
agreement_kappaas written: “ICC (Rads & Model) - Lumbar Translational Motion 6th Edition - Extension (mm)”0.769CI G
source quote (p.9)
“Translational Motion 6th Edition - Extension (mm) 0.769 (G)”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
drift signals on this device
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).