# K974544: Asu-1000 Diagnostic Ultrasound Transducer

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Mar 18, 1998 after 104 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- 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. The FDA summary names its predicate without a number.
- (no number) TomTek Echo-Scan system: named in the summary without a submission number

## Indications for use
Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Other Indications or Modes:3-D rendering of fetal and maternal structures in Obstetrics. Diagnostic Ultrasound imaging and Doppler analysis of the human body as follows: Other Indications or Modes:3-D rendering of fetal and maternal structures in Obstetrics.

Source page: https://510kreport.com/device/K974544
Methodology: https://510kreport.com/methodology