510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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GE Vingmed Ultrasound AS

Oslo, NO

GE Vingmed Ultrasound AS appears in FDA device records in Oslo, NO. FDA records list 11 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
6
Registered establishments
3

510(k) clearance history

FDA records hold 11 510(k) clearances for GE Vingmed Ultrasound AS between 1999 and 2015. The busiest year on record is 2013, with 3. The most recent is 2015, with 2.

Clearances by year, as a table
510(k) clearance decisions for GE Vingmed Ultrasound AS, by decision year
YearClearances
19991
20091
20102
20121
20133
20141
20152
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K150087Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging SystemIYNSubstantially Equivalent
K150085GE EchoPACLLZSubstantially Equivalent
K1410936VT-D ULTRASOUND TRANSDUCERITXSubstantially Equivalent
K131685GE ECHOPACLLZSubstantially Equivalent
K131514GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYNSubstantially Equivalent
K123894GE ECHOPACLLZSubstantially Equivalent
K120201GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYOSubstantially Equivalent
K101149GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEMIYOSubstantially Equivalent
K101324GE ECHOPAC MODEL BT10LLZSubstantially Equivalent
K092756GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEMITXSubstantially Equivalent
K991842SYSTEM FIVE/ECHOPAC WITH STRAIN RATE IMAGINGIYOSubstantially Equivalent

Registered establishments

FDA registered establishments for GE Vingmed Ultrasound AS, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96104823002808457GE VINGMED ULTRASOUND A/SSTRANDPROMENADEN 45, HORTEN Vestfold 3191 NO2026
30328074643032807464GE Vingmed Ultrasound ASGaustadalleen 21, Oslo 0349 NO2026
30335082923033508292GE Vingmed Ultrasound ASPrinsesse Kristinas Gate 3, Trondheim Trondelag 7030 NO2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-2317-2024GE Vivid Ultrasound products, Model Numbers: a) Vivid S70, H45041SWGE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.Class IIOpen, Classified
Z-2316-2024GE Vivid Ultrasound products, Model Numbers: a) Vivid E90, H45581LB; b) Vivid E95, H45581DAGE HealthCare has become aware of an issue with certain Vivid ultrasound systems where, due to a slow DICOM Worklist response time, incorrect patient name and demographics can be displayed on the ultrasound scanner screen rather than the intended patient selected by the user.Class IIOpen, Classified
Z-2127-2023GE Healthcare Vivid S70N, ultrasound deviceGE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.Class IIOpen, Classified
Z-2126-2023GE Healthcare Vivid S60N, ultrasound deviceGE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.Class IIOpen, Classified
Z-2125-2023GE Healthcare Vivid S70, ultrasound deviceGE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.Class IIOpen, Classified
Z-2124-2023GE Healthcare Vivid S60, ultrasound deviceGE HealthCare has become aware that certain Vivid ultrasound systems cannot boot up in a timely fashion. If this occurs, it can delay availability of the device in time-critical emergency situations.Class IIOpen, Classified

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Data as of , FDA export datePage updated Source: openFDA, public domain