# Terarecon,Inc.

- Location (FDA's records): Durham, NC
- FDA decisions: 14 (1998–2025): 14 510(k) clearances
- Product codes: LLZ (9), QIH (3), JAK (1), LMD (1)
- 510(k) review time since 2016: median 180 days, against 137 for FDA's reviews in the same codes and years (2 of 7 faster)
- Predicates its devices cite: 28 (10 its own); citations of its devices by later devices: 31 (10 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Medicsight: 2 (https://510kreport.com/company/medicsight)
- Siemens Medical Solutions USA, Inc.: 2 (https://510kreport.com/company/siemens-medical-solutions-usa)
- Circle Cardiovascular Imaging, Inc.: 1 (https://510kreport.com/company/circle-cardiovascular-imaging)
- Imatron, Inc.: 1 (https://510kreport.com/company/imatron)
- Coreline Soft Co., Ltd.: 1 (https://510kreport.com/company/coreline-soft)
- Pie Medical Imaging BV: 1 (https://510kreport.com/company/pie-medical-imaging)
- Ai Medic, Inc.: 1 (https://510kreport.com/company/ai-medic)
- Toshiba America Medical Systems, In.C: 1 (https://510kreport.com/company/toshiba-america-medical-systems-in-c)

## Firms that cite its devices most
- Medical Insight A/S: 2 (https://510kreport.com/company/medical-insight-a-s)
- Microsoft Corp.: 2 (https://510kreport.com/company/microsoft)
- Mercury Computer Systems, Inc.: 2 (https://510kreport.com/company/mercury-computer-systems)
- Cybermdx, Inc.: 2 (https://510kreport.com/company/cybermdx)
- GE Medical Systems: 1 (https://510kreport.com/company/ge-medical-systems)
- Micromri, Inc.: 1 (https://510kreport.com/company/micromri)
- Novarad Corporation: 1 (https://510kreport.com/company/novarad)
- Fujifilm Medical Systems U.S.A, Inc.: 1 (https://510kreport.com/company/fujifilm-medical-systems-usa)

## Its most-cited devices
- K011142: Aquarius Workstation (2001), cited by 8
- K061214: Aquariusaps Server (2006), cited by 8
- K012086: Aquariusnet Server (2001), cited by 7
- K121916: Intuition (2013), cited by 3
- K994329: Iivs Integrated Image Viewing Station (2000), cited by 2
- K200750: Neuro.Al Algorithm (2020), cited by 1

## Recent decisions
- K250288: TeraRecon Cardiovascular.Calcification.CT (Oct 23, 2025)
- K243158: TeraRecon Aorta.CT (1.1.0) (Jan 23, 2025)
- K241312: TeraRecon Cardiac.Chambers.MR (1.0.0) (Nov 5, 2024)
- K220349: TeraRecon Neuro (Aug 12, 2022)
- K200750: Neuro.Al Algorithm (Nov 6, 2020)
- K191585: iNtuition-Structural Heart Module (Jul 12, 2019)
- K180916: iNtuition-T1 Mapping and T2/T2* Mapping (Sep 24, 2018)
- K131447: Intuition - Tda, Tva, Parametric Mapping (Dec 24, 2013)

Source page: https://510kreport.com/company/terarecon