Clarify DL

K241350

GE Medical Systems Israel, Functional Imaging · cleared 2025-01-03 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Clarify DL is a software-only device for the reconstruction of NM bone SPECT scintigraphy images obtained using supported GE HealthCare SPECT and SPECT-CT systems.”

Algorithmdeep learning-based image reconstruction method

source quote (p.6)

“Clarify DL is a deep learning-based image reconstruction method intended to reduce noise and improve image quality of Nuclear Medicine bone SPECT scintigraphy images.”

Adaptive (vs locked)FDA source did not state this

PCCPYes

source quote (p.6)

“Clarify DL includes a Predetermined Change Control Plan (PCCP) with one planned modification. The modification is for making Clarify DL available for imaging data acquired using a SPECT-CT system that incorporates a different CT. Clarify DL remains unchanged and maintains the same intended use, indications for use and equivalent performance. Performance evaluation for the modification includes testing to confirm equivalence of the input CT data and that Clarify DL's overall IQ performance is maintained and substantially equivalent to its performance with imaging data from a supported SPECT-CT system. The user documentation will be updated to reflect the modification (i.e. description of new source of data, summary of release and performance evaluation).”

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

endpoints: Structure Similarity Index Measure (SSIM); Mean Squared Error (MSE); Peak Signal-to-Noise Ratio (PSNR); Contrast-to-Noise ratio (CNR); Contrast Recovery Coefficient (CRC)

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

sample size not stated · 11 site(s)

endpoints: overall Image Quality; Image Resolution; Noise Level

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

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 matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98428
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 (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).