FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TeraRecon Cardiovascular.Calcification.CT
K Number: K250288
·
Decision Oct 23, 2025
Classifications
1
FEI Numbers
217
Registration Numbers
217
Same Product Code
303
Applicant Total
14
Review Days
265
Basic Information
- Device Name
- TeraRecon Cardiovascular.Calcification.CT
- K Number
- K250288
- 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
- January 31, 2025
- Decision Date
- October 23, 2025
- Product Code
- QIH
- 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 |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | FDA class 2 | Radiology |
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|---|---|---|---|
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| K121916 | INTUITION | Apr 2, 2013 | Substantially Equivalent |
| K061214 | AQUARIUSAPS SERVER | May 15, 2006 | Substantially Equivalent |
| K012086 | AQUARIUSNET SERVER | Sep 13, 2001 | Substantially Equivalent |