Vscan Extend— 510(k) K161588
Substantially EquivalentGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
FDA 510(k) clearance K161588 for Vscan Extend, Substantially Equivalent on 2016-08-31. Applicant: GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. Device class: 2.
Clearance details
- Applicant
- GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
- Product code
- Code IYN
- Device class
- Class 2
- Regulation
- 21 CFR 892.1550
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Wauwatosa, WI, US
Recent devices under product code IYN
view all- K261313 — Vivid Explorer/Vivid Advanced/Vivid Focus
- K254027 — Digital Color Doppler Ultrasound System (Marvo 95/Marvo 95 Elite/Marvo 90/Marvo 90 CV/Marvo 90 Pro/Marvo 90 Exp/Marvo 90 Elite/Marvo Expert/Marvo 85/Marvo 85 Pro/Marvo 85 Exp/Marvo 85 Elite/Marvo Senior/Marvo 75 Elite/Marvo 75i/Fenix 95/Fenix 95 Elite/Fenix 90/Fenix 90 Elite/Fenix Expert/Fenix 85/Fenix 85 Elite/Fenix Senior/Fenix 75 Elite/Fenix 75i/Endo 80/Endo 90)
- K261668 — Venue Go
- K262311 — Alturion Series Diagnostic Ultrasound System
- K261288 — Handheld Ultrasound Scanner
More clearances from GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
view allAdverse events under product code IYN
product code IYN- Death
- 25
- Injury
- 163
- Malfunction
- 1,538
- Other
- 4
- Total
- 1,730
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K161588
K-number listed on FDA's recall record- Z-0518-2022 — GE Vscan Extend, being sold as "Vscan Extend Console"
- Z-0519-2022 — GE Vscan Extend, being sold as "Vscan Extend Dual DICOM"
- Z-0520-2022 — GE Vscan Extend, being sold as "Vscan Extend Dual USB"
- Z-0521-2022 — GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi"
- Z-0522-2022 — GE Vscan Extend, being sold as "Vscan Extend Sector DICOM"
- Z-0523-2022 — GE Vscan Extend, being sold as "Vscan Extend Sector USB"
- Z-0524-2022 — GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi"
- Z-1839-2019 — LVivo EF app on Vscan Extend. Sold under the following product names: a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN; b .Vscan Extend Dual USB, Model Number H41212RK; c. Vscan Extend Dual Wi-Fi, Model Numbers H41212YZ, H41212RL; d. Vscan Extend Sector DICOM, Model Number H41212ZD; e. Vscan Extend Sector USB, Model Number H41212RR; f. Vscan Extend Sector Wi-Fi, Model Number H41212ZC Product Usage: 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.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K161588.
Data sourced from openFDA. This site is unofficial and independent of the FDA.