SmartTarget
K170250SmartTarget, Ltd. · cleared 2017-06-07 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“The SmartTarget software is designed for the fusion/registration of transrectal ultrasound (TRUS) images of the prostate with three-dimensional (3D) images, such as a magnetic resonance image (MRI) or x-ray computed tomography (CT) image etcetera, during procedures for which TRUS is used to provide real-time imaging of the prostate, nearby anatomical structures, and instruments inserted into the prostate to guide instrument placement. The software supports the following tasks: computer-assisted surgical planning, allowing target regions to be defined within the prostate in a diagnostic/planning image and TRUS images; reconstruction of 3D TRUS images from multiple US video frames, captured at pre-set intervals as the TRUS probe is translated or rotated; and image fusion/registration wherein the spatial relationship between prostate in the diagnostic/planning image and TRUS images is calculated. The system software reproduces and supplements the visual information provided by real-time TRUS images, and superimposes a graphical representation of one or more target regions on to the reproduced TRUS images.”
source quote (p.4)
“The SmartTarget software is designed for the fusion/registration of transrectal ultrasound (TRUS) images of the prostate with three-dimensional (3D) images, such as a magnetic resonance image (MRI) or x-ray computed tomography (CT) image etcetera, during procedures for which TRUS is used to provide real-time imaging of the prostate, nearby anatomical structures, and instruments inserted into the prostate to guide instrument placement. The software supports the following tasks: computer-assisted surgical planning, allowing target regions to be defined within the prostate in a diagnostic/planning image and TRUS images; reconstruction of 3D TRUS images from multiple US video frames, captured at pre-set intervals as the TRUS probe is translated or rotated; and image fusion/registration wherein the spatial relationship between prostate in the diagnostic/planning image and TRUS images is calculated. The system software reproduces and supplements the visual information provided by real-time TRUS images, and superimposes a graphical representation of one or more target regions on to the reproduced TRUS images.”
Validation studies (1)
Bench
sample size not stated
endpoints: image alignment error; overall needle-tip placement error
standards: AAMI/ANSI/ES 60601-1, IEC 60601-1-2
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
- 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).