# K013723: Modification to: Eub-6500 Diagnostic Ultrasound Scanner

- Pathway: 510(k) (Special)
- Applicant: Hitachi Medical Corp.
- Decided: Feb 6, 2002 after 89 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
15 later devices descend from it; 2 cite it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K023401: EG-3830UT, Video Ultrasound Gastroscope (2003), 9 descendants of its own
- K090197: EG-3870UTK (2009), 6 descendants of its own
- K130247: Pentax EG-3870UTK Ultrasound Video Gastroscope + HI Vision Preirus (2013), 5 descendants of its own
- K162447: PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner (2017), 4 descendants of its own
- K053258: Eub-6500 Diagnostic Ultrasound Scanner (2005), 4 descendants of its own

## Recalls of this device
- May 12, 2008 · Not classified · Z-2054-2009: The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to bec
- May 7, 2004 · Not classified · Z-1005-04: Due to a software anomaly, various patient images may be intermixed within a single patient folder, which may result in mis-diagnosis and delay in treatment.

## Indications for use
Diagnostic ultrasound imaging or fluid flow analysis if the human body as follows:

Source page: https://510kreport.com/device/K013723
Methodology: https://510kreport.com/methodology