AIBOLIT 3D+

K211443

AIbolit Technologies, LLC · cleared 2022-01-07 · product code LLZ · Radiology

FDA 510(k) summary for AIBOLIT 3D+ (K211443)

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
0
Cited predicates
2
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“Aibolit 3D+ is a software only device, which processes CT images from a patient to create 3-dimensional images that may be manipulated to view the anatomy from virtually any perspective.”
AlgorithmAI software facilitates annotation of available images under guidance and control by the Radiologist; optional use of AI/ML algorithms for image segmentation as determined by Radiologist and with Radiologist's approval
source quote (p.8)
“AI software facilitates annotation of available images under guidance and control by the Radiologist”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“Cybersecurity”

Validation studies (0)

FDA source did not describe a validation study.

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
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
33
drift signals on this device
  • predicate_cohort_contagion

    K211443 shares predicate K173274 with K222676 (Ceevra Reveal 3), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K173274 sibling:K222676

  • predicate_cohort_contagion

    K211443 shares predicate K182643 with K242461 (IRISeg), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K182643 sibling:K242461

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K222458 (decision 2023-01-12) from Aibolit Technologies, LLC for a matching device line ("AIBOLIT 3D+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K222458

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • …and 27 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 2026-09-02.

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

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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/K211443