# K946053: Simview (TM) 3000

- Pathway: 510(k) (Traditional)
- Applicant: Siemens Medical Solutions USA, Inc.
- Decided: Mar 31, 1995 after 109 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: 5 (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
- Nov 6, 2008 · Not classified · Z-0646-2009: Excessive wear on drive belts used for Image Intensifier and/or X-ray head drive mechanisms may result in uncontrolled movement, which may cause injury.
- Mar 10, 2008 · Not classified · Z-2196-2008: The firm sent an Update Instruction, "TH003/08/S" for Motion Enable Switch/holder assembly. The switch holder allows the motion enable switch to be activated if inserted partially; thereby enabling in
- Feb 27, 2007 · Not classified · Z-0281-2008: Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
- Feb 27, 2007 · Not classified · Z-0283-2008: Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.
- Feb 27, 2007 · Not classified · Z-0284-2008: Loose Mounting Screws -- Cassette holder may become loose and result in the device dislodging and colliding with the patient.

Source page: https://510kreport.com/device/K946053
Methodology: https://510kreport.com/methodology