# K130308: Noblus Ultrasound Diagnostic System

- Pathway: 510(k) (Special)
- Applicant: Hitachi Aloka Medical, Ltd.
- Decided: Apr 5, 2013 after 57 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: 13 generations back to K935595 (1995). 68 ancestors in all.
59 later devices descend from it; 1 cites it directly.
0 of 128 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102901: HI Vision Avius Diagnostic Ultrasound Scanner, Hitachi Medical Systems America, Inc. (2010) Summary page 1.

## Most influential descendants
- K142368: Noblus Diagnostic Ultrasound Scanner (2015), 58 descendants of its own
- 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

## Indications for use
The Noblusm Ultrasound Diagnostic System is intended for use by trained personnel (doctor, sonographer, etc.) for the diagnostic ultrasound evaluation of Abdominal, Cardiac, Intra-operative, Fetal, Pediatric, Small Organ, Peripheral vessel, Biopsy, Trans-rectal, Trans-vaginal, Musculoskeletal, Neonatal Cephalic. Adult Cephalic, Endloscopy, Intra-luminal, Gynecology, Urology, and Laparoscopic clinical applications. The Modes of Operation of the Noblusm 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/K130308
Methodology: https://510kreport.com/methodology