# K991937: Ultrasound Scanner, Model Type 2101

- Pathway: 510(k) (Special)
- Applicant: B & K Medical A/S
- Decided: Jul 30, 1999 after 51 days
- Product code: IYO (System, Imaging, Pulsed Echo, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1560
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K943315 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943315: Ultrasound Scanner 2002, B&K Medical (1996) Summary page 1.

## Recalls of this device
- Nov 12, 2004 · Not classified · Z-0271-05: Defect at probe tip may effect sterilization and electrical safety

## Indications for use
Ultrasound scanner and transducers for B, M and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transrectal, Small organs, Transvaginal.

Source page: https://510kreport.com/device/K991937
Methodology: https://510kreport.com/methodology