Syngo Carbon Clinicals (VA41)

K251059

Siemens Healthineers AG · cleared 2025-10-24 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading.”
AlgorithmThe device includes tools for automated calculation of spine measurements (OrthoMatic Spine) and semi-automated lesion quantification. The OrthoMatic Spine core algorithm assesses spinal measurements.
source quote (p.7)
“OrthoMatic Spine – An interactive tool that provides automated calculation of spine measurements in CR and DX images of the entire spine in Frontal and Lateral acquisition. Lesion Quantification Tool to perform diameter measurements (longest diameter, perpendicular diameter) and to create segmentation objects of suspect lesions in lung parenchyma with one click (semi automatically). The OrthoMatic Spine core algorithm's outputs for six primary spinal measurements-Cobb angles, coronal balance, kyphosis angle, lordosis angle, and sagittal vertical alignment—were assessed against the mean values obtained from the radiologists' assessments.”
Adaptive (vs locked)No
source quote (p.12)
“These findings indicate that the algorithm closely replicates average rater performance and satisfies the predetermined clinical reliability acceptance criteria.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.13)
“Siemens Healthcare GmbH conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Contained in this submission are our cybersecurity considerations as they relate to the device Syngo Carbon Clinicals.”

Validation studies (1)

Reader study (MRMC)

n=150 images

endpoints: measurement deviations fell within the range of inter-reader variability for the major Cobb angle; thoracic kyphosis angle; lumbar lordosis angle; coronal balance; sagittal vertical alignment

standards: ISO 14971 Third Edition 2019-12, IEC 62304 Edition 1.1 2015-06 CONSOLIDATED VERSION, IEC 82304-1 Edition 1.0 2016-10, IEC 62366-1 Edition 1.1 2020-06 CONSOLIDATED VERSION

Reported performance (1 observation)

agreement_kappaas written: “measurement deviations fell within the range of inter-reader variability for the major Cobb angle, thoracic kyphosis angle, lumbar lordosis angle, coronal balance, and sagittal vertical alignment”stated without value
source quote (p.12)
“Algorithm performance was evaluated using cumulative distribution functions (CDFs), which demonstrated that the algorithm's measurement deviations fell within the range of inter-reader variability for the major Cobb angle, thoracic kyphosis angle, lumbar lordosis angle, coronal balance, and sagittal vertical alignment.”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K251059