Al-Rad Companion (Musculoskeletal)

K193267

Siemens Medical Solutions USA, Inc. · cleared 2020-03-16 · product code JAK · Radiology

FDA 510(k) summary for Al-Rad Companion (Musculoskeletal) (K193267)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
2
Performance observations
0
Product code
JAK
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Al-Rad Companion (Musculoskeletal) is software-only image post-processing application that uses deep learning algorithms to post-process CT data of the thorax.”
Algorithm3D Deep Image-to-Image network for organ segmentation, designed following a symmetric way as a convolutional encoder-decoder with 3D convolutional and bilinear upscaling layers.
source quote (p.5)
“Al-Rad Companion (Musculoskeletal) uses the same deep learning technology as in the previously cleared reference device Siemens Al-Rad Companion (Cardiovascular) (K183268). More precisely, a 3D Deep Image-to-Image network is used for organ segmentation. The main structure of the network is designed following a symmetric way as a convolutional encoder-decoder. All blocks of the network consist of 3D convolutional and bilinear upscaling layers.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.9)
“Siemens 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. Provided in this submission is a cybersecurity statement that considers IEC 80001-1:2010. The responsibility for compliance with IEC 80001-1-2010 is the hospital.”

Validation studies (1)

Retrospective clinical

n=140 cases

endpoints: ratio of vertebra height measurements lying within the LoA around the ground truth; ratio of vertebra density measurements lying within the LoA

standards: Digital Imaging and Communications in Medicine (DICOM) Set; PS 3.1 – 3.20, Medical Device Software -Software Life Cycle Processes; IEC 62304 Edition 1.1 2015-06, Medical devices - Application of risk management to medical devices; 14971 Second Edition 2007-03-01

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

25
recalls in product code, 24mo
216
MAUDE reports in code, 12mo
-12%
vs code's own 3-yr baseline
15
drift signals on this device
  • predicate_cohort_contagion

    K193267 shares predicate K183268 with K220497 (CoLumbo), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K183268 sibling:K220497

  • predicate_cohort_contagion

    K193267 shares predicate K183268 with K230534 (BriefCase-Quantification), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K183268 sibling:K230534

  • predicate_cohort_contagion

    K193267 shares predicate K183268 with K252029 (AI-CVD), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K183268 sibling:K252029

  • predicate_cohort_contagion

    K193267 shares predicate K123584 with K220783 (syngo.via RT Image Suite), whose product code MUJ recorded 35 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K123584 sibling:K220783

  • predicate_cohort_contagion

    K193267 shares predicate K183268 with K200714 (AVIEW), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K183268 sibling:K200714

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:98206

  • …and 9 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

  • Recalling firm matches this device's applicant (Siemens Medical Solutions USA, Inc) — same firm and product code, not necessarily this device · initiated 2025-12-19

    To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance.

    recall event 98206 (openFDA)

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 2026-08-26.

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.

Related FDA clearances

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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K193267