Segment 3DPrint
K211966Medviso AB · cleared 2022-05-06 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Segment 3DPrint is a software for review and segmentation of images from a medical scanner as well as of medical 3D models.”
source quote (p.7)
“AI bone segmentation algorithm was trained on 20 data sets, and 21 data sets were used for its validation.”
Validation studies (3)
Bench
sample size not stated · 1 site(s)
endpoints: Segment 3DPrint was considered to be of "moderate" level of concern.; Extensive testing of the software package is performed by an automated test suite prior to commercial release.; manual testing is performed by Application specialists and the software is evaluated at one beta test site.
standards: FDA's Guidance "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices”
Bench
n=12 other
endpoints: This yielded replicas with an accuracy of <1 mm, well suited for clinical use in all intended patient population groups.
Retrospective clinical
n=21 other
endpoints: The maximum 95th percentile surface distance between the ground truth segmentation and the resulting image was <1 mm.; Table 1 below presents the agreement between reference segmentation by expert readers and the segmentation by the automatic segmentation algorithm.
Reported performance (3 observations)
source quote (p.8)
“Mean 0.96”
source quote (p.8)
“Mean 0.92”
source quote (p.7)
“The accuracy of the final 3D model generated by Segment 3DPrint is < 1 mm.”
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).