ScanDiags Ortho L-Spine MR-Q
K242607ScanDiags AG · cleared 2025-02-21 · product code QIH · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.6)
“ScanDiags Ortho L-Spine MR-Q software is a software as a medical device (SaMD) intended for visualization, and quantification of lumbar spine anatomical structures including vertebral bodies, intervertebral discs, neuroforamina, thecal sacs from a set of standard lumbar spine MRI images in DICOM (Digital Imaging and Communications in Medicine) format.”
Algorithmdeep convolutional neural networks (DCNN), deep learning, image analysis, as well as regression-based machine learning methods
source quote (p.6)
“The semi-automatic segmentations are based on deep convolutional neural networks (DCNN) which are developed by applying well-established supervised deep learning methods on unstructured MRI scans (DICOM image format). ScanDiags Ortho L-Spine MR-Q combines deep learning, image analysis, as well as regression-based machine learning methods.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“The ScanDiags Ortho L-Spine MR-Q Software is HIPAA Compliant by preventing unauthorized access (only authenticated and authorized users can access DICOM data and preliminary Measurement Results in built-in ScanDiags DICOM Viewer), encrypting data in transfer (both DICOM-TLS, SSL certificates in use). The DICOM data transferred to and processed by ScanDiags Ortho L-Spine MR-Q Software only temporarily stores the data until it is either approved or rejected by the intended user. The vulnerability assessment and penetration testing demonstrates satisfactory security performance.”
Validation studies (1)
Retrospective clinical
n=100 patients · 2 site(s)
endpoints: segmentations within acceptable measurement range; Dice score above a set threshold
Reported performance (16 observations)
agreement_kappaas written: “Vertebra Area ICC”0.95CI 0.94 - 0.96
source quote (p.10)
“Area 0.95 [0.94 - 0.96]”
agreement_kappaas written: “Vertebra Anterior Height ICC”0.85CI 0.30 - 0.94
source quote (p.10)
“Anterior Height 0.85 [0.30 -0.94]”
agreement_kappaas written: “Vertebra Middle Height ICC”0.91CI 0.63 - 0.96
source quote (p.10)
“Middle Height 0.91 [0.63 -0.96]”
agreement_kappaas written: “Vertebra Posterior Height ICC”0.89CI 0.87 - 0.91
source quote (p.10)
“Posterior Height 0.89 [0.87 -0.91]”
agreement_kappaas written: “Neuroforamen Area ICC”0.9CI 0.86 - 0.93
source quote (p.10)
“Area 0.90 [0.86 - 0.93]”
agreement_kappaas written: “Intervertebral Disc Area ICC”0.92CI 0.87 - 0.94
source quote (p.10)
“Area 0.92 [0.87 -0.94]”
agreement_kappaas written: “Intervertebral Disc Anterior Height ICC”0.78CI 0.73 - 0.82
source quote (p.10)
“Anterior Height 0.78 [0.73 -0.82]”
agreement_kappaas written: “Intervertebral Disc Middle Height ICC”0.85CI 0.18 - 0.95
source quote (p.10)
“Middle Height 0.85 [0.18 -0.95]”
agreement_kappaas written: “Intervertebral Disc Posterior Height ICC”0.74CI 0.68 - 0.78
source quote (p.10)
“Posterior Height 0.74 [0.68 - 0.78]”
agreement_kappaas written: “Thecal Sac Area ICC”0.94CI 0.91 - 0.96
source quote (p.10)
“Area 0.94 [0.91 - 0.96]”
agreement_kappaas written: “Thecal Sac Anteroposterior Diameter ICC”0.92CI 0.90 - 0.94
source quote (p.10)
“Anteroposterior Diameter 0.92 [0.90 -0.94]”
agreement_kappaas written: “Thecal Sac Mediolateral Diameter ICC”0.86CI 0.83 - 0.88
source quote (p.10)
“Mediolateral Diameter 0.86 [0.83 -0.88]”
diceas written: “Vertebra DICE”0.95CI 0.95 - 0.96
source quote (p.10)
“Vertebra 0.95 [0.95 -0.96]”
diceas written: “Neuroforamen DICE”0.86CI 0.85 - 0.86
source quote (p.10)
“Neuroforamen 0.86 [0.85 -0.86]”
diceas written: “Intervertebral Disc DICE”0.89CI 0.89 - 0.90
source quote (p.10)
“Intervertebral Disc 0.89 [0.89 -0.90]”
diceas written: “Thecal Sac DICE”0.89CI 0.89 - 0.90
source quote (p.10)
“Thecal Sac 0.89 [0.89 -0.90]”
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).