# K914945: Diagnostic Ultrasound System Type 3535, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Bruel & Kjaer Industri A/S
- Decided: Jun 26, 1992 after 235 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
No predicates in its family tree.
122 later devices descend from it; 5 cite it directly.
2 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K992505: Teratech, Model 2000 Imaging Imaging (1999), 109 descendants of its own
- K070907: Interson Usb Ultrasound Probe System (2007), 106 descendants of its own
- K102153: Mobius Ultrasound Imaging System (2011), 103 descendants of its own
- K133833: Nuvis Diagnostic Ultrasound System (2014), 87 descendants of its own
- K152899: Philips Lumify Diagnostic Ultrasound System (2015), 79 descendants of its own

Source page: https://510kreport.com/device/K914945
Methodology: https://510kreport.com/methodology