Total clearances
3
2020-05-21 → 2026-07-28
Name variants in FDA filings: Caristo Diagnostics / Caristo Diagnostics , Ltd.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
2 |
2025-02-20 |
| SIU |
Predictive Indicator For Long-Term Cardiovascular Outcomes |
Class II |
Cardiovascular |
1 |
2026-07-28 |
Filings
All 510(k) clearances (3)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-28 |
DEN250042 |
CaRi-Heart |
SIU |
Class II |
Cardiovascular |
| 2025-02-20 |
K242240 |
CaRi-Plaque |
LLZ |
Class II |
Radiology |
| 2020-05-21 |
K200274 |
CariCloud |
LLZ |
Class II |
Radiology |