# K964990: Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System (SX-VA30)

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Feb 26, 1997 after 72 days
- Product code: JAA (System, X-Ray, Fluoroscopic, Image-Intensified)
- Device class: 2
- Regulation: 21 CFR 892.1650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K923813 (1992). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945400: Hitachi Dynamic 3D Imaging System,SF-VA100, Hitachi Medical Corp. of America (1995) Summary page 1.
- K923813: Philips Integris V3000 Rotational Angio Function, Philips Medical Systems, Inc. (1992). Our OCR of the scanned summary read K523813, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Philips Medical Systems Integris V3000”.

## Most influential descendants
- K991231: Hitachi Versiflex (1999), 0 descendants of its own

## Indications for use
The Hitachi SX-VA30 C-Arm Fluoroscopic/Angiographic System 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/K964990
Methodology: https://510kreport.com/methodology