# K930635: Multistar D Angiographic X-Ray System

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Sep 7, 1993 after 211 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: 7 (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-0167-2010: The table swivel locking mechanism may not completely engage and could result in uncontrolled patient movement during transfer resulting in a patient fall.
- May 1, 2009 · Not classified · Z-1437-2009: Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall.
- Aug 11, 2008 · Not classified · Z-0135-2009: Unintended movement of the system table and/or C arm.
- Aug 11, 2008 · Not classified · Z-0139-2009: Unintended movement of the system table and/or C arm.
- Aug 11, 2008 · Not classified · Z-0142-2009: Unintended movement of the system table and/or C arm.
- Aug 11, 2008 · Not classified · Z-0147-2009: Unintended movement of the system table and/or C arm.
- Aug 11, 2008 · Not classified · Z-0148-2009: Unintended movement of the system table and/or C arm.

Source page: https://510kreport.com/device/K930635
Methodology: https://510kreport.com/methodology