# K070077: Ultrasound Scanner Profocus, Model 2202

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Mar 5, 2007 after 56 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: 4 generations back to K935595 (1995). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032111: Acuson CV70 Cardiovascular System, Siemens Medical Solutions USA, Inc. (2003) Summary page 2.

## Indications for use
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color Doppler and combined mode imaging. Guidance of biopsy needles, geometrical measurements and calculation of parameters. Non monitoring ECG for superimposing the ultrasound information. An optional 3-D unit can reconstruct a series of 2-D images into a single 3-D volume and display this on the screen. Clinical applications: Abdominal, Cardiac, Fetal, Intraoperative, Neurosurgery, Obstetrics, Pediatrics, Transcranial (=Adult cephalic),Transrectal, Small organs, Transvaginal, Musculoskeletal

Source page: https://510kreport.com/device/K070077
Methodology: https://510kreport.com/methodology