EndoNaut

K222070

Therenva SAS · cleared 2022-10-25 · product code OWB · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“EndoNaut is an image fusion software solution and computerized navigational system intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices.”
AlgorithmMachine-learning algorithms for 3D/2D registration, motion detection, and contrast injection detection.
source quote (p.12)
“Features which call machine-learning algorithms: Registration 3D/2D, Motion detection, Contrast injection detection”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.19)
“Verification and validation activities have demonstrated that the EndoNaut (Server) software variant performs equally as the EndoNaut (Standalone) predicate software by providing reliable results, without functional regression and moreover, offers robust safety/security mechanisms.”

Validation studies (1)

Bench

sample size not stated

endpoints: electrical safety; EMC; functional testing; mechanical testing; meeting design specification; performing as intended; providing reliable results; without functional regression; robust safety/security mechanisms

standards: ISO 14971, IEC 62304, IEC 60601-1, ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text), IEC 60601-2, IEC 60601-1-6, 21 CFR § 820, ISO 13485

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

100
recalls in product code, 24mo
10937
MAUDE reports in code, 12mo
+44%
vs code's own 3-yr baseline
7
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2026-05-20): "Potential for loss of movement capability after adjusting the detector lift height to its maximum or minimum limits." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99079

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Medtronic Navigation, Inc.-Boxborough, initiated 2026-05-19): "Potential for image artifacts caused by an anomaly in the O-arm O2 Imaging System s detector panel firmware." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99041

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (Siemens Medical Solutions USA, Inc, initiated 2025-12-29): "Ortho images acquired with preset automatic horizontal flip are not flipped and when acquiring single images, there is the possibility that an image of a previous patient may be pr" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98244

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Six (6) identified software issues which may result in the following: system keeps restarting, AMC triple drive, C-Partition of Suite PC running out of free space, system remains i" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98096

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-12): "Philips has identified two (2) software issues affecting device systems that may result in loss of imaging (X-ray) functionality and/or loss of motorized movement, and/or incorrect" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98108

  • recall_reason_pattern

    Software/algorithm-related recall in product code OWB (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2025-12-08): "Nine (9) identified software issues which may result in the following: loss of X-ray after Pedal Tap, loss of X-ray after Phase Fault, missing live X-ray on the FlexVision monitor," Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98071

  • …and 1 more.

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/K222070