# K061685: Pulsera

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Sep 15, 2006 after 92 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K042646 (2004). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042646: Dynact, Siemens Medical Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K090590: Veradius, Model 718-130 (2009), 14 descendants of its own
- K133819: Veradius (2014), 12 descendants of its own
- K142708: Veradius Unity (2014), 11 descendants of its own
- K183040: Zenition 70 (2018), 6 descendants of its own
- K230871: Extron 5; Extron 7 (2023), 3 descendants of its own

## Indications for use
The 3D-RX Option on the BV Pulsera provides 3D imaging functionality and is intended to be used whenever the physician benefits from intra-operatively-generated 3D information of high contrast objects and anatomical structures.

Source page: https://510kreport.com/device/K061685
Methodology: https://510kreport.com/methodology