# K033184: Lateral Angiographic C-Arm Support MH-400

- Pathway: 510(k) (Traditional)
- Applicant: Shimadzu Corp.
- Decided: Dec 9, 2003 after 69 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: 1 generation back to K903372 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903372: Cath Multidirect BI-Plane Radio Syst MH-51A/MH-31A, Shimadzu Medical Systems (1990) Summary page 3.

## Indications for use
This device is intended to be used in the diagnosis of circulatory vascular system. This device is operated and used by Physicians and X-ray technologist. As mentioned at "Intended Use" in this clearance letter, the intended use of the MH-400 is the same as that of predecessor device MH-31A (K903372).

Source page: https://510kreport.com/device/K033184
Methodology: https://510kreport.com/methodology