# K152467: Touch Ultrasound

- Pathway: 510(k) (Abbreviated)
- Applicant: Carestream Health, Inc.
- Decided: Dec 9, 2015 after 100 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K000567 (2000). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043524: Ultrasound Scanner Pro Focus, Model 2202, B-K Medical A/S (2005) Summary page 11.
- K100919: Pro Focus 2202, Pro Focus 2202 UV Model: Type 2202, B-K Medical Aps (2011) Summary page 11.
- K140428: Ultrasound Scanner System BK2300, B-K Medical Aps (2014) Summary page 11.
- K150342: Touch Ultrasound, Carestream Health, Inc. (2015) Summary page 11.
- K130619: Acuson S1000 Diagnostic Ultrasound System, Siemens Medical Solutions USA, Inc. (2013) Summary page 11.

## Recalls of this device
- Nov 21, 2016 · Class II · Z-1052-2017: Software error; Carestream Health Inc, received a complaint stating that when a user accidentally obtains a measurement value of 0 and corrects the value in the report, the resulting measurement unit 
- Jul 8, 2016 · Class II · Z-2217-2016: A software issue related to the generic volume measurement functionality could result in the volume of the subject anatomy being overestimated. For example, measurement results of the anatomy may appe

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

Source page: https://510kreport.com/device/K152467
Methodology: https://510kreport.com/methodology