# K994373: Hdi 1500/SA 8800 Ultrasound System with Multiplane Transesophageal Ultrasound Transducer (MTP7-4)

- Pathway: 510(k) (Traditional)
- Applicant: Atl Ultrasound, Inc.
- Decided: Mar 24, 2000 after 88 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
Longest line of descent: 2 generations back to K926514 (1993). 3 ancestors in all.
27 later devices descend from it; 2 cite it directly.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961459: Level 10 Hdi, Advanced Technology Laboratories, Inc. (1997) Summary page 1.
- K963023: Ultrasound Gastroscope GF Type UM30P, Olympus America, Inc. (1997) Summary page 1.

## Most influential descendants
- K030191: Terason Model 2000/Bas Portable Ultrasound System (2003), 24 descendants of its own
- K032333: Cryocare CS Surgical System (2003), 13 descendants of its own
- K050347: Modification to Cryocare CS Surgical System (2005), 12 descendants of its own
- K060279: Cryocare CS Surgical System (2006), 9 descendants of its own
- K101333: Cryocare CS Surgical System (2010), 8 descendants of its own

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

Source page: https://510kreport.com/device/K994373
Methodology: https://510kreport.com/methodology