# K142368: Noblus Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Aloka Medical, Ltd.
- Decided: Jan 14, 2015 after 142 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: 15 generations back to K935595 (1995). 93 ancestors in all.
58 later devices descend from it; 7 cite it directly.
0 of 152 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130308: Noblus Ultrasound Diagnostic System, Hitachi Aloka Medical, Ltd. (2013) Summary page 4.
- K110673: HI Vision Ascendus Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2011) Summary page 18.
- K130881: Acuson S2000 and S3000, Siemens Medical Solutions USA, Inc. (2013) Summary page 45.
- K022928: Hudson 2020, 2040, 2060,Ultrasound Scanners, Hudson Diagnostic Imaging, LLC (2002) Summary page 45.

## Most influential descendants
- K171048: RS80A Diagnostic Ultrasound System (2017), 50 descendants of its own
- K173204: RS85 Diagnostic Ultrasound System (2018), 39 descendants of its own
- K173513: WS80A Diagnostic Ultrasound System (2018), 32 descendants of its own
- K181336: HS50 / HS60 Diagnostic Ultrasound System (2018), 31 descendants of its own
- K182595: HERA W10 Diagnostic Ultrasound System (2018), 26 descendants of its own

## Recalls of this device
- Jan 31, 2020 · Class II · Z-1341-2020: These 18 probes may have mis-wiring in the inner cables, causing decreased sensitivity and thus resulting in lower peak velocity readings.

## Indications for use
The Hitachi 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.), Trans-esophageal (Cardiac, Non- Cardiac) - Adult/Pediatric, Wound (Cavernous/Non-Cavernous), Fetal, Pediatric, Small Organ, Peripheral vessel, Biospy, 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/K142368
Methodology: https://510kreport.com/methodology