# K251268: Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

- Pathway: 510(k) (Traditional)
- Applicant: Edan Instruments, Inc.
- Decided: Dec 23, 2025 after 243 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: 21 generations back to K935595 (1995). 176 ancestors in all.
No later device cites it as a predicate yet.
6 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203406: Lumify Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2021) Summary page 5.

## Indications for use
The Nano Series Diagnostic Ultrasound System is intended for use by an appropriately trained and qualified healthcare professional for ultrasound evaluation in hospitals, clinics, road ambulances or at home. Nano Series Diagnostic Ultrasound System clinical applications include Abdominal, Gynecology, Obstetric, Small parts, Musculoskeletal, Urology, Peripheral vascular, Pediatric, Pleural/Thoracic and Cardiac. The Modes of Operation for Nano Series include B mode, M mode, Doppler modes, Harmonic Imaging and their combination modes.

Source page: https://510kreport.com/device/K251268
Methodology: https://510kreport.com/methodology