510(k) Report

FDA applicant

Terarecon,Inc.

Durham, NC14 decisions1998–20251 recall

FDA records 14 decisions for Terarecon,Inc. (Durham, NC) from 1998 to 2025: 14 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and QIH (Automated Radiological Image Processing Software). Since 2016 its 510(k)s took a median of 180 days from receipt to decision, against 137 for FDA’s reviews in the same codes and years. Its devices cite 28 predicates, 10 of them its own earlier devices. 1 recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Terarecon,Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2025

2013: 22018: 12019: 12020: 12022: 12024: 12025: 2
2007high 2 (2013) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Terarecon,Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Terarecon,Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological9decisions
  • QIHAutomated Radiological Image Processing Software3decisions
  • JAKSystem, X-Ray, Tomography, Computed1decision
  • LMDSystem, Digital Image Communications, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 7 510(k)s took a median of 180 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 137 days; 2 of its 7 were faster than that.

Whose devices does it build on?

Its devices cite 28 predicates; 10 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 31 times; 10 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K011142Aquarius WorkstationTerarecon,Inc. · 20018cite it
  • K061214Aquariusaps ServerTerarecon,Inc. · 20068cite it
  • K012086Aquariusnet ServerTerarecon,Inc. · 20017cite it
  • K121916IntuitionTerarecon,Inc. · 20133cite it
  • K994329Iivs Integrated Image Viewing StationTerarecon,Inc. · 20002cite it
  • K200750Neuro.Al AlgorithmTerarecon,Inc. · 20201cites it

What has FDA decided for it lately?

  • K250288TeraRecon Cardiovascular.Calcification.CTTerarecon,Inc. · 2025
  • K243158TeraRecon Aorta.CT (1.1.0)Terarecon,Inc. · 2025
  • K241312TeraRecon Cardiac.Chambers.MR (1.0.0)Terarecon,Inc. · 2024
  • K220349TeraRecon NeuroTerarecon,Inc. · 2022
  • K200750Neuro.Al AlgorithmTerarecon,Inc. · 2020
  • K191585iNtuition-Structural Heart ModuleTerarecon,Inc. · 2019
  • K180916iNtuition-T1 Mapping and T2/T2* MappingTerarecon,Inc. · 2018
  • K131447Intuition - Tda, Tva, Parametric MappingTerarecon,Inc. · 2013

All 14 as Terarecon,Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K121916Aquarius iNtuition Client Viewer. Findings Workflow module, RECIST 1.1: Picture…Jan 21, 2015Class II