PRAEVAorta®2

K243859

Nurea · cleared 2025-08-29 · product code QIH · Radiology

FDA 510(k) summary for PRAEVAorta®2 (K243859)

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
1
Performance observations
0
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“PRAEVAorta®2 is a software intended to be run on its own or as part of another medical device to automatically calculate maximum diameters of anatomical zones from a DICOM CT image containing blood vessels.”
Algorithmnon-adaptative machine learning algorithm
source quote (p.4)
“PRAEVAorta®2 is designed to measure the maximal transverse diameter of vessels and determine the maximal general diameter using a non-adaptative machine learning algorithm.”
Adaptive (vs locked)No
source quote (p.4)
“PRAEVAorta®2 is designed to measure the maximal transverse diameter of vessels and determine the maximal general diameter using a non-adaptative machine learning algorithm.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.12)
“Data security”

Validation studies (1)

Reader study (MRMC)

n=159 cases

endpoints: mean absolute error for total maximum orthogonal aorta diameter; correlation coefficient for total maximum orthogonal aorta diameter

standards: 21 CFR Part 860, 21 CFR Part 820, FDA SaMD Guidance, FDA Validation Guidance, IEC 62304: 2015, IEC 82304 : 2016, ISO 13485: 2016, ISO 14971: 2019, IEC 62366: 2015, ISO 20417 : 2021, ISO 15223-1:2021

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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

More AI/ML devices under product code QIH

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

ADAS 3D

K253969

Adas3D Medical S.L.

cleared 2026-06-29

Auto-Seg (SO-0012), Spine Auto-Seg (SO-0012)

K253628

Agada Medical, Ltd.

cleared 2026-06-29

syngo.CT Coronary Cockpit

K253786

Siemens Medical Solutions USA, Inc.

cleared 2026-06-25

CMN Capillary Function with Oncology Virtual Expert

K260316

Cercare Medical A/S

cleared 2026-06-22

Synapse PACS (7.6.0)

K261713

FUJIFILM Healthcare Americas Corporation

cleared 2026-06-18

MediAI-OA

K253172

Crescom Co., Ltd.

cleared 2026-06-15

AiORTA - Plan v2.0

K254207

ViTAA Medical Solutions, Inc.

cleared 2026-03-30

SwiftMR

K253775

Airs Medical, Inc.

cleared 2026-03-26

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K243859