# K893475: Uroview II

- Pathway: 510(k) (Traditional)
- Applicant: Oec-Diasonics, Inc.
- Decided: Aug 10, 1989 after 98 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: 1 (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
- May 12, 2003 · Not classified · Z-0945-03: Uncommanded motion of the urological table is possible should the hand control assembly be exposed to liquids.

Source page: https://510kreport.com/device/K893475
Methodology: https://510kreport.com/methodology