# K192901: HealthVCF

- Pathway: 510(k) (Traditional)
- Applicant: Zebra Medical Vision, Ltd.
- Decided: May 12, 2020 after 210 days
- Product code: QFM (Radiological Computer-Assisted Prioritization Software For Lesions)
- Device class: 2
- Regulation: 21 CFR 892.2080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN170073 (2018). 2 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183285: cmTriage, Curemetrix, Inc. (2019) Summary page 4.

## Most influential descendants
- K193271: uAI EasyTriage-Rib (2021), 3 descendants of its own
- K213319: Viz ANEURYSM, Viz ANX (2022), 2 descendants of its own
- K222692: BriefCase (2022), 1 descendant of its own
- K240612: Cina-VCF (2024), 0 descendants of its own
- K230074: Rapid Aneurysm Triage and Notification (2023), 0 descendants of its own

## Indications for use
HealthVCF is a passive notification for prioritization-only, parallel-workflow software tool used by clinicians to prioritize specific patients within the standard-of-care bone health setting for suspected vertebral compression fractures. HealthVCF uses an artificial intelligence algorithm to analyze chest and abdominal CT scans and flags those that are suggestive of the presence of at least one vertebral compression at the exam level. These flags are viewed by the clinician in Bone Health and Fracture Liaison Service programs in the medical setting via a worklist application on their Picture Archiving and Communication System (PACS). HealthVCF does not send a proactive alert directly to the user. HealthVCF does not provide diagnostic information beyond triage and prioritization, it does not remove cases from the radiology worklist, and should not be used in place of full patient evaluation, or relied upon to make or confirm diagnosis.

Source page: https://510kreport.com/device/K192901
Methodology: https://510kreport.com/methodology