# K160559: NOBLUS™ Ultrasound Diagnostic System

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Corporation
- Decided: Oct 18, 2016 after 232 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- 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: 16 generations back to K935595 (1995). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142368: Noblus Diagnostic Ultrasound Scanner, Hitachi Aloka Medical, Ltd. (2015) Summary page 4.

## Recalls of this device
- Apr 11, 2024 · Class II · Z-1884-2024: AC adapters of Noblus can heat up, and cause smoke in the worst case, when an excessive mechanical stress is applied to the socket for power cable (frequent insertion/removal of the power cable).

## Indications for use
The Noblus™ Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative (Spec.), Intra-operative (Neuro.), Trans-esophageal (Cardiac/Non-Cardiac) — Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal (Convent. / Superfic.), Neonatal Cephalic, Adult Cephalic, Endoscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications. The modes of Operation of the Hitachi Noblus™ Ultrasound Diagnostic System are B mode, M mode, PW mode (Pulse Wave Doppler), CW mode (Continuous Wave Doppler), Color Doppler, Amplitude Doppler (Color Flow Angiography), TDI (Tissue Doppler Imaging), 3D Imaging, 4D Imaging, and Real Time Tissue Elastography.

Source page: https://510kreport.com/device/K160559
Methodology: https://510kreport.com/methodology