FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTUITION
K Number: K121916
·
Decision Apr 2, 2013
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
14
Review Days
274
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- INTUITION
- K Number
- K121916
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Terarecon,Inc.
- Date Received
- July 2, 2012
- Decision Date
- April 2, 2013
- Product Code
- LLZ
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
2D Hip Planning Software
FDA 510(k)
FDA Class 2
·Radiology
CustoMED Viewer
FDA 510(k)
FDA Class 2
·Radiology
Helion Viewer Suite
FDA 510(k)
FDA Class 2
·Radiology
CMN Capillary Function with Virtual Expert for MRI, CT and CBCT
FDA 510(k)
FDA Class 2
·Radiology
SubtleHD-PET (1.x)
FDA 510(k)
FDA Class 2
·Radiology
HipGuide (V 1.0.0.0)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Terarecon,Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K250288 | TeraRecon Cardiovascular.Calcification.CT | Oct 23, 2025 | Substantially Equivalent |
| K243158 | TeraRecon Aorta.CT (1.1.0) | Jan 23, 2025 | Substantially Equivalent |
| K241312 | TeraRecon Cardiac.Chambers.MR (1.0.0) | Nov 5, 2024 | Substantially Equivalent |
| K220349 | TeraRecon Neuro | Aug 12, 2022 | Substantially Equivalent |
| K200750 | Neuro.Al Algorithm | Nov 6, 2020 | Substantially Equivalent |
| K191585 | iNtuition-Structural Heart Module | Jul 12, 2019 | Substantially Equivalent |
| K180916 | iNtuition-T1 Mapping and T2/T2* Mapping | Sep 24, 2018 | Substantially Equivalent |
| K131447 | INTUITION - TDA, TVA, PARAMETRIC MAPPING | Dec 24, 2013 | Substantially Equivalent |
| K061214 | AQUARIUSAPS SERVER | May 15, 2006 | Substantially Equivalent |
| K012086 | AQUARIUSNET SERVER | Sep 13, 2001 | Substantially Equivalent |