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Viz.ai

Active in EUDAMED
Also registered as VIZ.AI, INC.

United Statesfrom SRN EUDAMED SRN US-MF-000024837

Viz.ai is a medical device manufacturer based in the United States, with 37 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II; EU Class IIa) as of 13 Nov 2026.

Devices
37
Registrations
EUDAMED

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 26
  • FDA 510(k) 11
  • EUDAMED 3

A device listed in two registries counts in both.

Device classes
  • FDA Class II 34
  • EU Class IIa 3
Top EMDN categories
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000024837

At a glance

Counted by deviCERTS from registry records

Market reach

European Union
EUDAMED actor
Authorised rep.
AJW Technology Consulting GmbHDE

Catalogue37

Newest first, rows 1-37 of 37

Search and filter all 37 devices
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  • Viz ICH Ref K210209

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

  • Viz CTP Ref K180161

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

  • Viz ICH Ref K193658

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

  • Viz LVO 1.5

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz LVO 1.2

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz LVO 1.6

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz HCM Software

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz ICH+ Software

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

  • Viz ANEURYSM Software

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

  • Viz AAA Software

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

  • Viz RV/LV Software

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

  • Viz LVO 1.9

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz Subdural+ Software

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

  • Viz CTP 1.2

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

  • Viz LVO 1.11

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz LVO 1.3

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz LVO 1.7

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz ICH 1.3

    Active Regimes: CE MDR Registry: GUDID Class:II

  • Viz LVO 1.1

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz LVO 1.4

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz CTP 1.4

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

  • Viz CTP 1.1

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

  • Viz SDH (Viz Subdural) Viz SDH Software

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

  • Viz LVO 1.8

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz CTP 1.3

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

  • Viz LVO 1.10

    Active Regimes: De Novo Registry: GUDID Class:II

  • Viz AAA Ref K223443

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

  • Viz Subdural+, Viz SUBDURAL PLUS Ref K250354

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

  • Viz ANEURYSM, Viz ANX Ref K213319

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

  • Viz RV/LV Ref K221100

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

  • Viz LVO ContaCT Ref K223042

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

  • Viz HCM Ref DEN230003

    Active Regimes: De Novo Registry: De Novo Class:II

  • Viz SDH Ref K220439

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

  • Viz HDS, Viz Volume Plus, Viz ICH+ Ref K232363

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

  • Viz ICH Ref 081185203VIZICHBG

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIa

  • Viz LVO Ref 081185203VIZLVOE6

    Withdrawn Regimes: CE MDR, withdrawn Registry: EUDAMEDGUDID Class:IIa

  • Viz CTP Ref 081185203VIZCTPCM

    Active Regimes: CE MDR Registry: EUDAMEDGUDID Class:IIa

Rows 1-37 of 37

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000024837
EUDAMED status
Active
EUDAMED registered name
Viz.ai
Registered address
5000, Center Green Way, 27513, Cary, United States
Website
www.viz.ai
Phone
+1 866.849.4980(from company website)
PRRC contact
Jeff Naveda(public in EUDAMED)

From the company website

Read 18 Oct 2026

Viz.ai closes the gaps between patients, clinicians, and life-saving treatments with its leading-edge AI-powered care coordination solution.

From the manufacturer's own website. Source

Frequently asked questions

How many devices does Viz.ai have in the registry?

The registry currently lists 37 devices for Viz.ai. Devices recorded under merged duplicate company entries are counted once.

Which registries list Viz.ai's devices?

Among its 37 most recently registered devices, Viz.ai has devices listed in EUDAMED (3 devices), FDA 510(k) (11 devices) and FDA GUDID (26 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Viz.ai's devices fall under?

Among its 37 most recently registered devices, the classes recorded for Viz.ai's devices are Class IIa and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Viz.ai in the registry?

The most recently registered devices listed for Viz.ai include Viz ICH, Viz CTP, Viz LVO 1.5 and Viz LVO 1.2.

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