# K972465: Aloka SSD-1400 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Aloka Co., Ltd.
- Decided: Aug 15, 1997 after 45 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite 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)
- None. The FDA summary names its predicate without a number.
- (no number) Aloka SSD-1700: named in the summary without a submission number
- (no number) Aloka Omniview diagnostic ultrasound systems and transducers: named in the summary without a submission number

## Most influential descendants
- K012253: SSD-1000 Diagnostic Ultrasound System (2001), 1 descendant of its own
- K080176: Aloka Prosound 6 Diagnostic Ultrasound System (2008), 0 descendants of its own
- K020668: Aloka SSD-1000 Diagnostic Ultrasound System, Models Asu-1003, Ust-9121, Ust-9124 (2002), 0 descendants of its own

## Indications for use
The Aloka SSD-1400, like other marketed diagnostic ultrasound systems, is indicated for imaging body structures to aid in the diagnosis of disease or abnormality.

Source page: https://510kreport.com/device/K972465
Methodology: https://510kreport.com/methodology