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GE Medical Systems Ultrasound and Primary Care Diagnostics LLC

Active in EUDAMED
Also registered as GE Medical Systems Ultrasound and Primary Care Diagnostics

United Statesfrom SRN EUDAMED FDA SRN US-MF-000016119 FEI 3005860720

Devices
109
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 3 in force. 1 certificate has expired.

See certificates

Market reach

European Union
EUDAMED actor, 3 certificates
United States
FDA FEI
Authorised rep.
GE Medical Systems SCSFR

What GE Medical Systems Ultrasound and Primary Care Diagnostics LLC makes

GE Medical Systems Ultrasound and Primary Care Diagnostics LLC manufactures ultrasound imaging systems and diagnostic software. Their product portfolio includes the LOGIQ, Voluson, and Vivid series of ultrasound machines, as well as Venue point-of-care systems, lung guidance tools, and EchoPAC software.

The company is based in the United States, and its devices are classified as Class II and Class IIa medical devices. These products are listed in the FDA 510(k) database and the EUDAMED registry.

AI-generated from registry data, 5 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue109

Newest first, rows 1-50 of 109

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  • Venue Focus Ref Venue Focus R7W

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • 6800000PRM

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Vivid T8, Vivid T9 Ref K200851

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Logiq P10, Logiq P9, Logiq P8 Ref K203114

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid E80, Vivid E90, Vivid E95 Ref K170823

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid T9/Vivid T8 Ref K243628

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid E80, Vivid E90, Vivid E95 Ref K181685

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EchoPAC Software Only / EchoPAC Plug-in Ref K251342

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid T8, Vivid T9 Ref K221147

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Venue Go Ref K261668

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • LOGIQ Focus Ref K261835

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Voluson Expert 18 Ref K261933

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EchoPAC Software Only / EchoPAC Plug-in (v211) Ref K261623

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid Explorer/Vivid Advanced/Vivid Focus Ref K261313

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Lunar Astra Ref H8930DB

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIb

  • Venue Advanced Ref Venue Advanced R7W

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • AutoAs Ref 9685077

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Venue Fit Ref Venue Fit R6W

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Lung Guidance Ref 5984278

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Venue Go R7 UPG

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • LOGIQ e Ref K260398

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Logiq P10, Logiq P9, Logiq P8 Ref K214039 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EchoPAC Software Only Ref K170847

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Voluson™ Performance 16 Ref K250543

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EchoPAC Software Only Ref K200852

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Voluson Signature 20 Ref K233692

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • EchoPAC Software Only Ref K220940

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid E80/ Vivid E90/ Vivid E95 Ref K202658

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Logiq E10 Ref K231966

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Logiq E10 Ref 5969829

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Venue Go R6 UPG

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Venue R6 UPG

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • Logiq E10 R4R5_R6 Upg Ref 6003775

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • Caption AI Ref 5984922

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

  • GEHC DXA Bone Densitometers with enCORE version 18 Ref K191112 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • LOGIQ E10s Ref K251963

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Aria Ref K180782

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Automated Aortic Stenosis Software (AutoAS) Ref K254161

    Active Regimes: CE MDR 510(k) Registry: 510(k) Class:II

  • Vivid S60N, Vivid S70N Ref K220619 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vscan Air Ref K231301

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Versana Premier Ref K210438

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Versana Premier Ref K182277

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid iq Ref K181727

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid S60N / Vivid S70N Ref K211216 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • ViewPoint 6 Ref K203677 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Versana Balance Ref K191792

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Versana Balance Ref K220446

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid S60N, Vivid S70N Ref K182450 Open recall

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 Ref K160277

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vivid iq Ref K221148

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-50 of 109

Showing 1-50 of 109

Company details

EUDAMED SRN
US-MF-000016119
FDA FEI number
3005860720
EUDAMED status
Active
EUDAMED registered name
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC
Registered address
3200, N Grandview Blvd, 53188, Waukesha, United States
PRRC contact
Kelly Metivier(public in EUDAMED)
1 more person
  • James Raskob

EUDAMED certificates3

3 certificates2 valid, 1 expiredMDR 3next expiry 21 Jul 2030

EUDAMED certificates (3)

TÜV Rheinland LGA Products GmbH 0197 3 certificates

  • HZ 2221349-1 Active Supplemented

    Quality management system EU MDR

    Issued
    7 May 2026
    Expires
    5 Mar 2031
    Reason
    Change approved
  • HZ 2237176-1 Active Reissued

    Quality management system EU MDR

    Issued
    22 Jul 2025
    Expires
    21 Jul 2030
  • HZ 2237176-1 Expired

    Quality management system EU MDR

    Issued
    16 Aug 2024
    Expires
    21 Jul 2025

Frequently asked questions

How many devices does GE Medical Systems Ultrasound and Primary Care Diagnostics LLC have in the registry?

The registry currently lists 109 devices for GE Medical Systems Ultrasound and Primary Care Diagnostics LLC. Devices recorded under merged duplicate company entries are counted once.

Which registries list GE Medical Systems Ultrasound and Primary Care Diagnostics LLC's devices?

Among its 50 most recently registered devices, GE Medical Systems Ultrasound and Primary Care Diagnostics LLC has devices listed in EUDAMED (13 devices), FDA 510(k) (37 devices) and FDA GUDID (7 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do GE Medical Systems Ultrasound and Primary Care Diagnostics LLC's devices fall under?

Among its 50 most recently registered devices, the classes recorded for GE Medical Systems Ultrasound and Primary Care Diagnostics LLC's devices are Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for GE Medical Systems Ultrasound and Primary Care Diagnostics LLC?

EUDAMED lists 3 certificates for GE Medical Systems Ultrasound and Primary Care Diagnostics LLC (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 7 May 2026.

What are the newest devices from GE Medical Systems Ultrasound and Primary Care Diagnostics LLC in the registry?

The most recently registered devices listed for GE Medical Systems Ultrasound and Primary Care Diagnostics LLC include Venue Focus, 6800000PRM, Vivid T8, Vivid T9 and LOGIQ P10, LOGIQ P9, LOGIQ P8.

Generated automatically from registry data and not verified by a human reviewer.