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Terarecon Inc.

Active in EUDAMED

United Statesfrom SRN EUDAMED SRN US-MF-000008772

Terarecon Inc. 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 and I; EU Class IIa) and 1 FDA recall as of 13 Nov 2026.

Devices
37
Registrations
EUDAMED
FDA recalls
1

Registry facts

Counted by deviCERTS from registry records, 13 Nov 2026

Registries
  • FDA GUDID 21
  • FDA 510(k) 12
  • EUDAMED 7

A device listed in two registries counts in both.

Device classes
  • FDA Class II 29
  • EU Class IIa 5
  • FDA Class I 3
Top EMDN categories
FDA recalls
Sites and related companies
Identifiers
  • EUDAMED SRN US-MF-000008772
  • DUNS 021677872

At a glance

Counted by deviCERTS from registry records

EU certificates

1 of 1 in force.

See certificates

Market reach

European Union
EUDAMED actor, 1 certificate
United States
FDA recalls
Authorised rep.
Emergo Europe B.V.NL

What Terarecon Inc. makes

Terarecon Inc. makes radiological PACS software, radiology DICOM image processing application software, and radiological image interpretive software sharing portal. Specific products include iNtuition, Eureka, and AquariusAPS.

The company's devices are classified as Class I, Class II, and Class IIa and are listed in Eudamed, FDA 510(k), and FDA UDI registries. Terarecon Inc. is based in the United States.

AI-generated from registry data, 29 Sep 2026. Not verified by deviCERTS or the manufacturer.

Catalogue37

Newest first, rows 1-37 of 37

Search and filter all 37 devices
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  • TeraRecon Cardiac.Chambers.MR Ref 1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01

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

  • iNtuition Aquarius iNtuition Client

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

  • Eureka AI Results Explorer

    Listed Registry: GUDID Class:I

  • iNtuition ThinClient

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

  • Eureka AI Interoperability Platform

    Listed Registry: GUDID Class:I

  • AquariusAPS

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

  • iNtuition iNtuitionReview

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

  • Intuition Thin Client

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

  • Intuition Web

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

  • Intuition Intuition04

    Active Regimes: CE MDD 510(k) Registry: EUDAMEDGUDID Class:II

  • Intuition Server

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

  • iNtuition iNtuitionEMV

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

  • Intuition Client

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

  • iNtuition AQNet Server

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

  • iNtuition Mobile

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

  • TeraRecon Aorta.CT Aorta.CT01

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

  • iNtuition Aquarius Web

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

  • TeraRecon Cardiac.Chambers.MR Cardiac.Chambers.MR01

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

  • Intuition Mobile

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

  • Aqaps AQAPS04

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

  • Rtr-2000/Rtr-4000 Ref K974307

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

  • TeraRecon Aorta.CT (1.1.0) Ref K243158

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

  • Aquariusnet Server Ref K012086

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

  • Aquarius Workstation Ref K011142

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

  • Iivs Integrated Image Viewing Station Ref K994329

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

  • Aquariusaps Server Ref K061214

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

  • Neuro.Al Algorithm Ref K200750

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

  • iNtuition-Structural Heart Module Ref K191585

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

  • TeraRecon Cardiac.Chambers.MR (1.0.0) Ref K241312

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

  • iNtuition-T1 Mapping and T2/T2* Mapping Ref K180916

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

  • Intuition Ref K121916

    Active Regimes: CE MDR CE MDD 510(k) Registry: EUDAMED510(k) Class:II

  • Intuition - Tda, Tva, Parametric Mapping Ref K131447

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

  • TeraRecon Aorta.CT Ref 1

    Active Regimes: CE MDR Registry: EUDAMED Class:IIa

  • TeraRecon Neuro

    Active Regimes: CE MDD Registry: EUDAMEDGUDID Class:IIa

  • TeraRecon Neuro Ref 2

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

  • TeraRecon Cardiovascular.Calcification.CT Ref 1

    Active Regimes: CE MDR 510(k) Registry: EUDAMED Class:IIa

Rows 1-37 of 37

Company details

EUDAMED record synced 7 Nov 2026

EUDAMED SRN
US-MF-000008772
DUNS number
021677872
EUDAMED status
Active
EUDAMED registered name
TeraRecon, Inc.
EUDAMED abbreviated name
TeraRecon
Registered address
39650, Liberty Street, 94538, Fremont, CA, United States
PRRC contact
Patrick Willhite(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 12 Apr 2031

EUDAMED certificates (1)

TÜV Rheinland LGA Products GmbH 0197 1 certificate

  • HZ 2214790-1 Active

    Quality management system EU MDR

    Issued
    13 Apr 2026
    Expires
    12 Apr 2031

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

  • 2015

    • 21 Jan 2015 Z-1070-2015 Class II Terminated Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. Distribution: Worldwide Distribution-US (nationwide) and the countries of Canada, Switzerland, Germany, France and Italy. Submission number: K121916

Sites1

Frequently asked questions

How many devices does Terarecon Inc. have in the registry?

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

Which registries list Terarecon Inc.'s devices?

Among its 37 most recently registered devices, Terarecon Inc. has devices listed in EUDAMED (7 devices), FDA 510(k) (12 devices) and FDA GUDID (21 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Terarecon Inc.'s devices fall under?

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

Are there FDA recall records for Terarecon Inc.?

FDA recall records list 1 recall initiated by Terarecon Inc., the most recent initiated on 21 Jan 2015. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What EUDAMED certificates are recorded for Terarecon Inc.?

EUDAMED lists 1 certificate for Terarecon Inc. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 Apr 2026.

What are the newest devices from Terarecon Inc. in the registry?

The most recently registered devices listed for Terarecon Inc. include TeraRecon Cardiac.Chambers.MR, TeraRecon Cardiovascular.Calcification.CT Cardiovascular.Calcification.CT01, iNtuition Aquarius iNtuition Client and Eureka AI Results Explorer.

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