# K884912: Angiostar

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Feb 16, 1989 after 80 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- Jul 1, 2009 · Not classified · Z-0166-2010: The table swivel locking mechanism may not completely engage adn could result in uncontrolled patient movement during transfer resulting in a patient fall.
- Aug 11, 2008 · Not classified · Z-0133-2009: Unintended movement of the system table and/or C arm.
- Aug 11, 2008 · Not classified · Z-0134-2009: Unintended movement of the system table and/or C arm.

Source page: https://510kreport.com/device/K884912
Methodology: https://510kreport.com/methodology