# K040926: Ultrasound Scanner, Hudson Models 8000 and 9000

- Pathway: 510(k) (Traditional)
- Applicant: Hudson Diagnostic Imaging, LLC
- Decided: Jun 10, 2004 after 63 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
Longest line of descent: 6 generations back to K924432 (1993). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031552: Mycolor 202 Diagnostic Ultrasound System and Transducers, Medison America, Inc. (2003) Summary page 1.
- K983879: Aloka SSD-900 Diagnostic Ultrasound System, Aloka Co., Ltd. (1999) Summary page 1.

## Cited in the summary but kept off the family tree
- K011284: Thin Film Dressing for Ultrasound Exam, Martin E. Wendelken (2001). Our OCR of the scanned summary read K011284, FDA’s number for Thin Film Dressing for Ultrasound Exam (Martin E. Wendelken). Its FDA name has none of the distinctive words the summary uses for the device it names, “Hudson 2020, 2040, and 2060 Ultrasound Imaging Systems”. Kept off the family tree.

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

Source page: https://510kreport.com/device/K040926
Methodology: https://510kreport.com/methodology