# K073297: GE Logiq P6

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Dec 18, 2007 after 25 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K010329 (2001). 4 ancestors in all.
224 later devices descend from it; 2 cite it directly.
0 of 229 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060993: GE Logiq P5 and A5, General Electric Co. (2006) Summary page 1.

## Most influential descendants
- K101874: GE Logiq P6/P6 Pro (2010), 221 descendants of its own
- K122114: Logiq S7 Expert, Logiq S7 Pro (2012), 220 descendants of its own
- K131527: Logiq S8 (2013), 219 descendants of its own
- K133034: Logiq F Series (2014), 155 descendants of its own
- K133533: Logiq E (2014), 149 descendants of its own

## Recalls of this device
- Dec 28, 2018 · Class II · Z-0788-2019: Increased temperature in the probe-head surface with LOGIQ P6 Model BT07 and BT09 scanners when used in specific types of scans and with specific probes.
- Dec 23, 2011 · Not classified · Z-0834-2012: GE Healthcare has recently become aware of a safety issue associated with the Probe of your LOGIC P6 system that may impact patient safety. GE Logic P6 probe head has a possibility to cause burn injur

## Indications for use
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional and Superficial; Urology (including prostate); Transesophageal (TE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, vascular and neurological).

Source page: https://510kreport.com/device/K073297
Methodology: https://510kreport.com/methodology