PhysCade System

K250749

PhysCade, Inc. · cleared 2025-06-04 · product code DQK · Cardiovascular

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“The PhysCade™™ System (PhysCade) is an artificial intelligence (AI) enabled device intended to assist clinicians in their management of patients with heart rhythm disorders (arrhythmias). PhysCade is a medical decision support system which post-processes electrograms (EGMs) collected inside the heart during electrophysiology (EP) mapping procedures using compatible diagnostic EP catheters. The PhysCade software has advanced algorithms that analyze the collected EGMs to provide information on regions of interest in the heart that may be useful to the clinician to support clinical decisions together with other available patient-related information. The PhysCade System consists of a computer workstation, display, and custom software and is not connected to other devices or medical equipment.”
Algorithmartificial intelligence (AI) enabled device, advanced algorithms, AI algorithms
source quote (p.6)
“The PhysCade™™ System (PhysCade) is an artificial intelligence (AI) enabled device intended to assist clinicians in their management of patients with heart rhythm disorders (arrhythmias). PhysCade is a medical decision support system which post-processes electrograms (EGMs) collected inside the heart during electrophysiology (EP) mapping procedures using compatible diagnostic EP catheters. The PhysCade software has advanced algorithms that analyze the collected EGMs to provide information on regions of interest in the heart that may be useful to the clinician to support clinical decisions together with other available patient-related information. PhysCade uses AI algorithms that were developed and tested using datasets with the following characteristics:”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.11)
“Software/Firmware and cybersecurity verification and validation testing confirmed that the subject device meets the design input requirements and specifications”

Validation studies (1)

Retrospective clinical

n=109 patients

standards: IEC 62304 Edition 1.1 2015-06

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

28
recalls in product code, 24mo
423
MAUDE reports in code, 12mo
-1%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Spacelabs Healthcare, Ltd. Unit B Foxholes Centre; John Tate Road Hertford United Kingdom, initiated 2025-09-16): "Due to two distinct issues: 1. During patient admission, patient demographic fields may default to those of a previously viewed patient. 2. Systems configured with Resting/Rhythm " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97686

  • recall_reason_pattern

    Software/algorithm-related recall in product code DQK (Boston Scientific Corporation, initiated 2024-09-05): "Boston Scientific has received reports indicating the grid mark overlay on the cross-sectional view did not present correctly when an OptiCross 18 Peripheral Imaging Catheter was c" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:95331

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 Cardiovascular 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/K250749