# K023457: Ultrasound Scanner, Type 1101

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical A/S
- Decided: Nov 1, 2002 after 17 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: 2 generations back to K945072 (1995). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980557: Sonoline Elegra Diagnostic Ultrasound System with Superficial Musculoskeletal Imaging, Siemens Medical Solutions USA, Inc. (1998) Summary page 1.

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

Source page: https://510kreport.com/device/K023457
Methodology: https://510kreport.com/methodology