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Sign in to claim this brandTerarecon Inc.
United States·US-MF-000008772
Last updated May 25, 2026
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.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What does Terarecon Inc. make?
Terarecon Inc. makes radiological PACS software, radiology DICOM image processing application software, and radiological image interpretive software sharing portal, with specific products including iNtuition, Eureka, and AquariusAPS.
Where is Terarecon Inc. based?
Terarecon Inc. is based in the United States, as stated in the company's country information within the provided data.
Which registries list Terarecon Inc.'s devices?
Terarecon Inc.'s devices are listed in Eudamed, FDA 510(k), and FDA UDI registries, as explicitly noted in the LISTED IN field of the device data.
How are Terarecon Inc.'s devices classified?
Terarecon Inc.'s devices are classified as Class I, Class II, and Class IIa, according to the DEVICE CLASSES information provided in the data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 39650, Liberty Street, Fremont, CA, United States
- Website
- terarecon.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Patrick Willhite
- EUDAMED SRN
- US-MF-000008772
- FDA FEI Number
- —
- DUNS Number
- 021677872
Catalogue (34)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| iNtuition | Aquarius iNtuition Client | FDA UDI | Class II | Active |
| Eureka | Eureka AI Results Explorer | FDA UDI | Class I | Active |
| iNtuition | ThinClient | FDA UDI | Class II | Active |
| Eureka | Eureka AI Interoperability Platform | FDA UDI | Class I | Active |
| AquariusAPS | AquariusAPS | FDA UDI | Class II | Active |
| iNtuition | iNtuitionReview | FDA UDI | Class II | Active |
| Intuition | Intuition Thin Client | FDA UDI | Class II | Active |
| Intuition | Intuition Web | FDA UDI | Class II | Active |
| Intuition | Intuition04 | FDA UDI | Class II | Active |
| Intuition | Intuition Server | FDA UDI | Class II | Active |
| iNtuition | iNtuitionEMV | FDA UDI | Class II | Active |
| Intuition | Intuition Client | FDA UDI | Class II | Active |
| iNtuition | AQNet Server | FDA UDI | Class II | Active |
| iNtuition | iNtuition Mobile | FDA UDI | Class II | Active |
| TeraRecon Aorta.CT | Aorta.CT01 | FDA UDI | Class II | Active |
| iNtuition | Aquarius Web | FDA UDI | Class II | Active |
| TeraRecon Cardiac.Chambers.MR | Cardiac.Chambers.MR01 | FDA UDI | Class II | Active |
| Intuition | Intuition Mobile | FDA UDI | Class II | Active |
| Aqaps | AQAPS04 | FDA UDI | Class II | Active |
| Rtr-2000/Rtr-4000 | K974307 | FDA 510(k) | Class II | Active |
| TeraRecon Aorta.CT (1.1.0) | K243158 | FDA 510(k) | Class II | Active |
| Aquariusnet Server | K012086 | FDA 510(k) | Class II | Active |
| Aquarius Workstation | K011142 | FDA 510(k) | Class II | Active |
| Iivs Integrated Image Viewing Station | K994329 | FDA 510(k) | Class I | Active |
| Aquariusaps Server | K061214 | FDA 510(k) | Class II | Active |
| Neuro.Al Algorithm | K200750 | FDA 510(k) | Class II | Active |
| iNtuition-Structural Heart Module | K191585 | FDA 510(k) | Class II | Active |
| TeraRecon Cardiac.Chambers.MR (1.0.0) | K241312 | FDA 510(k) | Class II | Active |
| iNtuition-T1 Mapping and T2/T2* Mapping | K180916 | FDA 510(k) | Class II | Active |
| Intuition | K121916 | EUDAMEDFDA 510(k) | Class II | Active |
| Intuition - Tda, Tva, Parametric Mapping | K131447 | FDA 510(k) | Class II | Active |
| TeraRecon Aorta.CT | 1 | EUDAMED | Class IIa | Active |
| TeraRecon Neuro | 2 | EUDAMEDFDA UDI | Class IIa | Active |
| TeraRecon Cardiovascular.Calcification.CT | 1 | EUDAMED | Class IIa | Active |
Related Companies
Authorised Representatives
Importers
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Notified Bodies
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Authorities
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Jan 21, 2015 | Z-1070-2015 | — | terminated | Software anomaly related to RECIST1.1 target lesion evaluation criteria in Findings Workflow Module within the Aquarius iNtuition Client Viewer. |
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Terarecon, Inc. Durham, NC · US FEI 3014146081