# K991231: Hitachi Versiflex

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: May 24, 1999 after 42 days
- Product code: IZI (System, X-Ray, Angiographic)
- Device class: 2
- Regulation: 21 CFR 892.1600
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923813 (1992). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K964990: Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30), Hitachi Medical Systems America, Inc. (1997) Summary page 1.

## Indications for use
The SF-VA200 is intended to visualize anatomical structures by converting a pattern of x-radiation into an image through electronic amplification and recording, and, when used with injection of contrast medium, to visualize the heart or blood vessels.

Source page: https://510kreport.com/device/K991231
Methodology: https://510kreport.com/methodology