Bone VCAR (BVCAR)

K183204

GE Medical Systems SCS · cleared 2019-04-08 · product code JAK · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“Bone VCAR is a post processing application for use in the analysis of CT images. The software is intended to support clinicians in the review of images that include the spine by providing tools to label the spine and optimize the display of anatomy within the CT image.”

AlgorithmThe goal of the Bone VCAR software algorithm is to extract from a CT scan the positions and labels of the patient vertebrae in the image. The algorithm takes as input a CT scan acquisition and is compatible with a wide range of acquisitions for dedicated spine work, trauma, oncology and routine exam. Bone VCAR automated vertebra detection algorithm returns the list of detected vertebrae position in 3D coordinates and associated labels.

source quote (p.6)

“The goal of the Bone VCAR software algorithm is to extract from a CT scan the positions and labels of the patient vertebrae in the image. The algorithm takes as input a CT scan acquisition and is compatible with a wide range of acquisitions for dedicated spine work, trauma, oncology and routine exam. Bone VCAR automated vertebra detection algorithm returns the list of detected vertebrae position in 3D coordinates and associated labels.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Retrospective clinical

sample size not stated

endpoints: success rate greater than 90% for the capability of automatically labeling the spine

standards: 21CFR 820, ISO 13485

Reader study (MRMC)

sample size not stated

endpoints: automatic labeling of spine by Bone VCAR is faster than manually labeling; increases reading and reporting efficiency; providing accurate identification of vertebra

standards: 21CFR 820, ISO 13485

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

192

MAUDE reports in code, 12mo

-22%

vs code's own 3-yr baseline

drift signals on this device

recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm matches this device's applicant.
first seen 2026-07-08 · recall res_event_number:98738
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
recall_reason_pattern
Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97010
recall_reason_pattern
Software/algorithm-related recall in product code JAK (, initiated 2025-05-23): "Due to a software bug the robotic arm may incorrectly guide the instrument compared to the planning defined by user." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:96967
…and 3 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).