KOALA

K192109

IB Lab GmbH · cleared 2019-11-05 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“IB Lab KOALA is a radiological fully-automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee.”
Algorithmcomputer vision and machine learning algorithms
source quote (p.5)
“The predicate and subject software utilize computer vision and machine learning algorithms trained on medical images. The machine-learning algorithms allow for high accuracy in the detection and measurement of OA related symptoms visible on knee radiographs.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=1,149 patients

endpoints: Kellgren-Lawrence status (KL ≥ 2); Joint Space Narrowing Status (JSN OARSI grade > 0); Osteophytosis status (Ost OARSI grade > 0); Sclerosis status (ScI OARSI grade > 0)

Reported performance (8 observations)

sensitivity0.87CI 0.84, 0.9
source quote (p.6)
“0.87 (0.84, 0.9)”
specificity0.83CI 0.8, 0.86
source quote (p.6)
“0.83 (0.8, 0.86)”
sensitivityas written: “Joint Space Narrowing Status (JSN OARSI grade > 0) Sensitivity”0.83CI 0.8, 0.86
source quote (p.6)
“0.83 (0.8, 0.86)”
specificityas written: “Joint Space Narrowing Status (JSN OARSI grade > 0) Specificity”0.8CI 0.76, 0.83
source quote (p.6)
“0.8 (0.76, 0.83)”
sensitivityas written: “Osteophytosis status (Ost OARSI grade > 0) Sensitivity”0.86CI 0.81, 0.9
source quote (p.6)
“0.86 (0.81, 0.9)”
specificityas written: “Osteophytosis status (Ost OARSI grade > 0) Specificity”0.79CI 0.76, 0.83
source quote (p.6)
“0.79 (0.76, 0.83)”
sensitivityas written: “Sclerosis status (ScI OARSI grade > 0) Sensitivity”0.82CI 0.8, 0.87
source quote (p.6)
“0.82 (0.8, 0.87)”
specificityas written: “Sclerosis status (ScI OARSI grade > 0) Specificity”0.8CI 0.76, 0.83
source quote (p.6)
“0.8 (0.76, 0.83)”

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97993

  • …and 20 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/K192109