# K132677: Ultrasound Scanner Flex Focus 1202

- Pathway: 510(k) (Traditional)
- Applicant: B-K Medical Aps
- Decided: Jan 7, 2014 after 132 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
Longest line of descent: 15 generations back to K935595 (1995). 151 ancestors in all.
No later device cites it as a predicate yet.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120703: Zonare ZS3 Diagnostic Unltrasound System, Zonare Medical Systems, Inc. (2012) Summary page 1.
- K111513: CX50 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2011) Summary page 1.
- K121422: Aplio 500/400/300 Diagnostic Ultrasound System, Toshiba Medical Systems Coporation, Japan (2012) Summary page 1.

## Indications for use
Ultrasound scanner and transducers for B, Tissue and Contrast Harmonic Imaging, M, PWD,CWD, Color.Doppler, Vector Flow Imaging and combined mode Imaging. Signal analysis and display. 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. An optional Vector Flow Imaging (VFI) module: Color Flow Mapping (CFM) imaging mode with the ability to visualize both the axial and the transverse velocity. Clinical applications: Ultrasound Scanner Flex Focus 1202: Fetal, Obstetrics, Abdominal, lntraoperative, Neurosurgery, Small organ, Pediatric, Neonatal Cephalic, Cardiac, Transrectal, Tranavaiginal, Transurethral, Peripheral Vascular, Musculoskeletal. Ultrasound Transducer N13C6, Type 8862: Neonatal Cephalic.

Source page: https://510kreport.com/device/K132677
Methodology: https://510kreport.com/methodology