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SIUClass II

Predictive Indicator For Long-Term Cardiovascular Outcomes

21 CFR 870.2215 / Cardiovascular
FDA source (opens on fda.gov)

SIU is the FDA product code for Predictive Indicator For Long-Term Cardiovascular Outcomes, a class II device type, regulated under 21 CFR 870.2215. FDA's definition for this code reads: "The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with...". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SIU
Device name
Predictive Indicator For Long-Term Cardiovascular Outcomes
FDA definition
The predictive indicator for long term cardiovascular outcomes uses software algorithms to analyze inputs such as medical imaging data and cardiovascular risk factors to calculate a risk score, category, or probability that predicts long-term cardiovascular outcomes. The device is intended for adjunctive use with other physical vital sign parameters and patient information for preventive care and is not intended to independently direct patient management. The device is not intended for use in acute care settings or to direct treatment of current disease.
Regulation
21 CFR 870.2215
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SIU

By decision year
1 clearance under product code SIU with a decision year between 2026 and 2026, 2026 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SIU by decision year
YearClearances
20261

Applicants with the most clearances

Product code SIU
Applicants holding the most 510(k) clearances under product code SIU
ApplicantClearances
Caristo Diagnostics1

Companies listing this code with FDA

Companies whose registered establishments list this code