# K905198: Diagnostic Ultrasound System Type 3535

- Pathway: 510(k) (Traditional)
- Applicant: Bruel & Kjaer
- Decided: Aug 28, 1991 after 281 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
No predicates in its family tree.
12 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

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

## Most influential descendants
- K972672: Brachystepper Stepping Unit, Brachystepper Needle Guide Template, Brachystand Support and Manual Adjustment Accessory (1997), 6 descendants of its own
- K131161: EX3 Stepper, Classic Stepper, Multi-Purpose Workstation Stepper; Micro-Touch, Micro-Touch LP, Mulit-Purpose Workstation, (2013), 1 descendant of its own
- K992152: General Purpose Transducer Standoff, Biopsy Transducer Standoff, BI-Plane Endocavity Transducer Standoff (1999), 1 descendant of its own
- K982696: Interplant (1999), 1 descendant of its own
- K972192: Perception Inc. GPS-Xyz Diagnostic Ultrasound System (1997), 1 descendant of its own

Source page: https://510kreport.com/device/K905198
Methodology: https://510kreport.com/methodology