# K072164: DC-6 Diagnostic Ultrasound System

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- Decided: Sep 5, 2007 after 30 days
- Product code: ITX (Transducer, Ultrasonic, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 892.1570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K935595 (1995). 78 ancestors in all.
188 later devices descend from it; 12 cite it directly.
0 of 267 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063500: DC-6 Diagnostic Ultrasound System, Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (2006) Summary page 1.
- K010631: NEMIO, Toshiba America Medical Systems, In.C (2001)
- K012080: SSD-5000 Diagnostic Ultrasound System, Aloka Co., Ltd. (2001) Summary page 2.
- K042540: Philips IU22 Ultrasound System, Philips Ultrasound, Inc. (2004) Summary page 2.
- K990339: Sonos 5500 Imaging System M2424A Version B.O, Hewlett-Packard Co. (1999) Summary page 2.
- K062247: HD11 Diagnostic Ultrasound System, Philips Ultrasound, Inc. (2006) Summary page 2.
- K061129: GE Logiq 9, Models 2188900, 2375600, 2404587 and 5150000, General Electric Co. (2006) Summary page 2.

## Most influential descendants
- K080640: M5 Diagnostic Ultrasound System (2008), 182 descendants of its own
- K081320: DC-3, DC-3T Diagnostic Ultrasound System (2008), 180 descendants of its own
- K083001: M5 Diagnostic Ultrasound System (2008), 179 descendants of its own
- K083505: DC-3/DC-3T Diagnostic Ultrasound System (2008), 178 descendants of its own
- K091941: DC-3/DC-3T Diagnostic Ultrasound System (2009), 177 descendants of its own

## Indications for use
The device is intended for use by a qualitied physician for ultrasound evaluation of abdominal, cardiac, small pails (breast, testes, thyroid, etc.), peripheral vascular, fetal, transrectal, transvaginal, pediatric, neonatal cephalic, musculoskeletal (general and superficial). Urology/Prostate and intraoperative (liver, gallbladder, pancreas).

Source page: https://510kreport.com/device/K072164
Methodology: https://510kreport.com/methodology