# K151859: Synapse Cardiovascular

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical Systems U.S.A, Inc.
- Decided: Aug 12, 2015 after 35 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K190232: Synapse PACS (2019), 3 descendants of its own
- K243647: Synapse PACS (7.5) (2025), 1 descendant of its own
- K261713: Synapse PACS (7.6.0) (2026), 0 descendants of its own
- K192508: Medsynapse Ris Pacs & Medsynapse VNA (2019), 0 descendants of its own

## Recalls of this device
- Jan 3, 2024 · Class II · Z-1172-2024: The LV Mass (2D Bullet) equation may be calculated incorrectly, resulting in a variance in the mass of the left ventricle (LV Mass). If used as a main factor for diagnosis, there is a risk of misdiagn
- Apr 30, 2021 · Class II · Z-1775-2021: Software versions 6.0.4 to 6.2.1 using Advanced Reporting -possibility that a previously assigned internal patient database ID can be reused for a new patient. It was discovered that this value does n

Source page: https://510kreport.com/device/K151859
Methodology: https://510kreport.com/methodology