# K180995: Vscan Extend

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
- Decided: Jun 25, 2018 after 70 days
- Product code: IYN (System, Imaging, Pulsed Doppler, Ultrasonic)
- Device class: 2
- Regulation: 21 CFR 892.1550
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K935595 (1995). 156 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 167 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161588: Vscan Extend, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 4.
- K161224: LOGIQ V5 Expert, LOGIQ V5, LOGIQ V3, GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC (2016) Summary page 7.
- K130779: Lvivo EF System, Diacardio, Ltd. (2013) Summary page 7.

## Most influential descendants
- K202035: Vscan Air (2020), 3 descendants of its own
- K181934: Vivid T8, Vivid T9 (2018), 3 descendants of its own
- K200851: Vivid T8, Vivid T9 (2020), 2 descendants of its own
- K231301: Vscan Air (2023), 1 descendant of its own
- K221147: Vivid T8, Vivid T9 (2022), 1 descendant of its own

## Recalls of this device
- Nov 4, 2021 · Class II · Z-0520-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0523-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0518-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0522-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0519-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0524-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi
- Nov 4, 2021 · Class II · Z-0521-2022: The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer wi

## Indications for use
Vscan Extend is a general-purpose diagnostic ultrasound imaging system for use by qualified and trained healthcare professionals enabling visualization and measurement of anatomical structures and fluid. It's pocket-sized portability and simplified user interface enables integration into examination and training sessions indoors and in other environments described in the user manual. The information can be used for basic/focused assessments and adjunctively with other medical data for clinical diagnosis purposes during routine, periodic monitoring, and triage. With the phased array transducer on the sector probe, the specific clinical applications and exam types include: Cardiac; Abdominal; Renal; OB/GYN; Urology; Fetal, Evaluation of Presence of Fluid; Imaging Guidance for Needle/Catheter Placement (e.g. paracentesis, pericardiocentesis, thoracentesis, amniocentesis); Peripheral Vascular Imaging (e.g. arteries and veins); Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); Adult Cephalic; and Pediatrics. With the addition of the linear array transducer on the single dual headed probe solution, the specific clinical applications and exam types are expanded to include: Peripheral vascular imaging (e.g. lower extremity, carotid); Procedure Guidance for Arterial or Venous Vessels (e.g. central lines, upper extremity); Small Organs (e.g. thyroid); and Musculoskeletal (Long Bone; Hip, shoulder, elbow and Knee Joints); Evaluation of Presence of Fluid; Thoracic/Lung (e.g. pleural motion/sliding, line artifacts); and Pediatrics.

Source page: https://510kreport.com/device/K180995
Methodology: https://510kreport.com/methodology