AI-Rad Companion Organs RT

K193562

Siemens Medical Solutions USA, Inc. · cleared 2020-11-06 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Algorithmdeep-learning-based algorithms
source quote (p.3)
“AI-Rad Companion Organs RT is a post-processing software intended to automatically contour DICOM CT imaging data using deep-learning-based algorithms.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Siemens Healthineers adheres to the cybersecurity requirements as defined the FDA Guidance "Content of Premarket Submissions for Management for Cybersecurity in Medical Devices,” issued October 2, 2014 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.”

Validation studies (2)

Bench

sample size not stated

standards: 62366-1: 2015-02, 14971:2007, 62304: 2006/A1:2016, PS 3.1 - 3.20 (2016), 10918-1 1994-02-15

Retrospective clinical

n=113 patients

endpoints: DICE coefficient; absolute symmetric surface distance (ASSD); fail rate; median DICE score; median 95% Hausdorff (HD) value

Reported performance (1 observation)

diceas written: “median DICE score”0.85
source quote (p.12)
“MED: 0.85”

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
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K221305 (decision 2022-10-14) from Siemens Medical Solutions USA, Inc for a matching device line ("AI-Rad Companion Organs RT") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K221305

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/K193562