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

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

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); joint space width (JSW) measurements

standards: OARSI (Osteoarthritis Research Society International) guidelines

Reported performance (8 observations)

sensitivity0.87CI 0.84, 0.9

source quote (p.6)

“Kellgren-Lawrence status (KL ≥ 2) Sensitivity (95% CI) 0.87 (0.84, 0.9)”

specificity0.83CI 0.8, 0.86

source quote (p.6)

“Kellgren-Lawrence status (KL ≥ 2) Specificity (95% CI) 0.83 (0.8, 0.86)”

sensitivityas written: “Sensitivity (Joint Space Narrowing Status)”0.83CI 0.8, 0.86

source quote (p.6)

“Joint Space Narrowing Status (JSN OARSI grade > 0) Sensitivity (95% CI) 0.83 (0.8, 0.86)”

specificityas written: “Specificity (Joint Space Narrowing Status)”0.8CI 0.76, 0.83

source quote (p.6)

“Joint Space Narrowing Status (JSN OARSI grade > 0) Specificity (95% CI) 0.8 (0.76, 0.83)”

sensitivityas written: “Sensitivity (Osteophytosis status)”0.86CI 0.81, 0.9

source quote (p.6)

“Osteophytosis status (Ost OARSI grade > 0) Sensitivity (95% CI) 0.86 (0.81, 0.9)”

specificityas written: “Specificity (Osteophytosis status)”0.79CI 0.76, 0.83

source quote (p.6)

“Osteophytosis status (Ost OARSI grade > 0) Specificity (95% CI) 0.79 (0.76, 0.83)”

sensitivityas written: “Sensitivity (Sclerosis status)”0.82CI 0.8, 0.87

source quote (p.6)

“Sclerosis status (ScI OARSI grade > 0) Sensitivity (95% CI) 0.82 (0.8, 0.87)”

specificityas written: “Specificity (Sclerosis status)”0.8CI 0.76, 0.83

source quote (p.6)

“Sclerosis status (ScI OARSI grade > 0) Specificity (95% CI) 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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

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). 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).