Syngo Carbon Clinicals

K232856

Siemens Healthcare GmbH · cleared 2023-12-01 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Syngo Carbon Clinicals is a software only Medical Device, which provides dedicated advanced imaging tools for diagnostic reading.”

AlgorithmDeep learning algorithm for organ segmentation

source quote (p.9)

“This feature uses a deep learning algorithm for organ segmentation (algorithm that was cleared as part of the reference device syngo.via RT Image suite (K220783).”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedYes

source quote (p.22)

“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 (3)

Bench

sample size not stated

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

Bench

sample size not stated

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

Bench

sample size not stated

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 (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

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).