# K990198: AMIB7

- Pathway: 510(k) (Traditional)
- Applicant: Alliance Medical, Inc.
- Decided: Jun 29, 1999 after 159 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- 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 K900805 (1990). 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)
- K924126: EUB-405, Hitachi Medical Systems America, Inc. (1992) Summary page 1.
- K900805: Aloka 500 Diagnostic Ultrasound Scanning System, Ge Medical Systems Information Technologies (1990) Summary page 1.
- K922208: Fukuda Denshi Model UF-4500, Fukuda Denshi USA, Inc. (1993) Summary page 1.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

Source page: https://510kreport.com/device/K990198
Methodology: https://510kreport.com/methodology